Effect 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

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.

Study Overview

• Status: Recruiting
• Conditions: Intervention
• Intervention / Treatment: Behavioral: developmental care

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 Type: Interventional
• Enrollment (Estimated): 1600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lyu Tianchan; Phone Number: 18017590870; Email: lvtianchan1988@aliyun.com

Study Locations

• China
  • Shanghai / 上海
    • Shanghai, Shanghai / 上海, China, 201102
      • Recruiting
      • Children's Hospital of Fudan University
      • Contact: LYU tianchan; Phone Number: 02164935075; Email: lvtianchan1988@aliyun.com
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Not yet recruiting
      • Children's Hospital of Fudan University
      • Contact: Xiaojing Hu, PhD; Phone Number: 18017590869; Email: humama2015@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Developmental care; In stage 1, participant in this arm will receive the developmental care	Behavioral: developmental care; Individualized Developmental Care that includes the light, noise, sleep, etc.
No Intervention: Usual care; Participant in this arm will receive the usual care

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin to skin care duration	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	From the day admitted into the NICU until day on discharge, generally assessed up to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental involvement duration	Parental involvement in our study is defined as the parents take part in the daily Care Activities (diapering, bathing, clothing and feeding for their babies).Record the duration of parental involvement every day during the hospitalization by hours	From the day admitted into the NICU until day on discharge, generally assessed up to 1 year

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2024
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: developmental care
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 20240610

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Unidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan, the informed consent form and the related code. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to corresponding authors.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No