Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-02-05 @ 1:49 AM
Study NCT ID:
NCT03700957
Status:
UNKNOWN
Last Update Posted:
2018-10-09
First Post:
2018-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}], 'ancestors': [{'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-06', 'studyFirstSubmitDate': '2018-09-29', 'studyFirstSubmitQcDate': '2018-10-06', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Docosahexaenoic Acid in reducing the incidence of Necrotizing Enterocolitis in premature infants.', 'timeFrame': '10 days', 'description': 'Monitoring the change in the serum levels of Interleukin-1 beta'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Necrotizing Enterocolitis']}, 'referencesModule': {'references': [{'pmid': '28096129', 'type': 'BACKGROUND', '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.'}, {'pmid': '26846324', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34819793', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The study will assess the efficacy of Docosahexaenoic Acid in reducing the incidence of necrotizing enterocolitis in premature infants.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Weeks', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm neonates having a gestational age equal or less than 34 weeks at birth.\n* Weight (less than or equal 1.500 KG)\n* Clinically stable to begin enteral feeding\n\nExclusion Criteria:\n\n* Persistent bleeding at any level.\n* Receiving medication to avoid coagulation.\n* Persistent vomiting.\n* Gastrointestinal malformations.\n* Mother taking Omega-3 supplements and planning to breastfeed.'}, 'identificationModule': {'nctId': 'NCT03700957', 'briefTitle': 'The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'A Clinical Study on the Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates', 'orgStudyIdInfo': {'id': '73'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Docosahexaenoic Acid Group', 'description': 'participants will recieve 100 milligrams of Docosahexaenoic Acid per day for 14 days', 'interventionNames': ['Dietary Supplement: Docosahexaenoic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'participants will recieve placebo', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Docosahexaenoic Acid', 'type': 'DIETARY_SUPPLEMENT', 'description': '100 milligrams of Docosahexaenoic Acid', 'armGroupLabels': ['Docosahexaenoic Acid Group']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'placebo', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dina Abou El Fadl, Msc.', 'role': 'CONTACT', 'email': 'dkhaled69@gmail.com', 'phone': '201005442855'}, {'name': 'Yasmine Farid, MD', 'role': 'CONTACT', 'email': 'Yasmin_Aly_Farid@hotmail.com', 'phone': '201001449558'}], 'overallOfficials': [{'name': 'Dina Abou El Fadl, Msc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Future University in Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Dina Khaled Mohamed Abou El Fadl', 'investigatorAffiliation': 'Future University in Egypt'}}}}