Is Skin-to-Skin Care Helpful for Preterm Infants and Their Mothers After Birth?
Self-Regulatory Preterm Infant Care: Adaptation Postbirth
2 other identifiers
interventional
100
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 1996
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1996
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 10, 2009
CompletedAugust 10, 2009
August 1, 2009
5.4 years
June 8, 2009
August 7, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infant Temperature
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.
Secondary Outcomes (1)
Infant Behavioral State
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.
Study Arms (2)
Control group
NO INTERVENTIONControl 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.
Skin-to-Skin group
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Mother and Infant Dyads
- Infants:
- singleton birth
- to 36 completed weeks
- 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:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Kadlec Medical Center
Richmond, Washington, United States
Related Publications (7)
Moran M, Radzyminski SG, Higgins KR, Dowling DA, Miller MJ, Anderson GC. Maternal kangaroo (skin-to-skin) care in the NICU beginning 4 hours postbirth. MCN Am J Matern Child Nurs. 1999 Mar-Apr;24(2):74-9. doi: 10.1097/00005721-199903000-00006.
PMID: 10083783BACKGROUNDAnderson GC, Dombrowski MA, Swinth JY. Kangaroo care: not just for stable preemies anymore. Reflect Nurs Leadersh. 2001;27(2):32-4, 45. No abstract available.
PMID: 11987376BACKGROUNDDombrowski MA, Anderson GC, Santori C, Burkhammer M. Kangaroo (skin-to-skin) care with a postpartum woman who felt depressed. MCN Am J Matern Child Nurs. 2001 Jul-Aug;26(4):214-6. doi: 10.1097/00005721-200107000-00012.
PMID: 11452667BACKGROUNDAnderson GC, Chiu SH, Dombrowski MA, Swinth JY, Albert JM, Wada N. Mother-newborn contact in a randomized trial of kangaroo (skin-to-skin) care. J Obstet Gynecol Neonatal Nurs. 2003 Sep-Oct;32(5):604-11. doi: 10.1177/0884217503256616.
PMID: 14565739BACKGROUNDSwinth JY, Anderson GC, Hadeed AJ. Kangaroo (skin-to-skin) care with a preterm infant before, during, and after mechanical ventilation. Neonatal Netw. 2003 Nov-Dec;22(6):33-8. doi: 10.1891/0730-0832.22.6.33.
PMID: 14700180BACKGROUNDHake-Brooks SJ, Anderson GC. Kangaroo care and breastfeeding of mother-preterm infant dyads 0-18 months: a randomized, controlled trial. Neonatal Netw. 2008 May-Jun;27(3):151-9. doi: 10.1891/0730-0832.27.3.151.
PMID: 18557262BACKGROUNDChiu SH, Anderson GC. Effect of early skin-to-skin contact on mother-preterm infant interaction through 18 months: randomized controlled trial. Int J Nurs Stud. 2009 Sep;46(9):1168-80. doi: 10.1016/j.ijnurstu.2009.03.005. Epub 2009 Apr 10.
PMID: 19361802BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gene C Anderson, PhD, RN, FAAN
Case Western Reserve University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
June 8, 2009
First Posted
June 10, 2009
Study Start
July 1, 1996
Primary Completion
December 1, 2001
Study Completion
December 1, 2001
Last Updated
August 10, 2009
Record last verified: 2009-08