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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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
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.

Juyoung Lee, Professor contact

+82-2-920-5647

juyounglee@korea.ac.kr

Hannah Cho contact

hannahv2@korea.ac.kr

South Korea2 sites, 2 recruiting
  • Korea University Anam Hospital NICU

    Seoul, Seoul, 02841

    Juyoung Lee, Professor, +82-2-920-5647, juyounglee@korea.ac.kr

    Juyoung Lee

    Not yet recruiting
  • Korea University Anam Hospital NICU

    Seoul, Seoul, 02841

    Juyoung Lee, Professor, 029205647, juyounglee@korea.ac.kr

    Recruiting

Other trials in South Korea

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.

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 groups in NCT06777524
Study groupRoleWhat they receive
control groupNo interventionParents 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) groupExperimentalFor 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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).

    Measured: at 24months

  9. 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

  10. 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

  11. 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

  12. 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.

  1. First posted16 Jan 2025
  2. Study start10 Feb 2025
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2030 (estimated)

Resources

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)
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

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