NCT06777524招募中不适用
Short-term and Long-term Effects of Skin-to-skin Contact in Healthy Term Infants
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Percentage of any breast feeding (combined with formula and/or solid or not)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
- 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.
入排标准
- 年龄范围
- 1 Hour 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: skin-to-skin contact education (Behavioral)
结局指标
主要结局
Percentage of any breast feeding (combined with formula and/or solid or not)
时间窗: at 4 months of age
This includes both exclusive breastfeeding and partial breastfeeding combined with formula and/or solid food.
次要结局
- 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)
研究者
Juyoung Lee
Professor
Korea University Anam Hospital
研究点 (2)
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