Trial Outcomes & Findings for Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide (NCT NCT00569530)
NCT ID: NCT00569530
Last Updated: 2021-05-11
Results Overview
SP-B Content is the surfactant protein B found in terms of percentage of phospholipid measured one day after surfactant or sham dose.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
85 participants
Primary outcome timeframe
One day after dose
Results posted on
2021-05-11
Participant Flow
Participant milestones
| Measure |
Treatment Surfactant (Infasurf) ONY, NY
Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14.
|
Sham (no Treatment)
Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Sham Infants will not receive additional doses of Infasurf.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
42
|
|
Overall Study
COMPLETED
|
43
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
Baseline characteristics by cohort
| Measure |
Treatment Surfactant (Infasurf) ONY, NY
n=43 Participants
Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14.
|
Sham (no Treatment)
n=42 Participants
Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Sham Infants will not receive additional doses of Infasurf.
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.9 Days
STANDARD_DEVIATION 2.2 • n=5 Participants
|
10.5 Days
STANDARD_DEVIATION 2.8 • n=7 Participants
|
10.2 Days
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
14 infants
n=5 Participants
|
23 infants
n=7 Participants
|
37 infants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
29 infants
n=5 Participants
|
19 infants
n=7 Participants
|
48 infants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
13 infants
n=5 Participants
|
8 infants
n=7 Participants
|
21 infants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
25 infants
n=5 Participants
|
32 infants
n=7 Participants
|
57 infants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
5 infants
n=5 Participants
|
2 infants
n=7 Participants
|
7 infants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 infants
n=5 Participants
|
0 infants
n=7 Participants
|
0 infants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 infants
n=5 Participants
|
0 infants
n=7 Participants
|
0 infants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 infants
n=5 Participants
|
0 infants
n=7 Participants
|
0 infants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 infants
n=5 Participants
|
16 infants
n=7 Participants
|
25 infants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
29 infants
n=5 Participants
|
24 infants
n=7 Participants
|
53 infants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 infants
n=5 Participants
|
0 infants
n=7 Participants
|
0 infants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 infants
n=5 Participants
|
42 infants
n=7 Participants
|
85 infants
n=5 Participants
|
|
Antenatal Corticosteroids
|
32 infants
n=5 Participants
|
33 infants
n=7 Participants
|
65 infants
n=5 Participants
|
|
Prior surfactant treatment
|
43 infants
n=5 Participants
|
41 infants
n=7 Participants
|
84 infants
n=5 Participants
|
|
RSS at entry
|
3.4 cm H2O
STANDARD_DEVIATION 1.7 • n=5 Participants
|
3.2 cm H2O
STANDARD_DEVIATION 1.7 • n=7 Participants
|
3.3 cm H2O
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Multiple gestation
|
8 infants
n=5 Participants
|
10 infants
n=7 Participants
|
18 infants
n=5 Participants
|
PRIMARY outcome
Timeframe: One day after dosePopulation: 24 of 43 in the Treatment Group and 18 of 42 in the Sham group had samples analyzed. SpB content recorded as a percentage of Total Phospholipids.
SP-B Content is the surfactant protein B found in terms of percentage of phospholipid measured one day after surfactant or sham dose.
Outcome measures
| Measure |
Treatment Surfactant (Infasurf) ONY, NY
n=24 Participants
Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14.
|
Sham (no Treatment)
n=18 Participants
Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Sham Infants will not receive additional doses of Infasurf.
|
|---|---|---|
|
SP-B Content
|
19.9 Total surfactant protein (% of PL)
Interval 3.7 to 71.0
|
13.3 Total surfactant protein (% of PL)
Interval 4.3 to 47.8
|
SECONDARY outcome
Timeframe: 36 Weeks Post Menstrual AgeAlive without need for oxygen at 36 weeks post menstrual age.
Outcome measures
| Measure |
Treatment Surfactant (Infasurf) ONY, NY
n=43 Participants
Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14.
|
Sham (no Treatment)
n=42 Participants
Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Sham Infants will not receive additional doses of Infasurf.
|
|---|---|---|
|
Alive Without BPD at 36 Weeks Post Menstrual Age
|
16 Number of infants
|
14 Number of infants
|
Adverse Events
Treatment Surfactant (Infasurf) ONY, NY
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham (no Treatment)
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
Roberta R. Keller, MD
University of California, San Francisco
Phone: 415-514-3192
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place