Preterm
Conditions
Brief summary
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.
Interventions
DRUGbenoxinate hydrochloride 0.4% group
They will receive benoxinate hydrochloride 0.4% immediately before fundus
DRUGsaline 0.9% .
They will receive saline 0.9% before fundus examination in each eye .
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 12 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-Clinical assessment: | 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-Near-infrared spectroscopy (NIRS): | 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. |
Countries
Egypt
Outcome results
None listed