Skin-to Skin Contact on Newborn Temperature

Rachel Baker

Status: Completed

Conditions: Skin to Skin Contact; Pregnancy

Treatments: Behavioral: Skin-to-Skin Contact

Study type: Interventional

Funder types: Other

Identifiers

NCT02143193

11082-11-058

Details and patient eligibility

About

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.

Enrollment: 325 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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325 participants in 2 patient groups

Skin to Skin Contact

Experimental group

Description:

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

Treatment:

Behavioral: Skin-to-Skin Contact

Standard of Care

No Intervention group

Description:

standard care for newborn and mother immediately after vaginal birth