Skin-to-skin Contact in Healthy Term Infants
ConditionSkin-to-skin Contact
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-72
SponsorKorea University Anam Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
skin-to-skin contact education
BehavioralFor 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.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: control groupNo intervention 0 interventions
Group B: skin-to-skin contact (SSC) groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
at 4 months of ageSecondary outcomes
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.
Time frame
at 1 month, 8 months, and 12 months of age2
Korean-Edinburgh Postnatal Depression score
mother questionnaire range 0-30 low risk 0-8 borderline risk 9-12 high risk 13-30
Time frame
3 to 7 days, 1 month, and 4 months of infant age3
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
Time frame
3 to 7 days, 1 month, 4 months, 8 months, and 12 months of infant age4
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.
Time frame
at 1 month, 4 months, 8 months, and 12 months of infant ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov