Recruiting

Observational Study

Sponsor:

Vermont Oxford Network

Code:

NCT01825499

Conditions

Neonatology

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Registry

Study Details

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.

Conditions

Neonatology

Study ID

NCT01825499

Start date

Jan, 1990

Status verified date

Nov, 2024

Completion date

Dec, 2040

Anticipated

Primary completion date

Dec, 2040

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

60000 participants

Anticipated

Interventions and Outcome Measures

Arms

Very low birth weight infants

Infants <=1500 g or <=29 weeks gestational age admitted to Vermont Oxford Network member centers within 28 days of birth

Interventions

Registry

Primary outcome measure

  • Registry of baseline and outcome data for VLBW infants with data collected in a uniform manner [ Time Frame: up to 1 year ]

Central Contacts and Locations

Central contacts

Peter Pelaia

802-865-4814mail@vtoxford.org

Locations

Vermont Oxford Network

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Jeffrey D Horbar, MD

802-865-4814mail@vtoxford.org

More Information

Sponsor

Vermont Oxford Network

Last update posted

Nov 22, 2024

Last verified

Nov, 2024

Keywords

  • Birth weight
  • Gestational age
  • Very low birth weight
  • Infant
  • Neonatal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vermont Oxford Network on 2024-11-22.