Phase 3
N=511
Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia
Bronchopulmonary Dysplasia
Bottom Line
View on ClinicalTrials.gov: NCT01022580 ↗Enrolled (actual)
511
Serious AEs
10.4%
Results posted
May 2021
Primary outcome: Primary: Survival Without BPD at 36 Weeks Post Menstrual Age. — 79; 82 Participants — p=0.89
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Infasurf surfactant (ONY, Inc.) (Drug); Sham (No Treatment) (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Roberta Ballard
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival Without BPD at 36 Weeks Post Menstrual Age. |
79; 82 | 0.89 |
| SECONDARY Survival Without BPD at 40 Weeks |
148; 140 | 0.33 |
| SECONDARY Respiratory Outcomes of TOLSURF Infants at 1 Year Corrected Age |
80; 118; 54; 47; 74; 75 | — |
| SECONDARY Pulmonary Outcomes Through 2 Years of Age |
91; 98 | — |
| SECONDARY Percentage of Participants With Neurodevelopmental Impairment (NDI) at 2 Years. |
28; 32 | — |
Summary
The purpose of this study is to determine if late doses of Infasurf surfactant given when patients are receiving inhaled nitric oxide will interact to improve surfactant function and increase survival without BPD in treated infants.
Eligibility Criteria
Inclusion Criteria
- <=28 0/7 weeks gestational age
- Day of life 7-14
- Intubated and mechanically ventilated
- Plan to treat with inhaled nitric oxide
Exclusion Criteria
- Serious congenital malformations or chromosomal abnormalities
- Life expectancy <7 days from enrollment
- Clinically unstable
- Less tha 48 hours since last dose surfactant
- Ability to obtain 36 week primary outcome information is unlikely
Data sourced from ClinicalTrials.gov (NCT01022580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.