Skin-to Skin Contact on Newborn Temperature

Not Applicable

Completed

• Conditions: Pregnancy; Skin to Skin Contact
• Interventions: Behavioral: Skin-to-Skin Contact

• Registration Number: NCT02143193
• Lead Sponsor: Rachel Baker

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-05-16
• Study First Posted: 2014-05-20
• Status Verified: 2017-02
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 325

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skin to Skin Contact	Skin-to-Skin Contact	implement mother-baby Skin-to-Skin contact immediately after vaginal birth

Primary Outcome Measures

Name	Time	Method
Time to temperature stabilization until initial bath	one minute to 60 minutes after birth

Secondary Outcome Measures

Name	Time	Method
Time required for temperature re-stabilization after initial bath	on minute after initial bath until baby reaches desired temperature

Trial Locations

Locations (1)

Good Samaritan TriHealth Hospital; 🇺🇸 Cincinnati, Ohio, United States