Pain Response During Examination for Retinopathy of Prematurity
Not Applicable
Completed
- Conditions
- Retinopathy of Prematurity
- Interventions
- Behavioral: suck 12.5% dextrose in water 5 minutes before the procedure
- Registration Number
- NCT00648687
- Lead Sponsor
- National Bioethics Commission of Brazil
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I suck 12.5% dextrose in water 5 minutes before the procedure this group will receive oral water and glucose prior to eye exam
- Primary Outcome Measures
Name Time Method Pain secondary to eye examination 2 minutes after the exam
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil