RecruitingNot ApplicableNCT06515574

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


Sponsor

Children's Hospital of Fudan University

Enrollment

1,600 participants

Start Date

Aug 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 0 DaysMax Age: 30 Days

Inclusion Criteria3

  • Birth weights less than 1500 g
  • Admitted or transported to a level III NICU within 24h of birth
  • OI\>30

Exclusion Criteria4

  • Severe congenital malformations
  • various chromosomal disorders
  • genetic metabolic diseases,
  • severe neurological disorders

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Interventions

BEHAVIORALdevelopmental care

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


Locations(2)

Children's hospital of Fudan university

Shanghai, Shanghai / 上海, China

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

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NCT06515574


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