Clinical trial NCT01825499: Vermont Oxford Network Very Low Birth Weight Database
Official title: Vermont Oxford Network Very Low Birth Weight Database of Infants <=1500 Grams or <=29 Weeks Gestational Age At Birth
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neonatology
Keywords: Birth weight
Gestational age
Very low birth weight
Infant
Neonatal
Lead sponsor: Vermont Oxford Network
Sponsor class: NETWORK
First posted: 2013-04-05
Enrollment: 60000
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

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 criteria: 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

Primary outcomes:
measure: Registry of baseline and outcome data for VLBW infants with data collected in a uniform manner
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Vermont Oxford Network
state: Vermont
Study officials:
affiliation: Vermont Oxford Network
name: Jeffrey D Horbar, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Fraiman YS, Edwards EM, Horbar JD, Mercier CE, Soll RF, Litt JS. Racial Inequity in High-Risk Infant Follow-Up Among Extremely Low Birth Weight Infants. Pediatrics. 2023 Feb 1;151(2):e2022057865. doi: 10.1542/peds.2022-057865.
citation: Salazar EG, Handley SC, Greenberg LT, Edwards EM, Lorch SA. Association Between Neonatal Intensive Care Unit Type and Quality of Care in Moderate and Late Preterm Infants. JAMA Pediatr. 2023 Mar 1;177(3):278-285. doi: 10.1001/jamapediatrics.2022.5213.
citation: Edwards EM, Greenberg LT, Horbar JD, Gagliardi L, Adams M, Berger A, Leitao S, Luyt K, Ehret DEY, Rogowski JA. Discharge Age and Weight for Very Preterm Infants in Six Countries: 2012-2020. Neonatology. 2023;120(2):208-216. doi: 10.1159/000528013. Epub 2023 Jan 17.
citation: Coggins SA, Edwards EM, Flannery DD, Gerber JS, Horbar JD, Puopolo KM. Serratia Infection Epidemiology Among Very Preterm Infants in the Neonatal Intensive Care Unit. Pediatr Infect Dis J. 2023 Feb 1;42(2):152-158. doi: 10.1097/INF.0000000000003736. Epub 2022 Nov 2.
citation: Boghossian NS, Geraci M, Phibbs CS, Lorch SA, Edwards EM, Horbar JD. Trends in Resources for Neonatal Intensive Care at Delivery Hospitals for Infants Born Younger Than 30 Weeks' Gestation, 2009-2020. JAMA Netw Open. 2023 May 1;6(5):e2312107. doi: 10.1001/jamanetworkopen.2023.12107.
citation: Agha L, Staiger D, Brown C, Soll RF, Horbar JD, Edwards EM. Association of Hospital Adoption of Probiotics With Outcomes Among Neonates With Very Low Birth Weight. JAMA Health Forum. 2023 May 5;4(5):e230960. doi: 10.1001/jamahealthforum.2023.0960.
citation: Frade Garcia A, Edwards EM, de Andrade Lopes JM, Tooke L, Assenga E, Ehret DEY, Hansen A. Neonatal Admission Temperature in Middle- and High-Income Countries. Pediatrics. 2023 Sep 1;152(3):e2023061607. doi: 10.1542/peds.2023-061607.
citation: Rogowski J, Greenberg L, Edwards E, Ehret D, Horbar J. Horizontally integrated health systems and neonatal intensive care unit (NICU) care for very preterm infants. Health Aff Sch. 2023 Sep 11;1(3):qxad042. doi: 10.1093/haschl/qxad042. eCollection 2023 Sep.
citation: Culbreath K, Keefe G, Nes E, Edwards EM, Knell J, Morrow KA, Soll RF, Jaksic T, Horbar JD, Modi BP. Association between neurodevelopmental outcomes and concomitant presence of NEC and IVH in extremely low birth weight infants. J Perinatol. 2024 Jan;44(1):108-115. doi: 10.1038/s41372-023-01780-8. Epub 2023 Sep 21.
citation: Munoz FA, Carter EH, Edwards EM, Jerome M, Litt JS. Does faster weight trajectory lead to improved neurodevelopmental outcomes in ELBW infants with bronchopulmonary dysplasia? J Perinatol. 2024 Feb;44(2):301-306. doi: 10.1038/s41372-023-01808-z. Epub 2023 Oct 28.
citation: Horbar JD, Greenberg LT, Buzas JS, Ehret DEY, Soll RF, Edwards EM. Trends in Mortality and Morbidities for Infants Born 24 to 28 Weeks in the US: 1997-2021. Pediatrics. 2024 Jan 1;153(1):e2023064153. doi: 10.1542/peds.2023-064153.
citation: Handley SC, Salazar EG, Kunz SN, Lorch SA, Edwards EM. Transfer Patterns Among Infants Born at 28 to 34 Weeks' Gestation. Pediatrics. 2024 Jan 1;153(2):e2023063118. doi: 10.1542/peds.2023-063118.
citation: Nes E, Chugh PV, Keefe G, Culbreath K, Morrow KA, Ehret DEY, Soll RF, Horbar JD, Harting MT, Lally KP, Modi BP, Jaksic T, Edwards EM. Predictors of Mortality in Very Low Birth Weight Neonates With Congenital Diaphragmatic Hernia. J Pediatr Surg. 2024 May;59(5):818-824. doi: 10.1016/j.jpedsurg.2024.01.032. Epub 2024 Feb 1.
citation: Chugh PV, Nes E, Culbreath K, Keefe G, Edwards EM, Morrow KA, Ehret D, Soll RF, Modi BP, Horbar JD, Jaksic T. Comparing Healthcare Needs in Extremely Low Birth Weight Infants With NEC and Spontaneous Intestinal Perforation. J Pediatr Surg. 2024 Sep;59(9):1759-1764. doi: 10.1016/j.jpedsurg.2024.03.006. Epub 2024 Mar 16.
