The Effect of Family Integrated Care on Melatonin Level in Very Low Birth Weight Infants
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2022
CompletedFirst Posted
Study publicly available on registry
August 2, 2022
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedAugust 14, 2023
August 1, 2023
5 months
June 28, 2022
August 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Breast feeding rate
At the day 21 after the implementation of Family integrated care intervention
Changes in maternal milk volume
From baseline to day 21 after the implementation of Family integrated care intervention
Rate of weight gain
From baseline to day 21 after the implementation of Family integrated care intervention
Incidence of complications related to preterm birth
Through study completion, about an average of 21 days
Length of hospitalization
Through study completion, about an average of 21 days
- +1 more secondary outcomes
Study Arms (2)
Family integrated care intervention group
EXPERIMENTALProvide Family integrated care for very low birth weight infants in the NICU.
Routine nursing care group
OTHERPerform routine nursing care for very low birth weight infants in the NICU.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Newborns who require palliative care or surgical intervention;
- OI (oxygenation index) \<300 ;
- Newborns with severe congenital malformations;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaojing Hu, PhD
Children's Hospital of Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2022
First Posted
August 2, 2022
Study Start
December 1, 2023
Primary Completion
April 30, 2024
Study Completion
April 30, 2024
Last Updated
August 14, 2023
Record last verified: 2023-08