The comparison of inhaled salbutamol in two different doses and placebo on Transient tachypnoea of newborn

Determining the effect of inhaled salbutamol on treatment of Transient tachypnoea of newborn

A clinical trial with parallel groups, double-blinded, randomized (permuted block randomization), phase 3 on 90 children with transient tachypnoea, using www.sealedenvelope.com for randomization.

This study is performed in Firoozabadi and Akabarabadi Hospital. Newborns with tachypnea are randomly assigned into three groups. In the first and second intervention groups, newborns receive inhaled salbutamol. In the control group, newborns receive normal saline. In this study, participants and physicians did not know the type of medication they received.

Inclusion criteria: Diagnosis of TTN is based on the criteria of respiratory distress less than 6 hours after birth (respiration rate more than 60 breaths per minute, grunting, nasal flaring or retraction, cyanosis) and known findings on X-ray (fluid in minor fissures, hyperventilation , prominent central vascular markings, flattening of the diaphragm, increased anterior-posterior diameter, bilateral perihilar congestion). Non-inclusion criteria: Meconium aspiration, other known causes of tachypnea in infants such as (RDS, PPHN, pneumonia, meconium aspiration, premature sepsis of infants, polycythemia, hypocalcemia, hypoglycemia), Abnormal auscultation (Murmur) during cardiac examination

In the first and second intervention groups, newborns receive inhaled salbutamol through a nebulizer at a dose of 1.25 and 2.5 mg/kg respectively. In the third group, newborns receive normal saline.

Tachypnea duration

The randomization list was obtained from https://www.sealedenvelope.com by the Block Randomization method. To prepare a random list, equal blocks of 6 are used so that the number of samples is the same in all three arms of the study. Babies are equally assigned to three groups A, B, and C with an equal number of patients.

In the pharmaceutical company, the vials will be filled with salbutamol 1.25, 2.5 mg and normal saline 0.9% with the same volume and similar vials, and group A, B, and C labels will be placed on the vials. In this study, the only person who will know the content inside the vial is the neonatal specialist assistant. The neonatal specialist assistant has a role in allocating the randomized list and preparing raw materials, but will not have a role in the process of conducting the study directly and recording data. The NICU resident physician and nurse will be responsible for conducting the study and will not know the contents of the vials