Comparison of surfactant injection alone with simultaneous intratracheal administration of surfactant and oral bosentan in the prevention of bronchopulmonary dysplasia in premature infants with respiratory distress syndrome
Design
A controlled, parallel-group, double-blind, randomized, phase 4 clinical trial on 90 patients. A block method is used for randomization.
Settings and conduct
Premature infants with a gestational age of less than or equal to 37 weeks born during 2026 AH in the neonatal intensive care unit of Arak hospitals who have been admitted with respiratory distress syndrome and who meet the inclusion criteria and require surfactant injection will be included in the study.
Infants and parents will not know the type of medication received. Also, the outcome assessor will complete the checklist based on the patient assessment without knowing the medication received.
Participants/Inclusion and exclusion criteria
Babies with a gestational age of less than or equal to 37 weeks With moderate or severe neonatal respiratory distress syndrome requiring mechanical ventilation Requires an inspiratory oxygen fraction greater than 30% Absence of severe congenital anomalies
Intervention groups
Intervention group: This group of infants will receive oral bosentan in addition to BLES surfactant. This tablet is administered at a concentration of 1 mg/kg every twelve hours for a maximum of one month. Hospitalized infants will receive a vial of BLES surfactant at a dose of 5 cc/kg intratracheally.
Control group: This group will receive BLES surfactant alone at a dose of 5 cc/kg body weight.
Main outcome variables
Severity of respiratory distress at birth; need for ventilation; length of hospital stay; duration of mechanical ventilation; pneumothorax; incidence of pulmonary hemorrhage; incidence of intraventricular hemorrhage; mean airway pressure; need for subsequent doses of surfactant
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260119068615N1
Registration date:2026-02-14, 1404/11/25
Registration timing:prospective
Last update:2026-02-14, 1404/11/25
Update count:0
Registration date
2026-02-14, 1404/11/25
Registrant information
Name
Hadi Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3383 8310
Email address
h.mohamadi@arakmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-04-04, 1405/01/15
Expected recruitment end date
2026-10-07, 1405/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of oral bosentan in preventing Bronchopulmonary Dysplasia (BPD) in premature infants with respiratory distress syndrome
Public title
Effect of oral bosentan in preventing Bronchopulmonary Dysplasia (BPD) in premature infants with respiratory distress syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Babies with a gestational age of less than or equal to 37 weeks
With moderate or severe neonatal respiratory distress syndrome requiring mechanical ventilation
Requires an inspiratory oxygen fraction greater than 30%
Absence of severe congenital anomalies
Exclusion criteria:
Severe asphyxia
Cardiovascular instability shock
Oral intolerance to medications
The presence of drug side effects
Age
To 5 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be used to randomly assign participants. For this purpose, blocks of fixed size (e.g., blocks of 4 or 6) will be considered so that the allocation ratio between the two treatment groups remains balanced throughout the study. The order of allocation within each block will be determined using a random number table (or computer software) and will be placed as coded cards in opaque, impenetrable envelopes. As each eligible infant arrives, one envelope will be opened sequentially and the group allocation will be determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will not be aware of the type of medication they are receiving. Clinical caregivers will inject the medication prepared in the syringe based on the patient code. Also, the outcome assessor will complete the relevant checklist without knowing the type of intervention. The principal investigator will only be responsible for collecting the checklists and recording the information.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences