PUFAs in Preterm Infants

NCT06045130 | Not Yet Recruiting DMC

• 1 other identifier: 2023-HS-050
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

PUFAs

Outcome Measures

Primary Outcomes (1)

• Mortality and severe complications of premature infants

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

  before discharge

Secondary Outcomes (7)

• Mortality

  before discharge

• NEC

  before discharge

• PDA

  before discharge

• BPD

  before discharge

• IVH

  before discharge

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Bronchopulmonary Dysplasia; Sepsis; Leukomalacia, Periventricular; Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Encephalomalacia; Vascular Diseases; Cardiovascular Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: September 21, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 21, 2023

Record last verified: 2023-08