NCT00005289

Brief Summary

To investigate risk factors in bronchopulmonary dysplasia (BPD) and to elucidate the relationship between BPD, acute lung disease severity, respiration-related variables, water balance, nutrition, familial predisposition, and environmental, pregnancy, and delivery parameters.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,202

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 1987

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1987

Completed
12.9 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

21 years

First QC Date

May 25, 2000

Last Update Submit

July 12, 2019

Conditions

Bronchopulmonary DysplasiaLung DiseasesRespiratory Distress Syndrome

Study Arms (2)

1988-1991

2003-2004

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
\- Birthweight less than 1500 grams

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (27)

  • Farrell ET, Bates ML, Pegelow DF, Palta M, Eickhoff JC, O'Brien MJ, Eldridge MW. Pulmonary Gas Exchange and Exercise Capacity in Adults Born Preterm. Ann Am Thorac Soc. 2015 Aug;12(8):1130-7. doi: 10.1513/AnnalsATS.201410-470OC.

    PMID: 26053283BACKGROUND

  • Palta M, Gabbert D, Fryback D, Widjaja I, Peters ME, Farrell P, Johnson J. Development and validation of an index for scoring baseline respiratory disease in the very low birth weight neonate. Severity Index Development and Validation Panels and Newborn Lung Project. Pediatrics. 1990 Nov;86(5):714-21.

    PMID: 2235225RESULT

  • Palta M, Gabbert D, Weinstein MR, Peters ME. Multivariate assessment of traditional risk factors for chronic lung disease in very low birth weight neonates. The Newborn Lung Project. J Pediatr. 1991 Aug;119(2):285-92. doi: 10.1016/s0022-3476(05)80746-2.

    PMID: 1861218RESULT

  • Palta M, Weinstein MR, McGuinness G, Gabbert D, Brady W, Peters ME. A population study. Mortality and morbidity after availability of surfactant therapy. Newborn Lung Project. Arch Pediatr Adolesc Med. 1994 Dec;148(12):1295-301. doi: 10.1001/archpedi.1994.02170120057009.

    PMID: 7951809RESULT

  • Palta M, Sadek-Badawi M, Evans M, Weinstein MR, McGuinnes G. Functional assessment of a multicenter very low-birth-weight cohort at age 5 years. Newborn Lung Project. Arch Pediatr Adolesc Med. 2000 Jan;154(1):23-30.

    PMID: 10632246RESULT

  • Evans M, Palta M, Sadek M, Weinstein MR, Peters ME. Associations between family history of asthma, bronchopulmonary dysplasia, and childhood asthma in very low birth weight children. Am J Epidemiol. 1998 Sep 1;148(5):460-6. doi: 10.1093/oxfordjournals.aje.a009671.

    PMID: 9737558RESULT

  • Palta M, Sadek M, Lim TS, Evans M, McGuinness G. Association of tocolytic therapy with antenatal steroid administration and infant outcomes. Newborn Lung Project. Am J Perinatol. 1998 Feb;15(2):87-92. doi: 10.1055/s-2007-993904.

    PMID: 9514131RESULT

  • Palta M, Sadek M, Barnet JH, Evans M, Weinstein MR, McGuinness G, Peters ME, Gabbert D, Fryback D, Farrell P. Evaluation of criteria for chronic lung disease in surviving very low birth weight infants. Newborn Lung Project. J Pediatr. 1998 Jan;132(1):57-63. doi: 10.1016/s0022-3476(98)70485-8.

    PMID: 9470001RESULT

  • Palta M, Sadek M, Gabbert D, Brady W, Weinstein MR, McGuinness G, Peters ME. The relation of maternal complications to outcomes in very low birthweight infants in an era of changing neonatal care. Am J Perinatol. 1996 Feb;13(2):109-14. doi: 10.1055/s-2007-994303.

    PMID: 8672182RESULT

  • Weinstein MR, Peters ME, Sadek M, Palta M. A new radiographic scoring system for bronchopulmonary dysplasia. Newborn Lung Project. Pediatr Pulmonol. 1994 Nov;18(5):284-9. doi: 10.1002/ppul.1950180504.

    PMID: 7898966RESULT

  • Palta M, Sadek-Badawi M, Sheehy M, Albanese A, Weinstein M, McGuinness G, Peters ME. Respiratory symptoms at age 8 years in a cohort of very low birth weight children. Am J Epidemiol. 2001 Sep 15;154(6):521-9. doi: 10.1093/aje/154.6.521.

    PMID: 11549557RESULT

  • Hagen EW, Palta M, Albanese A, Sadek-Badawi M. School achievement in a regional cohort of children born very low birthweight. J Dev Behav Pediatr. 2006 Apr;27(2):112-20. doi: 10.1097/00004703-200604000-00005.

    PMID: 16682874RESULT

  • Palta M, Sadek-Badawi M, Madden K, Green C. Pulmonary testing using peak flow meters of very low birth weight children born in the perisurfactant era and school controls at age 10 years. Pediatr Pulmonol. 2007 Sep;42(9):819-28. doi: 10.1002/ppul.20662.

