Genetic factors and risk of persistent pulmonary hypertension in newborns
Official title: Prostaglandin G/H Synthase-1 (PTGS1) Genetic Variation and Increased Risk for Persistent Pulmonary Hypertension of the Newborn (PPHN)
Run by Medical College of Wisconsin · NCT00710177 · Data updated 2026-11-12
This study is trying to see if certain genetic changes in newborns are linked to a higher risk of persistent pulmonary hypertension when their mothers used pain relievers during pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 12 Months |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Status | Recruiting |
| Started | January 2006 |
| Main results expected | December 2027 |
| Study ends | December 2028 |
| Registry record updated | January 26, 2026 |
| Trial ID | NCT00710177 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants born at or after 34 weeks gestational age, either diagnosed with PPHN or healthy controls.
✕Probably not a fit
Patients with lethal congenital anomalies or significant structural congenital heart or gastrointestinal tract abnormalities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate the association between genetic variations in the PTGS1 gene and the risk of persistent pulmonary hypertension of the newborn (PPHN) related to in utero exposure to non-steroidal anti-inflammatory drugs (NSAIDs). The study will compare the incidence of PTGS1 genetic variants in infants diagnosed with PPHN to healthy control infants. By analyzing the genetic sequences, the researchers hope to identify specific variations that may increase susceptibility to ductal constriction and PPHN. This research could provide insights into the biological mechanisms underlying PPHN and its association with NSAID exposure during pregnancy.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and prevention strategies for PPHN in newborns.
How similar studies have gone: Other studies have suggested associations between genetic variations and susceptibility to conditions like PPHN, but this specific genetic focus on PTGS1 in relation to NSAID exposure is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where it's running
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Children's Wisconsin
Milwaukee, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: G. Ganesh Konduri, MD — Medical College of Wisconsin
- Study coordinator: G. Ganesh Konduri, MD
- Email: gkonduri@mcw.edu
- Phone: 414-266-6820
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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We're testing an automated closed-loop system to wean inhaled nitric oxide in newborns with persistent pulmonary hypertension (PPHN) to see if it standardizes the process and reduces staff workload.
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Treprostinil for newborns with persistent pulmonary hypertension
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Nebulized magnesium sulfate and sildenafil for treating newborns with severe pulmonary hypertension
This study is testing if a mix of nebulized magnesium sulfate and sildenafil can help newborns with severe pulmonary hypertension who are on breathing machines feel better compared to just using sildenafil alone.
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Dopamine versus norepinephrine for low blood pressure in newborns with pulmonary hypertension
This pilot test compares norepinephrine and dopamine as the first medicine to raise blood pressure in term and late‑preterm newborns with pulmonary hypertension and hypoxemic respiratory failure.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.