Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 3:03 AM
Study NCT ID:
NCT06416956
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-15', 'studyFirstSubmitDate': '2023-12-15', 'studyFirstSubmitQcDate': '2024-05-15', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiration', 'timeFrame': 'From baseline to two days later', 'description': 'Change in respiratory dynamics between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later'}, {'measure': 'Brain activity', 'timeFrame': 'From baseline to two days later', 'description': 'Change in EEG activity between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'From baseline to two days later', 'description': 'Change in heart rate between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later'}, {'measure': 'Oxygen saturation', 'timeFrame': 'From baseline to two days later', 'description': 'Change in oxygen saturation between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infant,Premature', 'Caffeine']}, 'descriptionModule': {'briefSummary': "This study investigates how brain activity and breathing changes in premature babies when their dose of caffeine treatment is changed or stopped. The study will assess premature babies receiving caffeine treatment as part of their clinical care. Brain activity will be recorded just before caffeine dose is changed and again two days afterwards. Breathing and other 'vital signs' (breathing rate, heart rate, oxygen saturation) will be recorded from the baby's monitor between the recordings of brain activity and for up to two weeks afterwards."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '37 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All participants will be inpatients on the Newborn Care Unit and born prematurely (before 37 weeks gestation)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Born to a mother aged 16 or over\n* Admitted to the Newborn Care Unit, John Radcliffe Hospital\n* Born prematurely (before 37 weeks' gestation)\n* Parent given informed written consent\n* Receiving caffeine citrate\n\nExclusion Criteria:\n\n* Known chromosomal abnormality or life-threatening congenital abnormality\n* Severe hypoxic insult at birth\n* Intraventricular haemorrhage grade III or IV or other severe neurological pathology"}, 'identificationModule': {'nctId': 'NCT06416956', 'acronym': 'Baby-CINO', 'briefTitle': 'Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants', 'orgStudyIdInfo': {'id': 'PID17161'}, 'secondaryIdInfos': [{'id': '23/SC/0397', 'type': 'OTHER', 'domain': 'Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preterm infant', 'description': 'Preterm infants receiving caffeine (prescribed clinically) will be studied', 'interventionNames': ['Drug: Caffeine']}], 'interventions': [{'name': 'Caffeine', 'type': 'DRUG', 'description': 'We will record infant\\'s brain activity and vital signs when caffeine dose is changed or caffeine treatment is stopped. The decision to change dose/stop treatment will be made by the clinical team as part of routine care. No changes in caffeine treatment will be carried out solely for research purposes.', 'armGroupLabels': ['Preterm infant']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'Oxfordshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Caroline Hartley', 'role': 'CONTACT', 'email': 'caroline.hartley@paediatrics.ox.ac.uk', 'phone': '+44 1865 234537'}, {'name': 'Caroline Hartley, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Newborn Care Unit, John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'centralContacts': [{'name': 'Caroline Hartley', 'role': 'CONTACT', 'email': 'caroline.hartley@paediatrics.ox.ac.uk', 'phone': '+44 1865 234537'}], 'overallOfficials': [{'name': 'Caroline Hartley', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}