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Pain Response During Examination for Retinopathy of Prematurity (ROP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00648687
First Posted: April 1, 2008
Last Update Posted: July 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Bioethics Commission of Brazil
  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: Triple (Care Provider, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Weeks to 6 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 14, 2008
First Posted: April 1, 2008
Last Update Posted: July 22, 2010
Last Verified: September 2009

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

Additional relevant MeSH terms:
Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases