Trial Outcomes & Findings for Hydrocortisone for Term Hypotension (NCT NCT01954056)
NCT ID: NCT01954056
Last Updated: 2021-07-06
Results Overview
This is measured as Yes if an infant died between birth and 22-26 months corrected gestational age; Otherwise, No.
COMPLETED
PHASE3
12 participants
Birth to 22-26 months corrected gestational age
2021-07-06
Participant Flow
Infants \< 48 hours of age and born at ≥ 34 weeks gestational age were screened for the study between June 2014 and July 2015 at the 16 NRN Clinical Centers. Those who were intubated and on mechanical ventilation for at least 2 hours within the first 72 hours were considered for the study.
Participant milestones
| Measure |
Placebo
Saline placebo
Placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Hydrocortisone
hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line
Hydrocortisone: • 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Birth to 60 Days of Life
STARTED
|
6
|
6
|
|
Birth to 60 Days of Life
COMPLETED
|
6
|
6
|
|
Birth to 60 Days of Life
NOT COMPLETED
|
0
|
0
|
|
Birth to 22-26 Mos. Corrected GA
STARTED
|
6
|
6
|
|
Birth to 22-26 Mos. Corrected GA
COMPLETED
|
6
|
5
|
|
Birth to 22-26 Mos. Corrected GA
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Saline placebo
Placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Hydrocortisone
hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line
Hydrocortisone: • 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Birth to 22-26 Mos. Corrected GA
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Hydrocortisone for Term Hypotension
Baseline characteristics by cohort
| Measure |
Hydrocortisone
n=6 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.5 weeks
STANDARD_DEVIATION 2.2 • n=99 Participants
|
39.4 weeks
STANDARD_DEVIATION 1.8 • n=107 Participants
|
38.4 weeks
STANDARD_DEVIATION 2.2 • n=206 Participants
|
|
Sex/Gender, Customized
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Maternal Race
Black
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Maternal Race
White
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Maternal Race
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Maternal Race
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Maternal Age, Continuous
|
32.2 years
STANDARD_DEVIATION 7.6 • n=99 Participants
|
26.7 years
STANDARD_DEVIATION 9.5 • n=107 Participants
|
29.4 years
STANDARD_DEVIATION 8.7 • n=206 Participants
|
|
Birth weight
|
3415 grams
STANDARD_DEVIATION 669.3 • n=99 Participants
|
3120.3 grams
STANDARD_DEVIATION 541 • n=107 Participants
|
3267.7 grams
STANDARD_DEVIATION 600.3 • n=206 Participants
|
|
Length
|
50.1 cm
STANDARD_DEVIATION 2.3 • n=99 Participants
|
49.8 cm
STANDARD_DEVIATION 1.5 • n=107 Participants
|
49.9 cm
STANDARD_DEVIATION 1.9 • n=206 Participants
|
|
Head circumference
|
34.4 cm
STANDARD_DEVIATION 2 • n=99 Participants
|
34.5 cm
STANDARD_DEVIATION 3.5 • n=107 Participants
|
34.5 cm
STANDARD_DEVIATION 2.7 • n=206 Participants
|
|
Apgar score less than 3 at 1 minute
No
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Apgar score less than 3 at 1 minute
Yes
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Apgar score less than 3 at 5 minutes
No
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Apgar score less than 3 at 5 minutes
Yes
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Apgar score less than 3 at 10 minutes
No
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Apgar score less than 3 at 10 minutes
Yes
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Apgar score less than 3 at 10 minutes
Unknown
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Infant Outborn
No
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Infant Outborn
Yes
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Oxygen
Yes
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Oxygen
No
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Bagging and Mask
No
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Bagging and Mask
Yes
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Chest Compression
No
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Chest Compression
Yes
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Intubation
No
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Intubation
Yes
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Medications or volume expanders
No
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Medications or volume expanders
Yes
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Maternal marital Status
Married
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Maternal marital Status
Single
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Maternal gravida
|
2.5 Number of pregnancies
n=99 Participants
|
1 Number of pregnancies
n=107 Participants
|
2 Number of pregnancies
n=206 Participants
|
|
Maternal parity
|
2.5 Number of successful pregnancies
n=99 Participants
|
1 Number of successful pregnancies
n=107 Participants
|
2 Number of successful pregnancies
n=206 Participants
|
|
Maternal multiple birth
No
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Maternal multiple birth
Yes
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Maternal prenatal care
No
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Maternal prenatal care
Yes
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Maternal antenatal steroids
No
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Maternal antenatal steroids
Yes
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Maternal documented chorioamnionitis
No
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Maternal documented chorioamnionitis
Yes
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Placental pathology performed
No
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Placental pathology performed
Yes
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Placental pathology performed
Unknown
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Final mode of delivery
Vaginal vertex
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Final mode of delivery
Cesarean section
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Final mode of delivery
Unknown
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Birth to 22-26 months corrected gestational agePopulation: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
This is measured as Yes if an infant died between birth and 22-26 months corrected gestational age; Otherwise, No.
Outcome measures
| Measure |
Hydrocortisone
n=6 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Death
No
|
6 Participants
|
6 Participants
|
|
Death
Yes
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Birth to 22-26 months corrected gestational agePopulation: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
This is measured as Yes if an any hearing impairment or visual impairment is noted, if non-normal gross motor function level is noted, any seizures have been noted, or if the cognitive, language, or motor scores of the Bayley III score are more than 1 standard deviation below the average; Otherwise, No.
Outcome measures
| Measure |
Hydrocortisone
n=6 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Number of Participants With Neurodevelopmental Impairment
Yes
|
3 Participants
|
3 Participants
|
|
Number of Participants With Neurodevelopmental Impairment
No
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Birth to 22-26 months corrected gestational agePopulation: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
A composite outcome that measures the occurrence of death or neurodevelomental impairment between birth and 22-26 months corrected gestational age.
Outcome measures
| Measure |
Hydrocortisone
n=6 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Number of Participants With Death or Neurodevelopmental Impairment
Yes
|
3 Participants
|
3 Participants
|
|
Number of Participants With Death or Neurodevelopmental Impairment
No
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Birth to 60 days of lifePopulation: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
This is measured as the number of days between birth and 60 days of life of mechanical ventialtion of laryngeal intubation.
Outcome measures
| Measure |
Hydrocortisone
n=6 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Duration of Mechanical Ventilation
|
8 Days
Interval 3.0 to 10.0
|
11 Days
Interval 3.0 to 19.0
|
SECONDARY outcome
Timeframe: Birth to 60 days of lifePopulation: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age. Excludes 4 infants (Hydrocortisone: 1, Placebo: 3) without information on full feeds.
The day of life at which full nipple feeds were reached between birth and 60 days of life. Full nipple feeds are defined as at least 120 mg/kg/day.
Outcome measures
| Measure |
Hydrocortisone
n=5 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=3 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Days to Full Feeds
|
16 Days
Interval 12.0 to 23.0
|
18 Days
Interval 8.0 to 22.0
|
SECONDARY outcome
Timeframe: Birth to 60 days of lifePopulation: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
This is measured as Yes if a gastronomy tube was placed anytime prior to final status between birth and 60 days of life; Otherwise, No
Outcome measures
| Measure |
Hydrocortisone
n=6 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Number of Participants With Need for Gastronomy Tube
No
|
6 Participants
|
6 Participants
|
|
Number of Participants With Need for Gastronomy Tube
Yes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Birth to 60 days of lifePopulation: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
This is measured as the number of days between birth and 60 days of life that an infant was on oxygen in the hospital.
Outcome measures
| Measure |
Hydrocortisone
n=6 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Duration of Oxygen Requirement
|
15.5 Days
Interval 3.0 to 33.0
|
18 Days
Interval 5.0 to 25.0
|
SECONDARY outcome
Timeframe: Birth to 60 days of lifePopulation: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
This is measured as Yes if an infant was discharged to home while on oxygen between birth and 60 days of life; Otherwise, No.
Outcome measures
| Measure |
Hydrocortisone
n=5 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Number of Participants With Need for Home Oxygen
No
|
5 Participants
|
4 Participants
|
|
Number of Participants With Need for Home Oxygen
Yes
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Birth to 60 days of lifePopulation: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
This is measured as the number of days between birth and 60 days of life that an infant was in the hospital. Infants who died or transferred to another care facility were not included.
Outcome measures
| Measure |
Hydrocortisone
n=5 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=5 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Hospital Length of Stay
|
27 Days
Interval 14.0 to 60.0
|
24 Days
Interval 14.0 to 38.0
|
SECONDARY outcome
Timeframe: Birth to 60 days of lifePopulation: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
This is measured as Yes if an infant had renal insufficieny between birth and 60 days of life; Otherwise, No. Renal insufficiency is defined as creatinine less than 2 during 7 days after first treatment
Outcome measures
| Measure |
Hydrocortisone
n=6 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Number of Participants With Renal Insufficiency
No
|
6 Participants
|
6 Participants
|
|
Number of Participants With Renal Insufficiency
Yes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Birth to 60 days of lifePopulation: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
This is measured as Yes if an infant necrotizing enterocolitis (NEC) between birth and 60 days of life; Otherwise, No. NEC could be proven with or without surgery
Outcome measures
| Measure |
Hydrocortisone
n=6 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Number of Participants With Necrotizing Enterocolitis
No
|
5 Participants
|
6 Participants
|
|
Number of Participants With Necrotizing Enterocolitis
Yes
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Birth to 60 days of lifePopulation: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
This is measured as Yes if an infant received ECMO treatment anytime between birth and 60 days of life; Otherwise, No. Extracorporeal membrane oxygenation (ECMO) is a treatment that uses a pump to circulate blood through an artificial lung back into the bloodstream of a very ill baby.
Outcome measures
| Measure |
Hydrocortisone
n=6 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Number of Participants With Need for ECMO Therapy
No
|
6 Participants
|
6 Participants
|
|
Number of Participants With Need for ECMO Therapy
Yes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 hours prior to study drug administration through 3 days post study drug administration.Population: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
This is measured as Yes if an infant was receiving inotropes on the specific day after the initiation of study drug.
Outcome measures
| Measure |
Hydrocortisone
n=6 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Number of Participants With Inotrope Exposure
Day 3 · No
|
4 Participants
|
4 Participants
|
|
Number of Participants With Inotrope Exposure
Day 3 · Yes
|
2 Participants
|
2 Participants
|
|
Number of Participants With Inotrope Exposure
Day 5 · No
|
5 Participants
|
4 Participants
|
|
Number of Participants With Inotrope Exposure
Day 5 · Yes
|
1 Participants
|
2 Participants
|
|
Number of Participants With Inotrope Exposure
Day 7 · No
|
5 Participants
|
5 Participants
|
|
Number of Participants With Inotrope Exposure
Day 7 · Yes
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 hours prior to study drug administration through 3 days post study drug administration.Population: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
This is calculated as the number of days on inotropes starting 24 hours prior to initiation of study drug, during the 7-day study drug administration period, and for 3 days after the study drug.
Outcome measures
| Measure |
Hydrocortisone
n=6 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Inotrope Duration
|
3 days
Interval 1.0 to 8.0
|
3 days
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: From start of study drug administration (7 days) through 3 days post study drug administration.Population: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
This is calculated as the maximum dose of all inotropes in the 10 days following the initiation of study drug administration. For the purposes of this calculation, dopamine and dobutamine doses were considered equivalent and 0.01 mcg/kg/min of epinephrine was equal to 5 mcg/kg/min of dopamine.
