Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-25 @ 4:56 PM
Study NCT ID:
NCT01480856
Status:
COMPLETED
Last Update Posted:
2014-10-15
First Post:
2011-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cobedding in Daily Weight Gain of Neonate Twins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-14', 'studyFirstSubmitDate': '2011-11-25', 'studyFirstSubmitQcDate': '2011-11-28', 'lastUpdatePostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily weight gain of cobedded preterm twins versus that of single-bedded preterm twins', 'timeFrame': 'patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks', 'description': 'The main objective of this study is to compare daily weight gain of cobedded preterm twins versus that of single-bedded preterm twins'}], 'secondaryOutcomes': [{'measure': 'cardiorespiratory stability', 'timeFrame': 'patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks', 'description': 'cardiorespiratory stability'}, {'measure': 'Thermoregulation', 'timeFrame': 'patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks', 'description': 'Thermoregulation'}, {'measure': 'parents well-being estimated through questionnaires', 'timeFrame': '5 weeks', 'description': 'parents well-being estimated through questionnaires'}, {'measure': 'newborns comfort', 'timeFrame': 'patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks', 'description': 'newborns comfort'}, {'measure': 'stop date of parenteral nutrition', 'timeFrame': 'patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks', 'description': 'stop date of parenteral nutrition'}, {'measure': 'date of removal of central catheter', 'timeFrame': 'patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks', 'description': 'date of removal of central catheter'}, {'measure': 'date of removal of nasogastric catheter', 'timeFrame': 'patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks', 'description': 'date of removal of nasogastric catheter'}, {'measure': 'stop date of oxygenotherapy', 'timeFrame': 'patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks', 'description': 'stop date of oxygenotherapy'}, {'measure': 'neuromotor development estimated by "Brunet Lezine" test at 2 years old', 'timeFrame': '2 years', 'description': 'neuromotor development estimated by "Brunet Lezine" test at 2 years old'}, {'measure': 'Hospitalization time length', 'timeFrame': 'patients will be followed for the duration of hospital stay in special bed (cobedding or single bed) , an expected average of 5 weeks', 'description': 'Hospitalization time length'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Preterm Newborn Twins']}, 'descriptionModule': {'briefSummary': 'Cobedding consists of associating twins in a common cocoon in order to maintain links developed in utero and reduce the stress of premature birth. The aim of this randomized, controlled prospective study is to compare efficacy (in term of newborn daily weight gain) and safety of cobedding versus single-bedding of preterm twins.', 'detailedDescription': 'Randomization will occur during the first 96 hours after birth.Twins randomized in the cobedding arm will be kept in the same cocoon until maximum 37 amenorrhea weeks. Each day, parameters (weight gain, …) will be registered.At two years old, neuromotor development of twins will be estimated by Brunet-Lezine test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At time of inclusion, twins must have been separated since less than 96h following birth.\n* twins born between 30 to 34 weeks of gestation\n* no severe congenital pathology\n* hospitalized at the intensive neonates care unit\n* Parents having given their non-opposition to this study within the 96 hours following twins birth -Time length of cobedding estimated by the investigator to be of three weeks -\n\nExclusion Criteria:\n\nInclusion criteria not fulfilled\n\n* safety reasons\n* prolonged lack of comfort clinically harmful for the newborn as per investigator conclusion.'}, 'identificationModule': {'nctId': 'NCT01480856', 'acronym': 'Cobedding', 'briefTitle': 'Cobedding in Daily Weight Gain of Neonate Twins', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Evaluation of the Efficacy of Cobedding in Daily Weight Gain of Neonate Twins', 'orgStudyIdInfo': {'id': '08/2-H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cobedding', 'description': 'Newborn twins are settled in a single bed : this is cobedding', 'interventionNames': ['Procedure: Cobedding']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Single -bedding', 'description': 'Newborn twins are settled in two beds : this is single-bedding', 'interventionNames': ['Procedure: Single-bedding']}], 'interventions': [{'name': 'Cobedding', 'type': 'PROCEDURE', 'description': 'Newborn twins are settled in a singe bed: this is cobedding', 'armGroupLabels': ['Cobedding']}, {'name': 'Single-bedding', 'type': 'PROCEDURE', 'description': 'Newborn twins are settled in two single beds : this is single-bedding', 'armGroupLabels': ['Single -bedding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'state': 'Loire atlantique', 'country': 'France', 'facility': 'Universitary Hospital Center', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}