Is Skin-to-Skin Care Helpful for Preterm Infants and Their Mothers After Birth?

This study has been completed.
Sponsor:
Information provided by:
National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier:
NCT00917085
First received: June 8, 2009
Last updated: August 7, 2009
Last verified: August 2009
  Purpose

To see if infant outcomes will improve when mothers are helped to hold their preterm infants skin-to-skin as soon as possible after birth and as often as possible and for as long as possible each time during the next five days.


Condition Intervention Phase
Moderate to Late Prematurity
Behavioral: Skin-to-Skin contact
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Self-Regulatory Preterm Infant Care: Adaptation Postbirth

Further study details as provided by National Institute of Nursing Research (NINR):

Primary Outcome Measures:
  • Infant Temperature [ Time Frame: A total of 60 measrements for each outcome beginning at birth once every 15 minutes and gradually decreasing in frequency to once every 6 hours by Day 5. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Infant Behavioral State [ Time Frame: A total of 60 measrements for each outcome beginning at birth once every 15 minutes and gradually decreasing in frequency to once every 6 hours by Day 5. ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: July 1996
Study Completion Date: December 2001
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Control infants received the same standard care as infants who were not in the study. Infants were kept warm in incubators or warmer beds and were wrapped in blankets when held by their mothers. Hospital staff was responsible for providing standard care.
Experimental: Skin-to-Skin group Behavioral: Skin-to-Skin contact
Infants in the Skin-to-Skin group also had standard care provided by hospital staff. In addition, the researchers facilitated skin-to-skin contact by placing diaper-clad infants prone between their mothers' breasts as soon as possible after birth. Thereafter the infants and their mothers experienced skin-to-skin contact as often as possible and for as long as possible each time throughout the protocol.
Other Name: Kangaroo Care

Detailed Description:

A similar intervention was studied in a RCT with fullterm infants but this was done with emphasis on close contact rather than skin-to-skin contact and lasted only the first 6 hours postbirth. This study was conducted by the same PI and funded by the National Center for Nursing Research, NIH 1990-1994. This research yielded numerous significant and beneficial differences.

Two pilot studies were done with healthy late preterm infants and mothers who planned to breastfeed. Skin-to-skin contact began in the delivery room. The first pilot was a descriptive exploratory study with 10 mother-infant dyads done in Cali, Colombia; skin-to-skin began at birth and lasted through hour 6 when all dyads went to the postpartum ward. Follow-up was through hospital discharge on the second day. All outcomes were positive.

The second pilot was an RCT done in the United States with a well balanced sample of 8 dyads, 4 in each group. Mean observation time lasted 47 hours (Medicaid required discharge time for the mothers) with skin-to-skin contact occurring 84% of the time. All outcomes favored the skin-to-skin group, for example 3.8 days to discharge home compared to 14.5 for the controls. Follow-up was at one year and similarly positive.

Similar differences were hypothesized for the RCT reported here in which the intervention was extended to the care of somewhat smaller and sicker preterm infants and lasted five days unless the infant was discharged sooner. The consent form was in layman terms, four pages long, and fulfilled all the requirements of the Institutional Review Boards of the Bolton School of Nursing at Case Western Reserve University, University Hospitals Case Medical Center and its General Clinical Research Center, and Kadlec Medical Center, Richmond, WA.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Mother and Infant Dyads

Infants:

  • singleton birth
  • 32 to 36 completed weeks
  • 5-minute Apgar score of 6 or more
  • weighed 1300 to 3000 grams
  • no birth defects that would interfere with feeding
  • healthy enough to experience skin-to-skin contact with their mothers.

Mothers:

  • 18 or more years of age
  • spoke English
  • free of serious drug abuse
  • well enough to experience skin-to-skin contact with their infants with assistance if needed.

Exclusion Criteria:

Infants:

  • too ill to be with their mothers
  • who have a condition that interferes with feeding.

Mothers:

  • who are too ill to care for their infant
  • are serious drug abusers.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00917085

Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States
United States, Washington
Kadlec Medical Center
Richmond, Washington, United States
Sponsors and Collaborators
Investigators
Principal Investigator: Gene C Anderson, PhD, RN, FAAN Case Western Reserve University
  More Information

Publications:
Responsible Party: Gene Cranston Anderson, PhD, RN, FAAN, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00917085     History of Changes
Other Study ID Numbers: 2R01NR02444-04A1, M01RR00080
Study First Received: June 8, 2009
Last Updated: August 7, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute of Nursing Research (NINR):
Preterm infant
Skin-to-skin contact
kangaroo care
temperature
behavioral state

ClinicalTrials.gov processed this record on September 16, 2014