Clinical trial NCT06461975: Effect of Benoxinate Hydrochloride Eye Drops on The Premature Infant Pain Profile Score During Retinopathy of Prematurity Screening
Official title: Effect of Benoxinate Hydrochloride Eye Drops on The Premature Infant Pain Profile Score During Retinopathy of Prematurity Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Retinopathy of Prematurity
Keywords: Infant stress
Retinopathy of prematurity
Benoxinate hydrochloride
PIPP score
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 88
Sex: ALL
Minimum age (years): 28
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, observational, double-blinded, cross-over
Primary purpose: DIAGNOSTIC

Brief summary: Aims: To evaluate the effects of topical Benoxinate HCL eye drops on the Premature Infant Pain Profile (PIPP) scores in infants undergoing Retinopathy of Prematurity (ROP) screening.

Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.

Detailed description: Aims: To evaluate the effects of topical Benoxinate HCL eye drops on Premature Infant Pain Profile (PIPP) scores in infants undergoing Retinopathy of Prematurity (ROP) screening.

Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.

Eligibility criteria: Inclusion Criteria:

* Preterm infants with GA ≤34 weeks and/or with birth weight ≤2000 g
* Preterm infants with larger GA or birth weight who were at increased risk of ROP according to the attending neonatologist
* Infants were believed to require at least 2 ROP screenings

Exclusion Criteria:

* Infants on muscle relaxants, analgesics, sedatives, or exogenous steroids
* Infants who required mechanical ventilation or continuous positive airway pressure at the first examination

Primary outcomes:
measure: PIPP score
timeFrame: 1-3 month after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine Alexandria University
Study officials:
affiliation: University of Alexandria
name: Islam Ahmed, M.D.
role: PRINCIPAL_INVESTIGATOR
References: