Trial Outcomes & Findings for Supplemental Oxygen Study (NCT NCT02464917)
NCT ID: NCT02464917
Last Updated: 2019-08-22
Results Overview
marker for metabolic acidosis
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
collected at the time of delivery and all umbilical cord values resulted within 1 hour of collection
Results posted on
2019-08-22
Participant Flow
Participant milestones
| Measure |
Supplemental Oxygen
Subjects in this arm will receive 10L/min via simple facemask
Device: simple facemask to administer supplemental oxygen
|
Room Air
This control arm will receive no supplemental oxygen
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
Baseline characteristics by cohort
| Measure |
Supplemental Oxygen
n=33 Participants
Subjects in this arm will receive 10L/min via simple facemask
Device: simple facemask to administer supplemental oxygen
|
Room Air
n=32 Participants
This control arm will receive no supplemental oxygen
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33 years
n=99 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
31 years
n=107 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
32 years
n=206 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
|
Sex/Gender, Customized
Female
|
33 Participants
n=99 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
32 Participants
n=107 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
65 Participants
n=206 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
|
Race/Ethnicity, Customized
Caucasian
|
5 Participants
n=99 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
6 Participants
n=107 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
11 Participants
n=206 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=99 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
8 Participants
n=107 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
14 Participants
n=206 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
|
Race/Ethnicity, Customized
Hispanic
|
16 Participants
n=99 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
11 Participants
n=107 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
27 Participants
n=206 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=99 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
6 Participants
n=107 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
12 Participants
n=206 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
|
Race/Ethnicity, Customized
Other / unknown
|
0 Participants
n=99 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
1 Participants
n=107 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
1 Participants
n=206 Participants • Overall number of participants in each groups is 35. However in supplemental oxygen group only 33 analyzed (n=2 umbilical arterial blood gas values unavailable) and in the room air group only 32 analyzed (n=1 umbilical venous blood gas value unavailable, n=1 umbilical venous and arterial blood gas value unavailable, n=1 less than 37 weeks enrolled)
|
PRIMARY outcome
Timeframe: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collectionmarker for metabolic acidosis
Outcome measures
| Measure |
Supplemental Oxygen
n=33 Participants
Subjects in this arm will receive 10L/min via simple facemask
Device: simple facemask to administer supplemental oxygen
|
Room Air
n=32 Participants
This control arm will receive no supplemental oxygen
|
|---|---|---|
|
Umbilical Cord pH Levels
|
7.29 pH
Interval 7.26 to 7.3
|
7.28 pH
Interval 7.25 to 7.3
|
SECONDARY outcome
Timeframe: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collectionmarker for metabolic acidosis
Outcome measures
| Measure |
Supplemental Oxygen
n=33 Participants
Subjects in this arm will receive 10L/min via simple facemask
Device: simple facemask to administer supplemental oxygen
|
Room Air
n=32 Participants
This control arm will receive no supplemental oxygen
|
|---|---|---|
|
Umbilical Cord Base Excess
|
-1.3 mEq/L
Interval -2.1 to -0.45
|
-1.6 mEq/L
Interval -3.0 to -0.4
|
SECONDARY outcome
Timeframe: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collectionmarker for metabolic acidosis
Outcome measures
| Measure |
Supplemental Oxygen
n=33 Participants
Subjects in this arm will receive 10L/min via simple facemask
Device: simple facemask to administer supplemental oxygen
|
Room Air
n=32 Participants
This control arm will receive no supplemental oxygen
|
|---|---|---|
|
Umbilical Cord Partial Pressure Carbon Dioxide (pCO2)
|
58 mmHg
Interval 51.0 to 61.5
|
58 mmHg
Interval 51.0 to 61.5
|
SECONDARY outcome
Timeframe: collected at the time of delivery and all umbilical cord values resulted within 1 hour of collectionmarker for metabolic acidosis
Outcome measures
| Measure |
Supplemental Oxygen
n=33 Participants
Subjects in this arm will receive 10L/min via simple facemask
Device: simple facemask to administer supplemental oxygen
|
Room Air
n=32 Participants
This control arm will receive no supplemental oxygen
|
|---|---|---|
|
Umbilical Cord Bicarbonate (HCO3)
|
26 mEq/L
Interval 25.0 to 27.0
|
26 mEq/L
Interval 25.0 to 27.0
|
SECONDARY outcome
Timeframe: completed at 5 minutes of life, Apgar <7quick test performed on all babies once born that access how babies transition after birth. The following signs are given values of 0, 1, or 2 and added to compute the Apgar score. The higher the points the better. maximum points is 10. minimum score is 0. Signs: Color (0=blue/pale, 1=acrocyanotic, 2=completely pink), Heart rate (0=absent, 1=\<100 minute, 2=\>100 minute), Reflex irritability(0=no response, 1=grimace, 2=cry), muscle tone (0=limp, 1=some flexion, 2=active motion), Respiration (0=absent, 1=weak cry; hypoventilation, 2=good, crying)
Outcome measures
| Measure |
Supplemental Oxygen
n=33 Participants
Subjects in this arm will receive 10L/min via simple facemask
Device: simple facemask to administer supplemental oxygen
|
Room Air
n=32 Participants
This control arm will receive no supplemental oxygen
|
|---|---|---|
|
Number of Newborns With an Apgar Score <7
|
0 newborns
|
0 newborns
|
SECONDARY outcome
Timeframe: completed once infant is discharged home; anticipate 1-4 dayssyndrome typically affecting premature babies due to immature lung maturation or development
Outcome measures
| Measure |
Supplemental Oxygen
n=33 Participants
Subjects in this arm will receive 10L/min via simple facemask
Device: simple facemask to administer supplemental oxygen
|
Room Air
n=32 Participants
This control arm will receive no supplemental oxygen
|
|---|---|---|
|
Number of Newborns With Respiratory Distress Syndrome
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: completed once infant is discharged home; anticipate 1-4 dayscondition that affects newborn bowels where the tissue undergoes necrosis
Outcome measures
| Measure |
Supplemental Oxygen
n=33 Participants
Subjects in this arm will receive 10L/min via simple facemask
Device: simple facemask to administer supplemental oxygen
|
Room Air
n=32 Participants
This control arm will receive no supplemental oxygen
|
|---|---|---|
|
Number of Newborns With Necrotizing Enterocolitis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: completed once infant is discharged home; anticipate 1-4 dayscondition that causes bleeding within the brain typically affecting premature babies
Outcome measures
| Measure |
Supplemental Oxygen
n=33 Participants
Subjects in this arm will receive 10L/min via simple facemask
Device: simple facemask to administer supplemental oxygen
|
Room Air
n=32 Participants
This control arm will receive no supplemental oxygen
|
|---|---|---|
|
Number of Newborns With Intraventricular Hemorrhage
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: completed once infant is discharged home; anticipate 1-4 daysneeding supplemental oxygen for the newborn through breathing device
Outcome measures
| Measure |
Supplemental Oxygen
n=33 Participants
Subjects in this arm will receive 10L/min via simple facemask
Device: simple facemask to administer supplemental oxygen
|
Room Air
n=32 Participants
This control arm will receive no supplemental oxygen
|
|---|---|---|
|
Number of Newborns Requiring Intubation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: completed once infant is discharged home; anticipate 1-4 daysif newborns need higher intensity of care they are transferred to the Neonatal Intensive Care Unit.
Outcome measures
| Measure |
Supplemental Oxygen
n=33 Participants
Subjects in this arm will receive 10L/min via simple facemask
Device: simple facemask to administer supplemental oxygen
|
Room Air
n=32 Participants
This control arm will receive no supplemental oxygen
|
|---|---|---|
|
Number of Newborns Admitted to the NICU (Neonatal Intensive Care Unit)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: completed once infant is discharged home; anticipate 1-4 daysOutcome measures
| Measure |
Supplemental Oxygen
n=33 Participants
Subjects in this arm will receive 10L/min via simple facemask
Device: simple facemask to administer supplemental oxygen
|
Room Air
n=32 Participants
This control arm will receive no supplemental oxygen
|
|---|---|---|
|
Neonatal Mortality
|
0 Participants
|
0 Participants
|
Adverse Events
Supplemental Oxygen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Room Air
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place