Skin-to Skin Contact on Newborn Temperature

NCT ID: NCT02143193

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-05-31

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.

Conditions

Pregnancy; Skin to Skin Contact

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Skin to Skin Contact

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

Group Type: EXPERIMENTAL

Skin-to-Skin Contact

Intervention Type: BEHAVIORAL

Standard of Care

standard care for newborn and mother immediately after vaginal birth

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Skin-to-Skin Contact

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Rachel Baker

OTHER

Sponsor Role: lead

Responsible Party

Rachel Baker

Nurse Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Karen Gromada, MSN, RN

Role: PRINCIPAL_INVESTIGATOR

TriHealth Inc.

Locations

Good Samaritan TriHealth Hospital

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

11082-11-058

Identifier Type: -

Identifier Source: org_study_id