Pain Response During Examination for Retinopathy of Prematurity

NCT ID: NCT00648687

Last Updated: 2010-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Retinopathy of Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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I

this group will receive oral water and glucose prior to eye exam

Group Type EXPERIMENTAL

suck 12.5% dextrose in water 5 minutes before the procedure

Intervention Type BEHAVIORAL

Newborns will suck 2 ml of D12.5W 5 minutes before eye exam for ROP

II

this group is the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

5 Weeks

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Bioethics Commission of Brazil

OTHER

Sponsor Role lead

Responsible Party

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Hospital de Clinicas de Porto Alegre

Principal Investigators

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Renato S Procianoy, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Locations

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Hospital de ClĂ­nicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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. doi: 10.6061/clinics/2013(02)oa13.

Reference Type DERIVED
PMID: 23525316 (View on PubMed)

Other Identifiers

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HCPA 07437

Identifier Type: -

Identifier Source: org_study_id

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