comparison of MIST and INSURE

Phase 3

Recruiting

Conditions: respiratory distress syndrom( RDS).
Diseases of the respiratory system(J00-J99)
certain conditions originating in the perinatal period (P00-P96)
J95-J99 Other diseases of the respiratory system
J00-J99

Registration Number: IRCT20240602061980N1

Lead Sponsor: Babol University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

all live births with a gestational age of 28 to 34 weeks who were born in Ayatollah Rouhani Hospital, Babol, and had clinical symptoms of respiratory distress syndrome.

Exclusion Criteria

congenital cyanotic heart disease
PPHN
pulmonary hypoplasia
sepsis
pneumonia

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determining and comparing the duration of CPAP respiratory support in the MIST group with the INSURE group. Timepoint: The duration of CPAP respiratory support is determined in hours. Method of measurement: time.

Secondary Outcome Measures

Name	Time	Method
Determining and comparing the need for surfactant re-administration in the MIST group with the INSURE group. Timepoint: in 12 hour. Method of measurement: Decision making based on the patient's clinical conditions and remaining respiratory distress and the need for high fio2.;Determining and comparing the frequency of pneumothorax in the MIST group with the INSURE group. Timepoint: during hospitalization period. Method of measurement: chest x-ray.;Determining and comparing the frequency of the need for mechanical ventilation in the MIST group with the INSURE group. Timepoint: Within 72 hours of treatment. Method of measurement: mechanical ventilator.;Determining and comparing the frequency of pulmonary haemorrhage in the MIST group with the INSURE group. Timepoint: during hospitalization. Method of measurement: chest x ray or significant bleeding from the tracheal tube.