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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06550440
Enrollment
1255
Registered
2024-08-13
Start date
2021-02-01
Completion date
2024-05-01
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very Low Birth Weight Infant

Keywords

very low birth weight infants, family integrated care

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.

Interventions

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.

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
28 Weeks to 32 Weeks
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
total duration of family integrated careFrom 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

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

Other

MeasureTime frameDescription
Retinopathy of prematurityFrom the day admitted into the NICU until day on discharge, an average of 2 months.diagnosed according to the International Classification of Retinopathy of Prematurity
Intraventricular hemorrhageFrom the day admitted into the NICU until day on discharge,an average of 2 months.the diagnosis is based on Paplie's classification
Late-onset sepsisFrom the day admitted into the NICU until day on discharge, an average of 2 months.sepsis occurs \>72h after birth
Bronchopulmonary dysplasiaFrom the day admitted into the NICU until day on discharge,an average of 2 months.oxygen is required at 36 weeks of corrected gestational age or at discharge

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026