Persistent Pulmonary Hypertension of the NewbornPPHNNCT00710177
PTGS1 Genetic Variation and Increased Risk for Persistent Pulmonary Hypertension of the Newborn
An observational study of Persistent Pulmonary Hypertension of the Newborn, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this study is to determine if normally occurring variations in a specific gene called PTGS-1 are associated with an increased risk of narrowing of the ductus arteriosus from exposure to over-the-counter pain medicines (NSAIDs). Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Persistent Pulmonary Hypertension of the Newborn
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants born greater than or equal to 34 weeks gestational age diagnosed with PPHN and normal, healthy infants born greater than or equal to 34 weeks gestational age.
Who may be able to join
- Infants born greater than or equal to 34 weeks gestational age diagnosed with PPHN and normal, healthy infants born greater than or equal to 34 weeks gestational age.
Who cannot join
- Patients will be excluded if they are diagnosed with lethal congenital anomalies
- structural congenital heart disease except presence of patent ductus arteriosus (PDA) or patent foramen ovale
- structural gastrointestinal tract abnormality that could interfere with meconium passage
- congenital anomalies such as diaphragmatic hernia, Potter's syndrome, or pulmonary hypoplasia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Wisconsin
Milwaukee, Wisconsin, 53226
Ganesh Konduri, MD
About this study
Official title: Prostaglandin G/H Synthase-1 (PTGS1) Genetic Variation and Increased Risk for Persistent Pulmonary Hypertension of the Newborn (PPHN)
The purpose of this study is to determine if normally occurring variations in a specific gene called PTGS-1 are associated with an increased risk of narrowing of the ductus arteriosus from exposure to over-the-counter pain medicines (NSAIDs).
Read the detailed description
Persistent pulmonary hypertension of the newborn (PPHN) occurs when the pulmonary vascular resistance fails to decrease at birth during the transition to postnatal life. The affected infants have severe hypoxemia, a 10% risk of mortality, and among survivors, a 30% incidence of long term neurodevelopmental and hearing deficits. The etiology of PPHN in the majority of affected infants remains unknown. Although constriction of fetal ductus arteriosus in response to maternal intake of non-steroidal anti-inflammatory drugs (NSAID) has been implicated in PPHN case reports, our laboratory was the first to provide objective evidence for such an association. Nearly 87% of infants with PPHN were exposed to NSAID in utero. Yet 25% of control infants also were exposed without developing PPHN. The basis for the biological susceptibility of some neonates to in utero NSAID exposure remains poorly understood. The hypothesis of this proposal is that PTGS1 genetic variation is associated with increased susceptibility to ductal constriction from in utero NSAID exposure and an increased risk of PPHN. This hypothesis will be tested through the following specific aims: Determine the incidence of PTGS1 sequence variants in PPHN patients versus matched controls. PTGS1 sequence will include all 11 exons, a minimum of 100 bp of exon flanking sequences, and 1 kbp of upstream regulatory information. Cycle sequencing will be performed followed by analysis using capillary electrophoresis. Differences in the frequency of sequence variants will be determined using Fisher's exact test. The study will also quantify NSAID exposure in meconium samples using a previously established GC/MS assay and correlate exposure levels to both the incidence of PPHN and the presence or absence of PTGS1 sequence variants using regression analysis. Benefits include the ability to predict risk for PPHN based on PTGS1 sequence and avoidance of such risk in the future, thereby reducing patient morbidity and mortality.
- Keywords
- PPHN, PTGS1, NSAID
- Medical subject headings
- Persistent Fetal Circulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PPHN | Infants born at >= 34 weeks who are diagnosed with clinical and/or echocardiographic evidence of PPHN | |
| Control | Randomly selected, normal healthy infants born at >= 34 weeks gestational age and do not have PPHN |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether or not a variation in the prostaglandin G/H Synthase-1 gene contributes to the incidence of PPHN in infants who are exposed to NSAIDs in utero.
