Impact of developmental care on very low birth weight infants
Official title: Effect of Developmental Care on Very Low Birth Weight Infants: a Stepped-wedge Cluster Randomised Trial
Run by Children's Hospital of Fudan University · NCT06515574 · Data updated 2026-11-12
This study is testing whether special care for very low birth weight babies in NICUs can help them stay healthier and shorten their time in the hospital while also supporting their families.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Days to 30 Days |
| Sex | All |
| Enrollment | 1600 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 2 sites (Shanghai, Shanghai / 上海 and 1 other locations) |
| Status | Recruiting |
| Started | August 30, 2024 |
| Main results expected | August 30, 2028 |
| Study ends | December 1, 2028 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT06515574 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are very low birth weight infants weighing less than 1500 grams who are admitted to a level III NICU within 24 hours of birth.
✕Probably not a fit
Patients with severe congenital malformations, chromosomal disorders, genetic metabolic diseases, or severe neurological disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of developmental care for very low birth weight (VLBW) infants in Neonatal Intensive Care Units (NICUs). It will assess whether this approach can reduce hospital stay lengths and enhance family-centered care opportunities. The study employs a 36-month stepped-wedge cluster-randomized design across 40 NICUs, where each unit will eventually implement a tailored developmental care bundle. Data will be collected at multiple time points to analyze the intervention's impact on both infants and their families.
Why it matters
Potential benefit: If successful, this approach could lead to shorter hospital stays and improved family involvement in the care of very low birth weight infants.
How similar studies have gone: Other studies have shown promising results with developmental care approaches in NICUs, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Birth weights less than 1500 g 2. Admitted or transported to a level III NICU within 24h of birth 3. OI\>30 Exclusion Criteria: 1. Severe congenital malformations 2. various chromosomal disorders 3. genetic metabolic diseases, 4. severe neurological disorders
Where it's running
-
Children's hospital of Fudan university
Shanghai, Shanghai / 上海, China Recruiting -
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China Not yet recruiting
Study contacts
- Study coordinator: Lyu Tianchan
- Email: lvtianchan1988@aliyun.com
- Phone: 18017590870
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.