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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 is a NA study that was terminated before completion, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 47 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03585192
The ClinicalTrials.gov registry entry for NCT03585192 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Skin Group is the first listed.
NCT03585192 reports 0 study locations.
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.
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