PUFAs in Preterm Infants

Not yet recruiting

• Conditions: BPD - Bronchopulmonary Dysplasia; Intraventricular Hemorrhage; Necrotizing Enterocolitis; Patent Ductus Arteriosus; Sepsis; Periventricular Leukomalacia

• Registration Number: NCT06045130
• Lead Sponsor: The First Hospital of Jilin University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-09-13
• Study First Submitted QC: 2023-09-13
• Last Update Submitted: 2023-09-13
• Study Start: 2023-09-21
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality and severe complications of premature infants	before discharge	incidence of death，NEC，PDA，BPD，IVH，PVL and sepsis

Secondary Outcome Measures

Name	Time	Method
Mortality	before discharge	death
PVL	before discharge	periventricular cysts on cranial ultrasound or magnetic resonance imaging
NEC	before discharge	Bell stage II or III
PDA	before discharge	confirmed by echocardiography
BPD	before discharge	nasal CPAP/NIPPV or invasive ventilation requirement at 36 weeks postmenstrual age or at discharge, transfer or death if before 36 weeks
IVH	before discharge	Papile grades 3-4
sepsis	before discharge	blood culture positive