New study aims to personalize care for tiny hearts
NCT ID NCT07374146
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study focuses on extremely preterm infants (born before 32 weeks) who have a heart condition called hsPDA. Researchers will collect blood samples and health data to create a model that predicts which infants need treatment. They are also developing a targeted drug-delivery system to treat the condition more precisely. The goal is to improve care for these vulnerable babies.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
Preterm infants (\<32 weeks' gestation) receiving care at our hospital will be enrolled. Exclusion criteria include severe congenital heart disease other than PDA, major malformations, chromosomal abnormalities, severe neurologic defects, severe infection, bleeding tendency, organ failure, contraindications to intravenous ibuprofen, or prior pharmacologic PDA treatment.
- Ages
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0 days to 1 day
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Gestational age \<32 weeks, regardless of sex;Parents or legal guardians are able to maintain effective communication with the investigators and agree to sign written informed consent. Exclusion Criteria: * Infants with severe congenital heart disease (other than PDA), such as severe tetralogy of Fallot, coarctation of the aorta, or pulmonary atresia; Major structural malformations at birth, chromosomal abnormalities, or severe neurological defects; Severe infection, bleeding tendency, or organ failure; Contraindications to intravenous ibuprofen, including but not limited to: active gastrointestinal bleeding or a history of severe gastrointestinal bleeding; confirmed necrotizing enterocolitis or intestinal perforation; severe renal impairment (e.g., oliguria or elevated serum creatinine); Prior treatment for PDA with other pharmacologic agents; Deemed unsuitable for participation in this study by the treating physician.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.