Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-02-25 @ 8:15 PM
Study NCT ID:
NCT01859533
Status:
COMPLETED
Last Update Posted:
2013-05-22
First Post:
2013-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positive End Expiratory Pressure With A T-piece Resuscitator For Near-Term and Term Infants With Respiratory Distress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059245', 'term': 'Transient Tachypnea of the Newborn'}], 'ancestors': [{'id': 'D012127', 'term': 'Respiratory Distress Syndrome, Newborn'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D059246', 'term': 'Tachypnea'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-20', 'studyFirstSubmitDate': '2013-05-16', 'studyFirstSubmitQcDate': '2013-05-20', 'lastUpdatePostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for admissions to NICU secondary to TTN', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Levels of plasma brain natriuretic peptide and clinical outcome [Time Frame: 24 hours].', 'timeFrame': '24 hours'}, {'measure': 'Duration of tachypnea.', 'timeFrame': 'until discharge'}, {'measure': 'Duration and type of oxygen therapy.', 'timeFrame': 'ntil discharge'}, {'measure': 'Antibiotic treatment.', 'timeFrame': 'until discharge'}, {'measure': 'Incidence of pulmonary air leaks', 'timeFrame': 'ntil discharge'}, {'measure': 'Length of hospital (NICU) stay', 'timeFrame': 'until discharge'}, {'measure': 'Death', 'timeFrame': 'until discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Transient Tachypnea of the Newborn']}, 'descriptionModule': {'briefSummary': 'Evaluating the effect of early application of Continuous positive airway pressure (CPAP) via Neopuff in cases of transient tachypnea of the newborn(TTN) and its role in decreasing the duration and complication of TTN.', 'detailedDescription': 'The aim of the study is to determine whether positive end expiratory pressure therapy (PEEP) administered early via a T piece based infant resuscitator (Neopuff) would safely reduce the incidence of TTN and the need for neonatal intensive care unit (NICU) admission of near term and term infants with respiratory distress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Near term infants (36-37 weeks gestational age) and Full term infants (38-41 weeks gestational age).\n* Presence of signs of respiratory distress (Tachypnea, intercostal and subcostal retractions, nasal flaring and grunting) evident shortly after birth.\n* Cesarean section (CS) was defined as elective when surgery was performed before the onset of labor, with all other cases defined as secondary CS.\n\nExclusion Criteria:\n\n* Presence of any of the risk factors for neonatal sepsis such as Prolonged Rupture of Membranes for ≥48 hours (PROM), maternal fever, maternal chorioamnionitis or positive maternal GBS colonization.\n* Presence of any other cause of respiratory distress, eg.\n\n * congenital malformations affecting the cardiorespiratory system ,\n * chromosomal aberrations,\n * depression at birth (Apgar score at 5 minutes of \\< 7 or umbilical artery pH of \\< 7.10),\n * fetal hydrops,\n * persistent pulmonary hypertension,\n * and meconium aspiration syndrome.'}, 'identificationModule': {'nctId': 'NCT01859533', 'briefTitle': 'Positive End Expiratory Pressure With A T-piece Resuscitator For Near-Term and Term Infants With Respiratory Distress', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Positive End Expiratory Pressure With A T-piece Resuscitator (Neopuff) For Near-Term and Term Infants With Respiratory Distress: A Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'Ain Shams Uni'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neopuff group', 'description': 'includes 34 newborns showing signs of TTN who received CPAP (5 cm of H2O) via T- piece (Neopuff; Fisher and Paykel Healthcare, Auckland, New Zealand).', 'interventionNames': ['Device: Neopuff']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'includes 30 newborns who will receive nasal prong oxygen treatment; standard care according to Siva Subramanian et al. (2010).'}], 'interventions': [{'name': 'Neopuff', 'type': 'DEVICE', 'otherNames': ['Early CPAP'], 'description': '* Group I neonates (Experimental group) includes 30 newborns showing signs of TTN who will receive administration of CPAP (5 cm of H2O) via T- piece (Neopuff; Fisher and Paykel Healthcare, Auckland, New Zealand).\n* Group II neonates (Control group) includes 30 newborns who will receive nasal prong oxygen treatment; standard care according to Siva Subramanian et al. (2010).', 'armGroupLabels': ['Neopuff group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rania A. El-Farrash, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, Egypt'}, {'name': 'Amani O. Mahmoud, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Pediatrics, Department of Pediatrics, Ain Shams University, Cairo, Egypt'}, {'name': 'Enas H. Abdul-Hady, M.B.B.Ch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Pediatrics', 'investigatorFullName': 'Rania Ali El-Farrash', 'investigatorAffiliation': 'Ain Shams University'}}}}