Skin-to Skin Contact on Newborn Temperature

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143193
• Other study ID #: 11082-11-058
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: May 2014

Study information

• Verified date: February 2017
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy
• Skin to Skin Contact

Intervention

Behavioral:
• Skin-to-Skin Contact

Locations

Country	Name	City	State
United States	Good Samaritan TriHealth Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Rachel Baker

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to first breastfeeding		30 to 90 minutes after birth
Other	Percentage of Weight Loss During Hospitalization		24-72 hours
Primary	Time to temperature stabilization until initial bath		one minute to 60 minutes after birth
Secondary	Time required for temperature re-stabilization after initial bath		on minute after initial bath until baby reaches desired temperature