PTGS1 Genetic Variation and Increased Risk for Persistent Pulmonary Hypertension of the Newborn
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 12
SponsorMedical College of Wisconsin
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: PPHN
Group B: Control
Trial outcomes
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.
Time frame
participants will be followed for the duration of hospital stay, an expected average of 3 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov