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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 : ( benoxinate hydrochloride 0.4% group ) | Active Comparator | They will receive benoxinate hydrochloride 0.4% immediately before fundus examination . |
|
| Group 2 : ( control group ) | Placebo Comparator | They will receive saline drops instead of benoxinate hydrochloride 0.4%. Randomization: simple randomization sampling using sealed envelope technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| benoxinate hydrochloride 0.4% group | Drug | They will receive benoxinate hydrochloride 0.4% immediately before fundus |
|
| 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) |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Shimaa Hafez, MBChB | Faculty of medicine, Alexandria University, Egypt | Principal Investigator |
| Hesham Ghazal, PhD | Faculty of medicine, Alexandria University, Egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marwa Mohamed Farag | Alexandria | 0356 | Egypt |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C005298 | benoxinate |
| D044382 | Population Groups |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
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| saline 0.9% . | Drug | They will receive saline 0.9% before fundus examination in each eye . |
|
| D000091642 | Urogenital Diseases |
| D017606 |
| Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |