Skin-to Skin Contact on Newborn Temperature

August 21, 2018 updated by: Rachel Baker

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

325

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan TriHealth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Skin to Skin Contact
implement mother-baby Skin-to-Skin contact immediately after vaginal birth
Behavioral: Skin-to-Skin Contact
No Intervention: Standard of Care
standard care for newborn and mother immediately after vaginal birth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to temperature stabilization until initial bath
Time Frame: one minute to 60 minutes after birth
one minute to 60 minutes after birth

Secondary Outcome Measures

Outcome Measure
Time Frame
Time required for temperature re-stabilization after initial bath
Time Frame: on minute after initial bath until baby reaches desired temperature
on minute after initial bath until baby reaches desired temperature

Other Outcome Measures

Outcome Measure
Time Frame
Time to first breastfeeding
Time Frame: 30 to 90 minutes after birth
30 to 90 minutes after birth
Percentage of Weight Loss During Hospitalization
Time Frame: 24-72 hours
24-72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rachel Baker

Investigators

  • Principal Investigator: Karen Gromada, MSN, RN, TriHealth Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 16, 2014

First Submitted That Met QC Criteria

May 16, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11082-11-058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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