Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-02-28 @ 6:42 AM
Study NCT ID:
NCT02833818
Status:
UNKNOWN
Last Update Posted:
2021-02-02
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intensive Dietary Intervention in Children With Birth Weight Between 1500 and 2000 g
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2016-01-11', 'studyFirstSubmitQcDate': '2016-07-12', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Growth at 4 months corrected months age', 'timeFrame': 'From birth until 4 months postmenstrual age (PMA)', 'description': 'Growth from birth, during hospital stay, at discharge/term and at 4 months PMA.'}, {'measure': 'Breastfed, full or partly, and solid food at 4 months PMA', 'timeFrame': 'From birth until 4 months PMA', 'description': 'Eating habits at discharge/term and at 4 months PMA .'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Perinatal Disorders of Growth and Development']}, 'descriptionModule': {'briefSummary': 'There are few scientific reports on preterm infants with birth weights between 1500 and 2000g. Adequate and properly balanced supply of nutrients believed to better growth and cognitive development in this patient group, and optimized nutrition is an important part of treatment There is a need for more studies that can provide knowledge of growth and weight development in preterm and small for gestational age (SGA) infants with a birth weight between 1500 and 2000g.', 'detailedDescription': 'There has been little focus, at least there are few scientific reports on preterm infants with birth weights between 1500 and 2000g, at least in Norway. Studies have shown the benefit of enhanced protein and energy supplements in very low birth weight infants (VLBW, birth weight \\< 1500g), regarding growth and neurodevelopment . Adequate and properly balanced supply of nutrients is believed to give better growth and cognitive development in premature infants with slightly higher birth weight, i.e between 1500 and 2000g (1). In an intervention study of VLBW children at four Norwegian hospitals we found lower supply of energy and protein than international recommendations (2). A larger proportion of premature children were stunted growth (weight below 10 percentile for age) during hospitalization. Although this applies to preterm infants with birth weight less than 1500 g, this may also be the case for larger premature patients.\n\nMore studies that can provide knowledge of growth rate, weight and neurodevelopmental outcomes in preterm and small for gestational age (SGA) infants are warranted. This study examines those with birth weight between 1500 and 2000g. Overall, this may provide new and useful knowledge that can help to optimize the nutrition to preterm and SGA infants with a this range of birth weights'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Weeks', 'minimumAge': '26 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Birth weight between 1500 and 2000g.\n2. No invasive catheters or ventilator (wish homogeneous group).\n3. No malformations or chromosomal disorders.\n4. Parents give informed written consent\n5. Born at study hospitals\n\nExclusion Criteria:\n\n1. Birth weight below 1500 and above 2000g.\n2. Invasive catheters or ventilator.\n3. Malformations or chromosomal disorders.'}, 'identificationModule': {'nctId': 'NCT02833818', 'acronym': 'CAKE', 'briefTitle': 'Effect of Intensive Dietary Intervention in Children With Birth Weight Between 1500 and 2000 g', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Akershus'}, 'officialTitle': 'Growth and Development of Premature Babies', 'orgStudyIdInfo': {'id': 'AkershusUH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAKE-intervention', 'description': 'Increased nutrition and dietary consultations. Growth rate followed by clinical nutritionists that supply high protein and energy if growth rate deviates from 17g/kg/day', 'interventionNames': ['Dietary Supplement: CAKE-intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CAKE-control', 'description': 'nutrition according to established procedures in the neonatal intensive care unit (NICU)', 'interventionNames': ['Dietary Supplement: CAKE-control']}], 'interventions': [{'name': 'CAKE-intervention', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['clinical nutritionist, high protein and energy'], 'description': 'Increased protein and energy supplementation and conversations', 'armGroupLabels': ['CAKE-intervention']}, {'name': 'CAKE-control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'nutrition according to established procedures', 'armGroupLabels': ['CAKE-control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Britt Nakstad, PhD MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Project leader'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elin Wahl Blakstad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'dr. Elin Wahl Blakstad', 'investigatorFullName': 'Elin Wahl Blakstad', 'investigatorAffiliation': 'University Hospital, Akershus'}}}}