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Risk Factors for Pulmonary Hypertension of the Newborn

Primary Purpose

Persistent Fetal Circulation Syndrome, Lung Diseases

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Persistent Fetal Circulation Syndrome

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    May 12, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005497
    Brief Title
    Risk Factors for Pulmonary Hypertension of the Newborn
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    October 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1998 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To conduct a multicenter case-control study of persistent pulmonary hypertension of the newborn (PPHN) in relation to maternal exposure to smoking and non-steroidal anti-inflammatory drugs (NSAIDs). Also, to assess other potential antenatal risk factors and collect and store buccal cell specimens for future analyses.
    Detailed Description
    BACKGROUND: Persistent pulmonary hypertension of the newborn (PPHN), previously called persistent fetal circulation, is a birth defect affecting approximately 1 in 1250 liveborn term infants; even with complex and high-risk interventions, PPHN results in substantial mortality and morbidity. This defect results from the inappropriate muscularization of fetal pulmonary vessels, and experimental and human evidence consistently suggests that maternal cigarette smoking and antenatal exposure to NSAIDs, particularly aspirin or ibuprofen, may play a role in the etiology of this condition. Because these exposures are quite prevalent (e.g., ibuprofen is currently taken in the first trimester or later in pregnancy by 15 percent and 3.2 percent of women, respectively), testing these hypotheses is of considerable public health importance. DESIGN NARRATIVE: The multicenter study had a case-control design. There were 560 case infants with PPHN and four controls per case (2240). All controls were drawn from the birth hospitals of cases; half the controls had malformations other than PPHN, and half had normal formations. Cases and controls were identified within five months of birth at 88 birth and tertiary hospitals in the areas surrounding Boston, Philadelphia, and Toronto. Mothers of subjects were interviewed by telephone within six months of delivery; a standardized questionnaire inquired in detail about demographic factors; reproductive, medical, and pregnancy illness histories; medication use (including a detailed focus on use of over-the-counter analgesic/antipyretic medications), smoking, and nutrition. Because of emerging genetic research suggesting an effect of NSAIDs on pathways possibly related to the etiology of PPHN, buccal swabs were also collected and stored for future analyses. Exposure prevalences were compared between mothers of cases and controls and relative risks were estimated, controlling for potential confounding factors. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Persistent Fetal Circulation Syndrome, Lung Diseases

    7. Study Design

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Allen Mitchell
    Organizational Affiliation
    Boston University

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    11096168
    Citation
    Hernandez-Diaz S, Werler MM, Walker AM, Mitchell AA. Folic acid antagonists during pregnancy and the risk of birth defects. N Engl J Med. 2000 Nov 30;343(22):1608-14. doi: 10.1056/NEJM200011303432204.
    Results Reference
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    PubMed Identifier
    12396998
    Citation
    Hernandez-Diaz S, Werler MM, Louik C, Mitchell AA. Risk of gestational hypertension in relation to folic acid supplementation during pregnancy. Am J Epidemiol. 2002 Nov 1;156(9):806-12. doi: 10.1093/aje/kwf129.
    Results Reference
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    PubMed Identifier
    11854652
    Citation
    Louik C, Werler MM, Mitchell AA. Erythromycin use during pregnancy in relation to pyloric stenosis. Am J Obstet Gynecol. 2002 Feb;186(2):288-90. doi: 10.1067/mob.2002.119718.
    Results Reference
    background
    PubMed Identifier
    11790682
    Citation
    Hernan MA, Hernandez-Diaz S, Werler MM, Mitchell AA. Causal knowledge as a prerequisite for confounding evaluation: an application to birth defects epidemiology. Am J Epidemiol. 2002 Jan 15;155(2):176-84. doi: 10.1093/aje/155.2.176.
    Results Reference
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    PubMed Identifier
    11384952
    Citation
    Hernandez-Diaz S, Werler MM, Walker AM, Mitchell AA. Neural tube defects in relation to use of folic acid antagonists during pregnancy. Am J Epidemiol. 2001 May 15;153(10):961-8. doi: 10.1093/aje/153.10.961.
    Results Reference
    background
    PubMed Identifier
    12749387
    Citation
    Waller DK, Tita AT, Werler MM, Mitchell AA. Association between prepregnancy maternal body mass index and the risk of having an infant with a congenital diaphragmatic hernia. Birth Defects Res A Clin Mol Teratol. 2003 Jan;67(1):73-6. doi: 10.1002/bdra.10003.
    Results Reference
    background
    PubMed Identifier
    12749386
    Citation
    Werler MM, Louik C, Mitchell AA. Epidemiologic analysis of maternal factors and amniotic band defects. Birth Defects Res A Clin Mol Teratol. 2003 Jan;67(1):68-72. doi: 10.1002/bdra.10001.
    Results Reference
    background
    PubMed Identifier
    12915504
    Citation
    Hernandez-Diaz S, Hernan MA, Meyer K, Werler MM, Mitchell AA. Case-crossover and case-time-control designs in birth defects epidemiology. Am J Epidemiol. 2003 Aug 15;158(4):385-91. doi: 10.1093/aje/kwg144.
    Results Reference
    background
    PubMed Identifier
    15672013
    Citation
    de Jong-Van den Berg LT, Hernandez-Diaz S, Werler MM, Louik C, Mitchell AA. Trends and predictors of folic acid awareness and periconceptional use in pregnant women. Am J Obstet Gynecol. 2005 Jan;192(1):121-8. doi: 10.1016/j.ajog.2004.05.085.
    Results Reference
    background
    PubMed Identifier
    16135938
    Citation
    Hernandez-Diaz S, Wu XF, Hayes C, Werler MM, Ashok TD, Badovinac R, Kelsey KT, Mitchell AA. Methylenetetrahydrofolate reductase polymorphisms and the risk of gestational hypertension. Epidemiology. 2005 Sep;16(5):628-34. doi: 10.1097/01.ede.0000172132.13513.e0.
    Results Reference
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    Risk Factors for Pulmonary Hypertension of the Newborn

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