Retinopathy of Prematurity
Conditions
Keywords
Infant stress, Retinopathy of prematurity, Benoxinate hydrochloride, PIPP score
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.
Interventions
DRUGBenoxinate Hydrochloride
The first group had the first examination done using the tear substitute Polyfresh ® eye drops and the second using the Benoxinate HCL drops Benox ® given just before the ROP screening.
DRUGartificial tear (Sodium Hyaluronate 2 mg/ml) eye drops.
The second group had the first examination done using the Benoxinate HCL drops Benox ® eye drops and the second using the tear substitute Polyfresh ®given just before the ROP screening.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A dedicated clinical pharmacist placed the topical benoxinate HCL (Benox ®, Removed for facilitating the blinded review). and the artificial tear (Sodium Hyaluronate 2 mg/ml) eye drops (Polyfresh ®, Removed for facilitating the blinded review) in identical bottles, each of them had a code that was changed every clinic and was not known to the examining ophthalmologist, the nurse in charge of swaddling the baby and putting the drops or the attending neonatologist monitoring the infant and recording the PIPP score. The clinical pharmacist would ensure that crossover was performed in the second examination of every study child.
Intervention model description
Prospective, observational, double-blinded, cross-over
Eligibility
Sex/Gender
ALL
Age
28 Days to 90 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PIPP score | 1-3 month after birth | The PIPP is a composite measure that includes seven indicators, each of which is rated on a four-point scale (0-3). The indicators include heart rate, oxygen saturation, GA, brow bulge, nasolabial furrow, behavioural state, and eye squeeze. Larger number indicates more stress (worse outcome) |
Countries
Egypt
Outcome results
None listed