Vermont Oxford Network Very Low Birth Weight Database

Neonatology Clinical Trial

— VON VLBW  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01825499
• Other study ID #: VON001
• Status: Recruiting
• Start date: January 1990
• Est. completion date: December 2040

Study information

• Verified date: May 2023
• Source: Vermont Oxford Network
• Contact: Peter Pelaia
• Phone: 802-865-4814
• Email: mail[@]vtoxford.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60000
• Est. completion date: December 2040
• Est. primary completion date: December 2040
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Neonatology

Intervention

Other:
• Registry

Locations

Country	Name	City	State
United States	Vermont Oxford Network	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Vermont Oxford Network

Country where clinical trial is conducted

United States, 

References & Publications (55)

Archer JM, Yeager SB, Kenny MJ, Soll RF, Horbar JD. Distribution of and mortality from serious congenital heart disease in very low birth weight infants. Pediatrics. 2011 Feb;127(2):293-9. doi: 10.1542/peds.2010-0418. Epub 2011 Jan 10. — View 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. — View Citation

Bernstein IM, Horbar JD, Badger GJ, Ohlsson A, Golan A. Morbidity and mortality among very-low-birth-weight neonates with intrauterine growth restriction. The Vermont Oxford Network. Am J Obstet Gynecol. 2000 Jan;182(1 Pt 1):198-206. doi: 10.1016/s0002-93 — View Citation

Boghossian NS, Geraci M, Edwards EM, Ehret DEY, Saade GR, Horbar JD. Regional and Racial-Ethnic Differences in Perinatal Interventions Among Periviable Births. Obstet Gynecol. 2020 Apr;135(4):885-895. doi: 10.1097/AOG.0000000000003747. — View Citation

Boghossian NS, Geraci M, Edwards EM, Horbar JD. In-Hospital Outcomes in Large for Gestational Age Infants at 22-29 Weeks of Gestation. J Pediatr. 2018 Jul;198:174-180.e13. doi: 10.1016/j.jpeds.2018.02.042. Epub 2018 Apr 7. — View Citation

Boghossian NS, Geraci M, Edwards EM, Horbar JD. Morbidity and Mortality in Small for Gestational Age Infants at 22 to 29 Weeks' Gestation. Pediatrics. 2018 Feb;141(2):e20172533. doi: 10.1542/peds.2017-2533. Epub 2018 Jan 18. — View 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. — View Citation

Boghossian NS, Geraci M, Lorch SA, Phibbs CS, Edwards EM, Horbar JD. Racial and Ethnic Differences Over Time in Outcomes of Infants Born Less Than 30 Weeks' Gestation. Pediatrics. 2019 Sep;144(3):e20191106. doi: 10.1542/peds.2019-1106. Epub 2019 Aug 12. — View Citation

Boghossian NS, Horbar JD, Carpenter JH, Murray JC, Bell EF; Vermont Oxford Network. Major chromosomal anomalies among very low birth weight infants in the Vermont Oxford Network. J Pediatr. 2012 May;160(5):774-780.e11. doi: 10.1016/j.jpeds.2011.11.005. Ep — View Citation

Boghossian NS, Horbar JD, Murray JC, Carpenter JH; Vermont Oxford Network. Anthropometric charts for infants with trisomies 21, 18, or 13 born between 22 weeks gestation and term: the VON charts. Am J Med Genet A. 2012 Feb;158A(2):322-32. doi: 10.1002/ajm — View Citation

De Nisi G, Berti M, Malossi R, Pederzini F, Pedrotti A, Valente A. Comparison of neonatal intensive care: Trento area versus Vermont Oxford Network. Ital J Pediatr. 2009 Mar 14;35(1):5. doi: 10.1186/1824-7288-35-5. — View Citation

Edwards EM, Greenberg LT, Ehret DEY, Lorch SA, Horbar JD. Discharge Age and Weight for Very Preterm Infants: 2005-2018. Pediatrics. 2021 Feb;147(2):e2020016006. doi: 10.1542/peds.2020-016006. — View Citation

Edwards EM, Lakshminrusimha S, Ehret DEY, Horbar JD. NICU Admissions for Meconium Aspiration Syndrome before and after a National Resuscitation Program Suctioning Guideline Change. Children (Basel). 2019 May 7;6(5):68. doi: 10.3390/children6050068. — View Citation

Finer NN, Horbar JD, Carpenter JH. Cardiopulmonary resuscitation in the very low birth weight infant: the Vermont Oxford Network experience. Pediatrics. 1999 Sep;104(3 Pt 1):428-34. doi: 10.1542/peds.104.3.428. — View Citation

Fisher JG, Bairdain S, Sparks EA, Khan FA, Archer JM, Kenny M, Edwards EM, Soll RF, Modi BP, Yeager S, Horbar JD, Jaksic T. Serious congenital heart disease and necrotizing enterocolitis in very low birth weight neonates. J Am Coll Surg. 2015 Jun;220(6):1 — View Citation

