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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01825499
Recruitment Status : Recruiting
First Posted : April 5, 2013
Last Update Posted : May 16, 2018
Information provided by (Responsible Party):
Vermont Oxford Network

Brief Summary:
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.

Condition or disease Intervention/treatment
Neonatology Other: Registry

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Vermont Oxford Network Very Low Birth Weight Database of Infants 401 to 1500 Grams or 22 to 29 Weeks Gestational Age at Birth
Study Start Date : January 1990
Estimated Primary Completion Date : December 2040
Estimated Study Completion Date : December 2040

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01825499

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Contact: Peter Pelaia 802-865-4814

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United States, Vermont
Vermont Oxford Network Recruiting
Burlington, Vermont, United States, 05401
Contact: Jeffrey D Horbar, MD    802-865-4814   
Sponsors and Collaborators
Vermont Oxford Network
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Study Chair: Jeffrey D Horbar, MD Vermont Oxford Network
Additional Information:
Publications of Results:

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Responsible Party: Vermont Oxford Network Identifier: NCT01825499    
Other Study ID Numbers: VON001
First Posted: April 5, 2013    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Vermont Oxford Network:
Birth weight
Gestational age
Very low birth weight
Additional relevant MeSH terms:
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Birth Weight
Body Weight