Effect of DHA on Proinflammatory Cytokines Including Platelets Activating Factor (PAF) in Preterm Neonates

NCT04746885 | Completed

• 1 other identifier: DHA in preterm
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether docosahexaenoic acid is effective in the prevention or reducing severity of necrotizing enterocolitis in preterm/low birth weight neonates.Necrotizing enterocolitis (NEC) is the most devastating gastrointestinal disease in neonates. The pathogenesis of NEC is not well defined but evidence strongly suggests that it is multifactorial . prematurity and enteral feeding are major risk factors for NEC. An excessive inflammatory response by the immature intestine to external stimuli, impaired intestinal barrier integrity and / or abnormal bacterial colonization are key factors implicated in pathophysiology of NEC.

Conditions

Neonatal Disease

Outcome Measures

Primary Outcomes (1)

• DEVELOPMENT OF NEC

  All infants will undergo follow-up from birth until reach 37 week corrected gestational age, discharge or death whichever comes first. The following primary outcome data will be recorded: Clinical examination and radiological investigations when clinically indicated for evidence of NEC.

  3-10 DAYS

Study Arms (2)

Group A

OTHER

(interventional group/ DHA): A minimum of 40 preterm infants will be included to receive 100mg DHA daily administered by enteral route for 30 days. This group will be subdivided into breast fed / artificially fed infants.

Dietary Supplement: DHA

Group B

OTHER

(control group / Placebo): 40 of preterm infant controls will be included to receive placebo (physically matched solution). This group will be subdivided into breast fed / artificially fed infants.

Dietary Supplement: DHA

Interventions

DHA DIETARY_SUPPLEMENT

Oral supplement

Group A; Group B

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm neonates having a gestational age equal or less than 32 weeks at birth, admitted in Ain Shams University NICU'S.

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 breastfed.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11566, Egypt

Location

Related Publications (4)

• Aderem A, Ulevitch RJ. Toll-like receptors in the induction of the innate immune response. Nature. 2000 Aug 17;406(6797):782-7. doi: 10.1038/35021228.

  PMID: 10963608 RESULT

• Meguro A, Kuribayashi R, Sakurada T, Sekine T, Aida H, Abe T. [Intravascular hemolysis due to residual shunt after patch closure of VSD: a case report]. Kyobu Geka. 1992 Jun;45(6):537-40. Japanese.

  PMID: 1602686 RESULT

• Axelsson A, Lindgren F. [Firecrackers--a risk of hearing injuries?]. Lakartidningen. 1987 Apr 15;84(16):1341-6. No abstract available. Swedish.

  PMID: 3586783 RESULT

• Miles EA, Calder PC. Modulation of immune function by dietary fatty acids. Proc Nutr Soc. 1998 May;57(2):277-92. doi: 10.1079/pns19980042. No abstract available.

  PMID: 9656331 RESULT

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: September 21, 2017
• Primary Completion: November 12, 2020
• Study Completion: January 1, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)