Back to resultsPain Response During Examination for Retinopathy of Prematurity (ROP)
Primary Purpose
Retinopathy of Prematurity
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
suck 12.5% dextrose in water 5 minutes before the procedure
Sponsored by
About this trial
This is an interventional prevention trial for Retinopathy of Prematurity focused on measuring prematurity, retinopathy of prematurity, pain, very low birth weight infants
Eligibility Criteria
Inclusion Criteria:
- all newborns equal or less than 1500 grams birth weight and/or equal or less than 32 weeks gestational age
Exclusion Criteria:
- the ones that died before 6 weeks old
Sites / Locations
- Hospital de Clínicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
I
II
Arm Description
this group will receive oral water and glucose prior to eye exam
this group is the control group.
Outcomes
Primary Outcome Measures
Pain secondary to eye examination
Secondary Outcome Measures
Full Information
NCT ID
NCT00648687
First Posted
March 14, 2008
Last Updated
July 21, 2010
Sponsor
National Bioethics Commission of Brazil
1. Study Identification
Unique Protocol Identification Number
NCT00648687
Brief Title
Pain Response During Examination for Retinopathy of Prematurity
Acronym
ROP
Official Title
Evaluation of the Pain Response During Examination for Retinopathy of Prematurity in Very Low Birth Weight Infants
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Bioethics Commission of Brazil
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity
Keywords
prematurity, retinopathy of prematurity, pain, very low birth weight infants
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Experimental
Arm Description
this group will receive oral water and glucose prior to eye exam
Arm Title
II
Arm Type
No Intervention
Arm Description
this group is the control group.
Intervention Type
Behavioral
Intervention Name(s)
suck 12.5% dextrose in water 5 minutes before the procedure
Intervention Description
Newborns will suck 2 ml of D12.5W 5 minutes before eye exam for ROP
Primary Outcome Measure Information:
Title
Pain secondary to eye examination
Time Frame
2 minutes after the exam
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Weeks
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all newborns equal or less than 1500 grams birth weight and/or equal or less than 32 weeks gestational age
Exclusion Criteria:
the ones that died before 6 weeks old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato S Procianoy, MD,PhD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23525316
Citation
Costa MC, Eckert GU, Fortes BG, Fortes Filho JB, Silveira RC, Procianoy RS. Oral glucose for pain relief during examination for retinopathy of prematurity: a masked randomized clinical trial. Clinics (Sao Paulo). 2013;68(2):199-204. doi: 10.6061/clinics/2013(02)oa13.
Results Reference
derived
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Pain Response During Examination for Retinopathy of Prematurity
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