Impact of developmental care on very low birth weight infants
Effect of Developmental Care on Very Low Birth Weight Infants: a Stepped-wedge Cluster Randomised Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1600 (estimated) |
| Ages | 0 Days to 30 Days |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 2 sites (Shanghai, Shanghai / 上海 and 1 other locations) |
| Trial ID | NCT06515574 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe congenital malformations, chromosomal disorders, genetic metabolic diseases, or severe neurological disorders may not benefit from this study.
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 performed: Other studies have shown promising results with developmental care approaches in NICUs, indicating potential for success in this trial.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai / 上海 and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.