Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-26 @ 11:43 PM
Study NCT ID:
NCT00638092
Status:
COMPLETED
Last Update Posted:
2015-05-18
First Post:
2008-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012974', 'term': 'Sodium Iodide'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D007454', 'term': 'Iodides'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1275}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-15', 'studyFirstSubmitDate': '2008-03-14', 'studyFirstSubmitQcDate': '2008-03-14', 'lastUpdatePostDateStruct': {'date': '2015-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appreciable neurodevelopmental impairment at 2 years corrected age. As measured by the three main domains of the Bayley III score: i.e. cognitive score, language composite score and motor composite score.', 'timeFrame': 'at 2 years corrected age', 'description': 'P ≤0.05 will be the level used to indicate statistical significance.Deaths and those infants with severe neurodevelopment disability will be scored 55 in the cognitive domain, 46 in the motor domain and 47 in the language domain. The primary outcome will be ordered as cognitive score, motor composite score and language composite score in all results presented.'}], 'secondaryOutcomes': [{'measure': 'Blood levels of T4, TSH and TBG on day 7, 14, 28 and 34 weeks corrected age.', 'timeFrame': '2 years corrected age'}, {'measure': "Neurodevelopment impairment as a composite of death or a Bayley III score of <85 in any of the score's three main subsets domains: cognitive, language and motor composites.", 'timeFrame': '2 years corrected age'}, {'measure': 'Neurodevelopmental impairment assessed as a difference between the iodine supplemented and placebo groups in each of the four subset scores of the Bayley III i.e. receptive communication, expressive communication, fine motor or gross motor.', 'timeFrame': '2 years corrected age'}, {'measure': 'Type and severity of illness: necrotising enterocolitis', 'timeFrame': '2 years corrected age', 'description': 'Type and severity of illness: necrotising enterocolitis'}, {'measure': 'Type and severity of illness:persistent ductus arteriosus', 'timeFrame': '2 years corrected age', 'description': 'Type and severity of illness:persistent ductus arteriosus'}, {'measure': 'Type and severity of illness: respiratory distress', 'timeFrame': '2 years corrected age', 'description': 'Type and severity of illness: respiratory distress'}, {'measure': 'Type and severity of illness:chronic lung disease (need for oxygen at 36 weeks corrected age)', 'timeFrame': '2 years corrected age', 'description': 'Type and severity of illness: chronic lung disease (need for oxygen at 36 weeks corrected age)'}, {'measure': 'Cranial ultrasound changes', 'timeFrame': '2 years corrected age', 'description': 'cranial ultrasound changes'}, {'measure': 'Acquired infection', 'timeFrame': '2 years corrected age', 'description': 'Acquired infection as indicated by medical notes during neonatal period'}, {'measure': 'Cranial ultrasound changes', 'timeFrame': '2 years corrected age', 'description': 'Type and severity of illness: necrotising enterocolitis, persistent ductus arteriosus, respiratory distress , chronic lung disease (need for oxygen at 36 weeks corrected age), cranial ultrasound changes, acquired infection; hearing and vision impairment; postnatal drug use (e.g. diamorphine, dexamethasone, dopamine, caffeine and indomethacin); nutritional status; BAPM level of care; highest recorded bilirubin levels; and death - immediate and underlying causes.'}, {'measure': 'Hearing and vision impairment', 'timeFrame': '2 years corrected age', 'description': 'Hearing and vision impairment as indicated by parental questionnaire'}, {'measure': 'Postnatal drug use', 'timeFrame': '2 years corrected age', 'description': 'diamorphine, dexamethasone, dopamine, caffeine and indomethacin'}, {'measure': 'Nutritional status', 'timeFrame': '2 years corrected age', 'description': 'Nutritional status collected on postnatal day 7, 14, 28 and 34 corrected weeks (as indicated by neonatal drug chart'}, {'measure': 'BAPM level of care', 'timeFrame': '2 years corrected age', 'description': 'BAPM level of care'}, {'measure': 'Highest recorded bilirubin levels', 'timeFrame': '2 years corrected age', 'description': 'highest recorded bilirubin levels; and death - immediate and underlying causes.'}, {'measure': 'Death - immediate and underlying causes.', 'timeFrame': '2 years corrected age', 'description': 'Death - immediate and underlying causes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hypothyroxinemia', 'preterm infants', 'iodine', 'neurodevelopmental outcome', 'Iodine supplementation', 'Randomised controlled trial'], 'conditions': ['Transient Hypothyroxinemia']}, 'referencesModule': {'references': [{'pmid': '24576827', 'type': 'BACKGROUND', 'citation': 'Williams F, Hume R, Ogston S, Brocklehurst P, Morgan K, Juszczak E; I2S2 team. A summary of the iodine supplementation study protocol (I2S2): a UK multicentre randomised controlled trial in preterm infants. Neonatology. 2014;105(4):282-9. doi: 10.1159/000358247. Epub 2014 Feb 27.'