Skin-to-skin Contact in Healthy Term Infants

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Percentage of any breast feeding (combined with formula and/or solid or not) [Срок оценки: at 4 months of age]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

South Korea · 2 центра

• Korea University Anam Hospital NICU — Seoul
• Korea University Anam Hospital NICU — Seoul

Публикации

• 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

Идентификаторы

NCT: NCT06777524 · 2024AN0613

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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