The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates
A Clinical Study on the Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The study will assess the efficacy of Docosahexaenoic Acid in reducing the incidence of necrotizing enterocolitis in premature infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedOctober 9, 2018
October 1, 2018
8 months
September 29, 2018
October 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Docosahexaenoic Acid Group
EXPERIMENTALparticipants will recieve 100 milligrams of Docosahexaenoic Acid per day for 14 days
Control Group
PLACEBO COMPARATORparticipants will recieve placebo
Interventions
100 milligrams of Docosahexaenoic Acid
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Persistent bleeding at any level.
- Receiving medication to avoid coagulation.
- Persistent vomiting.
- Gastrointestinal malformations.
- Mother taking Omega-3 supplements and planning to breastfeed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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.
PMID: 28096129BACKGROUNDBaack 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.
PMID: 26846324BACKGROUNDAbou El Fadl DK, Ahmed MA, Aly YA, Darweesh EAG, Sabri NA. Impact of Docosahexaenoic acid supplementation on proinflammatory cytokines release and the development of Necrotizing enterocolitis in preterm Neonates: A randomized controlled study. Saudi Pharm J. 2021 Nov;29(11):1314-1322. doi: 10.1016/j.jsps.2021.09.012. Epub 2021 Sep 25.
PMID: 34819793DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dina Abou El Fadl, Msc.
Future University in Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer
Study Record Dates
First Submitted
September 29, 2018
First Posted
October 9, 2018
Study Start
October 1, 2018
Primary Completion
June 1, 2019
Study Completion
September 1, 2019
Last Updated
October 9, 2018
Record last verified: 2018-10