Effect of Developmental Care on Very Low Birth Weight Infants

NCT06515574 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

  • Intervention

Interventions

BEHAVIORAL

developmental care

Individualized Developmental Care that includes the light, noise, sleep, etc.

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
0 Days
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-30
Primary Completion
2027-08-30
Completion
2027-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06515574 on ClinicalTrials.gov