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NCT02143193 · ClinicalTrials.gov registry record · NA
Skin-to Skin Contact on Newborn Temperature
A NA study of Pregnancy and Skin to Skin Contact, sponsored by Rachel Baker.
- Completed
- Registry status
- NA
- Development phase
- 325
- Enrollment target
- 1
- Study location
NCT02143193 is a NA study of Pregnancy and Skin to Skin Contact that has completed, run by Rachel Baker. The registered enrollment target is 325 participants, below the 871-participant average among 191 other Pregnancy trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02143193, a NA study of Pregnancy and Skin to Skin Contact, has completed, sponsored by Rachel Baker.
- COMPLETED
- Registry status
- NA
- Development phase
- 325 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will compare standard methods of stabilizing a newborn's temperature after birth with mother-infant skin-to-skin contact for stabilizing newborn temperature. The study will look at the effects of each warming method on the timing of newborns' initial bath and the effects on newborn initiation and percent weight loss by discharge. The study will use a randomized controlled trial (RCT) design to test a clinical intervention at TriHealth Good Samaritan Hospital. Study participants will be randomized to the intervention group (IG), which will implement mother-baby Skin-to-Skin (STS) immediately after vaginal birth, or to the control group (CG), which will receive standard care for newborn and mother immediately after vaginal birth. This study will test the hypothesis that mother-baby STS contact implemented immediately after delivery for a minimum of the newborn's first 60 minutes and with a resumption of STS (if a 15-minute break in STS occurs at some point after the first hour) until the newborn's temperature stabilizes after the initial bath will result in: 1. Improved newborn temperature stability and thermoregulation for newborns whether breast or formula-fed. 2. Initiation of effective breastfeeding behavior within 90 minutes of birth and the addition of at least one more breastfeeding within four hours of birth for breastfed newborns. 3. Avoidance of newborn weight loss of 10% or greater.
Conditions Studied
Interventions
- BEHAVIORAL Skin-to-Skin Contact
Study Locations (1)
Ohio
- Good Samaritan TriHealth Hospital - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2011-08 |
| Est. Completion | 2014-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02143193
The ClinicalTrials.gov registry entry for NCT02143193 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 325 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 871-participant average among 191 other Pregnancy trials with a reported enrollment target (63% lower). The listed sponsor is Rachel Baker, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which Skin-to-Skin Contact is the first listed.
NCT02143193 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT02143193 about?
NCT02143193 is a clinical study titled "Skin-to Skin Contact on Newborn Temperature". This study will compare standard methods of stabilizing a newborn's temperature after birth with mother-infant skin-to-skin contact for stabilizing newborn temperature. The study will look at the effects of each warming method on the timing of newborns' initial bath and the effects on newborn initia...
What is the current status of trial NCT02143193?
This trial is currently completed. It is a NA study. The enrollment target is 325 participants. The study started on 2011-08. Estimated completion is 2014-05.
What conditions does trial NCT02143193 study?
This clinical trial studies the following conditions: Pregnancy, Skin to Skin Contact.
What interventions are being tested in trial NCT02143193?
The interventions under investigation include: Skin-to-Skin Contact (BEHAVIORAL).
Who is sponsoring clinical trial NCT02143193?
This trial is sponsored by Rachel Baker, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02143193 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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