NCT05483231

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 0 Hours – 24 Hours
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Very Low Birth Weight Infant

Interventions

Type	Name	Description
BEHAVIORAL	Family integrated care intervention group	If the very low birth weight infants' vital signs are stable at 32 weeks of corrected gestational age, parents who have been fully trained will provide all non-medical care measures and developmental care for the VLBWIs in the NICU for not less than 6 hours per day for at least 3 weeks, and other medical practice and care measures will be the same as the routine group.
BEHAVIORAL	Routine nursing care group	Routine practice and in-hospital education will be given to the very low birth weight infants and parents. All care measures will be led by the nursing staff, without the participation of parents.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2022-08-02
• Last updated: 2023-08-14

Locations

1 site across 1 country: China