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Pain Response During Examination for Retinopathy of Prematurity

NCT00648687 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-07-22

No results posted yet for this study

Summary

Newborns infants equal or less than 1500 grams and/or equal and less than 32 weeks will have ophthalmologic examination for ROP at 6 weeks old. They will be randomized blindly to receive 2 ml of 12.5% dextrose in water (D12.5W) orally five minute before examination (intervention group) or nothing (control). NIPS scale will be applied two minutes before examination and two minutes after examination.

Conditions

  • Retinopathy of Prematurity

Interventions

BEHAVIORAL

suck 12.5% dextrose in water 5 minutes before the procedure

Newborns will suck 2 ml of D12.5W 5 minutes before eye exam for ROP

Sponsors & Collaborators

  • National Bioethics Commission of Brazil

    lead OTHER

Principal Investigators

  • Renato S Procianoy, MD,PhD · Hospital de Clinicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Weeks
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00648687 on ClinicalTrials.gov