Hemodynamically Significant Patent Ductus ArteriosusBTDS-IT-hsPDA-NCT07374146
Research on the Individualized Treatment Strategy for Extremely Preterm Infants With hsPDA Based on Biomarkers and Targeted Delivery Systems
An observational study of Hemodynamically Significant Patent Ductus Arteriosus, run by Peking University Third Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 days to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Hemodynamically Significant Patent Ductus Arteriosus
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 1 day
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Keywords
- Extremely premature infants, Biomarkers, Ibuprofen, Targeted delivery systems
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hsPDA
Did hsPDA occur? (Yes/No)
Measured: From birth until ductal closure or up to 3 weeks postnatal age
Secondary outcomes (1)
Trends in biomarker levels across different time points.
Measured: From birth until ductal closure or up to 3 weeks postnatal age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamically Significant Patent Ductus ArteriosusStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Tongyan, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374146
- Sponsor's protocol ID
- M20260024
- Other IDs
- A20260004
- Acronym
- BTDS-IT-hsPDA-
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Individualized Treatment Strategy for Extremely Preterm Infants With hsPDA Based on Biomarkers and Targeted Delivery Systems
- ClinicalTrials.gov ID
- NCT07374146
- Acronym / sponsor ID
- BTDS-IT-hsPDA- / M20260024
- Keywords
- Extremely premature infants, Biomarkers, Ibuprofen, Targeted delivery systems
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of hsPDA
Time frame: From birth until ductal closure or up to 3 weeks postnatal age
Did hsPDA occur? (Yes/No)
1 secondary outcome
Trends in biomarker levels across different time points.
Time frame: From birth until ductal closure or up to 3 weeks postnatal age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
Related trials for Hemodynamically Significant Patent Ductus Arteriosus
RecruitingObservational study
Relation Between Prostaglandin E2 Metabolite Levels and the Development of Hemodynamically Significant Patent Ductus Arteriosus in Preterm Neonates
Neonatal Prematurity, Patent Ductus Arteriosus in Preterm Infants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamically Significant Patent Ductus Arteriosus, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HUI Wu (8618810533012, xiaoyiwh107@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hsPDA (time frame: From birth until ductal closure or up to 3 weeks postnatal age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.