- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00917085
Is Skin-to-Skin Care Helpful for Preterm Infants and Their Mothers After Birth?
Self-Regulatory Preterm Infant Care: Adaptation Postbirth
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States
- University Hospitals Case Medical Center
-
-
Washington
-
Richmond, Washington, United States
- Kadlec Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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 Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gene C Anderson, PhD, RN, FAAN, Case Western Reserve University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2R01NR002444-04A1 (NIH)
- M01RR000080 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Moderate to Late Prematurity
-
Beer, Kenneth R., M.D., PAMedicis Pharmaceutical CorporationCompletedMild to Moderate Temporal Atrophy | Moderate to Severe Glabellar Rhytids | Moderate to Severe Periorbital RhytidsUnited States
-
Aqpha Medical B.V.Not yet recruitingModerate to Severe Nasolabial Fold
-
Daewoong Pharmaceutical Co. LTD.Completed
-
Galderma R&DCompletedModerate to Severe Glabellar LinesChina
-
EuBiologics Co.,LtdCompletedModerate to Severe Glabellar LinesKorea, Republic of
-
AllerganCompletedModerate to Severe Nasolabial FoldsGermany, Netherlands
-
IpsenCompletedModerate to Severe Glabellar LinesFrance, Germany
-
Daewoong Pharmaceutical Co. LTD.CompletedModerate to Severe Glabellar LineKorea, Republic of
-
JHM BioPharma (Tonghua) Co. , Ltd.Recruiting
-
AbbVieCompletedModerate to Severe Glabellar LinesJapan
Clinical Trials on Skin-to-Skin contact
-
Universidad de la SabanaUnknown
-
Mersin UniversityCompleted
-
National Taiwan University Hospital Hsin-Chu BranchUnknownMother-Child RelationshipTaiwan
-
Kutahya Health Sciences UniversityCompletedNurse's Role | BreastfeedingTurkey
-
Rachel BakerCompleted
-
National Taipei University of Nursing and Health...CompletedParent-Child Relations
-
University of CologneRecruitingPreterm Birth | Infant Development | Mother-Infant InteractionGermany
-
Johann Wolfgang Goethe University HospitalCompleted
-
Hawler Medical UniversityCompleted
-
Affiliated Hospital of Jiangnan UniversityCompletedPostpartum Anxiety | Parturition; PrecipitateChina