Skin-to-skin Contact in Healthy Term Infants

NCT06777524 | Recruiting

• 1 other identifier: 2024AN0613
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Skin-to-skin Contact

Keywords

skin-to-skin contact; infant; neurodevelopmental outcome

Outcome Measures

Primary Outcomes (1)

• Percentage of any breast feeding (combined with formula and/or solid or not)

  This includes both exclusive breastfeeding and partial breastfeeding combined with formula and/or solid food.

  at 4 months of age

Secondary Outcomes (12)

• Percentage of any breast feeding (combined with formula and/or solid or not)

  at 1 month, 8 months, and 12 months of age

• Korean-Edinburgh Postnatal Depression score

  3 to 7 days, 1 month, and 4 months of infant age

• Parent State-Trait Anxiety Inventory score

  3 to 7 days, 1 month, 4 months, 8 months, and 12 months of infant age

• Maternal Postnatal Attachment Scale score

  at 1 month, 4 months, 8 months, and 12 months of infant age

• Artificial intelligence (AI) analysis for infant general movement videos

  at 3-6 days, 1 and 4 months of age

Study Arms (2)

control group

NO INTERVENTION

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

skin-to-skin contact (SSC) group

EXPERIMENTAL

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).

Behavioral: skin-to-skin contact education

Interventions

skin-to-skin contact education 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.

skin-to-skin contact (SSC) group

Eligibility Criteria

• Age: 1 Hour - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (2)

Korea University Anam Hospital NICU

Seoul, Seoul, 02841, South Korea

NOT YET RECRUITING

Korea University Anam Hospital NICU

Seoul, Seoul, 02841, South Korea

RECRUITING

Related Publications (1)

• Cho H, Park J, Choe SA, Lee J. Short-term and long-term effects of skin-to-skin contact in healthy term infants: study protocol for a parallel-group double-blind randomised controlled trial. BMJ Open. 2025 Oct 14;15(10):e104809. doi: 10.1136/bmjopen-2025-104809.

  PMID: 41087107 DERIVED

Central Study Contacts

Juyoung Lee, Professor

CONTACT

+82-2-920-5647; juyounglee@korea.ac.kr

Hannah Cho

CONTACT

hannahv2@korea.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: * 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 16, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2030
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

KR (2)