Phase 3
Completed N=511
Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia
Source: ClinicalTrials.gov NCT01022580 ↗Enrolled (actual)
511
Serious AEs
10.4%
Results posted
May 2021
Primary outcomePrimary: Survival Without BPD at 36 Weeks Post Menstrual Age. — 79; 82 Participants — p=0.89
◆ Published Evidence
Established
83citations · ~8 / year
Randomized Trial of Late Surfactant Treatment in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide.
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.
Linked Publications (4)
-
Randomized Trial of Late Surfactant Treatment in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide.
-
The Randomized, Controlled Trial of Late Surfactant: Effects on Respiratory Outcomes at 1-Year Corrected Age.
-
Maternal Black Race and Persistent Wheezing Illness in Former Extremely Low Gestational Age Newborns: Secondary Analysis of a Randomized Trial.
-
Characteristics of Extremely Low Gestational Age Newborns Undergoing Tracheotomy: A Secondary Analysis of the Trial of Late Surfactant Randomized Clinical Trial.
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 | — |
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) 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.