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

NCT ID: NCT03700957

Last Updated: 2018-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2019-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Necrotizing Enterocolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Docosahexaenoic Acid Group

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

Group Type EXPERIMENTAL

Docosahexaenoic Acid

Intervention Type DIETARY_SUPPLEMENT

100 milligrams of Docosahexaenoic Acid

Control Group

participants will recieve placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo

Interventions

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Docosahexaenoic Acid

100 milligrams of Docosahexaenoic Acid

Intervention Type DIETARY_SUPPLEMENT

placebo

placebo

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Dina Khaled Mohamed Abou El Fadl

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dina Abou El Fadl, Msc.

Role: PRINCIPAL_INVESTIGATOR

Future University in Egypt

Central Contacts

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Dina Abou El Fadl, Msc.

Role: CONTACT

201005442855

Yasmine Farid, MD

Role: CONTACT

201001449558

References

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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.

Reference Type BACKGROUND
PMID: 28096129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26846324 (View on PubMed)

Abou 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.

Reference Type DERIVED
PMID: 34819793 (View on PubMed)

Other Identifiers

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73

Identifier Type: -

Identifier Source: org_study_id

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