Clinical trial NCT06550440: The Impact of Family Integrated Care on Extrauterine Growth Restriction at Discharge in Very Low Birth Weight Infants
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Very Low Birth Weight Infant
Keywords: very low birth weight infants
family integrated care
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 1255
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: very low birth weight infants

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.

Eligibility criteria: 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).

Primary outcomes:
measure: total duration of family integrated care
timeFrame: From the day admitted into the NICU until day on discharge，an average of 2 months.
Secondary outcomes:
measure: Birth weight
timeFrame: assessed at birth.
measure: Small for gestational age
timeFrame: assessed at birth.
measure: Necrotizing enterocolitis
timeFrame: From the day admitted into the NICU until day on discharge, an average of 2 months.
measure: gestational age
timeFrame: assessed at birth.
Other outcomes:
measure: Bronchopulmonary dysplasia
timeFrame: From the day admitted into the NICU until day on discharge，an average of 2 months.
measure: Retinopathy of prematurity
timeFrame: From the day admitted into the NICU until day on discharge, an average of 2 months.
measure: Intraventricular hemorrhage
timeFrame: From the day admitted into the NICU until day on discharge，an average of 2 months.
measure: Late-onset sepsis
timeFrame: From the day admitted into the NICU until day on discharge, an average of 2 months.
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xiaojing Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References: