Is Skin-to-Skin Care Helpful for Preterm Infants and Their Mothers After Birth?
Primary Purpose
Moderate to Late Prematurity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Skin-to-Skin contact
Sponsored by
About this trial
This is an interventional supportive care trial for Moderate to Late Prematurity focused on measuring Preterm infant, Skin-to-skin contact, kangaroo care, temperature, behavioral state
Eligibility 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.
Sites / Locations
- University Hospitals Case Medical Center
- Kadlec Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Skin-to-Skin group
Arm Description
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.
Outcomes
Primary Outcome Measures
Infant Temperature
Secondary Outcome Measures
Infant Behavioral State
Full Information
NCT ID
NCT00917085
First Posted
June 8, 2009
Last Updated
August 7, 2009
Sponsor
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT00917085
Brief Title
Is Skin-to-Skin Care Helpful for Preterm Infants and Their Mothers After Birth?
Official Title
Self-Regulatory Preterm Infant Care: Adaptation Postbirth
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
July 1996 (undefined)
Primary Completion Date
December 2001 (Actual)
Study Completion Date
December 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Late Prematurity
Keywords
Preterm infant, Skin-to-skin contact, kangaroo care, temperature, behavioral state
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Skin-to-Skin group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Skin-to-Skin contact
Other Intervention Name(s)
Kangaroo Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gene C Anderson, PhD, RN, FAAN
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Kadlec Medical Center
City
Richmond
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
10083783
Citation
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.
Results Reference
background
PubMed Identifier
11987376
Citation
Anderson 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.
Results Reference
background
PubMed Identifier
11452667
Citation
Dombrowski 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.
Results Reference
background
PubMed Identifier
14565739
Citation
Anderson 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.
Results Reference
background
PubMed Identifier
14700180
Citation
Swinth 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.
Results Reference
background
PubMed Identifier
18557262
Citation
Hake-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.
Results Reference
background
PubMed Identifier
19361802
Citation
Chiu 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.
Results Reference
background
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Is Skin-to-Skin Care Helpful for Preterm Infants and Their Mothers After Birth?
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