Effect of Developmental Care on Very Low Birth Weight Infants

Not Applicable

Recruiting

• Conditions: Intervention
• Interventions: Behavioral: developmental care

• Registration Number: NCT06515574
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

The goal of this clinical trial is to learn if developmental care works when implemented in very low birth weight infants. The main questions it aims to answer are:

* Does developmental care shorten the length of hospital stay in the very low birth weight infants?

* Does developmental care increase the opportunity of family centered care in the very low birth weight infants? The clinical trial will use a 36-month stepped-wedge cluster-randomised trial conducted across 40 Neonatal intensive care units . A developmental care bundle will be tailored to meet the identified needs of participating NICUs.

Detailed Description

Developmental care in the NICU focuses on creating a nurturing environment that supports the physical, emotional, and developmental needs of premature infants. This approach includes strategies like minimizing unnecessary noise and light, ensuring appropriate positioning and handling of infants, promoting skin-to-skin contact, and facilitating parental involvement in care.

The clinical trial investigates the effectiveness of developmental care in very low birth weight (VLBW) infants. The primary objectives are to determine whether developmental care can (1) reduce the length of hospital stay and (2) enhance the opportunity for family-centered care in these infants. The study employs a 36-month stepped-wedge cluster-randomised trial design, involving 40 Neonatal Intensive Care Units (NICUs).

In this trial, all NICUs will eventually receive the intervention, but the order in which they start implementing the developmental care bundle will be randomized. This approach allows each NICU to serve as its own control, comparing outcomes before and after the intervention.

Data collection will occur at multiple time points before and after the implementation of the developmental care bundle, enabling a comprehensive analysis of its impact. By tailoring interventions to each NICU's specific context and needs, the study aims to generate robust evidence on the benefits of developmental care for VLBW infants and their families.

Study Timeline

• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-23
• Study Start: 2024-08-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Primary Completion: 2027-08-30
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

Not provided

Exclusion Criteria

1. Severe congenital malformations
2. various chromosomal disorders
3. genetic metabolic diseases,
4. severe neurological disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Developmental care	developmental care	In stage 1, participant in this arm will receive the developmental care

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	From the day admitted into the NICU until day on discharge, generally assessed up to 1 year	Length of hospital stay (in days)

Secondary Outcome Measures

Name	Time	Method
Skin to skin care duration	From the day admitted into the NICU until day on discharge, generally assessed up to 1 year	Skin-to-skin care, also known as kangaroo care, involves placing a newborn baby directly on a parent's bare chest. Record the duration of skin to skin care every day during the hospitalization by hours

Trial Locations

Locations (2)

Children's hospital of Fudan university; 🇨🇳 Shanghai, Shanghai, China

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China