Neonatal Disease Clinical Trial
Official title:
Effect of DHA on Proinflammatory Cytokines Including Platelets Activating Factor (PAF) and it's Role in Prevention of Necrotizing Enterocolitis in Preterm/Very Low Birth Weight Neonates
Verified date | February 2021 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | January 1, 2021 |
Est. primary completion date | November 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 28 Days |
Eligibility | Inclusion Criteria: - Preterm neonates having a gestational age equal or less than 32 weeks at birth, admitted in Ain Shams University NICU'S. Weight (less than or equal 1.500 KG) Clinically stable to begin enteral feeding All Genders (Male, Female) Written informed consent by parents Sepsis will not be considered as exclusion criteria (according to SNAP 11; this score considers six physiologic variables such as blood pressure, temperature, the Po2/Fio2 ratio, serum PH, seizures and urine output, Töllner score (table 3) and Rodwell score Exclusion Criteria: - Persistent bleeding at any level. Receiving medication to avoid coagulation. Persistent vomiting. Gastrointestinal malformations. Mother taking Omega-3 supplements and planning to breastfed. |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Aderem A, Ulevitch RJ. Toll-like receptors in the induction of the innate immune response. Nature. 2000 Aug 17;406(6797):782-7. Review. — View Citation
Axelsson A, Lindgren F. [Firecrackers--a risk of hearing injuries?]. Lakartidningen. 1987 Apr 15;84(16):1341-6. Swedish. — View Citation
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. — View Citation
Miles EA, Calder PC. Modulation of immune function by dietary fatty acids. Proc Nutr Soc. 1998 May;57(2):277-92. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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