Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-28 @ 12:13 PM
Study NCT ID:
NCT01093495
Status:
COMPLETED
Last Update Posted:
2010-03-25
First Post:
2010-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D006819', 'term': 'Hyaline Membrane Disease'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012127', 'term': 'Respiratory Distress Syndrome, Newborn'}, {'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': 'D000072601', 'term': 'Cannula'}], 'ancestors': [{'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-24', 'studyFirstSubmitDate': '2010-03-24', 'studyFirstSubmitQcDate': '2010-03-24', 'lastUpdatePostDateStruct': {'date': '2010-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of oxygen use', 'timeFrame': '3 months', 'description': 'The number of days for oxygen use from the start of randomization until hospital discharge will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Length of respiratory support', 'timeFrame': '3 months', 'description': 'The number of days in which the subject requires any sort of respiratory support will be recorded, including: CPAP, nasal cannula and mechanical ventilation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nasal Continuous positive Airway pressure', 'Nasal Cannula', 'CPAP', 'Premature', 'RDS', 'HMD', 'NICU'], 'conditions': ['Respiratory Distress Syndrome', 'Hyaline Membrane Disease', 'Preterm Infants', 'Premature Infants']}, 'referencesModule': {'references': [{'pmid': '12076463', 'type': 'BACKGROUND', 'citation': 'Ho JJ, Henderson-Smart DJ, Davis PG. Early versus delayed initiation of continuous distending pressure for respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2002;2002(2):CD002975. doi: 10.1002/14651858.CD002975.'}, {'pmid': '12076445', 'type': 'BACKGROUND', 'citation': 'Ho JJ, Subramaniam P, Henderson-Smart DJ, Davis PG. Continuous distending pressure for respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2002;(2):CD002271. doi: 10.1002/14651858.CD002271.'}, {'pmid': '15930230', 'type': 'BACKGROUND', 'citation': 'Aly H, Massaro AN, Patel K, El-Mohandes AA. Is it safer to intubate premature infants in the delivery room? Pediatrics. 2005 Jun;115(6):1660-5. doi: 10.1542/peds.2004-2493.'}, {'pmid': '19564301', 'type': 'BACKGROUND', 'citation': 'Aly H, Massaro AN, Hammad TA, Narang S, Essers J. Early nasal continuous positive airway pressure and necrotizing enterocolitis in preterm infants. Pediatrics. 2009 Jul;124(1):205-10. doi: 10.1542/peds.2008-2588.'}, {'pmid': '18977958', 'type': 'BACKGROUND', 'citation': 'Abdel-Hady H, Matter M, Hammad A, El-Refaay A, Aly H. Hemodynamic changes during weaning from nasal continuous positive airway pressure. Pediatrics. 2008 Nov;122(5):e1086-90. doi: 10.1542/peds.2008-1193.'}, {'pmid': '17403854', 'type': 'BACKGROUND', 'citation': 'Aly H. Is there a strategy for preventing bronchopulmonary dysplasia? Absence of evidence is not evidence of absence. Pediatrics. 2007 Apr;119(4):818-20. doi: 10.1542/peds.2006-3026. No abstract available.'}, {'pmid': '16855619', 'type': 'BACKGROUND', 'citation': 'Aly H, Massaro AN, El-Mohandes AA. Can delivery room management impact the length of hospital stay in premature infants? J Perinatol. 2006 Oct;26(10):593-6. doi: 10.1038/sj.jp.7211575. Epub 2006 Jul 20.'}, {'pmid': '15342841', 'type': 'BACKGROUND', 'citation': 'Aly H, Milner JD, Patel K, El-Mohandes AA. Does the experience with the use of nasal continuous positive airway pressure improve over time in extremely low birth weight infants? Pediatrics. 2004 Sep;114(3):697-702. doi: 10.1542/peds.2003-0572-L.'}, {'pmid': '21276671', 'type': 'DERIVED', 'citation': 'Abdel-Hady H, Shouman B, Aly H. Early weaning from CPAP to high flow nasal cannula in preterm infants is associated with prolonged oxygen requirement: a randomized controlled trial. Early Hum Dev. 2011 Mar;87(3):205-8. doi: 10.1016/j.earlhumdev.2010.12.010. Epub 2011 Jan 26.'}]}, 'descriptionModule': {'briefSummary': 'There is little data published concerning the best approach to nasal continuous positive airway pressure (nCPAP) weaning. Potential complications associated with prolonged nCPAP therapy include gastric distension, nasal trauma,pneumothorax,agitation and nosocomial infection. Moreover, Infants on nCPAP may also require more intensive nursing care and the use of extra equipment. Therefore, minimizing the amount of time that a patient requires CPAP may be beneficial. On the other hand, removing CPAP too early may lead to complications that include: increasing apnea, increased oxygen requirement, increased work of breathing, the need to re-start CPAP, and intubation and mechanical ventilation. Moreover, an experimental study have demonstrated an improvement in lung growth after the prolonged use of CPAP.