Trial Outcomes & Findings for Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants (NCT NCT01748045)
NCT ID: NCT01748045
Last Updated: 2017-07-19
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
3 participants
Primary outcome timeframe
7 days
Results posted on
2017-07-19
Participant Flow
Participant milestones
| Measure |
Inhaled Nitric Oxide (iNO)
Number of participants who have started on iNO at 20 parts per million (ppm) for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide
|
Nitrogen Gas
Number of participants who have started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants
Baseline characteristics by cohort
| Measure |
Inhaled Nitric Oxide
n=2 Participants
iNO to start at 20ppm for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide
|
Nitrogen Gas
n=1 Participants
Placebo gas will be adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
1 days
STANDARD_DEVIATION 0 • n=99 Participants
|
1 days
STANDARD_DEVIATION 0 • n=107 Participants
|
1 days
STANDARD_DEVIATION 0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 7 daysOutcome measures
| Measure |
Inhaled Nitric Oxide
n=2 Participants
Number of participants who were started on inhaled Nitric Oxide (iNO) at 20 parts per million (ppm) for the first three days of life. The dose was then decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide
|
Nitrogen Gas
n=1 Participants
Number of participants who were started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas
|
|---|---|---|
|
Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 7 daysOutcome measures
| Measure |
Inhaled Nitric Oxide
n=2 Participants
Number of participants who were started on inhaled Nitric Oxide (iNO) at 20 parts per million (ppm) for the first three days of life. The dose was then decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide
|
Nitrogen Gas
n=1 Participants
Number of participants who were started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas
|
|---|---|---|
|
Number of Participants Who Had the Need for Exogenous Surfactant
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From hospital admission through dischargeparticipants who were followed for the duration of hospital stay
Outcome measures
| Measure |
Inhaled Nitric Oxide
n=2 Participants
Number of participants who were started on inhaled Nitric Oxide (iNO) at 20 parts per million (ppm) for the first three days of life. The dose was then decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide
|
Nitrogen Gas
n=1 Participants
Number of participants who were started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas
|
|---|---|---|
|
Total Length of Hospital Stay
|
17.5 days
Standard Deviation 2.5
|
11 days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: From Hospital Admission through dischargeParticipants were followed for the duration of hospital stay for use of supplemental oxygen
Outcome measures
| Measure |
Inhaled Nitric Oxide
n=2 Participants
Number of participants who were started on inhaled Nitric Oxide (iNO) at 20 parts per million (ppm) for the first three days of life. The dose was then decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide
|
Nitrogen Gas
n=1 Participants
Number of participants who were started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas
|
|---|---|---|
|
Total Duration of Supplemental Oxygen
|
5 days
Standard Deviation 1
|
3 days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: At 36 weeks postmenstrual age or 1-2month of ageDiagnosis of BPD by oxygen challenge test at 36 weeks post menstrual age (PMA) for infants born between 30 and 32 weeks gestational age (GA). For those born 32 1/7 - 36 weeks, an oxygen challenge test was performed at 1-2 months of age.
Outcome measures
| Measure |
Inhaled Nitric Oxide
n=2 Participants
Number of participants who were started on inhaled Nitric Oxide (iNO) at 20 parts per million (ppm) for the first three days of life. The dose was then decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide
|
Nitrogen Gas
n=1 Participants
Number of participants who were started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas
|
|---|---|---|
|
Diagnosis of Bronchopulmonary Dysplasia (BPD)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months corrected gestational agePopulation: Analysis not performed at one year corrected age, since study closed.
defined by a validated system of parental diaries and pulmonary questionnaires, as well as review of medical records (medical visits, respiratory medication use, emergency room visits, and hospital re-admissions)
Outcome measures
| Measure |
Inhaled Nitric Oxide
n=2 Participants
Number of participants who were started on inhaled Nitric Oxide (iNO) at 20 parts per million (ppm) for the first three days of life. The dose was then decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide
|
Nitrogen Gas
n=1 Participants
Number of participants who were started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas
|
|---|---|---|
|
Evidence of Chronic Respiratory Morbidity at 12 Months Corrected Gestational Age (CGA)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From hospital admission through dischargeparticipants were followed for the duration of hospital stay for respiratory support
Outcome measures
| Measure |
Inhaled Nitric Oxide
n=2 Participants
Number of participants who were started on inhaled Nitric Oxide (iNO) at 20 parts per million (ppm) for the first three days of life. The dose was then decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide
|
Nitrogen Gas
n=1 Participants
Number of participants who were started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas
|
|---|---|---|
|
Total Duration of Respiratory Support
|
5.5 days
Standard Deviation 1.5
|
4 days
Standard Deviation 0
|
Adverse Events
Inhaled Nitric Oxide
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Nitrogen Gas
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Inhaled Nitric Oxide
n=2 participants at risk
Number of participants who have started on iNO at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
inhaled nitric oxide
|
Nitrogen Gas
n=1 participants at risk
Number of participants who have started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued.
Placebo Comparator - nitrogen gas
|
|---|---|---|
|
Cardiac disorders
Murmur
|
50.0%
1/2 • Number of events 1
|
0.00%
0/1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place