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Clinical Trials/CTRI/2024/05/067736
CTRI/2024/05/067736CompletedNot Applicable

Efficacy of inhaled budesonide for reducing oxygen requirement in neonates with respiratory distress

UCMS and GTB Hospital1 site in 1 country84 target enrollmentStarted: June 25, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
84
Locations
1
Primary Endpoint
Mean duration of oxygen requirement

Study Overview

Brief Summary

This study has been designed to asses the efficacy of inhaled budesonide in reducing oxygen requirement in neonates with respiratory distress. Neonates with respiratory distress receiving inhaled budesonide will be compared with those receiving placebo and duration of oxygen requirement in two groups will be compared. Respiratory distress is one of most common reasons a neonate is admitted to the neonatal intensive care unit. Indian National Neonatal-Perinatal Database reported significant morbidity associated with neonates developing respiratory distress. Irrespective of the cause, lack of proper management of neonates with respiratory distress can result in respiratory failure and cardio pulmonary arrest. Oxygen therapy is an important part in management of neonates with respiratory distress but despite beneficial effect of oxygen therapy , long term oxygen therapy has shown to cause toxicity with evidence suggesting development of Bronchopulmonary dysplasia (BPD) and retinopathy of prematurity (ROP) in neonates on long term oxygen therapy. Budesonide is potent topical anti-inflammatory agent with powerful effects on respiratory system. It promotes production of anti-oxidant enzymes and can reduce bronchial and pulmonary edema. It also has anti inflammatory action by reducing production of anti inflammatory cytokines. .Severity of lung injury as indicated by oxygen dependency also reduced after administration of steroid. There is paucity of data on use of budesonide as first line agent in neonates with respiratory distress. Few studies have described the role of budesonide in neonates with Respiratory Distress Syndrome (RDS), Meconium Aspiration Syndrome (MAS), Transient Tachypnea of Newborn (TTN) and Bronchopulmonary Dysplasia (BPD) in reducing oxygen dependency and clinical improvement and the results have been mostly promising. Therefore, through this study, we propose to evaluate efficacy of inhaled budesonide in reducing oxygen dependency in neonates with Respiratory distress.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
0.00 Day(s) to 28.00 Day(s) (—)
Sex
All

Inclusion Criteria

  • All neonates (more than 34 weeks) up to 28 days of life with respiratory distress requiring an FiO2 more than 30 percent on day 4 of admission admitted in extra-mural NICU.

Exclusion Criteria

  • 1.Neonates who have non respiratory cause of respiratory distress (including congenital heart disease, Severe birth asphyxia, Polycythemia, Hypoglycemia etc.) 2.Neonates with Visible Gross Congenital Anomalies.
  • 3.Neonates requiring exogenous surfactant.

Outcomes

Primary Outcomes

Mean duration of oxygen requirement

Time Frame: randomization to day of discharge

Secondary Outcomes

  • Mean Downes score(At enrollment and then every 12 hours till 72 hours of budesonide nebulization)
  • Proportion of patients expired(randomization to day of expiry)
  • Mean duration of NICU and hospital stay(randomization to day of discharge)

Investigators

Sponsor
UCMS and GTB Hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Mohit Kumar Soni

University College of Medical Sciences and GTB hospital, Delhi

Study Sites (1)

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