Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06045130

PUFAs in Preterm Infants

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Necrotizing Enterocolitis BPD - Bronchopulmonary Dysplasia Brain Diseases Bronchopulmonary Dysplasia Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Ductus Arteriosus, Patent Encephalomalacia Enterocolitis Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases Heart Defects, Congenital Heart Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Infections Inflammation Intestinal Diseases Intraventricular Hemorrhage Leukomalacia, Periventricular Lung Diseases Lung Injury Nervous System Diseases Patent Ductus Arteriosus Pathologic Processes Pathological Conditions, Signs and Symptoms Periventricular Leukomalacia Respiratory Tract Diseases Sepsis Systemic Inflammatory Response Syndrome Vascular Diseases Ventilator-Induced Lung Injury

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

Primary outcomes

  1. Mortality and severe complications of premature infants

    Time frame: before discharge

    incidence of death，NEC，PDA，BPD，IVH，PVL and sepsis

Secondary outcomes

  1. Mortality

    Time frame: before discharge

    death

  2. NEC

    Time frame: before discharge

    Bell stage II or III

  3. PDA

    Time frame: before discharge

    confirmed by echocardiography

  4. BPD

    Time frame: before discharge

    nasal CPAP/NIPPV or invasive ventilation requirement at 36 weeks postmenstrual age or at discharge, transfer or death if before 36 weeks

  5. IVH

    Time frame: before discharge

    Papile grades 3-4

  6. PVL

    Time frame: before discharge

    periventricular cysts on cranial ultrasound or magnetic resonance imaging

  7. sepsis

    Time frame: before discharge

    blood culture positive

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

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

Acronym: PIPI

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Sep 21, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.