Vermont Oxford Network Very Low Birth Weight Database

Recruiting

• Conditions: Neonatology
• Interventions: Other: Registry

• Registration Number: NCT01825499
• Lead Sponsor: Vermont Oxford Network

Brief Summary

Vermont Oxford Network maintains a database for live born infants \<=1500 grams or \<=29 weeks gestational age who are born at participating hospitals or admitted to them within 28 days of birth, regardless of where in the hospital the infant receives care.

Detailed Description

The Database collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment. The data collected includes information on:

* Demographics of mother and infant

* Mother's health, labor and delivery

* Infant's health upon admission, procedures and interventions, and medical outcomes

These data are used to: provide member centers with reporting for use in quality improvement; examine associations between baseline characteristics, treatments, and outcomes; and track trends in incidences of disease and effectiveness of therapies.

Study Timeline

• Study Start: 1990-01
• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2040-12
• Study Completion: 2040-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60000

Inclusion Criteria

• Any infant who is born alive and whose birth weight is <=1500 grams or <=29 weeks 6 days gestational age (inclusive) who is born at or admitted to a Vermont Oxford Network member center within 28 days of life without having first gone home, regardless of the where the infant receives care

Exclusion Criteria

• Stillborn infants
• Infants discharged home prior to admission to a member center
• Infants admitted after 28 days

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Very low birth weight infants	Registry	Infants 401 to 1500 g or 22 to 29 weeks gestational age admitted to Vermont Oxford Network member centers within 28 days of birth

Primary Outcome Measures

Name	Time	Method
Registry of baseline and outcome data for VLBW infants with data collected in a uniform manner	up to 1 year	Data items include infant and maternal characteristics, delivery room interventions, respiratory care and outcomes, surgeries, infections, other serious complications, and length of stay. Time frames for data collection include: characteristics of birth; at day 28; and at discharge. Tracking ends at discharge home (including for infants transferred out) or at one year.

Trial Locations

Locations (1)

Vermont Oxford Network; 🇺🇸 Burlington, Vermont, United States