Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-28 @ 1:27 AM
Study NCT ID:
NCT05308134
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2021-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 615}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2021-11-10', 'studyFirstSubmitQcDate': '2022-03-31', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Milk Type Received', 'timeFrame': 'Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first', 'description': 'Type of milk consumed (i.e. parent, donor)'}, {'measure': 'Energy and Nutrient Intakes of Infants', 'timeFrame': 'Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first', 'description': 'Energy in kilocalories and nutrient intakes (i.e. macronutrients and micronutrients)'}, {'measure': 'Maternal Diet During Lactation', 'timeFrame': 'Study Day 35±3', 'description': 'Data on maternal diet during the first month of the intervention using the Canadian Diet History Questionnaire II'}], 'primaryOutcomes': [{'measure': 'Cognitive Composite Score', 'timeFrame': '18-24 months corrected age', 'description': 'Bayley Scales of Infant and Toddler Development'}], 'secondaryOutcomes': [{'measure': 'Language Composite Score', 'timeFrame': '18-24 months CA', 'description': 'Bayley Scales of Infant and Toddler Development'}, {'measure': 'Motor Composite Score', 'timeFrame': '18-24 months CA', 'description': 'Bayley Scales of Infant and Toddler Development'}, {'measure': 'Weight Gain during the intervention', 'timeFrame': 'Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first', 'description': 'Change in z-score'}, {'measure': 'Length gain during the intervention', 'timeFrame': 'Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first', 'description': 'Change in z-score'}, {'measure': 'Head circumference gain during the intervention', 'timeFrame': 'Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first', 'description': 'Change in z-score'}, {'measure': 'Body composition at the end of the intervention', 'timeFrame': '36 weeks corrected age', 'description': 'Skinfolds'}, {'measure': 'Serious Morbidity', 'timeFrame': 'Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first', 'description': 'Composite of death, NEC, late onset sepsis, chronic lung disease or severe retinopathy of prematurity (ROP)'}, {'measure': 'Health Economics', 'timeFrame': 'Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first', 'description': 'Total cost incurred for in-hospital care'}, {'measure': 'Weight at follow-up', 'timeFrame': '4 months corrected age', 'description': 'z score'}, {'measure': 'Length at follow-up', 'timeFrame': '4 months corrected age', 'description': 'z score'}, {'measure': 'Head Circumference at follow-up', 'timeFrame': '4 months corrected age', 'description': 'z score'}, {'measure': 'Body composition at follow-up (approximated)', 'timeFrame': '4 months corrected age', 'description': 'Skinfolds'}, {'measure': 'Body composition at follow-up (direct measurement)', 'timeFrame': '4 months corrected age', 'description': 'Air displacement plethysmography'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Very Low Birth Weight Infant']}, 'referencesModule': {'references': [{'pmid': '41047263', 'type': 'DERIVED', 'citation': "Beggs MR, Pichardo D, Chrzaniecki A, Kotsopoulos K, Bishara R, Ng E, Tomlinson C, Campbell D, Vaz S, Kiss A, Unger S, O'Connor DL. MaxiMoM InForM: individualised fortification of human milk for very low birthweight infants- protocol of a three-arm randomised clinical trial. BMJ Open. 2025 Oct 5;15(10):e105609. doi: 10.1136/bmjopen-2025-105609."}]}, 'descriptionModule': {'briefSummary': 'Very low birth weight infants have increased nutritional needs. Extra nutrients are added to their human milk feeds to help improve their nutritional status, growth and neurodevelopment. Standard fortification of human milk is routine in most neonatal units in North America, but despite the added nutrients, infants are often discharged from hospitals with poor growth, and their neurodevelopment remains suboptimal. Two individualized fortification methods, target and BUN adjustable, have been proposed to improve the nutrient supply to infants. However, there is currently insufficient evidence to support the implementation of individualized fortification or one method over the other. Therefore, this study will randomly assign very low birth weight infants to receive feeds fortified according to standard, target or BUN adjustable fortification methods until the end of the feeding intervention. Feedings will be prepared in milk preparation rooms to ensure caregivers and outcomes assessor remain blinded to feeding allocation. Growth, morbidities, and nutrient intakes will be determined throughout hospitalization and skinfolds assessed at 36 weeks. At 4 months CA, growth and body composition will be determined by air displacement plethysmography on a subset of infants. Neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development, at 18-24 months CA.', 'detailedDescription': 'The end of the feeding intervention is defined as: the infant is 36+0 weeks CA, is discharged home, or receives two oral feeds daily for three consecutive days without top-up. The exception to the 36+0 weeks intervention end-date is in the situation where an infant remains hospitalized but has not completed at least four weeks of the feeding intervention (i.e. 4 weeks following Study Day 1).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '21 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≤1250 g birth weight or Gestational Age \\<30+0 weeks and \\<1500 g birth weight.