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startJan 2006
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Pulmonary Hypertension of the NewbornStudies of the same condition, open and under way.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G. Ganesh Konduri, Medical College of Wisconsin
- Investigators
- G. Ganesh Konduri, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710177
- Sponsor's protocol ID
- PRO46055
- Acronym
- PPHN
- Status last verified
- Jan 2026
- First submitted
- 2 Jul 2008
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostaglandin G/H Synthase-1 (PTGS1) Genetic Variation and Increased Risk for Persistent Pulmonary Hypertension of the Newborn (PPHN)
- ClinicalTrials.gov ID
- NCT00710177
- Acronym / sponsor ID
- PPHN / PRO46055
- Keywords
- PPHN, PTGS1, NSAID
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 4 Jul 2008 (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.
The purpose of this study is to determine if normally occurring variations in a specific gene called PTGS-1 are associated with an increased risk of narrowing of the ductus arteriosus from exposure to over-the-counter pain medicines (NSAIDs).
Detailed description
Persistent pulmonary hypertension of the newborn (PPHN) occurs when the pulmonary vascular resistance fails to decrease at birth during the transition to postnatal life. The affected infants have severe hypoxemia, a 10% risk of mortality, and among survivors, a 30% incidence of long term neurodevelopmental and hearing deficits. The etiology of PPHN in the majority of affected infants remains unknown. Although constriction of fetal ductus arteriosus in response to maternal intake of non-steroidal anti-inflammatory drugs (NSAID) has been implicated in PPHN case reports, our laboratory was the first to provide objective evidence for such an association. Nearly 87% of infants with PPHN were exposed to NSAID in utero. Yet 25% of control infants also were exposed without developing PPHN. The basis for the biological susceptibility of some neonates to in utero NSAID exposure remains poorly understood. The hypothesis of this proposal is that PTGS1 genetic variation is associated with increased susceptibility to ductal constriction from in utero NSAID exposure and an increased risk of PPHN. This hypothesis will be tested through the following specific aims: Determine the incidence of PTGS1 sequence variants in PPHN patients versus matched controls. PTGS1 sequence will include all 11 exons, a minimum of 100 bp of exon flanking sequences, and 1 kbp of upstream regulatory information. Cycle sequencing will be performed followed by analysis using capillary electrophoresis. Differences in the frequency of sequence variants will be determined using Fisher's exact test. The study will also quantify NSAID exposure in meconium samples using a previously established GC/MS assay and correlate exposure levels to both the incidence of PPHN and the presence or absence of PTGS1 sequence variants using regression analysis. Benefits include the ability to predict risk for PPHN based on PTGS1 sequence and avoidance of such risk in the future, thereby reducing patient morbidity and mortality.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPHN | – | –Infants born at >= 34 weeks who are diagnosed with clinical and/or echocardiographic evidence of PPHN |
| Control | – | –Randomly selected, normal healthy infants born at >= 34 weeks gestational age and do not have PPHN |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants born greater than or equal to 34 weeks gestational age diagnosed with PPHN and normal, healthy infants born greater than or equal to 34 weeks gestational age.
Key inclusion criteria (1 listed)
- Infants born greater than or equal to 34 weeks gestational age diagnosed with PPHN and normal, healthy infants born greater than or equal to 34 weeks gestational age.
Key exclusion criteria (4 listed)
- Patients will be excluded if they are diagnosed with lethal congenital anomalies
- structural congenital heart disease except presence of patent ductus arteriosus (PDA) or patent foramen ovale
- structural gastrointestinal tract abnormality that could interfere with meconium passage
- congenital anomalies such as diaphragmatic hernia, Potter's syndrome, or pulmonary hypoplasia
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
To determine whether or not a variation in the prostaglandin G/H Synthase-1 gene contributes to the incidence of PPHN in infants who are exposed to NSAIDs in utero.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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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.
G. Ganesh Konduri, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Pulmonary Hypertension of the Newborn, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact G. Ganesh Konduri, MD (414-266-6820, gkonduri@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether or not a variation in the prostaglandin G/H Synthase-1 gene contributes to the incidence of PPHN in infants who are exposed to NSAIDs in utero. (time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026.