Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening

Study Overview
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Brief Summary
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Study of cerebral hemodynamic changes in preterm infant and the effect of topical anesthetic eye drops ( benoxinate hydrochloride 0.4% ) on PIPP score and cerebral hemodynamic changes during fundus examination in neonates with gestational age ≤ 34 weeks or birth weight ≤ 2.000 Kg regardless their gestational age , after postnatal day 28.

Official Title
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Hemodynamic Response Of Premature Brain To Pain During Retinopathy Of Prematurity Screening: A Randomized Controlled Trial

Conditions
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Preterm

Intervention / Treatment
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* Drug: benoxinate hydrochloride 0.4% group
* Drug: saline 0.9% .


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm infants with gestational age ≤34 weeks or infant with birth weight ≤ 2.000 Kg regardless their gestational age,with postnatal age ≥ 28 days undergoing routine ROP screening. Exclusion Criteria: Patients with any of the following will be excluded at the time of assessment: Evidence of intrauterine infection (TORCH). Chromosomal abnormalities. Major congenital anomalies. Major brain pathology such as Grade 3-4 intraventricular hemorrhage and periventricular leukomalacia.

Ages Eligible for Study
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Minimum Age: 4 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 : ( benoxinate hydrochloride 0.4% group )<br>They will receive benoxinate hydrochloride 0.4% immediately before fundus examination . | Drug: benoxinate hydrochloride 0.4% group<br>* They will receive benoxinate hydrochloride 0.4% immediately before fundus<br>|
| Placebo Comparator: Group 2 : ( control group )<br>They will receive saline drops instead of benoxinate hydrochloride 0.4%. Randomization: simple randomization sampling using sealed envelope technique. | Drug: saline 0.9% .<br>* They will receive saline 0.9% before fundus examination in each eye .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-Clinical assessment: | Pain score will be evaluated by using the premature infant pain profile (PIPP) assessed by the caring bedside nurse during fundus examination. It consists of heart rate(beat/minute), peripheral oxygen saturation in the right hand(%), and mean arterial blood pressure (mmHg). | 28 days postnatal age (time of screen of retinopathy of prematurity ,ROP) | 
| 2-Near-infrared spectroscopy (NIRS): | Measurements of cerebral oxygenation (crSO2) in (%) will be done by using near infrared spectroscopy (NIRS), device (INVOSTM 5100C Cerebral/ Somatic Oximeter Monitor; Covidien) by placing a neonatal brain sensor on the right frontoparietal area of the scalp. | 28 days postnatal age (time of screen of retinopathy of prematurity ,ROP) |