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Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn: Randomized controlled trial to assess:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salbutamol Group | Active Comparator | included babies who had received nebulized B2 agonist salbutamol (0.15 mg/kg) + 4ml normal saline |
|
| Epinephrine Group | Active Comparator | included babies who had received nebulized epinephrine (0, 05 ml/Kg) + 4ml normal saline |
|
| Saline Group | Placebo Comparator | include babies who had received nebulized 0.9% saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epinephrine Inhalation Solution | Drug |
| ||
| Salbutamol |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of oxygen support & O2 concentration until Downes' score less than 4 | through study completion, about 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay until Downes' score less than 4 | through study completion, about 1 year | |
| Type of respiratory support (oxygen delivery and oxygen concentration) | within 12 hours after intervention |
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Inclusion Criteria:
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:
Prominent central vascular markings
Widened interlobar fissures
Symmetrical perihilar congestion
Hyperaeration is evidenced by flattening and depression of the diaphragmatic domes.
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11288210 | Background | Bertrand P, Aranibar H, Castro E, Sanchez I. Efficacy of nebulized epinephrine versus salbutamol in hospitalized infants with bronchiolitis. Pediatr Pulmonol. 2001 Apr;31(4):284-8. doi: 10.1002/ppul.1040. | |
| 15605071 | Background | 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. |
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| ID | Term |
|---|---|
| D059245 | Transient Tachypnea of the Newborn |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Saline Inhalants | Drug |
|
| Effect of intervention on blood sugar (mg/dl) | within 12 hours after intervention |
| 6540983 | Background | 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. |
| 23736015 | Background | 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. |
| 23749815 | Background | 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. |
| 20807157 | Background | 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. |
| D012120 | Respiration Disorders |
| D059246 | Tachypnea |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |