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NCT03700957 Clinical Trial

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

Necrotizing Enterocolitis Clinical Trial

Official title:
A Clinical Study on the Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03700957
Other study ID # 73
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2018
Est. completion date September 2019

Study information
Verified date October 2018
Source Ain Shams University
Contact Dina Abou El Fadl, Msc.
Phone 201005442855
Email dkhaled69@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date September 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Weeks
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Docosahexaenoic Acid
100 milligrams of Docosahexaenoic Acid
Other:
• placebo
placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

References & Publications (2)

Baack ML, Puumala SE, Messier SE, Pritchett DK, Harris WS. Daily Enteral DHA Supplementation Alleviates Deficiency in Premature Infants. Lipids. 2016 Apr;51(4):423-33. doi: 10.1007/s11745-016-4130-4. Epub 2016 Feb 4. — View Citation

Shulhan J, Dicken B, Hartling L, Larsen BM. Current Knowledge of Necrotizing Enterocolitis in Preterm Infants and the Impact of Different Types of Enteral Nutrition Products. Adv Nutr. 2017 Jan 17;8(1):80-91. doi: 10.3945/an.116.013193. Print 2017 Jan. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of Docosahexaenoic Acid in reducing the incidence of Necrotizing Enterocolitis in premature infants. Monitoring the change in the serum levels of Interleukin-1 beta 10 days
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