Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-09 @ 5:55 AM
Study NCT ID:
NCT01759134
Status:
TERMINATED
Last Update Posted:
2013-10-25
First Post:
2012-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-10-24', 'studyFirstSubmitDate': '2012-01-02', 'studyFirstSubmitQcDate': '2013-01-01', 'lastUpdatePostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'growth', 'timeFrame': '3 months post discharge', 'description': 'weight (kg), length (cm), head circumference (cm).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Premature neonate', 'Post-discharge', 'Formula'], 'conditions': ['Premature Birth of Newborn']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the post-discharge growth of preterm infants fed with 2 different post discharge formulas.', 'detailedDescription': 'Infants will be randomized upon discharge from the NICU. We will follow weight, height and head circumference for three months following discharge, In addition any feeding difficulties will be noted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '34 Weeks', 'minimumAge': '30 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Preterm infants that are being fed only by formulas (mother chose not to breast feed, or cannot breast feed).\n2. Gestational week 30-34.\n\nExclusion Criteria:\n\n1. Congenital major malformation (e.g. congenital heart disease).\n2. Chromosomal abnormality (e.g. Down's syndrome)\n3. Gastrointestinal morbidity: S/P abdominal surgery, S/P NEC\n4. Milk allergy\n5. Chronic disease (e.g. oxygen treatment)"}, 'identificationModule': {'nctId': 'NCT01759134', 'briefTitle': 'Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': 'Comparison of Post-Discharge Growth of Premature Infants Using Two Different Formulas', 'orgStudyIdInfo': {'id': 'chammermanpdc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Post Discharge Formula', 'description': 'Babies will be given formula for first three months post discharge', 'interventionNames': ['Other: Post discharge formula']}], 'interventions': [{'name': 'Post discharge formula', 'type': 'OTHER', 'description': 'Babies will be given either materna sensitive or similac neosure', 'armGroupLabels': ['Post Discharge Formula']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Alona Bin-Nun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaare Zedek Medical Center'}, {'name': 'Cathy Hammerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaare Zedek Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}