Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-27 @ 11:38 PM
Study NCT ID:
NCT05006235
Status:
COMPLETED
Last Update Posted:
2021-08-16
First Post:
2021-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn (TTN)
Sponsor:
Organization:
Raw JSON
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Efficacy of nebulized epinephrine versus salbutamol in hospitalized infants with bronchiolitis. Pediatr Pulmonol. 2001 Apr;31(4):284-8. doi: 10.1002/ppul.1040.'}, {'pmid': '15605071', 'type': 'BACKGROUND', 'citation': 'Clark RH. The epidemiology of respiratory failure in neonates born at an estimated gestational age of 34 weeks or more. J Perinatol. 2005 Apr;25(4):251-7. doi: 10.1038/sj.jp.7211242.'}, {'pmid': '6540983', 'type': 'BACKGROUND', 'citation': 'Rawlings JS, Smith FR. Transient tachypnea of the newborn. An analysis of neonatal and obstetric risk factors. Am J Dis Child. 1984 Sep;138(9):869-71. doi: 10.1001/archpedi.1984.02140470067022.'}, {'pmid': '23736015', 'type': 'BACKGROUND', 'citation': 'Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Plavka R, Saugstad OD, Simeoni U, Speer CP, Vento M, Halliday HL; European Association of Perinatal Medicine. European consensus guidelines on the management of neonatal respiratory distress syndrome in preterm infants--2013 update. Neonatology. 2013;103(4):353-68. doi: 10.1159/000349928. Epub 2013 May 31.'}, {'pmid': '23749815', 'type': 'BACKGROUND', 'citation': 'Vollsaeter M, Roksund OD, Eide GE, Markestad T, Halvorsen T. Lung function after preterm birth: development from mid-childhood to adulthood. Thorax. 2013 Aug;68(8):767-76. doi: 10.1136/thoraxjnl-2012-202980. Epub 2013 Jun 7.'}, {'pmid': '20807157', 'type': 'BACKGROUND', 'citation': 'Yurdakok M. Transient tachypnea of the newborn: what is new? J Matern Fetal Neonatal Med. 2010 Oct;23 Suppl 3:24-6. doi: 10.3109/14767058.2010.507971.'}]}, 'descriptionModule': {'briefSummary': 'Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn: Randomized controlled trial to assess:', 'detailedDescription': "This is a randomized double-blind randomized controlled trial. It had been conducted at the Neonatal Intensive Care Unit (NICU) of Mansoura University Children's Hospital, Egypt Written informed consent had been taken from all parents whose infants were recruited in the study. The ethics committee of the faculty of medicine has approved the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Hours', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* babies with 35 weeks of gestation or more in the first 6 hours of life diagnosed with TTN according to the criteria of which are:\n\n * Tachypnea (respiratory rate exceeding 60 breaths/ min) within 6 hours after birth\n * Persistence of tachypnea for at least 12 hours\n * Mild cyanosis, nasal flaring, or retractions.\n * Chest radiograph indicating at least one of the following:\n* Prominent central vascular markings\n* Widened interlobar fissures\n* Symmetrical perihilar congestion\n* Hyperaeration is evidenced by flattening and depression of the diaphragmatic domes.\n\nExclusion Criteria:\n\n* Newborn infants with gestational age \\< 35 weeks\n* Meconium aspiration\n* Respiratory distress syndrome\n* Pneumonia\n* Congenital heart diseases including persistent pulmonary hypertension of the neworn (PPHN)\n* Sepsis or suspected sepsis\n* Polycythemia\n* Newborn infants with congenital malformations and chromosomal anomalies\n* Newborn infants with ventilatory support.\n* Newborn infants with arrhythmia'}, 'identificationModule': {'nctId': 'NCT05006235', 'briefTitle': 'Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn (TTN)', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University Children Hospital'}, 'officialTitle': 'Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn', 'orgStudyIdInfo': {'id': 'MansouraUCH0321'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Salbutamol Group', 'description': 'included babies who had received nebulized B2 agonist salbutamol (0.15 mg/kg) + 4ml normal saline', 'interventionNames': ['Drug: Salbutamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Epinephrine Group', 'description': 'included babies who had received nebulized epinephrine (0, 05 ml/Kg) + 4ml normal saline', 'interventionNames': ['Drug: Epinephrine Inhalation Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline Group', 'description': 'include babies who had received nebulized 0.9% saline', 'interventionNames': ['Drug: Saline Inhalants']}], 'interventions': [{'name': 'Epinephrine Inhalation Solution', 'type': 'DRUG', 'armGroupLabels': ['Epinephrine Group']}, {'name': 'Salbutamol', 'type': 'DRUG', 'armGroupLabels': ['Salbutamol Group']}, {'name': 'Saline Inhalants', 'type': 'DRUG', 'armGroupLabels': ['Saline Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahmed Noaman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ahmed Noaman', 'investigatorAffiliation': 'Mansoura University Children Hospital'}}}}