Clinical Trials Directory

Trials / Completed

CompletedNCT02143193

Skin-to Skin Contact on Newborn Temperature

The Effects of Skin-to-Skin Contact on Newborn Temperature, Initial Bath and Early Breastfeefing

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
325 (actual)
Sponsor
Rachel Baker · Academic / Other
Sex
Female
Age
18 Years – 50 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALSkin-to-Skin Contact

Timeline

Start date
2011-08-01
Primary completion
2014-05-01
Completion
2014-05-01
First posted
2014-05-20
Last updated
2018-08-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02143193. Inclusion in this directory is not an endorsement.