Clinical trial NCT05483231: The Effect of Family Integrated Care on Melatonin Level in Very Low Birth Weight Infants
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Very Low Birth Weight Infant
Keywords: Family integrated care
Melatonin
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 64
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility 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;

Primary outcomes:
measure: Changes on the level of Melatonin in very low birth weight infants
timeFrame: From baseline to day 21 after the implementation of Family integrated care intervention
Secondary outcomes:
measure: Breast feeding rate
timeFrame: At the day 21 after the implementation of Family integrated care intervention
measure: Changes in maternal milk volume
timeFrame: From baseline to day 21 after the implementation of Family integrated care intervention
measure: Rate of weight gain
timeFrame: From baseline to day 21 after the implementation of Family integrated care intervention
measure: Incidence of complications related to preterm birth
timeFrame: Through study completion, about an average of 21 days
measure: Length of hospitalization
timeFrame: Through study completion, about an average of 21 days
measure: Growth rate of head circumference
timeFrame: From baseline to day 21 after the implementation of Family integrated care intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xiaojing Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References: