The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates

Ain Shams University

Status: Unknown

Conditions: Necrotizing Enterocolitis

Treatments: Dietary Supplement: Docosahexaenoic Acid; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03700957

73

Details and patient eligibility

About

The study will assess the efficacy of Docosahexaenoic Acid in reducing the incidence of necrotizing enterocolitis in premature infants.

Full description

The efficacy of Docosahexaenoic Acid in reducing the incidence of necrotizing enterocolitis in preterm neonates will be evalutaed through measuring its immune-modulatory effect on proinflammatory cytokines.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 day to 3 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm neonates having a gestational age equal or less than 34 weeks at birth.
• Weight (less than or equal 1.500 KG)
• Clinically stable to begin enteral feeding

Exclusion criteria

• Persistent bleeding at any level.
• Receiving medication to avoid coagulation.
• Persistent vomiting.
• Gastrointestinal malformations.
• Mother taking Omega-3 supplements and planning to breastfeed.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Docosahexaenoic Acid Group

Experimental group

Description:

participants will recieve 100 milligrams of Docosahexaenoic Acid per day for 14 days

Treatment:

Dietary Supplement: Docosahexaenoic Acid

Control Group

Placebo Comparator group

Description:

participants will recieve placebo

Treatment:

Other: placebo