A study of intranasal remifentanil for intubation and surfactant administration in newborns

Phase 2

• Conditions: Pain management for premature infants undergoing intubation.; Reproductive Health and Childbirth - Complications of newborn; Anaesthesiology - Pain management

• Registration Number: ACTRN12612000386831
• Lead Sponsor: Associate Professor Ian Wright

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Born at John Hunter Childrens Hospital and transferred to Neonatal Intensive Care Unit.
Require the INSURE procedure as part of their medical care.
Are 28–44 weeks post-conceptional age at the time of the procedure.

Exclusion Criteria

Need for urgent intubation for resuscitation.
Major congenital anomalies likely to influence reliability of the primary outcome measure.
Severe neurological obtundation.
Current clinical seizures.
Concomitant muscle relaxant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of infants with good or excellent intubating conditions. <br><br>Base-line cardiorespiratory and sleep-wake data will be recorded in order to calculate the immediate post-procedural Premature Infant Pain Profile (PIPP) score. Real-time physiological data will be downloaded from monitors for later analysis. These include: blood pressure obtained using an arterial transducer or a non-invasive blood pressure module; heart rate obtained from an electrocardiogram lead attached to cardiogram/respiratory monitor; and oxygen saturation obtained from an oxygen saturation monitor.[1 and 3 minutes after intubation. Real-time physiological data will be downloaded from monitors for later analysis.]

Secondary Outcome Measures

Name	Time	Method
Pain assessed using the Premature Infant Pain Profile (PIPP) score[1 and 3 minutes after intubation];Number of intubation attempts and total duration (limit of 3 attempts OR 20 seconds each attempt OR intubation associated with desaturations and bradycardia).[The duration of the procedure];Adverse events including episodes of bradycardia and number of neonates requiring intervention (volume expanders or inotropes) for hypotension[The first hour after study drug administration];Ventilatory changes[The first hour after study drug administration];Neonatal outcome at discharge from NICU (satisfactory weight gain, equivalent to term corrected, breathing on own without respiratory support, can suck and feed without the need of assistance eg. gastric tube feeding, can maintain body temperature).[At discharge from NICU.]