PIPI: PUFAs in Preterm Infants

Sponsor

The First Hospital of Jilin University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06045130

Collaborator

(none)

600

Enrollment

35.3

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Necrotizing Enterocolitis Intraventricular Hemorrhage BPD - Bronchopulmonary Dysplasia Sepsis Periventricular Leukomalacia Patent Ductus Arteriosus

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 21, 2023

Anticipated Primary Completion Date :

Aug 31, 2026

Anticipated Study Completion Date :

Aug 31, 2026

Outcome Measures

Primary Outcome Measures

Mortality and severe complications of premature infants [before discharge]
incidence of death，NEC，PDA，BPD，IVH，PVL and sepsis

Secondary Outcome Measures

Mortality [before discharge]
death
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
PVL [before discharge]
periventricular cysts on cranial ultrasound or magnetic resonance imaging
sepsis [before discharge]
blood culture positive

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.