Skip to content

Skin-to Skin Contact on Newborn Temperature

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02143193
Enrollment
325
Registered
2014-05-20
Start date
2011-08-31
Completion date
2014-05-31
Last updated
2018-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy, Skin to Skin Contact

Keywords

Breastfeeding, Newborn, Formula, Temperature, Initial Bath

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.

Interventions

Sponsors

Rachel Baker
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Time to temperature stabilization until initial bathone minute to 60 minutes after birth

Secondary

MeasureTime frame
Time required for temperature re-stabilization after initial bathon minute after initial bath until baby reaches desired temperature

Other

MeasureTime frame
Time to first breastfeeding30 to 90 minutes after birth
Percentage of Weight Loss During Hospitalization24-72 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026