Epidemiology of Persistent Pulmonary Hypertension of the Newborn - SCOR in Lung Biology and Diseases in Infants and Children

This study has been completed.

Sponsor:

Information provided by:

National Heart, Lung, and Blood Institute (NHLBI)

ClinicalTrials.gov Identifier:

NCT00005323

First received: May 25, 2000

Last updated: June 23, 2005

Last verified: October 2001

History of Changes

Tracking Information
First Received Date ^ICMJE	May 25, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE	December 1991
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00005323 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Epidemiology of Persistent Pulmonary Hypertension of the Newborn - SCOR in Lung Biology and Diseases in Infants and Children
Official Title ^ICMJE	Not Provided
Brief Summary	To conduct an epidemiologic study of persistent pulmonary hypertension of the newborn ( PPHN) infant.
Detailed Description	BACKGROUND: The study on the epidemiology of persistent pulmonary hypertension of the newborn (PPHN) was a subproject within a Specialized Center of Research (SCOR) in Lung Biology and Diseases in Infants and Children. The SCOR and its subproject were awarded in December, 1991. Dollars were estimated at 20 percent of total center dollars. DESIGN NARRATIVE: Data from a previous study of PPHN were analyzed. The objectives were to: identify the effects of a variety of potentially adverse prenatal exposures from interview data; formulate multi-variate models of risk of PPHN to determine if smoking or use of prostaglandin inhibitors increased the risk of PPHN; explore associations of PPHN with history of illicit drug use and maternal hypoxia; examine the relationships of postnatal care and perinatal risk factors on the incidence and outcome of PPHN; test the relationships of PPHN to the biochemical presence of nicotine and drugs in neonatal urine.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Natural History
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition ^ICMJE	Lung Diseases Cardiovascular Diseases Defect, Congenital Heart Heart Diseases Persistent Fetal Circulation Syndrome
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Derkach IuS, Osherovich AM, Miasnenko AM. [Organization of the equipment and public health measures in virological laboratories of epidemiological health stations] Lab Delo. 1984;(6):374-7. Russian. No abstract available. Christou H, Adatia I, Van Marter LJ, Kane JW, Thompson JE, Stark AR, Wessel DL, Kourembanas S. Effect of inhaled nitric oxide on endothelin-1 and cyclic guanosine 5'-monophosphate plasma concentrations in newborn infants with persistent pulmonary hypertension. J Pediatr. 1997 Apr;130(4):603-11.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	November 1996
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	No eligibility criteria
Gender	Male
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00005323
Other Study ID Numbers ^ICMJE	4104
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Heart, Lung, and Blood Institute (NHLBI)
Verification Date	October 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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