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临床试验/NCT07747870
NCT07747870已完成不适用

Evaluation of Daily Skin-to-Skin Contact Duration in the Valenciennes Kangaroo Care Unit

Centre Hospitalier de Valenciennes1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
1
主要终点
Average daily duration of skin-to-skin contact

研究概览

简要总结

Kangaroo Mother Care promotes prolonged skin-to-skin contact between newborns and their parents. Although this practice is routinely encouraged in Kangaroo Care Units, the daily duration of skin-to-skin contact varies substantially between families.

This prospective observational study aims to estimate the average daily duration of skin-to-skin contact among newborns admitted to the Kangaroo Unit at Valenciennes Hospital and to identify maternal, neonatal, and organizational factors associated with this practice.

This non-interventional study does not modify routine clinical care. Data are collected from routinely available medical records, a brief parental questionnaire completed at enrollment, and the daily recording of skin-to-skin contact performed throughout hospitalization.

The study will provide a description of skin-to-skin practice in a specialized Kangaroo Unit and may help inform future strategies to support the implementation of Kangaroo Mother Care.

详细描述

Background

Kangaroo Mother Care (KMC) combines prolonged skin-to-skin contact between the newborn and a parent with breastfeeding support whenever possible. Evidence from randomized trials and systematic reviews has demonstrated that KMC improves physiological stability, breastfeeding, sleep organization, pain management, neurodevelopment, parent-infant bonding, and parental well-being in preterm infants.

Although KMC is widely recommended for clinically stable preterm infants, substantial variation exists in its implementation across neonatal units. Daily skin-to-skin duration differs considerably between families, even in dedicated Kangaroo Units where continuous parent-infant proximity is encouraged. The reasons for this variability remain incompletely understood.

The Kangaroo Unit at Valenciennes Hospital has routinely implemented Kangaroo Mother Care since 2005. A previous observational evaluation demonstrated that prolonged daily skin-to-skin contact could be achieved safely within this setting. However, important differences in practice between families were observed.

Rationale

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Minute 至 72 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm newborn with a gestational age between 33 weeks 0 days and 34 weeks 6 days and/or a birth weight of 1500g and 2000 g
  • admitted to the Kangaroo Unit within the first 72 hours after birth

排除标准

  • Mother-infant separation lasting more than 72 hours after birth
  • Triplet or higher-order multiple pregnancy
  • Refusal of participation by one or both parents
  • Cognitive impairment preventing provision of study information to a parent and/or collection of study data
  • Inability to communicate with the parents (e.g. language barrier)
  • Mother deprived of liberty
  • No health insurance coverage

研究组 & 干预措施

Kangaroo Unit Cohort

Eligible infants admitted to the Kangaroo Unit who received routine Kangaroo Mother Care according to standard clinical practice during hospitalization. The study was observational and did not modify patient management.

结局指标

主要结局

Average daily duration of skin-to-skin contact

时间窗: Up to 25 days (until discharge from the Kangaroo Unit)

Average duration of skin-to-skin contact per day (hours/day) during hospitalization in the Kangaroo Unit, excluding the admission and discharge days. Daily duration is routinely recorded by healthcare professionals.

次要结局

  • Association between parental, neonatal, socioeconomic, obstetric, postnatal and organizational characteristics and average daily duration of skin-to-skin contact(Up to 25 days (until discharge from the Kangaroo Unit))

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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