Skip to main content
OpenTrials
Completed

NCT Number: NCT02143193

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Good Samaritan TriHealth Hospital

Cincinnati, Ohio, 45220, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin-to-Skin contact

Behavioral

Primary outcomes

  1. Time to temperature stabilization until initial bath

    Time frame: one minute to 60 minutes after birth

Secondary outcomes

  1. Time required for temperature re-stabilization after initial bath

    Time frame: on minute after initial bath until baby reaches desired temperature

Other outcomes

  1. Time to first breastfeeding

    Time frame: 30 to 90 minutes after birth

  2. Percentage of Weight Loss During Hospitalization

    Time frame: 24-72 hours

Sponsors and collaborators

Lead sponsor

Rachel Baker

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 20, 2014
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.