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NCT02139800 · ClinicalTrials.gov registry record · NA
Sustained Aeration of Infant Lungs Trial
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 460
- Enrollment target
NCT02139800: Completed NA study, sponsored by University of Pennsylvania.
NCT02139800 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 460 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02139800, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 460 participants
- Enrollment target
Study Summary
This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants. Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring respiratory support at birth which of two lung opening strategies - either a standard PEEP/CPAP of 5-7 cm H2O in the delivery room (DR), as compared to early lung recruitment using Sustained Inflation (SI) in the DR, will result in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia (BPD) at 36 weeks gestational age. Hypotheses: 1. Early lung recruitment with SI superimposed upon standard PEEP/CPAP in the DR will reduce the need for mechanical ventilation in the first seven days of life, and reduce need for surfactant use; and 2. A policy of DR SI on standard PEEP/CPAP recruitment will confer better outcomes at 36 weeks post-menstrual age (PMA) than standard PEEP/CPAP
Primary Outcome
To determine in infants born at 23-26 weeks gestational age requiring respiratory support at birth, which of two treatment strategies when compared, results in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia.
Interventions
- PROCEDURE Standard of Care
- PROCEDURE Sustained Inflation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2014-08-27 |
| Est. Completion | 2020-03-23 |
| Phase | NA |
What the finished NCT02139800 record still lists
NCT02139800 is an interventional study that assigns participants to a tested intervention. The registered 460 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of Care is the first listed.
NCT02139800 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02139800 about?
NCT02139800 is a clinical study titled "Sustained Aeration of Infant Lungs Trial". This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants. Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring respiratory support at birth w...
What is the current status of trial NCT02139800?
This trial is currently completed. It is a NA study. The enrollment target is 460 participants. The study started on 2014-08-27. Estimated completion is 2020-03-23.
What interventions are being tested in trial NCT02139800?
The interventions under investigation include: Standard of Care (PROCEDURE), Sustained Inflation (PROCEDURE).
Who is sponsoring clinical trial NCT02139800?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02139800's enrollment target sits among peer trials
460 222nd of 2000 higher than 1,777 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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