Effect of Developmental Care on Very Low Birth Weight Infants
1 other identifier
interventional
1,600
1 country
2
Brief Summary
The goal of this clinical trial is to learn if developmental care works when implemented in very low birth weight infants. The main questions it aims to answer are:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2024
Longer than P75 for not_applicable
2 active sites
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
July 10, 2024
CompletedFirst Posted
Study publicly available on registry
July 23, 2024
CompletedStudy Start
First participant enrolled
August 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
March 16, 2026
March 1, 2026
3 years
July 10, 2024
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of hospital stay
Length of hospital stay (in days)
From the day admitted into the NICU until day on discharge, generally assessed up to 1 year
Secondary Outcomes (1)
Skin to skin care duration
From the day admitted into the NICU until day on discharge, generally assessed up to 1 year
Other Outcomes (1)
Parental involvement duration
From the day admitted into the NICU until day on discharge, generally assessed up to 1 year
Study Arms (2)
Developmental care
EXPERIMENTALIn stage 1, participant in this arm will receive the developmental care
Usual care
NO INTERVENTIONParticipant in this arm will receive the usual care
Interventions
Individualized Developmental Care that includes the light, noise, sleep, etc.
Eligibility Criteria
You may qualify if:
- Birth weights less than 1500 g
- Admitted or transported to a level III NICU within 24h of birth
- OI\>30
You may not qualify if:
- Severe congenital malformations
- various chromosomal disorders
- genetic metabolic diseases,
- severe neurological disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Children's hospital of Fudan university
Shanghai, Shanghai / 上海, 201102, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2024
First Posted
July 23, 2024
Study Start
August 30, 2024
Primary Completion (Estimated)
August 30, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Unidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan, the informed consent form and the related code. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to corresponding authors.