Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT07088302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EFFECT OF LACTASE ENZYME SUPPLEMENT ON PROTECTION AGAINST FEEDING INTOLERENCE IN PRETERM NEONATES
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'C562600', 'term': 'Lactase Deficiency, Congenital'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-19', 'studyFirstSubmitDate': '2025-07-19', 'studyFirstSubmitQcDate': '2025-07-19', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feeding intolerance:', 'timeFrame': 'first two weeks of life', 'description': 'vomiting number per day aspirates in ml/day abdominal distension by measuring abdominal circumference before and after feeds'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature', 'Feeding Disorders', 'Lactase Deficiency, Congenital']}, 'descriptionModule': {'briefSummary': "This study aims to study the effect of lactase enzyme in preventing feeding intolerance in preterm neonates in neonatal intensive care unit at Alexandria University Children's Hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Month', 'minimumAge': '3 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria will be as follows:\n\n* Preterm neonates ≤ 32 weeks gestational age.\n* Start feeding in the first 72 hours of life. 8. Exclusion criteria\n\nPatients with any of the following will be excluded:\n\n1. Parental consent lacking/refusal.\n2. Obvious major congenital abnormalities.\n3. Infants more than 72 hours of age at the time of randomization.\n4. Delayed introduction of feeding (beyond three days of life).\n5. Known galactosemia.\n6. Severe IUGR. -'}, 'identificationModule': {'nctId': 'NCT07088302', 'briefTitle': 'EFFECT OF LACTASE ENZYME SUPPLEMENT ON PROTECTION AGAINST FEEDING INTOLERENCE IN PRETERM NEONATES', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'EFFECT OF LACTASE ENZYME SUPPLEMENT ON PROTECTION AGAINST FEEDING INTOLERENCE IN PRETERM NEONATES', 'orgStudyIdInfo': {'id': '0108387'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lactase enzyme group', 'interventionNames': ['Drug: lactase administration']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'lactase administration', 'type': 'DRUG', 'description': '1 drop for each 10 ml of formula milk for 14 days', 'armGroupLabels': ['Lactase enzyme group']}, {'name': 'placebo', 'type': 'OTHER', 'description': '10 ml milk without lactase', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marwa M Farag, PhD', 'role': 'CONTACT', 'email': 'd.marwa.farag@gmail.com', 'phone': '01288681788'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Pediatrics', 'investigatorFullName': 'Marwa Mohamed Farag', 'investigatorAffiliation': 'Alexandria University'}}}}