Vermont Oxford Network Very Low Birth Weight Database (VON VLBW)

May 22, 2023 updated by: Vermont Oxford Network

Vermont Oxford Network Very Low Birth Weight Database of Infants 401 to 1500 Grams or 22 to 29 Weeks Gestational Age at Birth

Vermont Oxford Network maintains a database for live born infants 401 to 1500 grams or 22 to 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • Vermont Oxford Network
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Infants who are 401 to 1500 grams birth weight or 22 to 29 weeks gestational age and who are admitted to Vermont Oxford Network member centers within 28 days of birth without first going home

Description

Inclusion Criteria:

  • Any infant who is born alive and whose birth weight is 401 to 1500 grams or 22 weeks 0 days and 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Registry of baseline and outcome data for VLBW infants with data collected in a uniform manner
Time Frame: up to 1 year
Data items include infant and maternal characteristics, delivery room interventions, respiratory care and outcomes, surgeries, infections, comorbid conditions, 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.
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vermont Oxford Network

Investigators

  • Study Chair: Jeffrey D Horbar, MD, Vermont Oxford Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1990

Primary Completion (Anticipated)

December 1, 2040

Study Completion (Anticipated)

December 1, 2040

Study Registration Dates

First Submitted

March 27, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VON001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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