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NCT06045130 Clinical Trial

PUFAs in Preterm Infants

Sepsis Clinical Trial

— PIPI  

Official title:
Characteristics of PUFAs Composition in Preterm Infants and Its Impact on Disease Prognosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06045130
Other study ID # 2023-HS-050
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 21, 2023
Est. completion date August 31, 2026

Study information
Verified date August 2023
Source The First Hospital of Jilin University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The research endeavors to examine the critical composition of Polyunsaturated Fatty Acids (PUFAs) in premature infants across different gestational stages and under varying disease conditions, and delineate the metabolic attributes of PUFAs in premature infants and their interplay with the onset of diseases. This study anticipates furnishing a theoretical foundation for the rationalization of PUFAs supplementation in premature infants and for informing strategies related to disease prevention and management.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 600
Est. completion date August 31, 2026
Est. primary completion date August 31, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Infants born between 24 and 36 weeks of gestational age who are admitted within 24 hours of birth, including both premature and full-term newborns. - Exclusion Criteria: Infants with severe congenital developmental abnormalities, those requiring external supplementation of PUFAs in addition to standard intravenous nutrition and breastfeeding, and those with a severe prognosis indicating non-survival during their hospitalization. -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The First Hospital of Jilin University

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality and severe complications of premature infants incidence of death,NEC,PDA,BPD,IVH,PVL and sepsis before discharge
Secondary Mortality death before discharge
Secondary NEC Bell stage II or III before discharge
Secondary PDA confirmed by echocardiography before discharge
Secondary BPD nasal CPAP/NIPPV or invasive ventilation requirement at 36 weeks postmenstrual age or at discharge, transfer or death if before 36 weeks before discharge
Secondary IVH Papile grades 3-4 before discharge
Secondary PVL periventricular cysts on cranial ultrasound or magnetic resonance imaging before discharge
Secondary sepsis blood culture positive before discharge
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