Outcome measures
| Measure |
Hydrocortisone
n=6 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Maximum Inotrope Dose
|
9.5 mcg/kg/min
Standard Deviation 2.9
|
14.7 mcg/kg/min
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: Birth to 60 days of lifePopulation: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
This is calculated as fraction of inspired oxygen (FiO2), as a percentage, multiplied by the mean airway pressure divided by partial pressure of oxygen in arterial blood (PaO2), during study drug administration. A lower oxygenation index is better.
Outcome measures
| Measure |
Hydrocortisone
n=6 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Oxygenation Index
Before dose 1
|
10.7 Oxygenation Index
Standard Deviation 6.1
|
14.5 Oxygenation Index
Standard Deviation 8.6
|
|
Oxygenation Index
Before dose 5
|
7 Oxygenation Index
Standard Deviation 3.7
|
14.9 Oxygenation Index
Standard Deviation 6.9
|
|
Oxygenation Index
Before dose 9
|
6.6 Oxygenation Index
Standard Deviation 2.1
|
10.4 Oxygenation Index
Standard Deviation 5.3
|
|
Oxygenation Index
Before dose 13
|
5.8 Oxygenation Index
Standard Deviation 3
|
9.2 Oxygenation Index
Standard Deviation 4.2
|
|
Oxygenation Index
Before dose 15
|
4.7 Oxygenation Index
Standard Deviation 2
|
9.3 Oxygenation Index
Standard Deviation 0.8
|
|
Oxygenation Index
Before dose 17
|
5.9 Oxygenation Index
Standard Deviation 3.2
|
7.9 Oxygenation Index
Standard Deviation 1.1
|
|
Oxygenation Index
Before dose 18
|
3.7 Oxygenation Index
|
9.1 Oxygenation Index
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Birth to 60 days of lifePopulation: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
This is calculated as fraction of inspired oxygen (FiO2), as a percentage, multiplied by the mean airway pressure during study drug administration. Higher score means more severe.
Outcome measures
| Measure |
Hydrocortisone
n=6 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Respiratory Severity
Before dose 1
|
726.8 Percentage of inspired oxygen * cmH2O
Standard Deviation 371
|
1184.7 Percentage of inspired oxygen * cmH2O
Standard Deviation 518.7
|
|
Respiratory Severity
Before dose 5
|
518.8 Percentage of inspired oxygen * cmH2O
Standard Deviation 272.5
|
1041.2 Percentage of inspired oxygen * cmH2O
Standard Deviation 432.6
|
|
Respiratory Severity
Before dose 9
|
531.6 Percentage of inspired oxygen * cmH2O
Standard Deviation 196.5
|
925.8 Percentage of inspired oxygen * cmH2O
Standard Deviation 611.8
|
|
Respiratory Severity
Before dose 13
|
414.6 Percentage of inspired oxygen * cmH2O
Standard Deviation 230
|
776.8 Percentage of inspired oxygen * cmH2O
Standard Deviation 411.2
|
|
Respiratory Severity
Before dose 15
|
423 Percentage of inspired oxygen * cmH2O
Standard Deviation 158.8
|
899 Percentage of inspired oxygen * cmH2O
Standard Deviation 453.4
|
|
Respiratory Severity
Before dose 17
|
323 Percentage of inspired oxygen * cmH2O
Standard Deviation 117.8
|
785.8 Percentage of inspired oxygen * cmH2O
Standard Deviation 463.2
|
|
Respiratory Severity
Before dose 18
|
308.5 Percentage of inspired oxygen * cmH2O
Standard Deviation 139.3
|
694.7 Percentage of inspired oxygen * cmH2O
Standard Deviation 274
|
SECONDARY outcome
Timeframe: Birth to 60 days of lifePopulation: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
This is measured as Yes if an infant received fluid boluses anytime before or during study drug administration between birth and 60 days of life; Otherwise, No.
Outcome measures
| Measure |
Hydrocortisone
n=6 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Number of Participants With Fluid Boluses Given
Before dose 1 · No
|
2 Participants
|
2 Participants
|
|
Number of Participants With Fluid Boluses Given
Before dose 1 · Yes
|
4 Participants
|
4 Participants
|
|
Number of Participants With Fluid Boluses Given
Before dose 5 · No
|
5 Participants
|
4 Participants
|
|
Number of Participants With Fluid Boluses Given
Before dose 5 · Yes
|
1 Participants
|
2 Participants
|
|
Number of Participants With Fluid Boluses Given
Before dose 9 · No
|
5 Participants
|
5 Participants
|
|
Number of Participants With Fluid Boluses Given
Before dose 9 · Yes
|
1 Participants
|
1 Participants
|
|
Number of Participants With Fluid Boluses Given
Before dose 13 · No
|
5 Participants
|
6 Participants
|
|
Number of Participants With Fluid Boluses Given
Before dose 13 · Yes
|
1 Participants
|
0 Participants
|
|
Number of Participants With Fluid Boluses Given
Before dose 15 · No
|
6 Participants
|
4 Participants
|
|
Number of Participants With Fluid Boluses Given
Before dose 15 · Yes
|
0 Participants
|
1 Participants
|
|
Number of Participants With Fluid Boluses Given
Before dose 17 · No
|
6 Participants
|
6 Participants
|
|
Number of Participants With Fluid Boluses Given
Before dose 17 · Yes
|
0 Participants
|
0 Participants
|
|
Number of Participants With Fluid Boluses Given
Before dose 18 · No
|
6 Participants
|
6 Participants
|
|
Number of Participants With Fluid Boluses Given
Before dose 18 · Yes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Birth to 60 days of lifePopulation: The analysis population includes all randomized infants recruited from critically ill, term and late preterm infants diagnosed with cardiovascular insufficiency as defined by a need for inotrope therapy in the first 72 hours of age.
The number of fluid boluses given per participant, if any, before or during study drug administration between birth and 60 days of life
Outcome measures
| Measure |
Hydrocortisone
n=5 Participants
Hydrocortisone: 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=5 Participants
Saline placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Number of Boluses Given
Before dose 1
|
3 Boluses
Interval 1.0 to 7.0
|
3 Boluses
Interval 2.0 to 8.0
|
|
Number of Boluses Given
Before dose 5
|
2 Boluses
Interval 2.0 to 2.0
|
1 Boluses
Interval 1.0 to 1.0
|
|
Number of Boluses Given
Before dose 9
|
2 Boluses
Interval 2.0 to 2.0
|
1 Boluses
Interval 1.0 to 1.0
|
|
Number of Boluses Given
Before dose 13
|
1 Boluses
Interval 1.0 to 1.0
|
—
|
|
Number of Boluses Given
Before dose 15
|
—
|
1 Boluses
Interval 1.0 to 1.0
|
Adverse Events
Hydrocortisone
Placebo
Serious adverse events
| Measure |
Hydrocortisone
n=6 participants at risk
hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line Hydrocortisone: • 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 participants at risk
Saline placebo Placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Blood and lymphatic system disorders
HYPERBILIRUBINEMIA REQUIRING EXCHANGE TRANSFUSION
|
16.7%
1/6 • Number of events 1 • 10 days
|
0.00%
0/6 • 10 days
|
|
Cardiac disorders
HYPERTENSION, NEW AND SUSTAINED
|
16.7%
1/6 • Number of events 2 • 10 days
|
0.00%
0/6 • 10 days
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
16.7%
1/6 • Number of events 1 • 10 days
|
0.00%
0/6 • 10 days
|
Other adverse events
| Measure |
Hydrocortisone
n=6 participants at risk
hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line Hydrocortisone: • 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
Placebo
n=6 participants at risk
Saline placebo Placebo: 7 days of intravenous or intramuscular placebo (normal saline in equal volume)
1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
|
|---|---|---|
|
Cardiac disorders
ATRIAL TACHYCARDIA
|
0.00%
0/6 • 10 days
|
16.7%
1/6 • Number of events 1 • 10 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators must adhere to the Neonatal Research Network Publication policies
- Publication restrictions are in place
Restriction type: OTHER