Fisher JG, Jones BA, Gutierrez IM, Hull MA, Kang KH, Kenny M, Zurakowski D, Modi BP, Horbar JD, Jaksic T. Mortality associated with laparotomy-confirmed neonatal spontaneous intestinal perforation: a prospective 5-year multicenter analysis. J Pediatr Surg — View Citation

Fitzgibbons SC, Ching Y, Yu D, Carpenter J, Kenny M, Weldon C, Lillehei C, Valim C, Horbar JD, Jaksic T. Mortality of necrotizing enterocolitis expressed by birth weight categories. J Pediatr Surg. 2009 Jun;44(6):1072-5; discussion 1075-6. doi: 10.1016/j. — View 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 prospe — View 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: 10.10 — View Citation

Fullerton BS, Velazco CS, Sparks EA, Morrow KA, Edwards EM, Soll RF, Modi BP, Horbar JD, Jaksic T. Contemporary Outcomes of Infants with Gastroschisis in North America: A Multicenter Cohort Study. J Pediatr. 2017 Sep;188:192-197.e6. doi: 10.1016/j.jpeds.2 — View 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.2019-364 — View Citation

Hallowell SG, Rogowski JA, Spatz DL, Hanlon AL, Kenny M, Lake ET. Factors associated with infant feeding of human milk at discharge from neonatal intensive care: Cross-sectional analysis of nurse survey and infant outcomes data. Int J Nurs Stud. 2016 Jan; — View Citation

Hallowell SG, Spatz DL, Hanlon AL, Rogowski JA, Lake ET. Characteristics of the NICU work environment associated with breastfeeding support. Adv Neonatal Care. 2014 Aug;14(4):290-300. doi: 10.1097/ANC.0000000000000102. — View Citation

Han SM, Hong CR, Knell J, Edwards EM, Morrow KA, Soll RF, Modi BP, Horbar JD, Jaksic T. Trends in incidence and outcomes of necrotizing enterocolitis over the last 12 years: A multicenter cohort analysis. J Pediatr Surg. 2020 Jun;55(6):998-1001. doi: 10.1 — View 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 20 — View Citation

Hong CR, Fullerton BS, Mercier CE, Morrow KA, Edwards EM, Ferrelli KR, Soll RF, Modi BP, Horbar JD, Jaksic T. Growth morbidity in extremely low birth weight survivors of necrotizing enterocolitis at discharge and two-year follow-up. J Pediatr Surg. 2018 J — View Citation

Horbar JD, Badger GJ, Carpenter JH, Fanaroff AA, Kilpatrick S, LaCorte M, Phibbs R, Soll RF; Members of the Vermont Oxford Network. Trends in mortality and morbidity for very low birth weight infants, 1991-1999. Pediatrics. 2002 Jul;110(1 Pt 1):143-51. do — View Citation

Horbar JD, Badger GJ, Lewit EM, Rogowski J, Shiono PH. Hospital and patient characteristics associated with variation in 28-day mortality rates for very low birth weight infants. Vermont Oxford Network. Pediatrics. 1997 Feb;99(2):149-56. doi: 10.1542/peds — View Citation

Horbar JD, Carpenter JH, Badger GJ, Kenny MJ, Soll RF, Morrow KA, Buzas JS. Mortality and neonatal morbidity among infants 501 to 1500 grams from 2000 to 2009. Pediatrics. 2012 Jun;129(6):1019-26. doi: 10.1542/peds.2011-3028. Epub 2012 May 21. — View Citation

Horbar JD, Carpenter JH, Buzas J, Soll RF, Suresh G, Bracken MB, Leviton LC, Plsek PE, Sinclair JC; Vermont Oxford Network. Timing of initial surfactant treatment for infants 23 to 29 weeks' gestation: is routine practice evidence based? Pediatrics. 2004 — View 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 — View 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. JA — View 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/p — View Citation

Horbar JD, Soll RF, Edwards WH. The Vermont Oxford Network: a community of practice. Clin Perinatol. 2010 Mar;37(1):29-47. doi: 10.1016/j.clp.2010.01.003. — View Citation

Horbar JD. Increasing use of antenatal corticosteroid therapy between 1990 and 1993 in Vermont Oxford Network. J Perinatol. 1997 Jul-Aug;17(4):309-13. — View Citation

Horbar JD. The Vermont Oxford Network: evidence-based quality improvement for neonatology. Pediatrics. 1999 Jan;103(1 Suppl E):350-9. — View Citation

Hull MA, Fisher JG, Gutierrez IM, Jones BA, Kang KH, Kenny M, Zurakowski D, Modi BP, Horbar JD, Jaksic T. Mortality and management of surgical necrotizing enterocolitis in very low birth weight neonates: a prospective cohort study. J Am Coll Surg. 2014 Ju — View Citation