\n* Parental/guardian consent to participate.\n* Consent for the use of pasteurized donor milk if mother's milk is not available.\n\nExclusion Criteria:\n\n* Infant received fortifier or formula before Study Day 1.\n* Study Day 1 anticipated to occur after postnatal day 21.\n* Infants with congenital or chromosomal anomalies or brain injury that may affect growth or neurodevelopment.\n* Enrollment in any other clinical study affecting nutritional management during the feeding intervention.\n* Reasonable potential that the infant will be transferred to a NICU where the study protocol will not be continued before they have completed at least 4 weeks of the feeding intervention."}, 'identificationModule': {'nctId': 'NCT05308134', 'briefTitle': 'Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'MaxiMoM: Individualized Fortification of Human Milk for Infants Born ≤ 1250 g; a Three Arm Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '1861'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard fortification', 'interventionNames': ['Other: Standard fortification']}, {'type': 'EXPERIMENTAL', 'label': 'Target fortification', 'interventionNames': ['Other: Target fortification']}, {'type': 'EXPERIMENTAL', 'label': 'BUN adjustable fortification', 'interventionNames': ['Other: BUN adjustable fortification']}], 'interventions': [{'name': 'Standard fortification', 'type': 'OTHER', 'description': 'Standard fortification assumes that the nutrient content of human milk is constant and involves use of a standard fixed dose of multi-nutrient fortifier and as appropriate nutrient modulars.', 'armGroupLabels': ['Standard fortification']}, {'name': 'Target fortification', 'type': 'OTHER', 'description': 'Target fortification involves use of a multi-nutrient fortifier as well as weekly analysis of energy and macronutrients of human milk and subsequent addition of fat and protein modulars if needed.', 'armGroupLabels': ['Target fortification']}, {'name': 'BUN adjustable fortification', 'type': 'OTHER', 'description': 'BUN (blood urea nitrogen) adjustable fortification involves use of a multi-nutrient fortifier as well as weekly BUN tests and subsequent addition of a protein modular according to a prescribed algorithm.', 'armGroupLabels': ['BUN adjustable fortification']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2R3', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'L6R 3J7', 'city': 'Brampton', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'William Osler Health System-Brampton Civic Hospital', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'M9V 1R8', 'city': 'Etobicoke', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'William Osler Health System-Etobicoke General Hospital', 'geoPoint': {'lat': 43.64415, 'lon': -79.56985}}, {'zip': 'L3P 7P3', 'city': 'Markham', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'Markham Stouffville Hospital', 'geoPoint': {'lat': 43.86682, 'lon': -79.2663}}, {'zip': 'L5B 1B8', 'city': 'Mississauga', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'Trillium Health Partners-Missisauga Hospital', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L5M 2N1', 'city': 'Mississauga', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'Trillium Health Partners-Credit Valley Hospital', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L3Y 2P9', 'city': 'Newmarket', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'Southlake Regional Health Centre', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'M2K 1E1', 'city': 'North York', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'North York General Hospital'}, {'zip': 'M3M 0B2', 'city': 'North York', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'Humber River Hospital'}, {'zip': 'L1G 2B9', 'city': 'Oshawa', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'Lakeridge Health', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'L4C 4Z3', 'city': 'Richmond Hill', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'Mackenzie Health', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'zip': 'M1E 4B9', 'city': 'Scarborough Village', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'Scarborough Health Network-Centenary Hospital', 'geoPoint': {'lat': 43.73899, 'lon': -79.22124}}, {'zip': 'M1P 2V5', 'city': 'Scarborough Village', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'Scarborough Health Network-General Hospital', 'geoPoint': {'lat': 43.73899, 'lon': -79.22124}}, {'zip': 'M4C 3E7', 'city': 'Toronto', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'Michael Garron Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'Unity Health Toronto-St Michaels Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Sinai Health System-Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5S 1A1', 'city': 'Toronto', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M6R 1B5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Canada', 'facility': 'Unity Health Toronto-St Josephs Health Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': "Deborah O'Connor, PhD RD", 'role': 'CONTACT', 'email': 'deborah_l.oconnor@sickkids.ca', 'phone': '416-813-7844'}, {'name': 'Sharon Unger, MD', 'role': 'CONTACT', 'email': 'sharon.unger@sinaihealth.ca', 'phone': '416-586-8593'}], 'overallOfficials': [{'name': "Deborah O'Connor, PhD RD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}, {'name': 'Sharon Unger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sinai Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Associate Scientist', 'investigatorFullName': "Deborah O'Connor", 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}