Research on the Individualized Treatment Strategy for Extremely Preterm Infants With hsPDA Based on Biomarkers and Targeted Delivery Systems

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07374146

Acronym

BTDS-IT-hsPDA-

Enrollment

Registered

2026-01-28

Start date

2026-02-01

Completion date

2028-12-31

Last updated

2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamically Significant Patent Ductus Arteriosus

Keywords

Extremely premature infants, Biomarkers, Ibuprofen, Targeted delivery systems

Brief 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 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Days to 1 Days

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Contacts

CONTACTHUI Wu

xiaoyiwh107@126.com8618810533012

Outcome results