Phase 3
Completed N=85
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction) · Bronchopulmonary Dysplasia
Source: ClinicalTrials.gov NCT00569530 ↗
Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: SP-B Content — 19.9; 13.3 Total surfactant protein (% of PL)
◆ Published Evidence
Established
25citations · ~2 / year
Late administration of surfactant replacement therapy increases surfactant protein-B content: a randomized pilot study.
Summary
The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.
Linked Publications
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Late administration of surfactant replacement therapy increases surfactant protein-B content: a randomized pilot study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SP-B Content |
19.9; 13.3 | — |
| SECONDARY Alive Without BPD at 36 Weeks Post Menstrual Age |
16; 14 | — |
Eligibility Criteria
Inclusion Criteria
- Less than or equal to 1000 gm. birth weight
- Less than or equal to 30 weeks gestational age
- Day 7-14 of life
- Intubated and mechanically ventilated at any time days 7-14 of life
Exclusion Criteria
- Serious congenital malformations
- Life expectancy less than 7 days from enrollment
- Previous treatment with iNO
- Active pulmonary hemorrhage at time of enrollment
- Active air leak syndrome at time of enrollment
- Bilateral grade IV intracranial hemorrhage prior to enrollment
- Less than 48 hours from last clinical dose of early surfactant.
Data sourced from ClinicalTrials.gov (NCT00569530) and the linked publication. 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. Informational only — not medical advice.