- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00648687
Pain Response During Examination for Retinopathy of Prematurity (ROP)
July 21, 2010 updated by: National Bioethics Commission of Brazil
Evaluation of the Pain Response During Examination for Retinopathy of Prematurity in Very Low Birth Weight Infants
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil
- Hospital de Clinicas de Porto Alegre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 6 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: I
this group will receive oral water and glucose prior to eye exam
|
Newborns will suck 2 ml of D12.5W 5 minutes before eye exam for ROP
|
No Intervention: II
this group is the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain secondary to eye examination
Time Frame: 2 minutes after the exam
|
2 minutes after the exam
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Renato S Procianoy, MD,PhD, Hospital de Clinicas de Porto Alegre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
March 14, 2008
First Submitted That Met QC Criteria
March 31, 2008
First Posted (Estimate)
April 1, 2008
Study Record Updates
Last Update Posted (Estimate)
July 22, 2010
Last Update Submitted That Met QC Criteria
July 21, 2010
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCPA 07437
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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