Lake ET, Staiger D, Horbar J, Cheung R, Kenny MJ, Patrick T, Rogowski JA. Association between hospital recognition for nursing excellence and outcomes of very low-birth-weight infants. JAMA. 2012 Apr 25;307(16):1709-16. doi: 10.1001/jama.2012.504. — View Citation

Lake ET, Staiger D, Horbar J, Kenny MJ, Patrick T, Rogowski JA. Disparities in perinatal quality outcomes for very low birth weight infants in neonatal intensive care. Health Serv Res. 2015 Apr;50(2):374-97. doi: 10.1111/1475-6773.12225. Epub 2014 Sep 22. — View Citation

Lucey JF, Rowan CA, Shiono P, Wilkinson AR, Kilpatrick S, Payne NR, Horbar J, Carpenter J, Rogowski J, Soll RF. Fetal infants: the fate of 4172 infants with birth weights of 401 to 500 grams--the Vermont Oxford Network experience (1996-2000). Pediatrics. — View 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. — View Citation

Morales LS, Staiger D, Horbar JD, Carpenter J, Kenny M, Geppert J, Rogowski J. Mortality among very low-birthweight infants in hospitals serving minority populations. Am J Public Health. 2005 Dec;95(12):2206-12. doi: 10.2105/AJPH.2004.046730. — View Citation

Parker MG, Greenberg LT, Edwards EM, Ehret D, Belfort MB, Horbar JD. National Trends in the Provision of Human Milk at Hospital Discharge Among Very Low-Birth-Weight Infants. JAMA Pediatr. 2019 Oct 1;173(10):961-968. doi: 10.1001/jamapediatrics.2019.2645. — View Citation

Payne NR, Carpenter JH, Badger GJ, Horbar JD, Rogowski J. Marginal increase in cost and excess length of stay associated with nosocomial bloodstream infections in surviving very low birth weight infants. Pediatrics. 2004 Aug;114(2):348-55. doi: 10.1542/pe — View Citation

Rogowski JA, Horbar JD, Staiger DO, Kenny M, Carpenter J, Geppert J. Indirect vs direct hospital quality indicators for very low-birth-weight infants. JAMA. 2004 Jan 14;291(2):202-9. doi: 10.1001/jama.291.2.202. — View Citation

Rogowski JA, Staiger DO, Horbar JD. Variations in the quality of care for very-low-birthweight infants: implications for policy. Health Aff (Millwood). 2004 Sep-Oct;23(5):88-97. doi: 10.1377/hlthaff.23.5.88. — View Citation

Rogowski JA, Staiger DO, Patrick TE, Horbar JD, Kenny MJ, Lake ET. Nurse Staffing in Neonatal Intensive Care Units in the United States. Res Nurs Health. 2015 Oct;38(5):333-41. doi: 10.1002/nur.21674. Epub 2015 Aug 20. Erratum In: Res Nurs Health. 2016 Oc — View Citation

Rysavy MA, Horbar JD, Bell EF, Li L, Greenberg LT, Tyson JE, Patel RM, Carlo WA, Younge NE, Green CE, Edwards EM, Hintz SR, Walsh MC, Buzas JS, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Res — View 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. — View Citation

Soll RF, Edwards EM, Badger GJ, Kenny MJ, Morrow KA, Buzas JS, Horbar JD. Obstetric and neonatal care practices for infants 501 to 1500 g from 2000 to 2009. Pediatrics. 2013 Aug;132(2):222-8. doi: 10.1542/peds.2013-0501. Epub 2013 Jul 15. — View Citation

Sparks EA, Gutierrez IM, Fisher JG, Khan FA, Kang KH, Morrow KA, Soll RF, Edwards EM, Horbar JD, Jaksic T, Modi BP. Patterns of surgical practice in very low birth weight neonates born in the United States: a Vermont Oxford Network analysis. J Pediatr Sur — View Citation

Suresh G, Horbar JD, Plsek P, Gray J, Edwards WH, Shiono PH, Ursprung R, Nickerson J, Lucey JF, Goldmann D. Voluntary anonymous reporting of medical errors for neonatal intensive care. Pediatrics. 2004 Jun;113(6):1609-18. doi: 10.1542/peds.113.6.1609. — View Citation

Suresh GK, Horbar JD, Kenny M, Carpenter JH; Vermont Oxford Network. Major birth defects in very low birth weight infants in the Vermont Oxford Network. J Pediatr. 2001 Sep;139(3):366-73. doi: 10.1067/mpd.2001.117072. — View 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. — View Citation

Zupancic JA, Richardson DK, Horbar JD, Carpenter JH, Lee SK, Escobar GJ; Vermont Oxford Network SNAP Pilot Project Participants. Revalidation of the Score for Neonatal Acute Physiology in the Vermont Oxford Network. Pediatrics. 2007 Jan;119(1):e156-63. do — View Citation

* Note: There are 55 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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, 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.	up to 1 year

External Links

•   Public website with links to manuals and forms, additional articles, research guidelines