Research on the Individualized Treatment Strategy for Extremely Preterm Infants With hsPDA Based on Biomarkers and Targeted Delivery Systems (BTDS-IT-hsPDA-)

January 20, 2026 updated by: Han Tongyan, Peking University Third Hospital
This project aims to address the need for individualized precision therapy for hemodynamically significant patent ductus arteriosus (hsPDA) in extremely preterm infants by integrating clinical biomarker screening with the design of a targeted drug-delivery system, and advancing early prediction and targeted intervention in a stepwise manner. Infants born at <32 weeks' gestational age will be enrolled. Multi-time-point blood samples and relevant clinical parameters will be systematically collected, with a focus on measuring cardiac function biomarkers (NT-proBNP), inflammatory cytokines (IL-6), angiogenic factors (VEGF), and hematologic indices (PCT and PLR). A multi-marker combined predictive model will be developed to improve the identification of high-risk infants. Building on this foundation, a nano-delivery system will be constructed via self-assembly of ibuprofen molecules and targeting ligands to achieve localized, precise, and controlled release at the ductus arteriosus. Its therapeutic efficacy and safety will be evaluated through in-vitro release testing, cytotoxicity assays, and animal model experiments.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hsPDA
Time Frame: From birth until ductal closure or up to 3 weeks postnatal age
Did hsPDA occur? (Yes/No)
From birth until ductal closure or up to 3 weeks postnatal age

Secondary Outcome Measures

Outcome Measure
Time Frame
Trends in biomarker levels across different time points.
Time Frame: From birth until ductal closure or up to 3 weeks postnatal age
From birth until ductal closure or up to 3 weeks postnatal age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • M20260024
  • A20260004 (Other Identifier: Peking university third hospital)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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