Effect of Developmental Care on Very Low Birth Weight Infants
ConditionIntervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-30
SponsorChildren's Hospital of Fudan University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Birth weights less than 1500 g
Admitted or transported to a level III NICU within 24h of birth
OI>30
Disqualifiers
Severe congenital malformations
various chromosomal disorders
genetic metabolic diseases,
severe neurological disorders
Trial design
Design model
Sequential
Treatments tested in this trial
developmental care
BehavioralIndividualized Developmental Care that includes the light, noise, sleep, etc.
Treatment groups
1,600 Participants
are divided into 2 treatment groupsGroup A: Developmental careExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Length of hospital stay
Length of hospital stay (in days)
Time frame
From the day admitted into the NICU until day on discharge, generally assessed up to 1 yearSecondary outcomes
1
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
Time frame
From the day admitted into the NICU until day on discharge, generally assessed up to 1 yearOther outcomes
1
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
Time frame
From the day admitted into the NICU until day on discharge, generally assessed up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov