Recruiting

Gene Variation

Sponsor:

Medical College of Wisconsin

Code:

NCT00710177

Conditions

Persistent Pulmonary Hypertension of the Newborn

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

Study Details

Brief 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).

Conditions

Persistent Pulmonary Hypertension of the Newborn

Study ID

NCT00710177

Start date

Jan, 2006

Status verified date

Jan, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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 ]

Central Contacts and Locations

Central contacts

G. Ganesh Konduri, MD

414-266-6820gkonduri@mcw.edu

Kathleen M Meskin, BSN

414-337-7171kmeskin@mcw.edu

Locations

Children's Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Principal Investigator:

Ganesh Konduri, MD

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Keywords

  • PPHN
  • PTGS1
  • NSAID

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2026-01-26.