Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005497
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Risk Factors for Pulmonary Hypertension of the Newborn
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg ibuprofen is currently taken in the first trimester or later in pregnancy by 15 percent and 32 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 analgesicantipyretic 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
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 eg ibuprofen is currently taken in the first trimester or later in pregnancy by 15 percent and 32 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 analgesicantipyretic 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL058763 | NIH | None | httpsreporternihgovquickSearchR01HL058763 |