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Use of Sucrose to Relieve Pain During Eye Exams in Infants

Weill Cornell Medicine (WCM) logo

Weill Cornell Medicine (WCM)

Status

Terminated

Conditions

Retinopathy of Prematurity
Apnea of Prematurity
Pain

Treatments

Dietary Supplement: sucrose solution

Study type

Interventional

Funder types

Other

Identifiers

NCT00161694
0412007634

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

5+ weeks old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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