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The Effect of Family Integrated Care on Melatonin Level in Very Low Birth Weight Infants

Very Low Birth Weight Infant Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05483231
Study type Interventional
Source Children's Hospital of Fudan University
Contact Yi Zhang, Master
Phone +8618071608186
Email 20211170025@fudan.edu.cn
Status Not yet recruiting
Phase N/A
Start date December 1, 2023
Completion date April 30, 2024
View Details
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