PretermPhase 4NCT05666362
Hemodynamic Response to Pain During Retinopathy Of Prematurity Screening
A Phase 4 study testing benoxinate hydrochloride 0.4% group and saline 0.9% . in people with Preterm, run by Alexandria University at 1 site in Egypt.
Trial summary
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 … Read more about this study
- Who is it for?
- Ages 4 to 12 weeks
- Conditions the study is for
- Preterm
- What is being tested?
- benoxinate hydrochloride 0.4% group and saline 0.9% .
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2023to 15 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Response Of Premature Brain To Pain During Retinopathy Of Prematurity Screening: A Randomized Controlled Trial
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.
- Conditions
- Preterm
- Being tested
- benoxinate hydrochloride 0.4% group, saline 0.9% .
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benoxinate hydrochloride 0.4% groupDrug
They will receive benoxinate hydrochloride 0.4% immediately before fundus
saline 0.9% .Drug
They will receive saline 0.9% before fundus examination in each eye .
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : ( benoxinate hydrochloride 0.4% group ) | Active comparator | They will receive benoxinate hydrochloride 0.4% immediately before fundus examination . Receives: Drug: benoxinate hydrochloride 0.4% group |
| 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. Receives: Drug: saline 0.9% . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start20 Jan 2023
- Primary completion20 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Farag, Alexandria University
- Investigators
- Shimaa Hafez, MBChB, Principal investigator, Faculty of medicine, Alexandria University, EgyptHesham Ghazal, PhD, Study director, Faculty of medicine, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666362
- Sponsor's protocol ID
- 0107389
- Status last verified
- Feb 2025
- First submitted
- 17 Dec 2022
- Last updated
- 5 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Response Of Premature Brain To Pain During Retinopathy Of Prematurity Screening: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05666362
- Acronym / sponsor ID
- 0107389
- Conditions
- Preterm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : ( benoxinate hydrochloride 0.4% group ) | Active comparator | Drug: benoxinate hydrochloride 0.4% groupThey will receive benoxinate hydrochloride 0.4% immediately before fundus examination . |
| Group 2 : ( control group ) | Placebo comparator | Drug: saline 0.9% .They will receive saline drops instead of benoxinate hydrochloride 0.4%. Randomization: simple randomization sampling using sealed envelope technique. |
Who may qualify
- Ages
- 4 to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- Evidence of intrauterine infection (TORCH).
- Chromosomal abnormalities.
- Major congenital anomalies.
- Major brain pathology such as Grade 3-4 intraventricular hemorrhage and periventricular leukomalacia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| benoxinate hydrochloride 0.4% groupThey will receive benoxinate hydrochloride 0.4% immediately before fundus | Drug | Group 1 : ( benoxinate hydrochloride 0.4% group ) |
| saline 0.9% .They will receive saline 0.9% before fundus examination in each eye . | Drug | Group 2 : ( control group ) |
Primary outcome
1-Clinical assessment:
Time frame: 28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)
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).
2-Near-infrared spectroscopy (NIRS):
Time frame: 28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shimaa Hafez, MBChB principal investigator
Faculty of medicine, Alexandria University, Egypt
Hesham Ghazal, PhD study director
Faculty of medicine, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing benoxinate hydrochloride 0.4% group and saline 0.9% . in people with Preterm, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Clinical assessment: (time frame: 28 days postnatal age (time of screen of retinopathy of prematurity ,ROP)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.