Pain Response During Examination for Retinopathy of Prematurity
ROP
Evaluation of the Pain Response During Examination for Retinopathy of Prematurity in Very Low Birth Weight Infants
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 14, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJuly 22, 2010
September 1, 2009
2.3 years
March 14, 2008
July 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain secondary to eye examination
2 minutes after the exam
Study Arms (2)
I
EXPERIMENTALthis group will receive oral water and glucose prior to eye exam
II
NO INTERVENTIONthis group is the control group.
Interventions
Newborns will suck 2 ml of D12.5W 5 minutes before eye exam for ROP
Eligibility Criteria
You may qualify if:
- all newborns equal or less than 1500 grams birth weight and/or equal or less than 32 weeks gestational age
You may not qualify if:
- the ones that died before 6 weeks old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Related Publications (1)
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.
PMID: 23525316DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Renato S Procianoy, MD,PhD
Hospital de Clinicas de Porto Alegre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 14, 2008
First Posted
April 1, 2008
Study Start
March 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
July 22, 2010
Record last verified: 2009-09