Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001115628p
Ethics application status
Not yet submitted
Date submitted
24/09/2023
Date registered
25/10/2023
Date last updated
25/10/2023
Date data sharing statement initially provided
25/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Small drop administration of phenylephrine and cyclopentolate for retinopathy of prematurity eye examinations in preterm infants
Scientific title
Pilot randomised controlled trial for small drop administration device in preterm infants for retinopathy of prematurity eye examinations
Secondary ID [1] 310671 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Nano-ROP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinopathy of Prematurity 331582 0
Condition category
Condition code
Eye 328311 328311 0 0
Diseases / disorders of the eye
Reproductive Health and Childbirth 328497 328497 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention type: Silicone Device 2
Intervention description: A silicone tip will be attached to the top of eye drop bottle. Neonatal nursing staff will administer phenylephrine 1% and cyclopentolate 0.2% eye drops to preterm infants to prepare the eye for retinopathy of prematurity eye examinations. One set of eye drops will be administered 30 to 45 min before the eye examination. Up to two more doses can be administered (15 to 20 min apart) if needed, at the request of the ophthalmologist. Administration of eye drops will be recorded to confirm dose administration.
Intervention code [1] 327077 0
Diagnosis / Prognosis
Intervention code [2] 327186 0
Treatment: Devices
Comparator / control treatment
Trial Group A label: Plastic Device 1. Type: Active comparator.
Description: Neonatal nursing staff will attach the plastic casing from a 24-gauge needle (with needle removed) to the end of a 1mL syringe. Neonatal nursing staff will administer phenylephrine 1% and cyclopentolate 0.2% eye drops to preterm infants to prepare the eye for retinopathy of prematurity eye examinations. One set of eye drops will be administered 30 to 45 min before the eye examination. Up to two more doses can be administered (15 to 20 min apart) if needed, at the request of the ophthalmologist. Administration of eye drops will be recorded to confirm dose administration.
Control group
Active

Outcomes
Primary outcome [1] 336158 0
Successful retinopathy of prematurity eye examination
Timepoint [1] 336158 0
Immediately following eye examination
Secondary outcome [1] 427165 0
Nursing staff acceptability of device
Timepoint [1] 427165 0
During eye drop administration
Secondary outcome [2] 427166 0
Time to prepare and administer eye drops
Timepoint [2] 427166 0
During eye drop administration
Secondary outcome [3] 427167 0
Ophthalmologist rated ease of retinopathy of prematurity eye examination
Timepoint [3] 427167 0
Immediately following eye examination
Secondary outcome [4] 427168 0
Time for Ophthalmologist to perform the retinopathy of prematurity eye examination
Timepoint [4] 427168 0
At the time of the eye examination
Secondary outcome [5] 427169 0
Phenylephrine and cyclopentolate safety monitoring
Timepoint [5] 427169 0
Immediately after instillation of eye drops and until one week after eye examination
Secondary outcome [6] 427170 0
Whanau acceptability of device
Timepoint [6] 427170 0
Within one week of the eye examination

Eligibility
Key inclusion criteria
All preterm infants that meet the Dunedin Hospital Neonatal Intensive Care Unit ROP screening criteria (e.g., 30+6 weeks gestational age and / or 1250 g birth weight) in keeping with national guidelines.
Minimum age
23 Weeks
Maximum age
40 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Preterm infants who do not meet the inclusion criteria for ROPEE.
Preterm infants who are contraindicated to phenylephrine and / or cyclopentolate.
Preterm infants who have an eye infection.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of device will occur off site and by a member of the research team (DR) who is not part of data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will occur by computerised central randomisation. This will occur for ethnicity to ensure four Maori participants are randomised to each group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/11/2023
Actual
Date of last participant enrolment
Anticipated
29/02/2024
Actual
Date of last data collection
Anticipated
7/03/2024
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment outside Australia
Country [1] 25783 0
New Zealand
State/province [1] 25783 0
Otago

Funding & Sponsors
Funding source category [1] 315090 0
University
Name [1] 315090 0
University of Otago
Country [1] 315090 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
18 Frederick Street, Dunedin, 9016
Country
New Zealand
Secondary sponsor category [1] 316895 0
None
Name [1] 316895 0
Address [1] 316895 0
Country [1] 316895 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 313887 0
Health and Disability Ethics Committee
Ethics committee address [1] 313887 0
Ministry of Health Health and Disability Ethics Committees, 133 Molesworth Street, Thorndon, Wellington, New Zealand, 6011
Ethics committee country [1] 313887 0
New Zealand
Date submitted for ethics approval [1] 313887 0
03/11/2023
Approval date [1] 313887 0
Ethics approval number [1] 313887 0

Summary
Brief summary
To date, there has not been an evaluation of a suitable device to administer microdoses to preterm infants. The nanodrop eye drop device has been evaluated in adults and children, but not yet evaluated in preterm infants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129678 0
Dr Lisa Kremer
Address 129678 0
School of Pharmacy, University of Otago, 18 Frederick St, Dunedin, Otago, 9016
Country 129678 0
New Zealand
Phone 129678 0
+64 34797964
Fax 129678 0
Email 129678 0
lisa.kremer@otago.ac.nz
Contact person for public queries
Name 129679 0
Dr Lisa Kremer
Address 129679 0
School of Pharmacy, University of Otago, 18 Frederick St, Dunedin, 9016
Country 129679 0
New Zealand
Phone 129679 0
+64 34797275
Fax 129679 0
Email 129679 0
lisa.kremer@otago.ac.nz
Contact person for scientific queries
Name 129680 0
Dr Lisa Kremer
Address 129680 0
School of Pharmacy, University of Otago, 18 Frederick St, Dunedin, 9016
Country 129680 0
New Zealand
Phone 129680 0
+64 34797275
Fax 129680 0
Email 129680 0
lisa.kremer@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.