Genetic factors and risk of persistent pulmonary hypertension in newborns
Prostaglandin G/H Synthase-1 (PTGS1) Genetic Variation and Increased Risk for Persistent Pulmonary Hypertension of the Newborn (PPHN)
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | N/A to 12 Months |
| Sex | All |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT00710177 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born at or after 34 weeks gestational age, either diagnosed with PPHN or healthy controls.
Not a fit: Patients with lethal congenital anomalies or significant structural congenital heart or gastrointestinal tract abnormalities may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milwaukee, Wisconsin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.