Effect of developmental care on very low birth weight infants: a protocol for a stepped-wedge cluster randomized trial

Very low birth weight infants (VLBWIs), defined as those with a birth weight <1500 g, are at high risk of neurodevelopmental impairments, medical complications, and prolonged hospitalization due to physiological immaturity and exposure to stressful neonatal intensive care unit (NICU) environments. Developmental care (DC), an evidence-based approach including interventions such as skin-to-skin care (SSC), environmental light and noise modulation, and family-centered support, has shown significant potential in improving both short- and long-term outcomes for these vulnerable infants. However, the majority of existing evidence originates from high-income countries, and the adaptation, implementation, and scalability of DC practices in low-resource settings, such as China, remain limited. This study evaluates the effectiveness of a multimodal DC bundle in reducing the length of hospital stay (LOS) among VLBWIs and improving a range of clinical, developmental, environmental, and parental outcomes across 43 tertiary NICUs in China. We are conducting a stepped-wedge cluster randomized trial (SW-CRT), involving 43 tertiary NICUs across 36 cities and municipalities in China. The study population comprises VLBWIs (<1500 g) who are admitted within 24 h of birth. The DC intervention consists of 11 tailored components, including environmental management, parental involvement, developmental support, and feeding strategies. Study sites transition from control condition to the intervention phase in a randomized sequence over a 26-month implementation period. The primary outcome is LOS. Secondary outcomes include measures of family-centered care practices, environmental conditions (light and noise levels), short-term morbidity and mortality (bronchopulmonary dysplasia [BPD], retinopathy of prematurity [ROP], necrotizing enterocolitis [NEC], intraventricular hemorrhage [IVH]), neurodevelopmental status at discharge assessed using the Test of Infant Motor Performance (TIMP), and parental satisfaction measured by the EMPATHIC-30 questionnaire. Quantitative data will be analyzed using multivariable regression models that will account for clustering and temporal effects. A mixed-methods process evaluation will be conducted to assess implementation fidelity, along with identified barriers to and facilitators of the intervention delivery. This trial will generate robust, real-world evidence on the scalability and effectiveness of DC in NICUs across China, thereby supporting the development of standardized, evidence-based guidelines for DC in low-resource settings. ClinicalTrials.gov NCT06515574. Registered on 10 June 2024.