Effect of Developmental Care on Very Low Birth Weight Infants
NCT ID: NCT06515574
Last Updated: 2025-01-20
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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RECRUITING
NA
1600 participants
INTERVENTIONAL
2024-08-30
2027-12-01
Brief Summary
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* Does developmental care shorten the length of hospital stay in the very low birth weight infants?
* Does developmental care increase the opportunity of family centered care in the very low birth weight infants? The clinical trial will use a 36-month stepped-wedge cluster-randomised trial conducted across 40 Neonatal intensive care units . A developmental care bundle will be tailored to meet the identified needs of participating NICUs.
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Detailed Description
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The clinical trial investigates the effectiveness of developmental care in very low birth weight (VLBW) infants. The primary objectives are to determine whether developmental care can (1) reduce the length of hospital stay and (2) enhance the opportunity for family-centered care in these infants. The study employs a 36-month stepped-wedge cluster-randomised trial design, involving 40 Neonatal Intensive Care Units (NICUs).
In this trial, all NICUs will eventually receive the intervention, but the order in which they start implementing the developmental care bundle will be randomized. This approach allows each NICU to serve as its own control, comparing outcomes before and after the intervention.
Data collection will occur at multiple time points before and after the implementation of the developmental care bundle, enabling a comprehensive analysis of its impact. By tailoring interventions to each NICU's specific context and needs, the study aims to generate robust evidence on the benefits of developmental care for VLBW infants and their families.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Developmental care
In stage 1, participant in this arm will receive the developmental care
developmental care
Individualized Developmental Care that includes the light, noise, sleep, etc.
Usual care
Participant in this arm will receive the usual care
No interventions assigned to this group
Interventions
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developmental care
Individualized Developmental Care that includes the light, noise, sleep, etc.
Eligibility Criteria
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Inclusion Criteria
2. Admitted or transported to a level III NICU within 24h of birth
3. OI\>30
Exclusion Criteria
2. various chromosomal disorders
3. genetic metabolic diseases,
4. severe neurological disorders
0 Days
30 Days
ALL
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Responsible Party
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Locations
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Children's hospital of Fudan university
Shanghai, Shanghai / 上海, China
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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20240610
Identifier Type: -
Identifier Source: org_study_id
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