\n\nNasal cannula (NC) flows at 1-2 L/min may also generate a positive pressure in the airway of preterm infants. The use of NC flow to generate positive airway pressure would minimize many of the application issues of nCPAP. However, NC systems used in neonates routinely employ gas that is inadequately warmed and humidified, limiting the use of such flows due to increased risk of nasal mucosa injury, and possibly increasing the risk for nosocomial infection.\n\nThe purpose of this randomized controlled trial is to evaluate the clinical impact of two methods for weaning preterm infants from nCPAP.', 'detailedDescription': 'The objective of this study is to test the null hypothesis that in preterm infants with gestational age of 28 to 36 weeks who are stable on CPAP pressure of 5 cmH2O and with oxygen concentrations (FiO2) \\<0.30, keeping these infants on CPAP or changing them to NC flow of 1-2 L/min will not make any difference in length of hospitalization, length of respiratory support and incidence of complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Weeks', 'minimumAge': '28 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants born greater than or equal to 28 weeks (28+0) and less than 37 weeks (36+6) gestation\n* CPAP pressure of 5 cm H2O\n* FiO2 requirement = or \\<0.30\n* Clinically stable on these CPAP parameters for 24 hours pre-randomization:\n\n * Respiratory rate less than 60\n * No significant chest recession\n * No apnea requiring bagging and/or\n * Not more than 6 apneas requiring stimulation in the preceding 24 h.\n * Average saturation \\> or = 87%\n * Satisfactory ABG (pH\\> 7.25, PCO2 \\< 60, and Base deficit \\< -8)\n\nExclusion Criteria:\n\n* Life threatening congenital anomalies\n* Congenital cyanotic heart diseases\n* Congenital airway or chest wall abnormalities\n* Pulmonary hypoplasia\n* Known or suspected to have a neuromuscular disorder\n* Congenital neurological disorder, severe IVH (grade 3 or 4), PVL and hydrocephalus'}, 'identificationModule': {'nctId': 'NCT01093495', 'briefTitle': 'Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'A Randomized Controlled Trial on Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure', 'orgStudyIdInfo': {'id': '20081230'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPAP group', 'description': 'Subjects in this group will continue receiving CPAP until no oxygen requirement for 24 hours, then will be weaned off CPAP completely as long as they tolerate. CPAP will be re-instituted if subjects meet failing criteria. Another trial off CPAP will start 24 hours after failure and/or after being on 21% for 24 hours. CPAP will be weaned off directly to room air at all times.', 'interventionNames': ['Device: CPAP']}, {'type': 'EXPERIMENTAL', 'label': 'Nasal Cannula Group', 'description': 'Subjects will be weaned from CPAP (when FiO2 \\<0.30) to Nasal cannula (2 L/min) with whatever FiO2 they need until they are off oxygen and NC completely. However, if these infants fail on NC they will be put back to nCPAP. Infants will then be maintained on CPAP until stable on CPAP-30% for 24 hours. Infants will be tried for another weaning using NC. So, infants assigned to NC will be weaned only through NC. CPAP will be used only for stabilization in between trials if needed.', 'interventionNames': ['Device: Nasal Cannula']}], 'interventions': [{'name': 'CPAP', 'type': 'DEVICE', 'description': 'CPAP', 'armGroupLabels': ['CPAP group']}, {'name': 'Nasal Cannula', 'type': 'DEVICE', 'description': 'Nasal Cannula', 'armGroupLabels': ['Nasal Cannula Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': "Mansoura University Children's Hospital", 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Hesham Abdel Hady, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Mansoura University Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Hesham Abdel Hady', 'oldOrganization': "Mansoura University Children's Hospital"}}}}