Skin-to-skin Contact in Healthy Term Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2030-01-31

Brief Summary

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This is a prospective, double-blind, randomized controlled clinical trial study to investigate short- and long-term effects of mother-infant skin-to-skin contact in healthy term infants, in order to provide supporting data for emphasizing mother-infant skin contact and family-centered care in South Korea.

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Detailed Description

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Conditions

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Skin-to-skin Contact

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

* Randomization will be carried out by one investigator from the Department of Preventive Medicine, who does not have direct contact with the infants or their parents in the hospital.
* A computer program will be used to randomly assign participants into two groups using permuted blocks (4 and 6), stratified by first-born and subsequent-born infants, with a 1:1 random allocation. The assigned groups will be communicated to the principal investigator.
* Parents will not be informed of their assigned group, and the study will be described as an investigation on the infant's sleep, feeding, bonding, and overall health, so as not to influence the mother-infant contact time.
* All personnel responsible for scoring and evaluating the outcomes will also be blinded to group allocation, except for the researchers who provide education to the control and intervention groups. To ensure proper allocation concealment, the randomization sequence will remain concealed until the study is completed.

Study Groups

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control group

Parents of the control group will receive general education about sleep, breastfeeding, and bathing, which are provided to parents before going home after birth.

Group Type NO_INTERVENTION

No interventions assigned to this group

skin-to-skin contact (SSC) group

For the intervention group, additional education on the importance and clinical benefits of mother-infant skin-to-skin contact will be provided (including an educational video).

Group Type EXPERIMENTAL

skin-to-skin contact education

Intervention Type BEHAVIORAL

For the intervention group, additional education on the importance and clinical benefits of mother-infant skin-to-skin contact will be provided (including an educational video). They will be instructed to engage in a minimum of 6 hours of skin-to-skin contact per day with the infant's and mother's chests exposed for at least 15 minutes per session, and to keep a record of the contact time, as well as the time spent holding the clothed infant and a daily feeding diary.

Interventions

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skin-to-skin contact education

For the intervention group, additional education on the importance and clinical benefits of mother-infant skin-to-skin contact will be provided (including an educational video). They will be instructed to engage in a minimum of 6 hours of skin-to-skin contact per day with the infant's and mother's chests exposed for at least 15 minutes per session, and to keep a record of the contact time, as well as the time spent holding the clothed infant and a daily feeding diary.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Babies born at Korea University Anam Hospital
* Term infants (37 weeks or more)
* Infants with a birth weight of 2,500g or more
* Healthy infants with an Apgar score of 7 or higher at 5 minutes
* Mothers and infants without severe acute complications, such as requiring intensive care treatment immediately after delivery

Exclusion Criteria

* Preterm infants born at 37 weeks of less gestation
* Low birth weight infants weighing less than 2500g at birth
* Mothers under the age of 20
* Unmarried mothers
* Multiple pregnancies (twins or triplets)
* Parents do not consent to participation in the study

Minimum Eligible Age

1 Hour

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes