Skin-to-skin Contact in Healthy Term Infants

September 18, 2025 updated by: Juyoung Lee, Korea University Anam Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 02841
        • Not yet recruiting
        • Korea University Anam Hospital NICU
        • Contact:
        • Principal Investigator:
          • Juyoung Lee
        • Sub-Investigator:
          • Hannah Cho
      • Seoul, Seoul, South Korea, 02841
        • Recruiting
        • Korea University Anam Hospital NICU
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control group
Parents of the control group will receive general education about sleep, breastfeeding, and bathing, which are provided to parents before going home after birth.
Experimental: skin-to-skin contact (SSC) group
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).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at 4 months of age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Korean-Edinburgh Postnatal Depression score
Time Frame: 3 to 7 days, 1 month, and 4 months of infant age
mother questionnaire range 0-30 low risk 0-8 borderline risk 9-12 high risk 13-30
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
mother questionnaire range 20-80 no or low anxiety 20-37 moderate anxiety 38-44 high anxiety 45-80
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
mother questionnaire The score in the questionnaire ranges from 19 to 95, with a higher score indicating greater parent-infant attachment.
at 1 month, 4 months, 8 months, and 12 months of infant age
Developmental Screening (K-DST) score
Time Frame: at 4, 8, 12, 24 and 36 months of infant age

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.
at 4, 8, 12, 24 and 36 months of infant age
Bayley Scales of Infant Development III
Time Frame: at 24 months, and 36 months of infant age
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).
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
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.
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
mother questionnaire total score 0-2: low risk total score 3-7: moderate risk total score 8-20: high risk
at 24 months, and 36 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
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.
at 3-6 days, 1 and 4 months of age
Infant temperament measured by Korean-Infant Behavior Questionnaire-Revised (K-IBQ-R)
Time Frame: at 8 months
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.
at 8 months
Korean-Early Childhood Behavior Questionnaire-Revised (K-ECBQ-R)
Time Frame: at 24months

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).
at 24months
Child Behavior Checklist (CBCL)
Time Frame: at 24 and 36 months of age
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.
at 24 and 36 months of age
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
This includes both exclusive breastfeeding and partial breastfeeding combined with formula and/or solid food.
at 1 month, 8 months, and 12 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Korea University Anam Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024AN0613

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Collected data will be available upon request from the corresponding author after completion of the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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