Investigating the effect of inhaled salbutamol (Ventolin) in the improvement of the treatment of neonatal transient tachypnea

To evaluate the effect of inhaled salbutamol on transient tachypnea of the newborn

Randomized, double blind, controlled clinical trial with parallel groups, phase 2; sample size of 80 neonates. Allocation ratio 1:1 using block randomization with blocks of four. The sequence will be generated by a computer based random number generator (RANDINT), and allocation will be performed in blocks.

neonatal intensive care unit, Shahid Beheshti Hospital, Kashan, 2025. After consent, eligible neonates are block randomized one to one to inhaled salbutamol or 0.9 percent normal saline plus standard care. Double blind: coded, identical vials; parents, clinical staff and outcome assessors blinded.

Inclusion criteria: Term, near term or post term neonates; clinical signs and history of transient tachypnea of the newborn; at least one radiologic criterion such as pulmonary hyperinflation, bilateral perihilar vascular prominence or fluid in the transverse fissure. Exclusion criteria: Meconium aspiration; respiratory distress syndrome; congenital pneumonia; polycythemia; hypoglycemia; proven early onset sepsis; congenital heart disease; tachycardia above 180 beats per minute; arrhythmia; congenital anomalies.

Intervention: One dose of inhaled salbutamol (Ventolin, Cipla, India) 0.15 milligram equal to 0.15 milliliter per kilogram, nebulized over 20 minutes. Control: 0.9 percent normal saline 0.15 milliliter per kilogram, nebulized over 20 minutes. Both groups receive standard neonatal intensive care.

Primary outcome variables: Anderson–Silverman respiratory distress score; respiratory rate per minute; oxygen saturation; need for supplemental oxygen; length of hospital stay.

The primary method of randomization is block randomization with an allocation ratio of 1:1. Block size is set at four, and six balanced sequences are used: AABB, BBAA, BABA, ABAB, BAAB, ABBA (A = salbutamol intervention, B = normal saline control). Each subsequent block is randomly selected with equal probability to maintain balance throughout the recruitment process. Unit of randomization: The unit of randomization is the individual neonate. A total of 80 eligible neonates, after obtaining informed consent, will be randomly assigned to one of the two groups. Randomization tool: Block sequences are generated using a computer-based random number generator (RANDINT function). Generation of the random sequence: First, all possible balanced sequences for four-patient blocks (the six sequences listed above) are defined. Then, using the RANDINT function, a long sequence of block indices is generated with equal probability (repetition of blocks allowed) until the required number for 80 participants is covered. After confirming eligibility criteria, recording baseline variables, and obtaining consent, neonates will be assigned to either the intervention or control group according to the block sequence. The study is double-blind: participants (neonates) and their parents, clinical staff, and outcome assessors are blinded. Nebulized solutions of salbutamol (Astalin/Cipla) and 0.9% normal saline are identical in appearance, volume (0.15 ml/kg), container, and labeling, and are identified only by code.

This study is designed as a double-blind trial. Neonates and their parents are allocated to either the intervention or control group based on the block randomization system, which is purely statistical. The principal investigator is aware of the group assignment of each neonate. Outcome assessors and clinical caregivers are provided with a specific code for each neonate and are instructed regarding which vial should be administered. The vials are completely identical in appearance, volume, and packaging, without any identifying labels, and are distinguished only by code. The investigator informs the assessors which coded vial should be administered to each neonate.

Patient files with de-identified information, ensuring that the identity of participants is not traceable, will be available alongside the informed consent forms. Clinical reports will also be accessible, and all files can be obtained upon request by contacting the corresponding author via email.

6 months after publication

All of academic and scientific researchers

Non - commercial use will be approved.

Send the request to corresponding author via email M.Forouhari@kaums.ac.ir

Assessment of requests by corresponding author in 1 month - sending requested files via email if the request is valid.