Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-29 @ 9:06 PM
Study NCT ID:
NCT04962035
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2021-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurocognitive Follow-Up (FU) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-22', 'studyFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2021-07-05', 'lastUpdatePostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bayley-III scores at 24 months', 'timeFrame': '24 months of CA', 'description': 'Bayley Scales of Infant and Toddler Development, third edition (Bayley-III) cognitive score at 24 months of corrected age (CA). Composite scores range 40-160, with a mean of 100 and SD of 10 points. A composite score of 70 or less is an indication of a delay in child neurocognitive development.'}], 'secondaryOutcomes': [{'measure': 'Bayley-III scores at 18 months', 'timeFrame': '18 months of CA', 'description': 'Bayley Scales of Infant and Toddler Development, third edition (Bayley-III) cognitive score at 18 months of corrected age (CA). Composite scores range 40-160, with a mean of 100 and SD of 10 points. A composite score of 70 or less is an indication of a delay in child neurocognitive development.'}, {'measure': 'Weight', 'timeFrame': 'At enrollment, 18 and 24 months of CA', 'description': 'Child weight (g)'}, {'measure': 'Length/height', 'timeFrame': 'At enrollment, 18 and 24 months of CA', 'description': 'Child length/height (cm)'}, {'measure': 'Head circumference', 'timeFrame': 'At enrollment, 18 and 24 months of CA', 'description': 'Child head circumference (cm)'}, {'measure': 'Child temperament scores', 'timeFrame': 'At 18 and 24 months of CA', 'description': 'Parent-reported child temperament questionnaire validated specifically for children between the ages of 18 and 36 months'}, {'measure': 'Developmental Milestone scores', 'timeFrame': 'At 18 and 24 months of CA', 'description': 'Parent-reported achievements of specific age-appropriate milestones (yes/no responses to child performing specific milestones or not)'}, {'measure': 'Number of healthcare usage', 'timeFrame': 'At 18 and 24 months of CA', 'description': 'Retrospective parent-reported recall of the number of healthcare usage and hospitalizations'}, {'measure': 'Feeding patterns', 'timeFrame': 'At 18 and 24 months of CA', 'description': 'Feeding practice outcomes collected retrospectively at each visit via a parent-reported questionnaire related to breastfeeding duration, prevalence of formula feeding, and age at initiation of complementary feeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Developmental Delay']}, 'referencesModule': {'references': [{'pmid': '39649400', 'type': 'DERIVED', 'citation': 'Kwinta P, Lazarova S, Demova K, Chen Y, Hartweg M, Krattinger LF, Fumero C, Buczynska A, Durlak W, Uhrikova Z, Kozar M, Samuel TM, Zibolen M. Effects of two-stage preterm formulas on growth, nutritional biomarkers, and neurodevelopment in preterm infants. Front Pediatr. 2024 Nov 22;12:1427050. doi: 10.3389/fped.2024.1427050. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'This is a follow-up study of a recently completed trial (17.14.INF) evaluating the growth of pre-term infants. Enrolled children will undergo neurocognitive assessments at 18- and 24-months of corrected age (CA).', 'detailedDescription': 'This is a follow-up study of a recently completed multi-center, prospective, single-arm, open-label interventional trial (17.14.INF - Alprem RTF: NCT03728764) evaluating the growth of pre-term infants receiving a two-stage PTF feeding system while in the neonatal care unit and continuing until 30 days post-discharge.\n\nEnrolled children will undergo neurocognitive assessments at 18- and 24-months of corrected age (CA). The timing of the cognitive assessments aligns with routine check-up visits and reflect the period at which developmental delays may first become evident.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '25 Months', 'minimumAge': '17 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants who have previously participated in the 17.14.INF Alprem RTF study are eligible to participate, wherein preterm infants of gestational age ≥ 27 weeks and ≤ 32 weeks with body weight \\<1500g and appropriate for gestational age (AGA) as defined by weight ≥10 percentile and ≤90 percentile on the Fenton growth chart had been enrolled.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Infants / children born prematurely who were enrolled into the original clinical trial and who are less than 24 m of CA.\n2. Having obtained his / her parents' (or his or her legally accepted guardian written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parent(s) / legal guardian has been informed of all pertinent aspects of the study.\n\nExclusion Criteria:\n\n1\\. Infants identified retrospectively as not meeting the inclusion or exclusion criteria for the original study."}, 'identificationModule': {'nctId': 'NCT04962035', 'briefTitle': 'Neurocognitive Follow-Up (FU) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Neurocognitive Scores of Predominantly Formula Fed Preterm Infants in Early Childhood Years', 'orgStudyIdInfo': {'id': '2006INF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Alprem RTF Brain Follow-up', 'description': 'Neurocognitive Follow-up of children previously having participated in the Alprem RTF study', 'interventionNames': ['Other: Neurocognitive Follow-up']}], 'interventions': [{'name': 'Neurocognitive Follow-up', 'type': 'OTHER', 'description': 'Standard clinical and parent-reported outcomes on cognitive development, temperament and overall health conditions.', 'armGroupLabels': ['Alprem RTF Brain Follow-up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30-663', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Klinika Chorob Dzieci, Uniwersytecki Szpital Dzieciecy', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '3659', 'city': 'Martin', 'country': 'Slovakia', 'facility': 'Univerzitna nemocnica Martin', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}, {'zip': '940 34', 'city': 'Nové Zámky', 'country': 'Slovakia', 'facility': 'Fakultna nemocnica s poliklinikou Nove Zamky', 'geoPoint': {'lat': 47.98544, 'lon': 18.16195}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}