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Clinical Trials/NCT06777524
NCT06777524RecruitingNot Applicable

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

Korea University Anam Hospital2 sites in 1 country130 target enrollmentStarted: February 10, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
130
Locations
2
Primary Endpoint
Percentage of any breast feeding (combined with formula and/or solid or not)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description

  • Randomization will be carried out by one investigator from the Department of Preventive Medicine, who does not have direct contact with the infants or their parents in the hospital.
  • A computer program will be used to randomly assign participants into two groups using permuted blocks (4 and 6), stratified by first-born and subsequent-born infants, with a 1:1 random allocation. The assigned groups will be communicated to the principal investigator.
  • Parents will not be informed of their assigned group, and the study will be described as an investigation on the infant's sleep, feeding, bonding, and overall health, so as not to influence the mother-infant contact time.
  • All personnel responsible for scoring and evaluating the outcomes will also be blinded to group allocation, except for the researchers who provide education to the control and intervention groups. To ensure proper allocation concealment, the randomization sequence will remain concealed until the study is completed.

Eligibility Criteria

Ages
1 Hour to 72 Hours (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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).

Intervention: skin-to-skin contact education (Behavioral)

Outcomes

Primary Outcomes

Percentage of any breast feeding (combined with formula and/or solid or not)

Time Frame: at 4 months of age

This includes both exclusive breastfeeding and partial breastfeeding combined with formula and/or solid food.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Juyoung Lee

Professor

Korea University Anam Hospital

Study Sites (2)

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