Lung DiseasesNCT00005323
Epidemiology of Persistent Pulmonary Hypertension of the Newborn - SCOR in Lung Biology and Diseases in Infants and Children
An observational study of Lung Diseases and Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To conduct an epidemiologic study of persistent pulmonary hypertension of the newborn ( PPHN) infant. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Lung Diseases, Cardiovascular Diseases, Defect, Congenital Heart
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 1991to Nov 1996
- 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
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To conduct an epidemiologic study of persistent pulmonary hypertension of the newborn ( PPHN) infant.
Read the 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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Lung Diseases, Cardiovascular Diseases, Defect, Congenital Heart, Heart Diseases, Persistent Fetal Circulation Syndrome
- Medical subject headings
- Lung Diseases, Cardiovascular Diseases, Heart Defects, Congenital, Heart Diseases, Persistent Fetal Circulation Syndrome
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 startDec 1991
- Study completionNov 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005323
- Sponsor's protocol ID
- 4104
- Other IDs
- P50HL046491
- Status last verified
- Oct 2001
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
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. No abstract available. Russian.
PubMed 6206298Christou 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. doi: 10.1016/s0022-3476(97)70245-2.
PubMed 9108859
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Persistent Pulmonary Hypertension of the Newborn - SCOR in Lung Biology and Diseases in Infants and Children
- ClinicalTrials.gov ID
- NCT00005323
- Acronym / sponsor ID
- 4104
- Conditions
- Lung Diseases, Cardiovascular Diseases, Defect, Congenital Heart, Heart Diseases, Persistent Fetal Circulation Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Dec 1991
- Study completion
- Nov 1996 (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 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.
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
- Male only
- 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 18 Feb 2016.
- Background: PubMed 6206298Derkach 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. No abstract available. Russian.
- Background: PubMed 9108859Christou 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. doi: 10.1016/s0022-3476(97)70245-2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Cardiovascular 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 18 Feb 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 NCT00005323, which also lists 2 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 18 Feb 2016.