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IRCT20250811066816N1 IRCT 2025-08-28 Kashan University of Medical Sciences Effect of salbutamol on neonatal transient tachypnea Investigating the effect of inhaled salbutamol (Ventolin) in the improvement of the treatment of neonatal transient tachypnea 2025-09-26 anticipated 80 Complete https://irct.ir/trial/85750 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 1-2 Transient Tachypnea of newborn. Intervention 1: intervention group: they will receive a single dose of inhaled salbutamol (Ventolin, manufactured by Cipla, India) at a dose of 0.15 milligram equivalent to 0.15 milliliter per kilogram of body weight, administered by nebulizer over 20 minutes. Intervention 2: The control group: They will receive 0.9 percent normal saline at the same volume by nebulizer. Both groups will simultaneously receive standard neonatal intensive care. Yes - There is a plan to make this available What will be shared: 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. When: 6 months after publication To whom: All of academic and scientific researchers Conditions: Non - commercial use will be approved. Where to obtain: Send the request to corresponding author via email M.Forouhari@kaums.ac.ir How to obtain: Assessment of requests by corresponding author in 1 month - sending requested files via email if the request is valid. Comments:
public Mohammad Mahdi Foruhari
Pezeshk Blvd., Qotb Blvd.
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5544 2015 M.Forouhari@kaums.ac.ir Kashan University of Medical Sciences scientific Mohammad Mahdi Foruhari
Pezeshk Blvd., Qotb Blvd.
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5544 2015 M.Forouhari@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Neonates with gestational age at term, near-term, or post-term Presence of clinical manifestations and history suggestive of TTN At least one radiologic criterion of TTN, including:Pulmonary hyperinflationBilateral perihilar vascular prominenceFluid in the transverse fissureOr similar findings no limit 28 days Both History of meconium aspiration Respiratory distress syndrome (RDS) Congenital pneumonia Polycythemia Hypoglycemia Proven early-onset sepsis Congenital heart disease Tachycardia exceeding 180 beats per minute Cardiac arrhythmia Congenital anomalies P22.1 Transient tachypnea of newborn Treatment - Drugs Placebo intervention group: they will receive a single dose of inhaled salbutamol (Ventolin, manufactured by Cipla, India) at a dose of 0.15 milligram equivalent to 0.15 milliliter per kilogram of body weight, administered by nebulizer over 20 minutes. The control group: They will receive 0.9 percent normal saline at the same volume by nebulizer. Both groups will simultaneously receive standard neonatal intensive care. Respiratory distress score. Timepoint: Before treatment and after treatment at intervals of 30 minutes, one hour, and four hours. Method of measurement: This system is a clinical tool for assessing the severity of respiratory distress in neonates. It evaluates five main indicators: grunting, nasal flaring, xiphoid retraction, lower chest retraction, and upper chest retraction.Method of measurement: Each indicator is evaluated by direct clinical observation of a trained physician or nurse, including the presence or absence of sounds such as grunting with a stethoscope, assessment of nasal wing movements, and observation and palpation of chest wall movements in different regions during inspiration and expiration.Scoring system: For each of the five indicators, the severity of findings is scored from 0 to 2.Score 0: No sign or normal condition (for example, no grunting, no retraction).Score 1: Mild or minimal finding (for example, grunting audible with stethoscope, slight retraction or nasal flaring).Score 2: Clear or severe finding (for example, grunting audible without stethoscope, marked nasal flaring, severe chest retraction with see-saw breathing).Final interpretation: The total score ranges from 0 to 10. Lower scores indicate mild or absent respiratory distress, while higher scores represent more severe distress requiring further intervention. Length of Hospital Stay. Timepoint: At admission and at discharge. Method of measurement: Based on the patient’s medical records. Respiratory Rate. Timepoint: Before starting treatment, 30 minutes, one hour, and four hours after. Method of measurement: Counting the respiratory rate for one minute based on abdominal and chest movements of the neonate. Heart rate. Timepoint: Before starting treatment, 30 minutes, one hour, and four hours after. Method of measurement: Based on pulse oximetry information. Oxygen saturation. Timepoint: Before starting treatment, 30 minutes, one hour, and four hours after. Method of measurement: Based on pulse oximetry information. Kashan University of Medical Sciences Approved 2025-07-27 Research Ethics Committees of Faculty of Medicine & Faculty of Dentistry- Kashan University of Medic Kashan university of medical science., Pezeshk Blvd., Qotb Blvd. Kashan Isfehan Iran (Islamic Republic of)