Clinical trial
Hemodynamic Response Of Premature Brain To Pain During Retinopathy Of Prematurity Screening: A Randomized Controlled Trial
Name
0107389
Description
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.
Trial arms
Trial start
2023-01-20
Estimated PCD
2024-03-20
Trial end
2024-04-01
Status
Recruiting
Treatment
benoxinate hydrochloride 0.4% group
They will receive benoxinate hydrochloride 0.4% immediately before fundus
Arms:
Group 1 : ( benoxinate hydrochloride 0.4% group )
saline 0.9% .
They will receive saline 0.9% before fundus examination in each eye .
Arms:
Group 2 : ( control group )
Size
40
Primary endpoint
1-Clinical assessment:
28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)
2-Near-infrared spectroscopy (NIRS):
28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-01-31
Organization
Alexandria UniversityProduct
Benoxinate hydrochlorideIndication
PretermProduct
Saline 0.9%