Evaluation of the effect of use of budesonide nebulizer on reducing bronchopulmonary dysplasia in preterm infants less than 32 weeks a randomized of clinical trial

Evaluate the efficacy of inhaled budesonide in preterm infants for preventing BPD. Secondary objectives were assessing its effects on the duration of respiratory support, hospital stay, the incidence of severe BPD, and mortality before 36 post-menstrual age (PMA). We also evaluated related complications

Clinical trial with control group with parallel groups, Double-blind, Randomized, Phase 3 on 70 patients.

kamali hospital

Preterm infants (25–32 weeks GA), ≤12 hours old, requiring respiratory support, were eligible. Exclusion criteria included birth weight ≤500 g or >1500 g, major congenital anomalies, pneumothorax, or early-onset sepsis prior to randomization. All eligible infants meeting these conditions were enrolled in the study.

Eligible infants received the first dose within 24 hours of birth. Inhaled budesonide or placebo (normal saline) was nebulized every 12 hours for 7 days. Delivery method depended on respiratory support type. The protocol ensured consistent dosing and full blinding across all stages, with indistinguishable appearance of both solutions.

Bronchopulmonary dysplasia/Mortality rate/Severity of Bronchopulmonary dysplasia/Need for supplemental oxygen/duration of mechanical ventilation duration of non-invasive ventilation/Intraventricular hemorrhage/Incidence of early and late onset sepsis

Due to practical limitations encountered during the data collection process and a lower-than-anticipated number of enrolled participants, a revision of the initially estimated sample size became necessary. To obtain a more accurate and realistic estimation, the G*Power statistical software was used. The recalculation was performed based on a statistical power of 0.80, a significance level (α) of 0.05, and the expected effect size. As a result, the sample size was adjusted to reflect feasible implementation within the available resources and study conditions. This revision was made to maintain scientific rigor and ensure the generalizability and statistical validity of the study findings. The updated sample size has been reflected in the final IRCT registration. In addition, and in line with the principles of proper clinical trial design, the randomization and blinding methods used in the study were clarified and updated. These revisions were made to ensure adherence to appropriate procedures for random allocation and multi-level blinding (including physicians, data analysts, outcome assessors, and clinical staff). Detailed information was provided regarding the use of the Sealed Envelope web-based software for randomization with a 1:1 allocation ratio, as well as the procedures implemented to preserve blinding throughout all stages of the trial, including drug preparation, administration, outcome assessment, and data analysis. These updates were made to enhance scientific transparency, improve reproducibility, and strengthen the methodological quality of the trial as registered in IRCT. Moreover, to better target a high-risk neonatal population and reduce heterogeneity in the study sample, an additional exclusion criterion was introduced. Infants with a birth weight greater than 1500 grams were excluded from the study. This adjustment aimed to focus the investigation on preterm infants at higher risk for bronchopulmonary dysplasia (BPD), thereby improving the precision of the findings and their clinical relevance. This change has also been incorporated into the updated IRCT registration.

Once the eligibility of participants was confirmed and prospective consent obtained, infants were randomly assigned to either receive inhaled budesonide or placebo using the Sealed Envelope web-based randomization software (https://www.sealedenvelope.com) with an allocation ratio of 1:1.

To maintain blinding, physicians, data analysts, outcome assessors, and trial investigators were blinded to the randomization group throughout the study. The study medications were prepared by a designated clinical manager who was not involved in clinical care. Both the budesonide and placebo solutions were colorless, indistinguishable in appearance, and prepared in equal volume. The designated clinical manager labeled study medications based on the patient’s code. Outcome data were recorded by a neonatal specialist who was unaware of the administered drugs. All clinical staff, caregivers, the principal investigator and data analysts were blinded during data collection and analysis.