The Impact of Family Integrated Care on Extrauterine Growth Restriction at Discharge in Very Low Birth Weight Infants

Completed

• Conditions: Very Low Birth Weight Infant
• Interventions: Behavioral: family integrated care

• Registration Number: NCT06550440
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2023-11-30
• Study Completion: 2024-05-01
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-11
• Study First Posted: 2024-08-13
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1255

Inclusion Criteria

1. Newborns admitted to 17 units in 8 provinces from February 2021 to November 2023;
2. Birth weight < 1500 g, gestational age < 32 weeks;
3. admitted in NICU within 24 hours after birth;
4. 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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the control group	family integrated care	Very low birth weight infants without extrauterine growth restriction at discharge.
the case group	family integrated care	Very low birth weight infants with extrauterine growth restriction at discharge.

Primary Outcome Measures

Name	Time	Method
total duration of family integrated care	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 Outcome Measures

Name	Time	Method
Necrotizing enterocolitis	From the day admitted into the NICU until day on discharge, an average of 2 months.	diagnosed according to the Bella classification
Birth weight	assessed at birth.	birth weight in grams
Small for gestational age	assessed at birth.	birth weight\<10th percentile of the neonatal growth curve for infants of the same sex and gestational age
gestational age	assessed at birth.	gestational age at weeks

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China