Skin-to-skin Contact in Healthy Term Infants

Short-term and Long-term Effects of Skin-to-skin Contact in Healthy Term Infants

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.

Study Overview

• Status: Recruiting
• Conditions: Skin-to-skin Contact
• Intervention / Treatment: Behavioral: skin-to-skin contact education

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juyoung Lee, Professor; Phone Number: +82-2-920-5647; Email: juyounglee@korea.ac.kr
• Study Contact Backup: Name: Hannah Cho; Email: hannahv2@korea.ac.kr

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea, 02841
      • Not yet recruiting
      • Korea University Anam Hospital NICU
      • Contact: Juyoung Lee, Professor; Phone Number: +82-2-920-5647; Email: juyounglee@korea.ac.kr
      • Principal Investigator: Juyoung Lee
      • Sub-Investigator: Hannah Cho
    • Seoul, Seoul, South Korea, 02841
      • Recruiting
      • Korea University Anam Hospital NICU
      • Contact: Juyoung Lee, Professor; Phone Number: 029205647; Email: juyounglee@korea.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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).	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Korean-Edinburgh Postnatal Depression score	mother questionnaire range 0-30 low risk 0-8 borderline risk 9-12 high risk 13-30	3 to 7 days, 1 month, and 4 months of infant age
Parent State-Trait Anxiety Inventory score	mother questionnaire range 20-80 no or low anxiety 20-37 moderate anxiety 38-44 high anxiety 45-80	3 to 7 days, 1 month, 4 months, 8 months, and 12 months of infant age
Maternal Postnatal Attachment Scale score	mother questionnaire The score in the questionnaire ranges from 19 to 95, with a higher score indicating greater parent-infant attachment.	at 1 month, 4 months, 8 months, and 12 months of infant age
Developmental Screening (K-DST) score	mother questionnaire, score of each developmental area K-DST has 6 domains; gross motor, fine motor, cognition, language, social skills, and self-help. The total score was evaluated based on the transfer points of each domain. The K- DST results are broadly grouped into 5 categories: (1) good, (2) requires follow-up examination, (3) requires detailed assessment, (4) continued care, and (5) other.	at 4, 8, 12, 24 and 36 months of infant age
Bayley Scales of Infant Development III	scale scores for each development areas (cognitive, language, motor) score range : 0-200 above average (1-2 SD, score 116-130) average ( 1 to 1 SD, score 85-115) below average (1 to-2 SD, score 84-70) well below average (<-2 SD, scores < 70).	at 24 months, and 36 months of infant age
Sequenced Language Scale for Infant (SELSI)	percentile of each area (receptive and expressive language abilities). the raw scores is classified in accordance with standard guidelines: average, within -1 SD of the mean; mild delay, up to -2 SD; and delay, >-2 SDs below the mean scores.	at 24 months, and 36 months of infant age
Modified Checklist for Autism in Toddlers (M-CHAT)	mother questionnaire total score 0-2: low risk total score 3-7: moderate risk total score 8-20: high risk	at 24 months, and 36 months of infant age
Artificial intelligence (AI) analysis for infant general movement videos	AI algorithms will be developed for analyzing infant movement captured in video. For this, computer vision techniques will be used for tracking joint movement and extracting relevant features. Machine learning models will then be trained to identify deviation from typical movement patterns, and system's performance will be evaluated using long-term development outcome measures.	at 3-6 days, 1 and 4 months of age
Infant temperament measured by Korean-Infant Behavior Questionnaire-Revised (K-IBQ-R)	IBQ assessed 6 domains of infant temperament (activity level, soothability, fear, distress to limitations, smiling and laughter, and duration of orienting).The items on the IBQ ask parents to rate the frequency of specific temperament-related behaviors observed over the past week.	at 8 months
Korean-Early Childhood Behavior Questionnaire-Revised (K-ECBQ-R)	The Early Childhood Behavior Questionnaire (ECBQ) is a parent-report tool used to assess temperament in young children, based on observable behaviors. It includes 201 items grouped into 18 fine-grained subscales, which are further organized into three broad temperament factors; Surgency - Reflects high energy and positive emotions (e.g., impulsivity, activity level, high-intensity pleasure, sociability and positive anticipation); Negative Emotionality - Captures sensitivity to negative experiences (e.g., discomfort, fear, motor activation, sadness, perceptual sensitivity, shyness, soothability and frustration scales).; Effortful Control - Represents self-regulation and attention skills (e.g.,inhibitory control, attention shifting, low-intensity pleasure, cuddliness and attention focusing).	at 24months
Child Behavior Checklist (CBCL)	behavior screening questionnaire result t-score ≤ 59: non-clinical symptoms, t-score between 60 and 64: at risk for problem behaviors t-score ≥ 65: clinical symptoms.	at 24 and 36 months of age
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 1 month, 8 months, and 12 months of age

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 16, 2025

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: infant; neurodevelopmental outcome; skin-to-skin contact
• Other Study ID Numbers: 2024AN0613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Collected data will be available upon request from the corresponding author after completion of the study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No