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

History of Changes

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:

MedlinePlus related topics: Birth Weight Drinking Water Premature Babies Retinal Disorders

Drug Information available for: Dextrose

U.S. FDA Resources

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):

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.

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 May 23, 2013

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