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

NCT06550440 | Completed

• 1 other identifier: 20240712
• Study Type: observational
• Target: 1,255
• Locations: 1 country
• Sites: 1

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.

Conditions

Very Low Birth Weight Infant

Keywords

very low birth weight infants; family integrated care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Birth weight

  assessed at birth.

• Small for gestational age

  assessed at birth.

• Necrotizing enterocolitis

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

• gestational age

  assessed at birth.

Other Outcomes (4)

• Bronchopulmonary dysplasia

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

• Retinopathy of prematurity

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

• Intraventricular hemorrhage

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

Study Arms (2)

the control group

Very low birth weight infants without extrauterine growth restriction at discharge.

Behavioral: family integrated care

the case group

Very low birth weight infants with extrauterine growth restriction at discharge.

Behavioral: family integrated care

Interventions

family integrated care BEHAVIORAL

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; the control group

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

very low birth weight infants

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Qiu MF, Zhang Y, Tang YZ, Dou YL, Wang Y, Lyu TC, Fan QL, Ma YL, Li F, Rong H, Tang YF, Gu WW, Chen XC, Liu D, Wang H, Xiao J, Zhang LL, Wang Y, Ye RM, Li D, Li XX, Pang Y, Lin M, Lin M, Xuan Y, Hu XJ; Research Group of Developmental Care for Very Low Birth Weight Infants in China. An investigation into the impact of family integrated care on extrauterine growth restriction at discharge in very low birth weight infants: a multi-centre study. J Glob Health. 2025 Aug 11;15:04168. doi: 10.7189/jogh.15.04168.

  PMID: 40785514 DERIVED

Study Officials

• Xiaojing Hu, PhD

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 13, 2024
• Study Start: February 1, 2021
• Primary Completion: November 30, 2023
• Study Completion: May 1, 2024
• Last Updated: October 21, 2024

Record last verified: 2024-10

Locations

CN (1)