Skin-to Skin Contact on Newborn Temperature

NCT02143193 | Completed DMC

• 1 other identifier: 11082-11-058
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 1

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. 1.Improved newborn temperature stability and thermoregulation for newborns whether breast or formula-fed.
2. 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. 3.Avoidance of newborn weight loss of 10% or greater.

Conditions

Pregnancy; Skin to Skin Contact

Keywords

Breastfeeding; Newborn; Formula; Temperature; Initial Bath

Outcome Measures

Primary Outcomes (1)

• Time to temperature stabilization until initial bath

  one minute to 60 minutes after birth

Secondary Outcomes (1)

• Time required for temperature re-stabilization after initial bath

  on minute after initial bath until baby reaches desired temperature

Other Outcomes (2)

• Time to first breastfeeding

  30 to 90 minutes after birth

• Percentage of Weight Loss During Hospitalization

  24-72 hours

Study Arms (2)

Skin to Skin Contact

EXPERIMENTAL

implement mother-baby Skin-to-Skin contact immediately after vaginal birth

Behavioral: Skin-to-Skin Contact

Standard of Care

NO INTERVENTION

standard care for newborn and mother immediately after vaginal birth

Interventions

Skin-to-Skin Contact BEHAVIORAL

Skin to Skin Contact

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rachel Baker: lead

Study Sites (1)

Good Samaritan TriHealth Hospital

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Karen Gromada, MSN, RN

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse Researcher

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 20, 2014
• Study Start: August 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 23, 2018

Record last verified: 2017-02

Locations

US (1)