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citation: Leahy BF, Edwards EM, Ehret DEY, Soll RF, Yeager SB, Flyer JN. Transcatheter and Surgical Ductus Arteriosus Closure in Very Low Birth Weight Infants: 2018-2022. Pediatrics. 2024 Aug 1;154(2):e2024065905. doi: 10.1542/peds.2024-065905.
citation: Edwards EM, Ehret DEY, Soll RF, Horbar JD. Survival of Infants Born at 22 to 25 Weeks' Gestation Receiving Care in the NICU: 2020-2022. Pediatrics. 2024 Oct 1;154(4):e2024065963. doi: 10.1542/peds.2024-065963.
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citation: Walsh MC, Yao Q, Horbar JD, Carpenter JH, Lee SK, Ohlsson A. Changes in the use of postnatal steroids for bronchopulmonary dysplasia in 3 large neonatal networks. Pediatrics. 2006 Nov;118(5):e1328-35. doi: 10.1542/peds.2006-0359.
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citation: Fullerton BS, Sparks EA, Morrow KA, Edwards EM, Soll RF, Jaksic T, Horbar JD, Modi BP. Hospital transfers and patterns of mortality in very low birth weight neonates with surgical necrotizing enterocolitis. J Pediatr Surg. 2016 Jun;51(6):932-5. doi: 10.1016/j.jpedsurg.2016.02.051. Epub 2016 Mar 3.
citation: McBride CA, Bernstein IM, Badger GJ, Horbar JD, Soll RF. The effect of maternal hypertension on mortality in infants 22, 29weeks gestation. Pregnancy Hypertens. 2015 Oct;5(4):362-6. doi: 10.1016/j.preghy.2015.10.002. Epub 2015 Oct 27.
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citation: Horbar JD, Ehrenkranz RA, Badger GJ, Edwards EM, Morrow KA, Soll RF, Buzas JS, Bertino E, Gagliardi L, Bellu R. Weight Growth Velocity and Postnatal Growth Failure in Infants 501 to 1500 Grams: 2000-2013. Pediatrics. 2015 Jul;136(1):e84-92. doi: 10.1542/peds.2015-0129.
citation: Horbar JD, Edwards EM, Greenberg LT, Morrow KA, Soll RF, Buus-Frank ME, Buzas JS. Variation in Performance of Neonatal Intensive Care Units in the United States. JAMA Pediatr. 2017 Mar 6;171(3):e164396. doi: 10.1001/jamapediatrics.2016.4396. Epub 2017 Mar 6.
citation: Fullerton BS, Hong CR, Velazco CS, Mercier CE, Morrow KA, Edwards EM, Ferrelli KR, Soll RF, Modi BP, Horbar JD, Jaksic T. Severe neurodevelopmental disability and healthcare needs among survivors of medical and surgical necrotizing enterocolitis: A prospective cohort study. J Pediatr Surg. 2017 Oct 12:S0022-3468(17)30651-6. doi: 10.1016/j.jpedsurg.2017.10.029. Online ahead of print.
citation: Boghossian NS, Geraci M, Edwards EM, Morrow KA, Horbar JD. Anthropometric Charts for Infants Born Between 22 and 29 Weeks' Gestation. Pediatrics. 2016 Dec;138(6):e20161641. doi: 10.1542/peds.2016-1641. Epub 2016 Nov 18.
citation: Horbar JD, Edwards EM, Greenberg LT, Profit J, Draper D, Helkey D, Lorch SA, Lee HC, Phibbs CS, Rogowski J, Gould JB, Firebaugh G. Racial Segregation and Inequality in the Neonatal Intensive Care Unit for Very Low-Birth-Weight and Very Preterm Infants. JAMA Pediatr. 2019 May 1;173(5):455-461. doi: 10.1001/jamapediatrics.2019.0241.
citation: Belfort MB, Edwards EM, Greenberg LT, Parker MG, Ehret DY, Horbar JD. Diet, weight gain, and head growth in hospitalized US very preterm infants: a 10-year observational study. Am J Clin Nutr. 2019 May 1;109(5):1373-1379. doi: 10.1093/ajcn/nqz008.
citation: Smith BJ, Flyer JN, Edwards EM, Soll RF, Horbar JD, Yeager SB. Outcomes for Ectopia Cordis. J Pediatr. 2020 Jan;216:67-72. doi: 10.1016/j.jpeds.2019.09.014. Epub 2019 Oct 24.
citation: Han SM, Watters KF, Hong CR, Edwards EM, Knell J, Morrow KA, Soll RF, Jaksic T, Horbar JD, Modi BP. Tracheostomy in Very Low Birth Weight Infants: A Prospective Multicenter Study. Pediatrics. 2020 Mar;145(3):e20192371. doi: 10.1542/peds.2019-2371. Epub 2020 Feb 25.
citation: Gray MM, Edwards EM, Ehret DEY, Brei BK, Greenberg LT, Umoren RA, Ringer S, Horbar J. Resuscitation Opportunities for Fellows of Very Low Birth Weight Infants in the Vermont Oxford Network. Pediatrics. 2020 Jul;146(1):e20193641. doi: 10.1542/peds.2019-3641. Epub 2020 Jun 12.