Pain Response During Examination for Retinopathy of Prematurity

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.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Neurologic Manifestations Obstetric Labor Complications Obstetric Labor, Premature Pain Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Retinal Diseases Signs and Symptoms Urogenital Diseases

Age range

5 week–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

suck 12.5% dextrose in water 5 minutes before the procedure

Behavioral

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

Primary outcomes

Pain secondary to eye examination

Time frame: 2 minutes after the exam

Sponsors and collaborators

Lead sponsor

National Bioethics Commission of Brazil

Other

Registry information

Official study title

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

Acronym: ROP

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Apr 1, 2008
Registry last updated: Jul 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed