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Clinical Trials/NCT06550440
NCT06550440
Completed
Not Applicable

The Impact of Family Integrated Care on the Occurrence of Extrauterine Growth Restriction at Discharge in Very Low Birth Weight Infants: a Multicenter, Retrospective Case-control Study

Children's Hospital of Fudan University1 site in 1 country1,255 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Very Low Birth Weight Infant
Sponsor
Children's Hospital of Fudan University
Enrollment
1255
Locations
1
Primary Endpoint
total duration of family integrated care
Status
Completed
Last Updated
last year

Overview

Brief Summary

To explore the influence of multi-angle factors, including family integrated care, on extrauterine growth restriction at discharge of very low birth weight infants.

Detailed Description

To explore the influence of multi-angle factors, including family integrated care, on extrauterine growth restriction at discharge of very low birth weight infants.Very low birth weight infants admitted to 17 neonatal intensive care units in 8 provinces and cities in southeast China from February 2021 to November 2023 were retrospectively included, which were divided into case group and control group according to whether there was extrauterine growth restriction (defined as the weight below the 10th percentile of children of the same age at discharge). The general situation at birth, the length of hospital stay, the incidence of complications during hospital stay, the feeding situation, the length of family participation care and the perinatal situation of the mother were compared between the two groups. The generalized linear mixed model was used to analyze the influencing factors of extrauterine growth retardation at discharge, and the results of influencing factors were visualized by GraphPad Prism 9.0 software.

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
May 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Newborns admitted to 17 units in 8 provinces from February 2021 to November 2023;
  • Birth weight \< 1500 g, gestational age \< 32 weeks;
  • admitted in NICU within 24 hours after birth;
  • premature infants without complications (including bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, intraventricular hemorrhage and late-onset septicemia) at the time of admission.

Exclusion Criteria

  • death occurred during hospitalization;
  • Incomplete outcome data (lack of EUGR data at discharge).

Outcomes

Primary Outcomes

total duration of family integrated care

Time Frame: From the day admitted into the NICU until day on discharge,an average of 2 months.

Trained NICU staffs effectively educate parents as part of the NICU team so that they can proactively provide active care for the baby, rather than passive caregivers. Parents are primarily involved in care such as bottle feeding, diaper changing, skin-to-skin contact and so on.We calculate total duration of family integrated care in hours.

Secondary Outcomes

  • Necrotizing enterocolitis(From the day admitted into the NICU until day on discharge, an average of 2 months.)
  • Birth weight(assessed at birth.)
  • Small for gestational age(assessed at birth.)
  • gestational age(assessed at birth.)

Study Sites (1)

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