Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-02-20 @ 3:33 PM
Study NCT ID:
NCT06515405
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-03
First Post:
2024-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007416', 'term': 'Intestinal Perforation'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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': 'D006854', 'term': 'Hydrocortisone'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-07-17', 'size': 274463, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-17T11:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-01', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-22', 'lastUpdatePostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Necrotising enterocolitis', 'timeFrame': 'From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months', 'description': 'UK National Neonatal Audit Programme definition'}, {'measure': 'Severe necrotising enterocolitis', 'timeFrame': 'From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months', 'description': 'Necrotising enterocolitis confirmed at surgery or post-mortem or stated as cause of death'}, {'measure': 'Pragmatically defined necrotising enterocolitis', 'timeFrame': 'From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months', 'description': 'a recorded diagnosis of necrotising enterocolitis and received at least 5 consecutive days of antibiotics whilst also nil by mouth'}, {'measure': 'Late onset sepsis', 'timeFrame': 'From postnatal day 3 until the date of discharge from final neonatal unit, assessed up to 24 months', 'description': 'One or more episodes of a positive blood or cerebrospinal fluid culture with either a pure or mixed growth of a known pathogenic organism after the first three days following birth'}, {'measure': 'Brain injury occurring at or soon after birth', 'timeFrame': 'From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months', 'description': 'Intracranial haemorrhage, perinatal stroke, central nervous system infection, kernicterus (bilirubin encephalopathy), periventricular leukomalacia or any recorded seizure'}, {'measure': 'Treated retinopathy of prematurity', 'timeFrame': 'From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months', 'description': 'Cryotherapy, laser therapy or injection of anti-vascular endothelial growth factor therapy for ROP in either or both eyes'}], 'primaryOutcomes': [{'measure': 'Gastrointestinal (GI) perforation', 'timeFrame': 'From date of birth until day 14 of life', 'description': 'A baby will be considered to have had a gastrointestinal perforation if their National Neonatal Research Database record includes a record of a GI perforation in the diagnoses field.'}], 'secondaryOutcomes': [{'measure': 'Survival without gastrointestinal perforation', 'timeFrame': 'From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months', 'description': 'Baby survived to discharge from neonatal unit without a gastrointestinal perforation'}, {'measure': 'Mortality before discharge home', 'timeFrame': 'From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months', 'description': 'Baby died before discharge from neonatal unit'}, {'measure': 'Total length of stay', 'timeFrame': 'From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months', 'description': 'Length of stay in neonatal care'}, {'measure': 'Proportion of days on unit being mechanically ventilated', 'timeFrame': 'From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months'}, {'measure': 'Bronchopulmonary dysplasia', 'timeFrame': "From date of birth until 36 weeks' postmenstrual age (PMA)", 'description': "any respiratory or ventilatory support or supplemental oxygen at 36 weeks' postmenstrual age (PMA)"}, {'measure': 'Bronchopulmonary dysplasia', 'timeFrame': "From date of birth until 36 weeks' postmenstrual age (PMA)", 'description': 'Using an adapted Jensen criteria based on the highest level of respiratory support at 36 weeks PMA'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Preterm Infant', 'Hydrocortisone'], 'conditions': ['Intestinal Perforation']}, 'descriptionModule': {'briefSummary': "A large, randomised control trial, the PREMILOC trial, has established that giving low dose hydrocortisone prophylactically in the first ten days of life reduces the risk of bronchopulmonary dysplasia in babies born before 32 weeks' gestation. However, the PREMILOC trial was underpowered to investigate rarer side effects, such as gastrointestinal perforation. This study aims to establish whether the odds of gastrointestinal perforation increase when extremely preterm infants are given prophylactic hydrocortisone in the first ten days of life.\n\nThis retrospective cohort study will use routinely collected data from the U.K. National Neonatal Research Database. The investigators will examine the records of all infants born before 28 weeks' gestation and cared for in English and Welsh neonatal units between 2016 and 2023. Infants will be considered exposed if they received hydrocortisone for at least eight consecutive days, beginning on postnatal day 1 or 2. The primary outcome will be gastrointestinal perforation, as recorded in the infant's neonatal unit record. This outcome will be validated with the original care teams for a sample of babies. Data will be analysed using a propensity score matched approach to reduce the impact of confounding."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Infants born before 28 weeks' gestation and admitted to English and Welsh neonatal units.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nInfants who:\n\n* were admitted to a neonatal unit between the 1st January 2016 and 31st March 2023 and\n* received any of their care in a NHS neonatal unit in England and Wales (part of UK Neonatal Collaborative and therefore contributing data to the NNRD) and\n* were born before 28 weeks' gestation.\n\nExclusion Criteria:\n\n* They have missing data for principal background variables (gestational age at birth, birth weight, year of birth and date of death for those that died).\n* Their recorded birthweight absolute value z score exceeds 4 or is missing.\n* They died on postnatal day 1 or 2 ."}, 'identificationModule': {'nctId': 'NCT06515405', 'briefTitle': 'Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants: A Protocol for a Retrospective Cohort Study Using Routinely Collected Data', 'orgStudyIdInfo': {'id': '293603'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Not exposed to early hydrocortisone', 'interventionNames': ['Drug: Hydrocortisone']}, {'label': 'Exposed to early hydrocortisone', 'interventionNames': ['Drug: Hydrocortisone']}], 'interventions': [{'name': 'Hydrocortisone', 'type': 'DRUG', 'description': "Cohort members will be considered to be exposed to early hydrocortisone if either:\n\n1. They receive early hydrocortisone started on postnatal day 1 or 2 and given for more than seven consecutive days OR\n2. They receive early hydrocortisone started on postnatal day 1 or 2 and are being cared for in a PROHYDRO unit but die on or before postnatal day 8.\n\nPROHYDRO units are defined as units who, at the time the baby was born, had implemented a protocol for use of prophylactic hydrocortisone as part of routine care for babies born less than 28 weeks' gestation. A unit may change from being a non-PROHYDRO unit to a PROHYDRO unit if a new early hydrocortisone protocol is introduced during the study period (2016-2023).", 'armGroupLabels': ['Exposed to early hydrocortisone', 'Not exposed to early hydrocortisone']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW10 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Study protocol available now. Analysis code will be available after publication of results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}