Clinical trial NCT02143193: Skin-to Skin Contact on Newborn Temperature
Official title: The Effects of Skin-to-Skin Contact on Newborn Temperature, Initial Bath and Early Breastfeefing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Skin to Skin Contact
Keywords: Breastfeeding
Newborn
Formula
Temperature
Initial Bath
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2014-05-20
Enrollment: 325
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Time to temperature stabilization until initial bath
timeFrame: one minute to 60 minutes after birth
Secondary outcomes:
measure: Time required for temperature re-stabilization after initial bath
timeFrame: on minute after initial bath until baby reaches desired temperature
Other outcomes:
measure: Time to first breastfeeding
timeFrame: 30 to 90 minutes after birth
measure: Percentage of Weight Loss During Hospitalization
timeFrame: 24-72 hours
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan TriHealth Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Karen Gromada, MSN, RN
role: PRINCIPAL_INVESTIGATOR
References: