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Effect of omega-3 and omega-6 in prevention of necrotizing enterocolitis

The effect of omega-3 and omega-6 on the frequency of Necrotizing enterocolitis in premature neonates

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250625066253N1
Enrollment
66
Registered
2026-01-10
Start date
2025-09-23
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing Enterocolitis. Necrotizing enterocolitis of newborn

Interventions

Intervention 1: Intervention group: Neonates in this group will receive oral Docosahexaenoic Acid (DHA) syrup (Brand: Advancis Omega Mousse, Pharmodietica, Portugal). The concentration is 129 mg of DH

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 238 Days

Inclusion criteria

Inclusion criteria: Born at a gestational age of less than 34 weeks Admitted to the Neonatal Intensive Care Unit (NICU) Able to tolerate oral feeding without significant gastrointestinal complications

Exclusion criteria

Exclusion criteria: Chromosomal abnormalities Critical illness requiring extensive resuscitation (eg, low Apgar scores, cardiovascular shock, unstable hemodynamics) Sepsis Life-threatening infections Intraventricular hemorrhage (IVH) grade III or higher Major congenital heart defects Suspected gastrointestinal atresia Malrotation Any gastrointestinal condition requiring surgical intervention

Design outcomes

Primary

MeasureTime frame
Incidence of necrotizing enterocolitis according to modified Bell's criteria. Timepoint: Before the intervention, daily during the intervention, and one week after the completion of the intervention. Method of measurement: using modified Bell's criteria based on clinical, laboratory, and radiographic findings.

Secondary

MeasureTime frame
Feeding intolerance. Timepoint: Before the intervention, daily during the intervention, and one week after the completion of the intervention. Method of measurement: clinical examination.;Abdominal distension. Timepoint: Before the intervention, daily during the intervention, and one week after the completion of the intervention. Method of measurement: clinical examination.;Thrombocytopenia. Timepoint: Before the intervention, daily during the intervention, and one week after the completion of the intervention. Method of measurement: Laboratory evaluation will be performed using the electrical impedance method with a Mindray brand cell counter.;Abdominal wall discoloration. Timepoint: Before the intervention, daily during the intervention, and one week after the completion of the intervention. Method of measurement: clinical examination.;Abdominal tenderness. Timepoint: Before the intervention, daily during the intervention, and one week after the completion of the intervention. Method of measurement: clinical examination.;Neutropenia. Timepoint: Before the intervention, daily during the intervention, and one week after the completion of the intervention. Method of measurement: Laboratory evaluation will be performed using the electrical impedance method with a Mindray brand cell counter.;Metabolic acidosis. Timepoint: Before the intervention, daily during the intervention, and one week after the completion of the intervention. Method of measurement: using blood gas analyzer Radiometer brand.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAynaz Parvaz

Kerman University of Medical Sciences

aynazparvaz@gmail.com+98 34 3248 3501

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026