Clinical Trials Directory

Trials / Completed

CompletedNCT00648687

Pain Response During Examination for Retinopathy of Prematurity

Evaluation of the Pain Response During Examination for Retinopathy of Prematurity in Very Low Birth Weight Infants

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
National Bioethics Commission of Brazil · Academic / Other
Sex
All
Age
5 Weeks – 6 Months
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALsuck 12.5% dextrose in water 5 minutes before the procedureNewborns will suck 2 ml of D12.5W 5 minutes before eye exam for ROP

Timeline

Start date
2008-03-01
Primary completion
2010-06-01
Completion
2010-06-01
First posted
2008-04-01
Last updated
2010-07-22

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT00648687. Inclusion in this directory is not an endorsement.