The purpose of this study is to see if an oral sucrose solution can comfort premature infants during their necessary eye exams. We believe that the use of this solution prior to the eye exams will lead to a decrease in pain as measured by rise in heart rate and 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, has a drop in their heart rate, or has a drop in their oxygen levels.

Condition	Intervention
Apnea of Prematurity Retinopathy of Prematurity Pain Control	Drug: sucrose solution

Further Study Details: 

Expected Total Enrollment:  300

Ages Eligible for Study:  5 Weeks and above,  Genders Eligible for Study:  Both

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 1500g and infants between 1500g and 2000g who require supplemental oxygen.

Exclusion Criteria:

• Any infant who is unable to safely suckle 0.5cc 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 wil be excluded.

Please refer to this study by ClinicalTrials.gov identifier  NCT00161694

Tamara L Rousseau, MD      212-746-3530    tlrousseau2001@yahoo.com

New York
      NYPH- Weill Cornell Medical Center, New York,  New York,  10021,  United States; Recruiting

Study chairs or principal investigators

Tamara L Rousseau, MD,  Principal Investigator,  Neonatology Fellow at NYPH-Weill Cornell Medical Center   

Study ID Numbers:  0412007634
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00161694
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13