Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-02-20 @ 6:03 PM
Study NCT ID:
NCT01722760
Status:
COMPLETED
Last Update Posted:
2015-11-06
First Post:
2012-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease - The AD-ON Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': 'D014894', 'term': 'Weights and Measures'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Air samples for Nitrogen oxide NO. Maternal, cord and neonatal blood samples for vitamins A and D.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-05', 'studyFirstSubmitDate': '2012-10-24', 'studyFirstSubmitQcDate': '2012-11-06', 'lastUpdatePostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bronchopulmonary Dysplasia', 'timeFrame': 'From premature birth to a one year follow up', 'description': 'The incidence of BPD and the correlation the the above mentioned biomarkers.'}], 'primaryOutcomes': [{'measure': 'Tidal exhaled Nitrogen Oxide', 'timeFrame': '6-7 measures within the first 2 months of life and at 1 year of age.', 'description': 'Reference material of tidal expiratory NO in a cohort of neonates admitted to Neonatal Intensive Care Unit and Neonatal Care Unit will be made.\n\nAll children in the study will be measured on 8 occasions including a one year follow up.\n\nAssociation with Bronchopulmonary Dysplasia (BPD) and the measures above will be noted.'}], 'secondaryOutcomes': [{'measure': 'Vitamin levels', 'timeFrame': 'From birth to a one year follow up', 'description': 'Blood levels of Vitamins A (s-retinol) and D (se-25(OH)D2 and D3) will be measured at 3 preset occasions and at one year follow up, as well as maternal and cord blood at the time of birth.\n\nReference material will be made and association to BPD will be noted.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neonatal', 'Preterm', 'Bronchopulmonary Dysplasia', 'Nasal Continuous Positive airway Pressure (CPAP)', 'Oxygen', 'Vitamin A', 'Vitamin D', 'Nitrogen oxide (NO)', 'Reference material'], 'conditions': ['Term Delivery With Preterm Labor, Third Trimester', 'Term Delivery With Preterm Labor, Unspecified Trimester', 'Bronchopulmonary Dysplasia']}, 'descriptionModule': {'briefSummary': 'Children born prematurely are of greater risk of developing chronic lung disease (Bronchopulmonary Dysplasia).\n\nWith an increase in the amount of premature children, we expect an increasing number of children with BPD.\n\nToday we do not have many ways of predicting or treating this condition, and the children are usually in hospital for several months after birth. Many are dismissed with home oxygen. Children with BPD are typically often re-submitted to hospital with respiratory disease the first couple of years, and some of them have problems throughout childhood and into adulthood.\n\nOther scientists have found a correlation between BPD and Chronic Obstructive Pulmonary Disease (COPD).\n\nThe condition as well as the treatment (steroids), are associated with great risk of adverse effects as Cerebral Palsy, blindness, deafness and mental retardation.\n\nThe investigators wish to find a safe way to identify the children in greater risk of developing BPD, who could therefore benefit from a more intensive treatment.An early diagnosis would increase the possibility of predicting the prognosis.\n\nOther studies have proven a connection between both low vitamin A and D and high exhaled nitrogen oxide (NO) with lung disease.\n\nWith this trial the investigators wish to make a reference material for NO and vitamins A and D in infants admitted to the neonatal department at two hospitals in Denmark, both with and without treatment with nasal Continuous Positive Airway Pressure.\n\nThe investigators furthermore wish to describe an eventual connection between BPD and these factors by examining a large group of children on 7 specific occasions within the first two months of life and at a one year follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Term and preterm infants admitted to Neonatal Care Unit for reference material as control group.\n\nPreterm infants admitted to Neonatal Intensive Care Unit developing BPD as study group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCohort inclusion - All term and preterm infants admitted to Neonatal (Intensive) Care Unit. Gestational Age 24-42 weeks.\n\nExclusion Criteria:\n\n1. Children with ciliary dyskinesia, as NO is distinguishable lower in these children.\n2. Children who can not cooperate to the examination.\n3. Children so dependant on oxygen, that the examination/measurement is not possible.\n4. Children with pneumothorax\n5. Children having a diagnosed pneumonia verified by tracheal secrete.\n6. Children with bigger congenital anomalies'}, 'identificationModule': {'nctId': 'NCT01722760', 'briefTitle': 'Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease - The AD-ON Study', 'organization': {'class': 'OTHER', 'fullName': 'Hillerod Hospital, Denmark'}, 'officialTitle': 'AD-ON: The Danish Study on Tidal Neonatal Nitrogen Oxide (NO) and Vitamins A and D as Possible Predictors of BPD', 'orgStudyIdInfo': {'id': 'H-4-2012-091'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Term and preterm infants', 'description': 'Term and preterm infants', 'interventionNames': ['Procedure: measurements']}], 'interventions': [{'name': 'measurements', 'type': 'PROCEDURE', 'armGroupLabels': ['Term and preterm infants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'state': 'Region H', 'country': 'Denmark', 'facility': 'Neonatal departement GN, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '3400', 'city': 'Hilleroed', 'state': 'Region H', 'country': 'Denmark', 'facility': 'Children´s Departement, North Zealand Hospital, Hilleroed'}], 'overallOfficials': [{'name': 'Birgitte J Schmidt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Children´s Dep, North Zealand Hospital Hilleroed, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillerod Hospital, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Birgitte Johanne Schmidt', 'investigatorAffiliation': 'Hillerod Hospital, Denmark'}}}}