Actively Recruiting
Effect of Developmental Care on Very Low Birth Weight Infants: a Stepped-wedge Cluster Randomised Trial
Led by Children's Hospital of Fudan University · Updated on 2026-03-16
1600
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of developmental care on very low birth weight infants in neonatal intensive care units (NICUs). The study aims to find out if developmental care can shorten hospital stays and increase opportunities for family-centered care. This trial uses a 36-month stepped-wedge cluster-randomised design involving 40 NICUs, with each unit receiving the intervention in a random order. The intervention involves individualized developmental care, which includes managing light, noise, sleep, positioning, handling, skin-to-skin contact, and encouraging parental involvement. The study compares outcomes before and after implementing the developmental care bundle, with one group receiving developmental care and another receiving usual care. Each NICU serves as its own control during the trial. Participants are monitored from admission to discharge, typically up to one year, with data collected at multiple points. Researchers will measure the length of hospital stay as the primary outcome, along with secondary outcomes like the duration of skin-to-skin care. The study will provide detailed insights into the impact of developmental care on the physical and emotional well-being of very low birth weight infants and their families.
CONDITIONS
Brief Title
Effect of Developmental Care on Very Low Birth Weight Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Birth weight less than 1500 grams
- Admitted or transported to a level III NICU within 24 hours of birth
- Oxygenation Index (OI) greater than 30
You will not qualify if you...
- Severe congenital malformations
- Various chromosomal disorders
- Genetic metabolic diseases
- Severe neurological disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From NICU admission until discharge, generally up to 1 year
Participants receive individualized developmental care in the NICU, focusing on minimizing noise and light, promoting skin-to-skin contact, and involving families in care.
Care occurs continuously during hospital stay with multiple daily interactions
Duration - Up to 1 year after discharge
Participants are monitored after discharge to assess long-term outcomes such as developmental progress and family-centered care benefits.
Follow-up visits scheduled as per NICU protocol
Trial Site Locations
Total: 2 locations
1
Children's hospital of Fudan university
Shanghai, Shanghai / 上海, China, 201102
Actively Recruiting
2
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
Research Team
L
Lyu Tianchan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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