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Recruiting NCT06777524

Skin-to-skin Contact in Healthy Term Infants

No phase Interventional Skin-to-skin Contact

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: skin-to-skin contact education.
Who it may be relevant to
Registry conditions: Skin-to-skin Contact. Basic parameters: 1 Hour — 72 Hours · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Short-term and Long-term Effects of Skin-to-skin Contact in Healthy Term Infants

Overview

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.

Interventions

  • Behavioral skin-to-skin contact education
    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.

Primary outcome measures

  • Percentage of any breast feeding (combined with formula and/or solid or not) [Time frame: at 4 months of age]
Secondary outcome measures (12)
  • Percentage of any breast feeding (combined with formula and/or solid or not) [Time frame: at 1 month, 8 months, and 12 months of age]
  • Korean-Edinburgh Postnatal Depression score [Time frame: 3 to 7 days, 1 month, and 4 months of infant age]
  • Parent State-Trait Anxiety Inventory score [Time frame: 3 to 7 days, 1 month, 4 months, 8 months, and 12 months of infant age]
  • Maternal Postnatal Attachment Scale score [Time frame: at 1 month, 4 months, 8 months, and 12 months of infant age]
  • Artificial intelligence (AI) analysis for infant general movement videos [Time frame: at 3-6 days, 1 and 4 months of age]
  • Developmental Screening (K-DST) score [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) [Time frame: at 8 months]
  • Korean-Early Childhood Behavior Questionnaire-Revised (K-ECBQ-R) [Time frame: at 24months]
  • Bayley Scales of Infant Development III [Time frame: at 24 months, and 36 months of infant age]
  • Sequenced Language Scale for Infant (SELSI) [Time frame: at 24 months, and 36 months of infant age]
  • Modified Checklist for Autism in Toddlers (M-CHAT) [Time frame: at 24 months, and 36 months of infant age]
  • Child Behavior Checklist (CBCL) [Time frame: at 24 and 36 months of age]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

South Korea · 2 centers
  • Korea University Anam Hospital NICU — Seoul
  • Korea University Anam Hospital NICU — Seoul

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. PMID 41087107

Identifiers

NCT: NCT06777524 · 2024AN0613

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