Premedication with Intravenous Midazolam for Neonatal Endotracheal Intubatio

Phase 3

Recruiting

Conditions: pain during endotracheal intubation.

Registration Number: IRCT20130329012869N2

Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 105

Inclusion Criteria

Gestational age of less than 37 weeks
Presence of respiratory distress syndrome and the need for nasal continuous positive airway pressure (Nasal CPAP)with a fraction of inspired oxygen (Fio2)of at least 40% to maintain arterial oxygen saturation between 90 to95%
To be a candidate for surfactant treatment with Intubation Surfactant Rapid Extubation ( INSURE) method

Exclusion Criteria

Maxillofacial anomalies, congenital heart diseases
Previous endotracheal intubation
Twice or more failed attempts for intubation

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Score. Timepoint: Before intervention and immediatly after intubation. Method of measurement: Premature Infant Pain Profile (PIPP).

Secondary Outcome Measures

Name	Time	Method
Heart Rate. Timepoint: At the beginning of the study; before drug injection; immediately after intubation and 10 minutes after intubation. Method of measurement: Observation and pulse oxymeter.;Arterial Blood Pressure. Timepoint: At the beginning of the study; before drug injection; immediately after intubation and 10 minutes after intubation. Method of measurement: Observation and pulse oxymeter.;Arterial Oxygen Saturation Percent. Timepoint: At the beginning of the study; before drug injection; immediately after intubation and 10 minutes after intubation. Method of measurement: Observation and pulse oxymeter.;Number of Attempts for Intubation. Timepoint: During the intubation. Method of measurement: Observation.;Duration of Intubation. Timepoint: During the intubation. Method of measurement: Timer.