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

NCT00710177 | Recruiting

• 1 other identifier: PRO46055
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

PPHN; PTGS1; NSAID

Outcome Measures

Primary Outcomes (1)

• 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.

  participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Study Arms (2)

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

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, meconium

MeSH Terms

Conditions

Persistent Fetal Circulation Syndrome

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• G. Ganesh Konduri, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

G. Ganesh Konduri, MD

CONTACT

414-266-6820; gkonduri@mcw.edu

Kathleen M Meskin, BSN

CONTACT

414-337-7171; kmeskin@mcw.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Division of Neonatology

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: January 1, 2006
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)