MedPath

The effect of two different doses of Fentanyl on sedation of infants with respiratory distress syndrome under mechanical ventilatio

Phase 3
Conditions
Respiratory distress syndrome of newborn.
Respiratory distress syndrome of newborn
Registration Number
IRCT2017082517413N27
Lead Sponsor
Vice Chancellor for Research, Baqiyatallah University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
60
Inclusion Criteria

Infants between 2.5 and 4 kg of weight with respiratory distress syndrome who needed intubation and mechanical ventilation
Exclusion criteria: Patients lower than 2.5 kg and more than 4 kg; congenital heart disease; brain anomalies; metabolic or chromosomal syndromes

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Respiratory rate. Timepoint: before and one hour after intervention. Method of measurement: Respiration count in one minute by nurse.;Arterial Oxygen saturation. Timepoint: before and one hour after intervention. Method of measurement: Pulse Oxymetry.;Duration of hospitalization. Timepoint: Beginning of study to discharge. Method of measurement: Counting hospital stay days.;Duration of Ventilation. Timepoint: After Intervention. Method of measurement: Counting ventilator-dependent days.;Oxygen concentration. Timepoint: before and one hour after intervention. Method of measurement: Mechanical ventilation device.
Secondary Outcome Measures
NameTimeMethod
Pneumothorax. Timepoint: After Intervention. Method of measurement: Plain chest X-ray.
© Copyright 2025. All Rights Reserved by MedPath