    PMID: 17659600RESULT

  • Hagen EW, Sadek-Badawi M, Albanese A, Palta M. A comparison of Wisconsin neonatal intensive care units with national data on outcomes and practices. WMJ. 2008 Nov;107(7):320-6.

    PMID: 19180870RESULT

  • Hagen EW, Sadek-Badawi M, Carlton DP, Palta M. Permissive hypercapnia and risk for brain injury and developmental impairment. Pediatrics. 2008 Sep;122(3):e583-9. doi: 10.1542/peds.2008-1016.

    PMID: 18762492RESULT

  • Palta M, Sadek-Badawi M, Carlton DP. Association of BPD and IVH with early neutrophil and white counts in VLBW neonates with gestational age <32 weeks. J Perinatol. 2008 Sep;28(9):604-10. doi: 10.1038/jp.2008.65. Epub 2008 Jun 19.

    PMID: 18563166RESULT

  • Palta M, Sadek-Badawi M. PedsQL relates to function and behavior in very low and normal birth weight 2- and 3-year-olds from a regional cohort. Qual Life Res. 2008 Jun;17(5):691-700. doi: 10.1007/s11136-008-9346-1. Epub 2008 May 6.

    PMID: 18459069RESULT

  • Hagen EW, Sadek-Badawi M, Palta M. Daycare attendance and risk for respiratory morbidity among young very low birth weight children. Pediatr Pulmonol. 2009 Nov;44(11):1093-9. doi: 10.1002/ppul.21104.

    PMID: 19824048RESULT

  • McManus BM, Robert SA, Albanese A, Sadek-Badawi M, Palta M. Racial disparities in health-related quality of life in a cohort of very low birthweight 2- and 3-year-olds with and without cerebral palsy. Dev Med Child Neurol. 2011 May;53(5):467-9. doi: 10.1111/j.1469-8749.2011.03923.x. Epub 2011 Mar 17.

    PMID: 21410692RESULT

  • McManus BM, Robert SA, Albanese A, Sadek-Badawi M, Palta M. Relationship between neighborhood disadvantage and social function of Wisconsin 2- and 3-year-olds born at very low birth weight. Arch Pediatr Adolesc Med. 2011 Feb;165(2):119-25. doi: 10.1001/archpediatrics.2010.185. Epub 2010 Oct 4.

    PMID: 20921342RESULT

  • Witt WP, Litzelman K, Spear HA, Wisk LE, Levin N, McManus BM, Palta M. Health-related quality of life of mothers of very low birth weight children at the age of five: results from the Newborn Lung Project Statewide Cohort Study. Qual Life Res. 2012 Nov;21(9):1565-76. doi: 10.1007/s11136-011-0069-3. Epub 2011 Dec 10.

    PMID: 22161725RESULT

  • McManus BM, Robert S, Albanese A, Sadek-Badawi M, Palta M. Racial disparities in health-related quality of life in a cohort of very-low-birth-weight 2- and 3-year-olds with and without asthma. J Epidemiol Community Health. 2012 Jul;66(7):579-85. doi: 10.1136/jech.2010.132886. Epub 2011 Feb 17.

    PMID: 21330462RESULT

  • Bates ML, Pillers DA, Palta M, Farrell ET, Eldridge MW. Ventilatory control in infants, children, and adults with bronchopulmonary dysplasia. Respir Physiol Neurobiol. 2013 Nov 1;189(2):329-37. doi: 10.1016/j.resp.2013.07.015. Epub 2013 Jul 22.

    PMID: 23886637RESULT

  • McManus BM, Robert S, Albanese A, Sadek-Badawi M, Palta M. Predictors of receiving therapy among very low birth weight 2-year olds eligible for Part C early intervention in Wisconsin. BMC Pediatr. 2013 Jul 11;13:106. doi: 10.1186/1471-2431-13-106.

    PMID: 23845161RESULT

  • Haraldsdottir K, Watson AM, Goss KN, Beshish AG, Pegelow DF, Palta M, Tetri LH, Barton GP, Brix MD, Centanni RM, Eldridge MW. Impaired autonomic function in adolescents born preterm. Physiol Rep. 2018 Mar;6(6):e13620. doi: 10.14814/phy2.13620.

    PMID: 29595875RESULT

  • Bates ML, Farrell ET, Eldridge MW. Abnormal ventilatory responses in adults born prematurely. N Engl J Med. 2014 Feb 6;370(6):584-5. doi: 10.1056/NEJMc1311092. No abstract available.

    PMID: 24499235RESULT

  • Goss KN, Beshish AG, Barton GP, Haraldsdottir K, Levin TS, Tetri LH, Battiola TJ, Mulchrone AM, Pegelow DF, Palta M, Lamers LJ, Watson AM, Chesler NC, Eldridge MW. Early Pulmonary Vascular Disease in Young Adults Born Preterm. Am J Respir Crit Care Med. 2018 Dec 15;198(12):1549-1558. doi: 10.1164/rccm.201710-2016OC.

    PMID: 29944842RESULT

MeSH Terms

Conditions

Bronchopulmonary DysplasiaLung DiseasesRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRespiration Disorders

Study Officials

  • Mari Palta

    University of Wisconsin, Madison

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

July 1, 1987

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

July 17, 2019

Record last verified: 2019-07