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Skin-to Skin Contact on Newborn Temperature

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02143193
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Rachel Baker, TriHealth Inc.

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.

Condition or disease Intervention/treatment Phase
Pregnancy Skin to Skin Contact Behavioral: Skin-to-Skin Contact Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Skin-to-Skin Contact on Newborn Temperature, Initial Bath and Early Breastfeefing
Study Start Date : August 2011
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: Skin to Skin Contact
implement mother-baby Skin-to-Skin contact immediately after vaginal birth
Behavioral: Skin-to-Skin Contact
No Intervention: Standard of Care
standard care for newborn and mother immediately after vaginal birth



Primary Outcome Measures :
  1. Time to temperature stabilization until initial bath [ Time Frame: one minute to 60 minutes after birth ]

Secondary Outcome Measures :
  1. Time required for temperature re-stabilization after initial bath [ Time Frame: on minute after initial bath until baby reaches desired temperature ]

Other Outcome Measures:
  1. Time to first breastfeeding [ Time Frame: 30 to 90 minutes after birth ]
  2. Percentage of Weight Loss During Hospitalization [ Time Frame: 24-72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143193


Locations
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United States, Ohio
Good Samaritan TriHealth Hospital
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
Rachel Baker
Investigators
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Principal Investigator: Karen Gromada, MSN, RN TriHealth Inc.

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Responsible Party: Rachel Baker, Nurse Researcher, TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02143193    
Other Study ID Numbers: 11082-11-058
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: February 2017
Keywords provided by Rachel Baker, TriHealth Inc.:
Breastfeeding
Newborn
Formula
Temperature
Initial Bath