The Effect of Family Integrated Care on Melatonin Level in Very Low Birth Weight Infants
NCT ID: NCT05483231
Last Updated: 2023-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
64 participants
INTERVENTIONAL
2023-12-01
2024-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Family integrated care intervention group
Provide Family integrated care for very low birth weight infants in the NICU.
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.
Routine nursing care group
Perform routine nursing care for very low birth weight infants in the NICU.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* OI (oxygenation index) \<300 ;
* Newborns with severe congenital malformations;
0 Hours
24 Hours
ALL
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Responsible Party
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Principal Investigators
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Xiaojing Hu, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Fudan University
Locations
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-453
Identifier Type: -
Identifier Source: org_study_id
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