PUFAs in Preterm Infants (PIPI)

September 13, 2023 updated by: The First Hospital of Jilin University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Neonates born within 24 hours who were admitted to the Neonatology Department of the First Hospital of Jilin University, including premature infants born between 24 and 36 weeks of gestational age and full-term infants from September 2023 to August 2026, n

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality and severe complications of premature infants
Time Frame: before discharge
incidence of death，NEC，PDA，BPD，IVH，PVL and sepsis
before discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: before discharge
death
before discharge
NEC
Time Frame: before discharge
Bell stage II or III
before discharge
PDA
Time Frame: before discharge
confirmed by echocardiography
before discharge
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
before discharge
IVH
Time Frame: before discharge
Papile grades 3-4
before discharge
PVL
Time Frame: before discharge
periventricular cysts on cranial ultrasound or magnetic resonance imaging
before discharge
sepsis
Time Frame: before discharge
blood culture positive
before discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 21, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-HS-050

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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