Effectiveness of an Oral Sucrose Solution in Reducing Pain and Anxiety Associated With Neonatal Ophthalmologic Examination

Weill Medical College of Cornell University1 site in 1 country300 target enrollmentJuly 2005

ConditionsApnea of Prematurity Retinopathy of Prematurity Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Apnea of Prematurity
Sponsor: Weill Medical College of Cornell University
Enrollment: 300
Locations: 1
Status: Terminated
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to see if an oral sucrose solution can comfort premature infants during their necessary eye exams. The investigators believe that the use of this solution prior to the eye exams will lead to a decrease in pain as measured by a rise in heart rate and a fall in oxygen saturation. In addition this will lead to a decrease in events in the 12 hours following examination. Events include episodes when the infants temporarily stop breathing, have a drop in their heart rates, or have a drop in their oxygen levels.

Registry

clinicaltrials.gov

Start Date

July 2005

End Date

TBD

Last Updated

17 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Weill Medical College of Cornell University

Eligibility Criteria

Inclusion Criteria

•All premature infants admitted to the Neonatal Intensive Care Unit requiring serial dilated examinations to assess for retinopathy of prematurity will be candidates for this study. This includes all infants with a birthweight of less than 1500 g and infants between 1500 g and 2000 g who require supplemental oxygen.

Exclusion Criteria

•Any infant who is unable to safely suckle 0.5 cc of fluid will be excluded from the study. This includes infants that are being maintained on ventilators and those with serious gastrointestinal complications that may be exacerbated by an oral fluid bolus.
•Any infant being maintained on narcotics for any reason will not be eligible for the study.
•All infants with major congenital anomalies will be excluded.