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NCT01773746 · ClinicalTrials.gov registry record · NA
Study of Room Air Versus 60% Oxygen for Resuscitation of Premature Infants
A NA study, sponsored by Sharp HealthCare.
- Terminated
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT01773746: Clinical Trial NA study, sponsored by Sharp HealthCare.
NCT01773746 is a NA study that was terminated before completion, run by Sharp HealthCare. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01773746, a NA study, was terminated before completion, sponsored by Sharp HealthCare.
- TERMINATED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study Summary
The most appropriate initial oxygen concentration for the resuscitation of the extremely low birth weight infant has not been established using large well designed, randomized, blinded, prospective trials and the level of oxygen utilized by practitioners in this situation is highly variable. This proposed trial will use targeted oxygen saturation levels over the first 15 to 20 minutes of life to compare a low and a higher initial oxygen level for the resuscitation of such infants, and will be large enough to evaluate short term outcomes of survival without oxygen at 36 weeks and survival without retinopathy of prematurity, and the long term outcome of survival without significant neurodevelopmental impairment at 2 years of age. Such information is urgently required to provide an evidence basis for the initial oxygen concentration for resuscitation of these very preterm infants.
Primary Outcome
To determine if resuscitation starting with 21% oxygen and a targeted SpO2 strategy will increase survival without significant neurodevelopmental impairment at 18 to 22 months when compared with starting with 60% oxygen and a targeted SpO2 strategy.
Interventions
- OTHER Neonatal Resuscitation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2013-08 |
| Est. Completion | 2017-03-01 |
| Phase | NA |
Why NCT01773746 stopped before completion
NCT01773746 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Neonatal Resuscitation is the first listed.
NCT01773746 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01773746 about?
NCT01773746 is a clinical study titled "Study of Room Air Versus 60% Oxygen for Resuscitation of Premature Infants". The most appropriate initial oxygen concentration for the resuscitation of the extremely low birth weight infant has not been established using large well designed, randomized, blinded, prospective trials and the level of oxygen utilized by practitioners in this situation is highly variable. This pr...
What is the current status of trial NCT01773746?
This trial is currently terminated. It is a NA study. The enrollment target is 80 participants. The study started on 2013-08. Estimated completion is 2017-03-01.
What interventions are being tested in trial NCT01773746?
The interventions under investigation include: Neonatal Resuscitation (OTHER).
Who is sponsoring clinical trial NCT01773746?
This trial is sponsored by Sharp HealthCare, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01773746's enrollment target sits among peer trials
80 994th of 2000 higher than 941 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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