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

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

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

Study Overview

• Status: Completed
• Conditions: Very Low Birth Weight Infant
• Intervention / Treatment: Behavioral: family integrated care

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 Type: Observational
• Enrollment (Actual): 1255

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

very low birth weight infants

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
the control group; Very low birth weight infants without extrauterine growth restriction at discharge.	Behavioral: family integrated care; Trained NICU nurses give effective education to parents of children, and regard parents as a part of NICU team, so that they can actively provide positive care for babies instead of passive caregivers. Parents mainly participate in nursing care such as bottle feeding, changing diapers, skin contact and so on.
the case group; Very low birth weight infants with extrauterine growth restriction at discharge.	Behavioral: family integrated care; Trained NICU nurses give effective education to parents of children, and regard parents as a part of NICU team, so that they can actively provide positive care for babies instead of passive caregivers. Parents mainly participate in nursing care such as bottle feeding, changing diapers, skin contact and so on.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total duration of family integrated care	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.	From the day admitted into the NICU until day on discharge，an average of 2 months.

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bronchopulmonary dysplasia	oxygen is required at 36 weeks of corrected gestational age or at discharge	From the day admitted into the NICU until day on discharge，an average of 2 months.
Retinopathy of prematurity	diagnosed according to the International Classification of Retinopathy of Prematurity	From the day admitted into the NICU until day on discharge, an average of 2 months.
Intraventricular hemorrhage	the diagnosis is based on Paplie's classification	From the day admitted into the NICU until day on discharge，an average of 2 months.
Late-onset sepsis	sepsis occurs >72h after birth	From the day admitted into the NICU until day on discharge, an average of 2 months.

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Principal Investigator: Xiaojing Hu, PhD, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 11, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: very low birth weight infants; family integrated care
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 20240712

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No