The Effect of Family Integrated Care on Melatonin Level in Very Low Birth Weight Infants in Neonatal Intensive Care Unit: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Changes on the level of Melatonin in very low birth weight infants
研究概览
简要总结
This study will explore the effect of Family integrated care (FICare) on the level of melatonin and other clinical outcomes in very low birth weight infants (VLBWIs) by integrating families into the neonatal intensive care unit (NICU) care team and participating in the daily care of VLBWIs, as well as the influence of FIcare on parents' outcomes.
详细描述
This study is a multicenter randomized controlled trial which mainly explores the effect of Family integrated care (FICare) on melatonin levels in very low birth weight infants (VLBWIs) in neonatal intensive care unit (NICU). The intervention group will use a FICare intervention program, mainly for families who have been fully trained by the NICU professional team and need to stay in the NICU to accompany and care for the VLBWIs for not less than 6 hours a day for at least 3 weeks. All non-medical care measures and developmental supportive care will be provided by parents as much as possible. The control group received routine nursing interventions in which all non-medical interventions are led by NICU staff and without parental involvement. The level of melatonin, clinical and parental outcomes in VLBWIs are compared between the intervention group and the control group to evaluate the effect of FICare intervention program.
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
- None
入排标准
- 年龄范围
- 0 Hours 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight < 1500g;
- •Gestational age < 32w;
- •Admit within 24 hours of birth;
- •The parents are conscious and able to cooperate, have certain learning and reading comprehension skills, and are capable of caring for their babies. They are committed to receiving training and caring for their babies for not less than 6 hours a day for at least 21 days;
- •Voluntarily participate in this study and sign informed consent.
- •Exclusion Criteria
- •Newborns who require palliative care or surgical intervention;
- •OI (oxygenation index) <300 ;
- •Newborns with severe congenital malformations;
排除标准
- 未提供
结局指标
主要结局
Changes on the level of Melatonin in very low birth weight infants
时间窗: From baseline to day 21 after the implementation of Family integrated care intervention
At 32 weeks of corrected gestational age (baseline) and day 21 after the implementation of FICare intervention, melatonin will be quantitatively measured by high performance liquid chromatography-mass spectrometry (HPLC-MS) with saliva samples collected by a specially-assigned person.
次要结局
- Breast feeding rate(At the day 21 after the implementation of Family integrated care intervention)
- Changes in maternal milk volume(From baseline to day 21 after the implementation of Family integrated care intervention)
- Rate of weight gain(From baseline to day 21 after the implementation of Family integrated care intervention)
- Incidence of complications related to preterm birth(Through study completion, about an average of 21 days)
- Length of hospitalization(Through study completion, about an average of 21 days)
- Growth rate of head circumference(From baseline to day 21 after the implementation of Family integrated care intervention)