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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
130
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.
Korea University Anam Hospital NICU
Seoul, Seoul, South Korea
NOT_YET_RECRUITINGKorea University Anam Hospital NICU
Seoul, Seoul, South Korea
RECRUITINGPercentage 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.
Time frame: at 4 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.
Time frame: at 1 month, 8 months, and 12 months of age
Korean-Edinburgh Postnatal Depression score
mother questionnaire range 0-30 low risk 0-8 borderline risk 9-12 high risk 13-30
Time frame: 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
Time frame: 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.
Time frame: at 1 month, 4 months, 8 months, and 12 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: at 3-6 days, 1 and 4 months of 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.
Time frame: at 4, 8, 12, 24 and 36 months of infant 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.
Time frame: 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 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).
Time frame: at 24months
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).
Time frame: 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.
Time frame: 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
Time frame: at 24 months, and 36 months of infant age
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.
Time frame: at 24 and 36 months of age