NCT Number: NCT07374146
Research on the Individualized Treatment Strategy for Extremely Preterm Infants With hsPDA Based on Biomarkers and Targeted Delivery Systems
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.
Trial opening soon.
Get NotifiedKey information
Age range
0 day–1 day
Sex eligibility
All sexes
Study type
Observational
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Incidence of hsPDA
Time frame: From birth until ductal closure or up to 3 weeks postnatal age
Did hsPDA occur? (Yes/No)
Secondary outcomes
-
Trends in biomarker levels across different time points.
Time frame: From birth until ductal closure or up to 3 weeks postnatal age
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Peking University Third Hospital
Other
Registry information
Acronym: BTDS-IT-hsPDA-
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Jan 28, 2026
- Registry last updated
- Jan 28, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.