Skin-to Skin Contact on Newborn Temperature

Study Overview
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Brief Summary
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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: Improved newborn temperature stability and thermoregulation for newborns whether breast or formula-fed. 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. Avoidance of newborn weight loss of 10% or greater.

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

Conditions
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Pregnancy, Skin to Skin Contact

Intervention / Treatment
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* Behavioral: Skin-to-Skin Contact


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin to Skin Contact<br>implement mother-baby Skin-to-Skin contact immediately after vaginal birth | Behavioral: Skin-to-Skin Contact<br> <br> |
| No Intervention: Standard of Care<br>standard care for newborn and mother immediately after vaginal birth | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to temperature stabilization until initial bath |  | one minute to 60 minutes after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time required for temperature re-stabilization after initial bath |  | on minute after initial bath until baby reaches desired temperature | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breastfeeding, Newborn, Formula, Temperature, Initial Bath