Pain Response During Examination for Retinopathy of Prematurity

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00648687

Acronym

ROP

Enrollment

100

Registered

2008-04-01

Start date

2008-03-31

Completion date

2010-06-30

Last updated

2010-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinopathy of Prematurity

Keywords

prematurity, retinopathy of prematurity, pain, very low birth weight infants

Brief summary

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.

Interventions

BEHAVIORALsuck 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Weeks to 6 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pain secondary to eye examination	2 minutes after the exam

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026