comparison of MIST and INSURE

Effectiveness of surfactant administration in two different methods (MIST, INSURE) on the short-term outcome of preterm infants with respiratory distress syndrome: a randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240602061980N1

Enrollment

Registered

2024-07-11

Start date

2024-06-11

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory distress syndrom( RDS). Diseases of the respiratory system(J00-J99)

Interventions

Intervention 1: Intervention group:This group receives intratracheal surfactant by the MIST( minimal invasive surfactant therapy) method.In this method, when the baby is under CPAP, a thin 6f tube is

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: congenital cyanotic heart disease PPHN pulmonary hypoplasia sepsis pneumonia

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamira Pournajaf

Babol University of Medical Sciences

s.pournajaf@mubabol.ac.ir+98 11 3232 0443

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026