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

Fudan University

Status: Not yet enrolling

Conditions: Very Low Birth Weight Infant

Treatments: Behavioral: Routine nursing care group; Behavioral: Family integrated care intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT05483231

2021-453

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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;

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Family integrated care intervention group

Experimental group

Description:

Provide Family integrated care for very low birth weight infants in the NICU.

Treatment:

Behavioral: Family integrated care intervention group

Routine nursing care group

Other group

Description:

Perform routine nursing care for very low birth weight infants in the NICU.

Treatment:

Behavioral: Routine nursing care group