Skin-to-skin Contact in Healthy Term Infants

Not Applicable

Recruiting

• Conditions: Skin-to-skin Contact

• Registration Number: NCT06777524
• Lead Sponsor: Korea University Anam Hospital

Brief Summary

This is a prospective, single-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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-16
• Study Start: 2025-02-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-01-31
• Study Completion: 2030-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Breastfeeding rate	at 4 months of age

Secondary Outcome Measures

Name	Time	Method
Breastfeeding rate	at 1 month, 8 months, and 12 months of age
time spent on skin-to-skin contact per day	during first 2 weeks after hospital discharge
time spent on holding the infant per day	during first 2 weeks after hospital discharge	as clothed
Korean-Edinburgh Postnatal Depression score	3 to 7 days, 1 month, and 4 months of infant age	mother questionnaire range 0-30 low risk 0-8 borderline risk 9-12 high risk 13-30
Parent State-Trait Anxiety Inventory score	3 to 7 days, 1 month, 4 months, 8 months, and 12 months of infant age	mother questionnaire range 20-80 no or low anxiety 20-37 moderate anxiety 38-44 high anxiety 45-80
Maternal Postnatal Attachment Scale score	at 1 month, 4 months, 8 months, and 12 months of infant age	mother questionnaire The score in the questionnaire ranges from 19 to 95, with a higher score indicating greater parent-infant attachment.
Artificial intelligence (AI) analysis for infant general movement videos	at 3-6 days, 1 and 4 months of age	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.
Developmental Screening (K-DST) score	at 4, 8, 12, 24 and 36 months of infant age	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.
Infant temperament measured by Korean-Infant Behavior Questionnaire-Revised (K-IBQ-R)	at 8 months	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.
Korean-Early Childhood Behavior Questionnaire-Revised (K-ECBQ-R)	at 24months	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; 1. Surgency - Reflects high energy and positive emotions (e.g., impulsivity, activity level, high-intensity pleasure, sociability and positive anticipation); 2. Negative Emotionality - Captures sensitivity to negative experiences (e.g., discomfort, fear, motor activation, sadness, perceptual sensitivity, shyness, soothability and frustration scales).; 3. Effortful Control - Represents self-regulation and attention skills (e.g.,inhibitory control, attention shifting, low-intensity pleasure, cuddliness and attention focusing).
Bayley Scales of Infant Development III	at 24 months, and 36 months of infant age	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).
Sequenced Language Scale for Infant (SELSI)	at 24 months, and 36 months of infant age	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.
Modified Checklist for Autism in Toddlers (M-CHAT)	at 24 months, and 36 months of infant age	mother questionnaire total score 0-2: low risk total score 3-7: moderate risk total score 8-20: high risk
Child Behavior Checklist (CBCL)	at 24 and 36 months of age	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.

Trial Locations

Locations (1)

Korea University Anam Hospital NICU; 🇰🇷 Seoul, Korea, Republic of