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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | suck 12.5% dextrose in water 5 minutes before the procedure | Newborns 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.