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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 1 month, 8 months, and 12 months of age |
| Korean-Edinburgh Postnatal Depression score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juyoung Lee, Professor | Contact | +82-2-920-5647 | juyounglee@korea.ac.kr | |
| Hannah Cho | Contact | hannahv2@korea.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital NICU | Not yet recruiting | Seoul | Seoul | 02841 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41087107 | Derived | 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. |
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Collected data will be available upon request from the corresponding author after completion of the study.
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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 |
| 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 |
| 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 |
| 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
| 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). | 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 |
| 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 |
| Korea University Anam Hospital NICU | Recruiting | Seoul | Seoul | 02841 | South Korea |
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