Clinical trial NCT06777524: Skin-to-skin Contact in Healthy Term Infants
Official title: Short-term and Long-term Effects of Skin-to-skin Contact in Healthy Term Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin-to-skin Contact
Keywords: skin-to-skin contact
infant
neurodevelopmental outcome
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 130
Sex: ALL
Minimum age (years): 1
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective, single-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.


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

Primary outcomes:
measure: Breastfeeding rate
timeFrame: at 4 months of age
Secondary outcomes:
measure: Breastfeeding rate
timeFrame: at 1 month, 8 months, and 12 months of age
measure: time spent on skin-to-skin contact per day
timeFrame: during first 2 weeks after hospital discharge
measure: time spent on holding the infant per day
timeFrame: during first 2 weeks after hospital discharge
measure: Korean-Edinburgh Postnatal Depression score
timeFrame: 3 to 7 days, 1 month, and 4 months of infant age
measure: Parent State-Trait Anxiety Inventory score
timeFrame: 3 to 7 days, 1 month, 4 months, 8 months, and 12 months of infant age
measure: Maternal Postnatal Attachment Scale score
timeFrame: at 1 month, 4 months, 8 months, and 12 months of infant age
measure: Artificial intelligence (AI) analysis for infant general movement videos
timeFrame: at 3-6 days, 1 and 4 months of age
measure: Developmental Screening (K-DST) score
timeFrame: at 4, 8, 12, 24 and 36 months of infant age
measure: Infant temperament measured by Korean-Infant Behavior Questionnaire-Revised (K-IBQ-R)
timeFrame: at 8 months
measure: Korean-Early Childhood Behavior Questionnaire-Revised (K-ECBQ-R)
timeFrame: at 24months
measure: Bayley Scales of Infant Development III
timeFrame: at 24 months, and 36 months of infant age
measure: Sequenced Language Scale for Infant (SELSI)
timeFrame: at 24 months, and 36 months of infant age
measure: Modified Checklist for Autism in Toddlers (M-CHAT)
timeFrame: at 24 months, and 36 months of infant age
measure: Child Behavior Checklist (CBCL)
timeFrame: at 24 and 36 months of age
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital NICU
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital NICU
Study officials:
References: