Status:
COMPLETED
Inhaled Nitrous Oxide for Pain Relief During Eye Exam in the Pre-term Infant
Lead Sponsor:
Nabeel Ali
Conditions:
Retinopathy of Prematurity
Eligibility:
All Genders
32+ years
Phase:
PHASE3
Brief Summary
The primary objective of the proposed study is to show that inhaled equimolar mixture of oxygen and nitrous oxide (EMONO) will reduce pain associated with retinal exam in the preterm infant, as compar...
Detailed Description
Methods 1. Study population: Eligible patients will be healthy preterm infants born at 30 0/7 or less than weeks of gestation, or weigh less than 1500 grams at birth, requiring retinopathy of pre...
Eligibility Criteria
Inclusion
- Requiring retinal exam for ROP screening
- Clinically stable
- At least 30 0/7 weeks of corrected gestational age at the time of study
- Not on mechanical ventilation or CPAP at the time of study
- Requiring an inspired concentration of oxygen less than 50%
Exclusion
- \- Craniofacial malformations
- Cyanotic cardiac disease
- Hemodynamically significant cardiac lesions
- Known pneumothorax or pneumomediastinum
- Congenital pulmonary malformations
- Neuromuscular disease
- Receiving opiates, benzodiazepines or barbiturates at the time of study
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00623220
Start Date
March 1 2008
End Date
April 1 2010
Last Update
October 30 2013
Active Locations (1)
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1
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1