Actively Recruiting
Study on Developmental Care Effects in Very Low Birth Weight Infants in NICUs
Led by Children's Hospital of Fudan University · Updated on 2026-03-16
1600
Participants Needed
2
Research Sites
13 weeks
Total Duration
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
Research Team
L
Lyu Tianchan
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