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NeonatologyVON VLBWNCT01825499

Vermont Oxford Network Very Low Birth Weight Database

An observational study of Neonatology, run by Vermont Oxford Network at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 28 days
Conditions the study is for
Neonatology
What is being tested?
Registry
How many people
60,000 participants
Where
1 siteUnited States
Study dates
Jan 1990to Dec 2040
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 28 days
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Peter Pelaia contact

802-865-4814

mail@vtoxford.org

United States1 site, 1 recruiting

  • Vermont Oxford Network

    Burlington, Vermont, 05401

    Jeffrey D Horbar, MD, 802-865-4814, mail@vtoxford.org

    Recruiting

Other trials in United States

About this study

Official title: Vermont Oxford Network Very Low Birth Weight Database of Infants <=1500 Grams or <=29 Weeks Gestational Age at Birth

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.

Read the 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.

Conditions
Neonatology
Being tested
Registry
Keywords
Birth weight, Gestational age, Very low birth weight, Infant, Neonatal
Medical subject headings
Birth Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RegistryOther

Study groups in NCT01825499
Study groupRoleWhat they receive
Very low birth weight infantsInfants <=1500 g or <=29 weeks gestational age admitted to Vermont Oxford Network member centers within 28 days of birth
Receives: Other: Registry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Registry of baseline and outcome data for VLBW infants with data collected in a uniform manner

    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.

    Measured: up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2013 (estimated)
  2. Study startJan 1990
  3. Primary completionDec 2040 (estimated)
  4. Study completionDec 2040 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT01825499
Sponsor's protocol ID
VON001
Acronym
VON VLBW
Status last verified
Nov 2024
First submitted
27 Mar 2013
Last updated
22 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Prakalapakorn SG, Greenberg L, Edwards EM, Ehret DEY. Trends in Retinopathy of Prematurity Screening and Treatment: 2008-2018. Pediatrics. 2021 Jun;147(6):e2020039966. doi: 10.1542/peds.2020-039966. Epub 2021 May 11.

    PubMed 33975923

  • Jensen EA, Edwards EM, Greenberg LT, Soll RF, Ehret DEY, Horbar JD. Severity of Bronchopulmonary Dysplasia Among Very Preterm Infants in the United States. Pediatrics. 2021 Jul;148(1):e2020030007. doi: 10.1542/peds.2020-030007. Epub 2021 Jun 2.

    PubMed 34078747

  • Edwards EM, Greenberg LT, Profit J, Draper D, Helkey D, Horbar JD. Quality of Care in US NICUs by Race and Ethnicity. Pediatrics. 2021 Aug;148(2):e2020037622. doi: 10.1542/peds.2020-037622. Epub 2021 Jul 22.

    PubMed 34301773

  • Flannery DD, Edwards EM, Puopolo KM, Horbar JD. Early-Onset Sepsis Among Very Preterm Infants. Pediatrics. 2021 Oct;148(4):e2021052456. doi: 10.1542/peds.2021-052456. Epub 2021 Sep 7.

    PubMed 34493539

  • Boghossian NS, Geraci M, Edwards EM, Horbar JD. Changes in hospital quality at hospitals serving black and hispanic newborns below 30 weeks' gestation. J Perinatol. 2022 Feb;42(2):187-194. doi: 10.1038/s41372-021-01222-3. Epub 2021 Oct 2.

    PubMed 34601491

  • Runte KE, Flyer JN, Edwards EM, Soll RF, Horbar JD, Yeager SB. Variation of Patent Ductus Arteriosus Treatment in Very Low Birth Weight Infants. Pediatrics. 2021 Nov;148(5):e2021052874. doi: 10.1542/peds.2021-052874. Epub 2021 Oct 21.

    PubMed 34675131

  • Edwards EM, Greenberg LT, Ehret DEY, Soll RF, Lanzieri TM, Horbar JD. STORCH Infections Among Very Low Birth Weight and Preterm Infants: 2018-2020. Pediatrics. 2022 Jan 1;149(1):e2021053655. doi: 10.1542/peds.2021-053655. No abstract available.

    PubMed 35104887

  • Keefe G, Culbreath K, Edwards EM, Morrow KA, Soll RF, Modi BP, Horbar JD, Jaksic T. Current outcomes of infants with esophageal atresia and tracheoesophageal fistula: A multicenter analysis. J Pediatr Surg. 2022 Jun;57(6):970-974. doi: 10.1016/j.jpedsurg.2022.01.060. Epub 2022 Feb 14.

    PubMed 35300859

  • Culbreath K, Keefe G, Edwards EM, Morrow KA, Soll RF, Jaksic T, Horbar JD, Modi BP. Morbidity associated with laparotomy-confirmed spontaneous intestinal perforation: A prospective multicenter analysis. J Pediatr Surg. 2022 Jun;57(6):981-985. doi: 10.1016/j.jpedsurg.2022.01.058. Epub 2022 Feb 14.

    PubMed 35287964

  • Salazar EG, Handley SC, Greenberg LT, Edwards EM, Lorch SA. Measuring quality of care in moderate and late preterm infants. J Perinatol. 2022 Oct;42(10):1294-1300. doi: 10.1038/s41372-022-01377-7. Epub 2022 Mar 30.

    PubMed 35354940

  • Boghossian NS, Greenberg LT, Edwards EM, Horbar JD. Transfer Patterns of Very Low Birth Weight Infants for Convalescent Care. Pediatrics. 2022 Jun 1;149(6):e2021054866. doi: 10.1542/peds.2021-054866.

    PubMed 35588188

  • Culbreath K, Knell J, Keefe G, Nes E, Han SM, Edwards EM, Morrow KA, Soll RF, Jaksic T, Horbar JD, Modi BP. Impact of concomitant necrotizing enterocolitis on mortality in very low birth weight infants with intraventricular hemorrhage. J Perinatol. 2023 Jan;43(1):91-96. doi: 10.1038/s41372-022-01434-1. Epub 2022 Jun 17.

    PubMed 35715599

  • Handley SC, Salazar EG, Greenberg LT, Foglia EE, Lorch SA, Edwards EM. Variation and Temporal Trends in Delivery Room Management of Moderate and Late Preterm Infants. Pediatrics. 2022 Aug 1;150(2):e2021055994. doi: 10.1542/peds.2021-055994.

    PubMed 35851607

  • Mangiza M, Ehret DEY, Edwards EM, Rhoda N, Tooke L. Morbidity and mortality in small for gestational age very preterm infants in a middle-income country. Front Pediatr. 2022 Aug 9;10:915796. doi: 10.3389/fped.2022.915796. eCollection 2022.

    PubMed 36016879

  • Flannery DD, Edwards EM, Coggins SA, Horbar JD, Puopolo KM. Late-Onset Sepsis Among Very Preterm Infants. Pediatrics. 2022 Dec 1;150(6):e2022058813. doi: 10.1542/peds.2022-058813.

    PubMed 36366916

Questions about this trial

What is this clinical trial studying?

An observational study of Neonatology, run by Vermont Oxford Network at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Peter Pelaia (802-865-4814, mail@vtoxford.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01825499, which also lists 60 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.

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