Persistent Fetal Circulation SyndromeNCT00005497
Risk Factors for Pulmonary Hypertension of the Newborn
An observational study of Persistent Fetal Circulation Syndrome and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Persistent Fetal Circulation Syndrome, Lung Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1998to Mar 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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.
- Medical subject headings
- Persistent Fetal Circulation Syndrome, Lung Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startApr 1998
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Persistent Fetal Circulation SyndromeStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Allen Mitchell, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005497
- Sponsor's protocol ID
- 5015
- Other IDs
- R01HL058763
- Status last verified
- Oct 2005
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
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.
PubMed 11096168Hernandez-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.
PubMed 12396998Louik 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.
PubMed 11854652Hernan 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.
PubMed 11790682Hernandez-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.
PubMed 11384952Waller 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.
PubMed 12749387Werler 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.
PubMed 12749386Hernandez-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.
PubMed 12915504de 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.
PubMed 15672013Hernandez-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.
PubMed 16135938
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Pulmonary Hypertension of the Newborn
- ClinicalTrials.gov ID
- NCT00005497
- Acronym / sponsor ID
- 5015
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1998
- Study completion
- Mar 2004 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 11096168Hernandez-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.
- Background: PubMed 12396998Hernandez-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.
- Background: PubMed 11854652Louik 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.
- Background: PubMed 11790682Hernan 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.
- Background: PubMed 11384952Hernandez-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.
- Background: PubMed 12749387Waller 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.
- Background: PubMed 12749386Werler 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.
- Background: PubMed 12915504Hernandez-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.
- Background: PubMed 15672013de 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.
- Background: PubMed 16135938Hernandez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allen Mitchell
Boston University
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Fetal Circulation Syndrome and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005497, which also lists 10 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 13 May 2016.