Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening

Alexandria University

Status and phase: Completed; Phase 4

Conditions: Preterm

Treatments: Drug: benoxinate hydrochloride 0.4% group; Drug: saline 0.9% .

Study type: Interventional

Funder types: Other

Identifiers

NCT05666362

0107389

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 4 to 12 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups, including a placebo group

Group 1 : ( benoxinate hydrochloride 0.4% group )

Active Comparator group

Description:

They will receive benoxinate hydrochloride 0.4% immediately before fundus examination .

Treatment:

Drug: benoxinate hydrochloride 0.4% group

Group 2 : ( control group )

Placebo Comparator group

Description:

They will receive saline drops instead of benoxinate hydrochloride 0.4%. Randomization: simple randomization sampling using sealed envelope technique.

Treatment:

Drug: saline 0.9% .