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Could your genes raise Baby's risk from common painkillers?

NCT ID NCT00710177

Knowledge-focused Sponsor: Medical College of Wisconsin Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is investigating whether natural differences in the PTGS1 gene make some newborns more likely to develop a serious lung condition called persistent pulmonary hypertension (PPHN) after their mothers took over-the-counter pain relievers (NSAIDs) during pregnancy. Researchers will compare 200 infants—some with PPHN and some healthy—to see if genetic variations play a role. The goal is to better understand why some babies are affected, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help identify newborns at higher risk for PPHN after NSAID exposure, potentially guiding safer medication use during pregnancy.
What could go wrong
This is an observational study, not a treatment trial. It may not find a clear genetic link, and results may not change current medical practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Jan 2006

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

Up to 12 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

persistent fetal circulation syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Persistent pulmonary hypertension of the newborn

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

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