Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-24 @ 10:37 PM
Study NCT ID:
NCT01569633
Status:
WITHDRAWN
Last Update Posted:
2022-11-21
First Post:
2012-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Prokinetics in Early Enteral Feeding in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'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'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008787', 'term': 'Metoclopramide'}, {'id': 'D004917', 'term': 'Erythromycin'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'very poor enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-17', 'studyFirstSubmitDate': '2012-03-30', 'studyFirstSubmitQcDate': '2012-03-30', 'lastUpdatePostDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Prokinetics and PLACEBO IN EARLY ENTERAL NUTRITION OF EXTREME PRETERM INFANTS; DOUBLE BLIND CROSS OVER TRIAL', 'timeFrame': '24 MONTHS', 'description': 'Time to reach full enteral feeding in both infants. Which of the two medication help better in reaching full enteral feeding.'}], 'secondaryOutcomes': [{'measure': 'Comaparison of Prokintics and Placebo in Early Enteral Nutrition of Extreme Preterm Infants; Double blind cross over trial.', 'timeFrame': '24 months', 'description': 'Duration of Total Parental Nutrition; duration of direct hyperbilirubinemia,'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Feeding Disorder', 'Nutrition Disorder', 'Infant,Premature']}, 'descriptionModule': {'briefSummary': 'Objective of this study are:\n\n1\\) To determine if medication help extreme preterm infants to tolerate feeding better by reaching full feeding earlier.2) Out of two medication; which one is better for efficacy 1) Erythromycin 2) Metoclopramide. Infants who meet inclusion criteria would be entered to study after parental consent. Infant would be blinded to care givers. Infants will be randomized to receive one of three medication for 7-14 days. If infants fail on one medication they will be allowed to crossover to other medication. Infant would be allowed to treat like other infants. Blindness can be broken if deem necessary by attending neonatologist.', 'detailedDescription': "Inclusion Critera:\n\n1. Weight below 1250 grams\n2. Age less than 14 days\n3. Feeding intolerance; If feeding residual more than 30% on q3 hr feeding; 5 times out of 8 times, feeding residual more than 20% on q4 hr feeding 4 feeding out of 6 feeding or failure to advance feeding of more than 20ml/kg in 72 hrs.\n\nExclusion Criteria\n\n1. GI malformation or perforation\n2. Genetic disorder\n3. Parents can't read English. After consent, if infants meet inclusion criteria, he would be allowed to receive one of the following three medication. 1) Erythromycin at 1mg/kg/dose q8 hr 2) Metoclopramide 0.1mg/kg/dose q8 hrs and Placebo. If infant fails to get better, he would be crossover to one of the remaining two."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Weight below 1250 grams\n2. Age less than 14 days\n3. Feeding intolerance; If feeding residual more than 30% on q3 hr feeding; 5 times out of 8 times, feeding residual more than 20% on q4 hr feeding 4 feeding out of 6 feeding or failure to advance feeding of more than 20ml/kg in 72 hrs.\n\nExclusion Criteria\n\n1. GI malformation or perforation\n2. Genetic disorder\n3. Parents can't read English. After consent, if infants meet inclusion criteria, he would be allowed to receive one of the following three medication. 1) Erythromycin at 1mg/kg/dose q8 hr 2) Metoclopramide 0.1mg/kg/dose q8 hrs and Placebo. If infant fails to get better, he would be crossover to one of the remaining two."}, 'identificationModule': {'nctId': 'NCT01569633', 'briefTitle': 'Use of Prokinetics in Early Enteral Feeding in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'East Tennessee State University'}, 'officialTitle': 'Pilot Study for Use of Prokinetics in Early Enteral Feeding of Preterm Infants ; Double Blind; Cross Over Study Comparing Eryththromycin, Metoclopramide and Placebo', 'orgStudyIdInfo': {'id': 'ft2011ep'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'This group of infant will not receive any medication but sugar water or placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metclopramide', 'description': 'This group of infants will receive Metoclopramide at 0.1mg/kg q8 hrs.', 'interventionNames': ['Drug: Metclopramide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Erythromycin', 'description': 'mediaction used to treat feeding disorder', 'interventionNames': ['Drug: Erythromycin']}], 'interventions': [{'name': 'Metclopramide', 'type': 'DRUG', 'otherNames': ['reglan'], 'description': 'Dose of metoclopramide is 0.1miligram per kilogram every eight hours for 7-14 days.', 'armGroupLabels': ['Metclopramide']}, {'name': 'Erythromycin', 'type': 'DRUG', 'description': 'Dose of erythromycin is 1 miligram per kilogram every eight hours', 'armGroupLabels': ['Erythromycin']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'The dose of sugar water is 1 ml per 8 hours.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37604', 'city': 'Johnson City', 'state': 'Tennessee', 'country': 'United States', 'facility': 'East Tennessee State University', 'geoPoint': {'lat': 36.31344, 'lon': -82.35347}}], 'overallOfficials': [{'name': 'Darshan S Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'East Tennessee State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Tennessee State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Professor of Pediatrics', 'investigatorFullName': 'Darshan Shah, M.D.', 'investigatorAffiliation': 'East Tennessee State University'}}}}