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Not yet recruiting NCT06045130

PUFAs in Preterm Infants

Observational Necrotizing Enterocolitis Intraventricular Hemorrhage BPD - Bronchopulmonary Dysplasia Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Necrotizing Enterocolitis, Intraventricular Hemorrhage, BPD - Bronchopulmonary Dysplasia, Sepsis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Mortality and severe complications of premature infants [Time frame: before discharge]
Secondary outcome measures (7)
  • Mortality [Time frame: before discharge]
  • NEC [Time frame: before discharge]
  • PDA [Time frame: before discharge]
  • BPD [Time frame: before discharge]
  • IVH [Time frame: before discharge]
  • PVL [Time frame: before discharge]
  • sepsis [Time frame: before discharge]

Eligibility criteria

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.

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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.

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06045130 · 2023-HS-050

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