Pain Response During Examination for Retinopathy of Prematurity

Retinopathy of Prematurity Clinical Trial

— ROP  

Official title:

Evaluation of the Pain Response During Examination for Retinopathy of Prematurity in Very Low Birth Weight Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00648687
• Other study ID #: HCPA 07437
• Status: Completed
• Phase: N/A
• First received: March 14, 2008
• Last updated: July 21, 2010
• Start date: March 2008
• Est. completion date: June 2010

Study information

• Verified date: September 2009
• Source: National Bioethics Commission of Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Weeks to 6 Months

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
National Bioethics Commission of Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain secondary to eye examination		2 minutes after the exam	No