Comparison of pain perception during MIST and INSURE

Comparison of pain perception during surfactant administration in two different methods (MIST, INSURE) in preterm infants with respiratory distress syndrome: a randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240602061980N2

Enrollment

Registered

2025-01-04

Start date

2024-12-21

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

respiratory distress syndrome (RDS). Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention group:This group receives intratracheal surfactant using the MIST method (minimal invasive surfactant therapy). In the MIST method, while the infant is on nasal CPAP, a th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: all live births with gestational age of 28 to 34 weeks without any predetermined genetic disorders who were born in Ayatollah Rouhani Hospital of Babol clinical symptoms of respiratory distress syndrome

Exclusion criteria

Exclusion criteria: loss of consciousness during surfactant therapy seizure during surfactant therapy any neuromuscular disease

Design outcomes

Primary

Measure	Time frame
Comparison of pain score during two different procedures (MIST, INSURE) in premature infants with respiratory distress syndrome. Timepoint: During the procedure (MIST, INSURE). Method of measurement: Neonatal Infant Pain Scale (NIPS).	—

Secondary

Measure	Time frame
Determining the score of pain during endotracheal intubation. Timepoint: During the procedure. Method of measurement: Neonatal Infant Pain Scale (NIPS).;Determining the score of pain during insertion of a 6f endotracheal tube. Timepoint: During the procedure. Method of measurement: Neonatal Infant Pain Scale (NIPS).;Comparing the score of pain during endotracheal intubation and insertion of a 6f endotracheal tube. Timepoint: During the procedure. Method of measurement: Neonatal Infant Pain Scale (NIPS).;Comparing the heart rate changes between the MIST and INSURE groups. Timepoint: During the procedure. Method of measurement: Monitor and pulse oximeter.;Comparing the Blood oxygen saturation changes between the MIST and INSURE groups. Timepoint: During the procedure. Method of measurement: Monitor and pulse oximeter.	—

Measure

Time frame

Determining the score of pain during endotracheal intubation. Timepoint: During the procedure. Method of measurement: Neonatal Infant Pain Scale (NIPS).;Determining the score of pain during insertion of a 6f endotracheal tube. Timepoint: During the procedure. Method of measurement: Neonatal Infant Pain Scale (NIPS).;Comparing the score of pain during endotracheal intubation and insertion of a 6f endotracheal tube. Timepoint: During the procedure. Method of measurement: Neonatal Infant Pain Scale (NIPS).;Comparing the heart rate changes between the MIST and INSURE groups. Timepoint: During the procedure. Method of measurement: Monitor and pulse oximeter.;Comparing the Blood oxygen saturation changes between the MIST and INSURE groups. Timepoint: During the procedure. Method of measurement: Monitor and pulse oximeter.

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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 3234 6963

Outcome results

None listed

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