ClinicalTrials.gg
Not yet recruitingNCT06045130PIPIUpdated Sep 21, 2023

PUFAs in Preterm Infants

An observational study in Necrotizing Enterocolitis, Intraventricular Hemorrhage and BPD - Bronchopulmonary Dysplasia, sponsored by The First Hospital of Jilin University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by The First Hospital of Jilin University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • PUFAs
03

In context

Enterocolitis, Necrotizing

228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.

This study's planned enrollment of 600 is above the median of 144 across 95 observational studies indexed under Enterocolitis, Necrotizing.

Browse Enterocolitis, Necrotizing studies →

Lead sponsor

The First Hospital of Jilin University is the lead sponsor of 185 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

-

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.

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Mortality and severe complications of premature infants

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

    Time frame: before discharge

Secondary outcomes

  1. Mortality

    death

    Time frame: before discharge

  2. NEC

    Bell stage II or III

    Time frame: before discharge

  3. PDA

    confirmed by echocardiography

    Time frame: before discharge

  4. BPD

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

    Time frame: before discharge

  5. IVH

    Papile grades 3-4

    Time frame: before discharge

  6. PVL

    periventricular cysts on cranial ultrasound or magnetic resonance imaging

    Time frame: before discharge

  7. sepsis

    blood culture positive

    Time frame: before discharge

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06045130
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
Sep 21, 2023 (estimated)
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Sep 21, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion