Pain Response During Examination for Retinopathy of Prematurity (ROP)

This study has been completed.
Sponsor:
Information provided by:
National Bioethics Commission of Brazil
ClinicalTrials.gov Identifier:
NCT00648687
First received: March 14, 2008
Last updated: July 21, 2010
Last verified: September 2009
  Purpose

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.


Condition Intervention
Retinopathy of Prematurity
Behavioral: suck 12.5% dextrose in water 5 minutes before the procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the Pain Response During Examination for Retinopathy of Prematurity in Very Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by National Bioethics Commission of Brazil:

Primary Outcome Measures:
  • Pain secondary to eye examination [ Time Frame: 2 minutes after the exam ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
this group will receive oral water and glucose prior to eye exam
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
No Intervention: II
this group is the control group.

  Eligibility

Ages Eligible for Study:   5 Weeks to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00648687

Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil
Sponsors and Collaborators
National Bioethics Commission of Brazil
Investigators
Principal Investigator: Renato S Procianoy, MD,PhD Hospital de Clinicas de Porto Alegre
  More Information

No publications provided by National Bioethics Commission of Brazil

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Renato Procianoy, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00648687     History of Changes
Other Study ID Numbers: HCPA 07437
Study First Received: March 14, 2008
Last Updated: July 21, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by National Bioethics Commission of Brazil:
prematurity
retinopathy of prematurity
pain
very low birth weight infants

Additional relevant MeSH terms:
Retinal Diseases
Retinopathy of Prematurity
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on April 17, 2014