}], 'seeAlsoLinks': [{'url': 'http://www.euthyroid.org', 'label': 'Supports programme of work'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine whether iodide supplementation of neonates born under 31 weeks gestation improves neurodevelopment measured at two years of age.', 'detailedDescription': 'Iodine is essential for the synthesis of thyroxine, and thyroxine is essential for normal brain development in utero and for the first 2-3 years of life. The recommended iodine intake in parenteral nutrition regimens is 1 μg/kg/day and commercially available parenteral solutions for infants reflect these recommendations. In the absence of other iodine sources, infants are vulnerable to negative iodine balance and insufficiency. As many preterm infants are fed parenterally for prolonged periods with solutions which have been shown to be iodine-deficient, the I2S2 Trial was designed as a UK multicentre randomised controlled trial to establish whether iodine supplementation of preterm infants benefits neurodevelopment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Hours', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All infants born under 31 weeks gestation\n\nExclusion Criteria:\n\n* Mother exposed to excess iodine during pregnancy or delivery'}, 'identificationModule': {'nctId': 'NCT00638092', 'acronym': 'I2S2', 'briefTitle': 'A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants Follow-up at 2 Years', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'A Randomised Controlled Trial of Iodide Supplementation in Preterm Infants With Follow-up at 2 Years', 'orgStudyIdInfo': {'id': '08/S0501/31'}, 'secondaryIdInfos': [{'id': '2008-001024-31', 'type': 'EUDRACT_NUMBER'}, {'id': '08/S0501/31', 'type': 'OTHER', 'domain': 'REC Reference'}, {'id': '09/800/03', 'type': 'OTHER_GRANT', 'domain': 'NIHR EME'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iodine', 'description': 'This is the hypothetical active arm', 'interventionNames': ['Drug: sodium iodide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'this is the hypothetical placebo', 'interventionNames': ['Drug: Sodium Chloride']}], 'interventions': [{'name': 'sodium iodide', 'type': 'DRUG', 'description': 'sodium iodide 30 micrograms/kg/day, daily dose, from randomisation (within 42 hours of birth) to 34 corrected weeks gestation', 'armGroupLabels': ['Iodine']}, {'name': 'Sodium Chloride', 'type': 'DRUG', 'description': 'Sodium Chloride 30 micrograms/kg/day, daily dose, from randomisation (from within 42 hours of birth)to 34 corrected weeks gestation', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DD1 9SY', 'city': 'Dundee', 'state': 'Tayside', 'country': 'United Kingdom', 'facility': 'Ninewells Hospital and Medical School', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'BT12 6BB', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Royal Maternity Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'B9 5SS', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Heartlands Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'University Hospital Coventry', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'DE22 3NE', 'city': 'Derby', 'country': 'United Kingdom', 'facility': 'Derbyshire Childrens Hospital', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'zip': 'G31 2ER', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Princess Royal Maternity Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Southern General Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'KA2 0BE', 'city': 'Kilmarnock', 'country': 'United Kingdom', 'facility': 'Crosshouse Hospital', 'geoPoint': {'lat': 55.61171, 'lon': -4.49581}}, {'zip': 'LE1 5WW', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Leicester Royal Infirmary', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'BT47 6SB', 'city': 'Londonderry', 'country': 'United Kingdom', 'facility': 'Altnagelvin Area Hospital', 'geoPoint': {'lat': 54.9981, 'lon': -7.30934}}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'James Cook University Hospital', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Royal Victoria Infirmary', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'NG5 1PW', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham City Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': "Queen's Medical Centre", 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'RG1 5AN', 'city': 'Reading', 'country': 'United Kingdom', 'facility': 'Royal Berkshire Hospital', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}, {'zip': 'S10 2SF', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Jessops Wing Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Stockton-on-Tees', 'country': 'United Kingdom', 'facility': 'University Hospital of North Tees', 'geoPoint': {'lat': 54.56848, 'lon': -1.3187}}, {'zip': 'SR4 7TP', 'city': 'Sunderland', 'country': 'United Kingdom', 'facility': 'Sunderland City Hospitals', 'geoPoint': {'lat': 54.90465, 'lon': -1.38222}}, {'zip': 'ML2 0DP', 'city': 'Wishaw', 'country': 'United Kingdom', 'facility': 'Wishaw General Hospital', 'geoPoint': {'lat': 55.76667, 'lon': -3.91667}}], 'overallOfficials': [{'name': 'Fiona Williams, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Dundee'}, {'name': 'Peter Brocklehurst, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'UCL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Dundee', 'class': 'OTHER'}, {'name': 'National Institute for Health Research, United Kingdom', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}