The effect of nebulized Salbutamol versus nebulized Epinephrine in treatment of transient tachypnea of neonates in neonatal intensive care unit

Determining the effect of nebulized salbutamol versus nebulized epinephrine in treatment of transient tachypnea of neonates in neonatal intensive care unit

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 180 patients. Sealed envelopes were used for randomization.

Infants diagnosed with transient tachypnea will be evaluated in the neonatal intensive care unit in Al-Zahra hospital of Tabriz city. The clinical expert evaluating the results of the study and the person analyzing the study data are blinded.

Inclusion criteria were transient tachypnea of neonates and admission at neonatal intensive care unit. Neonates with first minute apgar below 4, respiratory distress syndrome caused by surfactant deficiency, congenital anomalies, syndromes of chromosomal disorders, congenital heart diseases, premature neonatal sepsis, meconium aspiration and infants with metabolic disorders will excluded.

Intervention group 1: In the salbutamol group, salbutamol nebulizer will be prescribed with a dose of 0.15 mg per kilogram of body weight of infants. Intervention group 2: In the epinephrine group, 0.5 ml per kilogram of the infants weight will be prescribed from a 1 mg/ml ampoule of epinephrine. Control group: 2 ml of normal saline will be nebulized.

Oxygen saturation

Subject: Request for Correction of Trial Registration Information in the IRCT Registry (IRCT20221028056324N1) Dear Sir/Madam, We would like to inform you that some inconsistencies were inadvertently introduced in the initially registered information of the clinical trial with registration number IRCT20221028056324N1. As the study has now been completed, and in order to ensure full alignment of the registry entry with the approved protocol, the final manuscript, and international standards (ICMJE and CONSORT), we kindly request that the following corrections be considered and applied. 1. Correction of Primary and Secondary Outcomes At the time of initial registration, several physiological variables, including oxygen saturation (SpO₂), respiratory rate (RR), heart rate (HR), and fraction of inspired oxygen (FiO₂), were inadvertently entered under the primary outcomes section. In addition, the designated field for secondary outcomes was left incomplete due to a clerical oversight. However, the study protocol from the outset prespecified a single primary outcome: Primary outcome: Change in oxygen saturation percentage (SpO₂) This outcome was also used for the sample size calculation. All other physiological variables and clinical endpoints were predefined as secondary outcomes, as listed below: Primary outcome: Oxygen saturation (SpO₂) Secondary outcomes: Respiratory rate; Heart rate; FiO₂; Number of nebulizer administrations; Duration of NCPAP support (days); Time to first enteral feeding (hours); Time to full enteral feeding (days); Duration of supplemental oxygen (days); Length of hospital stay (days) We kindly request that the primary and secondary outcomes be corrected in the registry accordingly. 2. Correction of Sample Size At the time of initial IRCT registration, a provisional minimum sample size of 90 neonates (30 per group) was entered. Prior to trial initiation and before any participant enrollment or randomization, the required sample size was recalculated using more precise data from the study by Babaei et al. (1). Based on oxygen saturation data: The required sample size was calculated as 46 neonates per group (α = 0.05, power = 80%). Allowing for 30% attrition, the final sample size was increased to 60 neonates per group (180 neonates in total). This scientifically justified revision was implemented prior to participant recruitment and did not introduce any risk of bias. We kindly request that the sample size be updated accordingly in the registry. 3. Correction of Trial Registration and Recruitment Timing There is an ambiguity in the timing section of the registry entry that has resulted in the study being displayed as “registered while recruiting,” whereas the trial was prospectively registered and conducted. The correct sequence of events is as follows: Ethics approval: 03 October 2022 IRCT registration approval: 09 September 2023 Estimated recruitment start date recorded in the registry: 01 September 2023 Actual start of recruitment and intervention: 02 October 2023 The date of 01 September 2023 recorded in the registry represents only an estimated recruitment start date entered during preregistration and does not reflect the actual initiation of participant enrollment. No participants were enrolled prior to trial registration. We kindly request that the actual recruitment start date be corrected so that the study is appropriately classified as prospectively registered. 4. Update of Recruitment Status As participant recruitment and follow-up have been fully completed, the recruitment status of the study has been updated to Completed. We kindly ask for confirmation of this final status, if required. We sincerely appreciate your time and cooperation in correcting the registry information and in supporting transparency and accuracy in clinical trial reporting. Thank you very much for your kind assistance. Sincerely, Dr. Nazila Khanzadeh Principal Investigator and Trial Registrant Email: Lotfalinezhadm@gmail.com Contact number: +98 914 400 5440 Reference Babaei H, Dabiri S, Mohammadi Pirkashani L, Mohsenpour H. Effects of Salbutamol on the Treatment of Transient Tachypnea of the Newborn. Iranian Journal of Neonatology. 2019;10(1):42–49.

Randomization of the study groups will be done using a sealed envelope. Patients will be evaluated in three groups including intervention group 1, intervention group 2 and control group. 90 envelopes in three groups of A, B or C will prepared (30 each) and sealed. Then when the patients arrive at the neonatal intensive care unit, the envelopes are opened by the nurse delivering the patient and The grouping will be written as A, B or C on the clinical file. Then, according to the desired group, the intervention will be prescribed for the patients.

The specialist that evaluating the final effect of the intervention and possible complications as well as the person analyzing the data will be blinded to the type of intervention.

Study data is categorized and coded with no identifiable individuals.

Access to study data after publication of the result is available in the journal.

Anyone interested in using the data can access the study data.

Study data can be used for comparison with other results.

Refer to the study's scientific or public accountability person for data. Dear researchers can access the data in a limited and coded manner, after completing the project end and acceptance of the scientific article, by sending a data access request from the accredited research centers with coordination with the university research committee.

Refer to the study's scientific or public accountability person for data. Dear researchers can access the data in a limited and coded manner, after completing the project end and acceptance of the scientific article, by sending a data access request from the accredited research centers with coordination with the university research committee.