Skin-to-skin ContactNCT06777524
Skin-to-skin Contact in Healthy Term Infants
A study testing skin-to-skin contact education in people with Skin-to-skin Contact, run by Korea University Anam Hospital at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Skin-to-skin Contact
- What is being tested?
- skin-to-skin contact education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 10 Feb 2025to 31 Jan 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hannah Cho contact
South Korea2 sites, 2 recruiting
- Not yet recruiting
Korea University Anam Hospital NICU
Seoul, Seoul, 02841
Juyoung Lee, Professor, +82-2-920-5647, juyounglee@korea.ac.kr
Juyoung Lee
- Recruiting
Korea University Anam Hospital NICU
Seoul, Seoul, 02841
Juyoung Lee, Professor, 029205647, juyounglee@korea.ac.kr
About this study
Official title: 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.
- Conditions
- Skin-to-skin Contact
- Being tested
- skin-to-skin contact education
- Keywords
- skin-to-skin contact, infant, neurodevelopmental outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin-to-skin contact educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: skin-to-skin contact education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 4 months of age
Secondary outcomes (12)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: at 24 and 36 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start10 Feb 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin-to-skin ContactStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juyoung Lee, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777524
- Sponsor's protocol ID
- 2024AN0613
- Status last verified
- Sep 2025
- First submitted
- 6 Jan 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Collected data will be available upon request from the corresponding author after completion of the study.
Publications
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.
PubMed 41087107