PTGS1 Genetic Variation and Increased Risk for Persistent Pulmonary Hypertension of the Newborn

Last updated: March 14, 2023
Sponsor: Medical College of Wisconsin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Circulation Disorders

Pulmonary Arterial Hypertension

Treatment

N/A

Clinical Study ID

NCT00710177
CHW 06/02, GC 49
  • Ages < 12
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Infants born greater than or equal to 34 weeks gestational age diagnosed with PPHN andnormal, healthy infants born greater than or equal to 34 weeks gestational age.

Exclusion

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 meconiumpassage
  • congenital anomalies such as diaphragmatic hernia, Potter's syndrome, or pulmonaryhypoplasia

Study Design

Total Participants: 200
Study Start date:
January 01, 2006
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Children's Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Froedtert Memorial Lutheran Hospital

    Wauwatosa, Wisconsin 53226
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.