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IRCT20170201032346N4 IRCT 2020-11-28 Ramsar Campus, Mazandaran University of Medical Sciences The effects of nebulized salbutamol on transient tachypnea of neonates treatment. The effects of nebulized salbutamol on Transient Tachypnea of Neonates (TTN) treatment in Neonatal Intensive Care Unit (NICU) of Rajaei hospital of Tonekabon. 2016-12-21 anticipated 88 Complete https://irct.ir/trial/25232 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: participant are randomized with Distance randomization method. two groups of 44 patients are assigned to treatment or placebo group. each patient is assigned to a unique code provided by Distance randomization service from www.sealedenvelope.com, Blinding description: Placebo are provided by the company producing the product. in terms of appearance drug and placebo are identical. Caregivers prescribe the drug. The research technician is assigned to lead two arms of study based on patient's assigned group. Caregivers, investigators and data analyser are blinded to the study groups. N/A Transient tachypnea of neonates. Intervention 1: Intervention group: Inhalational 15mg/kg salbutamol (Ventolin Respiratory Solution, salbutamol sulfate 5 mg/mL) in 2 mL of 0.9 saline in a single dose is administered by nebulizer. Intervention 2: Control group: 2 cc of 0.9% saline is used in a single dose by nebulizer. Yes - There is a plan to make this available What will be shared: all collected deidentified data for primary and secondary outcome measures are going to be shared When: after publishing the study, data are going to be available To whom: data are going to be available to all researchers and clinician irrespective to their employment sector Conditions: permission are granted upon request for secondary and meta-analysis Where to obtain: requests are gathered through principle researcher's e-mail address How to obtain: upon verification of request and reason data are given in three month. Comments:
public Firouzi Hossein
No.20 ,Taleghani Ave., Ramsar.
Ramsar Iran (Islamic Republic of) 4691786953 +1 155230181 firoozihosein@mazums.ac.ir Ramsar Campus, Mazandaran University of Medical Sciences scientific Firouzi Hossein
No.20 ,Taleghani Ave., Ramsar.
Ramsar Iran (Islamic Republic of) 4691786953 +1 155230181 firoozihosein@mazums.ac.ir Ramsar Campus, Mazandaran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of TTN before 6 hour of birth according to Rawling and Smith criteria. no limit 3 days Both Diagnosis of respiratory distress syndrome Presence of end-organ dysfunction Sepsis Diagnosis P22.1 Transient tachypnea of newborn Treatment - Drugs Placebo Intervention group: Inhalational 15mg/kg salbutamol (Ventolin Respiratory Solution, salbutamol sulfate 5 mg/mL) in 2 mL of 0.9 saline in a single dose is administered by nebulizer. Control group: 2 cc of 0.9% saline is used in a single dose by nebulizer. TTN score. Timepoint: 20 minutes and 6 hours after treatment. Method of measurement: According to clinical severity criteria of transient tachypnea of neonates, disease is scored from 0 to 13. Higher score indicate more severe disease. The criteria includes: Expiratory grunting: None=0, Intermittent=1, Continuous=2. Supraclavicular Retraction: None=0, Mild=1, Moderate=2, Severe=3. Subcostal Retraction: None=0, Mild=1, Moderate=2, Severe=3. Cyanosis: None=0, Acral=1, Central=2. Nasal Flaring: None=0, Mild=1, Moderate=2, Severe=3. Heart rate. Timepoint: 20 minutes and 6 hours after treatment. Method of measurement: Cardiac Monitoring. Beats per minutes. Respiratory rate. Timepoint: 20 minutes and 6 hours after treatment. Method of measurement: Cardiac Monitoring. cycle per minutes. O2 Saturation. Timepoint: 20 minutes and 6 hours after treatment. Method of measurement: Pulseoximeter, Percentage. Body temperature. Timepoint: 20 minutes and 6 hours after treatment. Method of measurement: Thermometer. degree of Celsius. Ramsar Campus, Mazandaran University of Medical Sciences Approved 2020-11-25 Ethics committee of Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences, Vice Chancellor of Research, Moalem st, Moalem sq, Sari, Mazandaran, Iran. Sari Mazandaran Iran (Islamic Republic of)