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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 1

Conditions: Moderate to Late Prematurity

Treatments: Behavioral: Skin-to-Skin contact

Study type: Interventional

Funder types: NIH

Identifiers

NCT00917085

M01RR000080 (U.S. NIH Grant/Contract)

2R01NR002444-04A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control group

No Intervention group

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.

Skin-to-Skin group

Experimental group

Treatment:

Behavioral: Skin-to-Skin contact