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Clinical Trials/NCT02143193
NCT02143193
Completed
Not Applicable

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

Rachel Baker1 site in 1 country325 target enrollmentAugust 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Rachel Baker
Enrollment
325
Locations
1
Primary Endpoint
Time to temperature stabilization until initial bath
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.
Registry
clinicaltrials.gov
Start Date
August 2011
End Date
May 2014
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Rachel Baker
Responsible Party
Sponsor Investigator
Principal Investigator

Rachel Baker

Nurse Researcher

TriHealth Inc.

Eligibility Criteria

Inclusion Criteria

  • Woman in labor presenting with
  • An uncomplicated pregnancy
  • Full-term gestation: 38 0/7 weeks
  • Single gestation
  • Vertex presentation
  • Plans to deliver without general anesthesia
  • Likelihood of a vaginal delivery

Exclusion Criteria

  • A complication of pregnancy at the time of admission
  • An inability to speak or understand English language
  • Preterm gestation: 37 6/7 weeks
  • A multiple gestation
  • Non-vertex presentation
  • Plan for delivery with general anesthesia
  • Planned Cesarean delivery

Outcomes

Primary Outcomes

Time to temperature stabilization until initial bath

Time Frame: one minute to 60 minutes after birth

Secondary Outcomes

  • Time required for temperature re-stabilization after initial bath(on minute after initial bath until baby reaches desired temperature)

Study Sites (1)

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