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Skin-to Skin Contact on Newborn Temperature

NCT02143193 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2018-08-23

No results posted yet for this 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

  • Pregnancy
  • Skin to Skin Contact

Interventions

BEHAVIORAL

Skin-to-Skin Contact

Sponsors & Collaborators

  • Rachel Baker

    lead OTHER

Principal Investigators

  • Karen Gromada, MSN, RN · TriHealth Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02143193 on ClinicalTrials.gov