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NCT03585192 · ClinicalTrials.gov registry record · NA
Safety of Immediate Skin-to-Skin Contact After Vaginal Birth in Vigorous Late-Preterm Neonates
A NA study, sponsored by University Hospitals Cleveland Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 47
- Enrollment target
NCT03585192: Clinical Trial NA study, sponsored by University Hospitals Cleveland Medical Center.
NCT03585192 is a NA study that was terminated before completion, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 47 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03585192, a NA study, was terminated before completion, sponsored by University Hospitals Cleveland Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 47 participants
- Enrollment target
Study Summary
Late-preterm neonates are born between 34 and 36 weeks 7 days gestational age (GA). Neonates born less than 34 weeks GA are at increased risk for morbidity and directly admitted to the Neonatal Intensive Care Unit (NICU). Skin-to-skin contact (SSC) is a standard of care in many units to aid in post-natal transitioning. Current guidelines published by the Neonatal Resuscitation Program (NRP) and American Academy of Pediatrics (AAP) recommend only "vigorous, term" neonates initiate immediate SSC. There is no published data regarding safety or guidelines relating to late-preterm neonates and immediate SSC. Therefore, the investigators hypothesize that post-natal transitioning after immediate SSC within the first hours after birth will be no worse for vigorous, singleton 35 0/7 to 36 6/7 week neonates compared to those who transition to SSC after an initial period of 20 minutes observation under the radiant warmer.
Primary Outcome
The investigators will track the number of times skin-to-skin contact is disrupted within the first hour of life and document reasons for interruption.
Interventions
- OTHER Skin Group
- OTHER Warmer Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2017-11-08 |
| Est. Completion | 2019-05-01 |
| Phase | NA |
Why NCT03585192 stopped before completion
NCT03585192 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Skin Group is the first listed.
NCT03585192 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03585192 about?
NCT03585192 is a clinical study titled "Safety of Immediate Skin-to-Skin Contact After Vaginal Birth in Vigorous Late-Preterm Neonates". Late-preterm neonates are born between 34 and 36 weeks 7 days gestational age (GA). Neonates born less than 34 weeks GA are at increased risk for morbidity and directly admitted to the Neonatal Intensive Care Unit (NICU). Skin-to-skin contact (SSC) is a standard of care in many units to aid in post-...
What is the current status of trial NCT03585192?
This trial is currently terminated. It is a NA study. The enrollment target is 47 participants. The study started on 2017-11-08. Estimated completion is 2019-05-01.
What interventions are being tested in trial NCT03585192?
The interventions under investigation include: Skin Group (OTHER), Warmer Group (OTHER).
Who is sponsoring clinical trial NCT03585192?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03585192's enrollment target sits among peer trials
47 1400th of 2000 higher than 599 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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