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OpenTrials
Completed

NCT Number: NCT05666362

Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening

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.

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Key information

Conditions

Preterm Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

4 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Marwa Mohamed Farag

Alexandria, 0356, Egypt

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

benoxinate hydrochloride 0.4% group

Drug

They will receive benoxinate hydrochloride 0.4% immediately before fundus

saline 0.9% .

Drug

They will receive saline 0.9% before fundus examination in each eye .

Primary outcomes

  1. 1-Clinical assessment:

    Time frame: 28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)

    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).

  2. 2-Near-infrared spectroscopy (NIRS):

    Time frame: 28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)

    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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 27, 2022
Registry last updated
Feb 5, 2025

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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