Trials / Completed
CompletedNCT00569530
Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 85 (actual)
- Sponsor
- Roberta Ballard · Academic / Other
- Sex
- All
- Age
- 7 Days – 14 Days
- Healthy volunteers
- Not accepted
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.
Detailed description
Surfactant dysfunction may contribute to the development of bronchopulmonary dysplasia (BPD) in persistently ventilated preterm infants. The investigators conducted a multi-center, randomized, blinded pilot study to assess the safety and efficacy of late administration of surfactant (Calfactant - high in protein B) in combination with prolonged inhaled nitric oxide in preterm infants \< 1000 grams birthweight (BW). Calfactant is one of several types of exogenous surfactant. Calfactant has the highest % of surfactant protein B of the different types.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Infasurf (ONY Inc.) | Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated. |
| DRUG | Sham | Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated. |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2007-12-07
- Last updated
- 2021-05-11
- Results posted
- 2016-06-28
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00569530. Inclusion in this directory is not an endorsement.