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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Very Low Birth Weight Infant
• Intervention / Treatment: Behavioral: Family integrated care intervention group; Behavioral: Routine nursing care group

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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Zhang, Master; Phone Number: +8618071608186; Email: 20211170025@fudan.edu.cn
• Study Contact Backup: Name: Xiaojing Hu, PhD; Phone Number: +8618017590869; Email: humama2015@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children's Hospital of Fudan University
      • Contact: Yi Zhang, Master; Phone Number: +8618071608186; Email: 20211170025@fudan.edu.cn
      • Contact: Xiaojing Hu, PhD; Phone Number: +8618017590869; Email: humama2015@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 day (Child)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family integrated care intervention group; Provide Family integrated care for very low birth weight infants in the NICU.	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.
Other: Routine nursing care group; Perform routine nursing care for very low birth weight infants in the NICU.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes on the level of Melatonin in very low birth weight infants	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.	From baseline to day 21 after the implementation of Family integrated care intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast feeding rate	Data will be acquired at the day 21 after the implementation of FICare intervention by a specially-assigned person. Breastfeeding rate = number of VLBWI fed from mother's milk/total number of VLBWI enrolled in each group *100%.	At the day 21 after the implementation of Family integrated care intervention
Changes in maternal milk volume	At 32 weeks of corrected gestational age (baseline) and day 21 after the implementation of FICare intervention, maternal milk volume will be collected from lactation diary records issued before the intervention.	From baseline to day 21 after the implementation of Family integrated care intervention
Rate of weight gain	Weight is measured by a parent or nurse. Rate of weight gain = ( Weight measured at day 21 after the intervention - weight measured at 32 weeks of corrected gestational age)/total number of intervention days.	From baseline to day 21 after the implementation of Family integrated care intervention
Incidence of complications related to preterm birth	Complications related to preterm birth include neonatal sepsis, bronchopulmonary dysplasia (BPD), intraventicular hemorrhage (IVH), periventricular leukinomalacia (PVL), and retinopathy of prematurity (ROP). These complications are diagnosed by a neonatologist. If any of these conditions occurred during the intervention, complications related to preterm birth would be considered. Data will be obtained from the case system or data collection form.	Through study completion, about an average of 21 days
Length of hospitalization	Length of hospitalization refers to the total number of days from 32 weeks of corrected gestational age (baseline) to the day of discharge. Data will be obtained from the case system.	Through study completion, about an average of 21 days
Growth rate of head circumference	Head circumference is measured by a parent or nurse. Growth rate of head circumference = ( head circumference measured at day 21 after the intervention - head circumference measured at 32 weeks of corrected gestational age)/total number of intervention days.	From baseline to day 21 after the implementation of Family integrated care intervention

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Principal Investigator: Xiaojing Hu, PhD, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Melatonin; Family integrated care
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 2021-453

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No