Trial record 19 of 38 for:    Open Studies | "Gestational Age"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Vermont Oxford Network
Sponsor:
Information provided by (Responsible Party):
Vermont Oxford Network
ClinicalTrials.gov Identifier:
NCT01825499
First received: March 27, 2013
Last updated: April 4, 2013
Last verified: April 2013
  Purpose

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 the infant receives care.


Condition Intervention
Neonatology
Other: Registry

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Vermont Oxford Network:

Primary Outcome Measures:
  • Registry of baseline and outcome data for VLBW infants with data collected in a uniform manner [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    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.


Study Start Date: January 1990
Estimated Study Completion Date: December 2040
Estimated Primary Completion Date: December 2040 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01825499

Contacts
Contact: Lynn Stillman 802-865-4814 mail@vtoxford.org
Contact: Beth Anderson 802-865-4814 mail@vtoxford.org

Locations
United States, Vermont
Vermont Oxford Network Recruiting
Burlington, Vermont, United States, 05401
Contact: Jeffrey D Horbar, MD    802-865-4814    mail@vtoxford.org   
Sponsors and Collaborators
Vermont Oxford Network
Investigators
Study Chair: Jeffrey D Horbar, MD Vermont Oxford Network
  More Information

Additional Information:
Publications:

Responsible Party: Vermont Oxford Network
ClinicalTrials.gov Identifier: NCT01825499     History of Changes
Other Study ID Numbers: VON001
Study First Received: March 27, 2013
Last Updated: April 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vermont Oxford Network:
Birth weight
Gestational age
Very low birth weight

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014