Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000773235
Ethics application status
Approved
Date submitted
30/04/2018
Date registered
8/05/2018
Date last updated
8/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Studying the effect of retinopathy of prematurity screening on cerebral and gut regional oxygenation.
Scientific title
Effect of Retinopathy Of Prematurity screening on cerebral and somatic (splanchnic) regional oxygenation and cardiovascular stability in neonates (ROP-Ox)
Secondary ID [1] 294745 0
HDEC 18/NTB/10
Universal Trial Number (UTN)
U1111-1213-1086
Trial acronym
ROP-Ox (Retinopathy Of Prematurity regional Oxygenation)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prematurity 307637 0
Retinopathy of Prematurity 307638 0
Condition category
Condition code
Eye 306703 306703 0 0
Diseases / disorders of the eye
Reproductive Health and Childbirth 306704 306704 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Inclusion and exclusion criteria:

Infants will be considered for recruitment into the study if they meet the criteria for screening for ROP

Study methods:
This is an observational study. The decision to screen a neonate for retinopathy of prematurity is based on evidence-based local guidelines.

Informed parental consent will be obtained in all cases prior to data collection.

Once the parental consent is obtained, following data will be collected as part of this study:

Patient characteristics:
• Gestational age
• Postnatal age
• Ethnicity
• Sex
• Birth weight (customized centile)
• Weight at time of ROP screening
• Respiratory support required at time of examination
• Caffeine treatment


Cerebral and gastrointestinal (splanchnic) oxygenation levels will be measured for 1hrs pre-, during and for 3 hours post Retinopathy of Prematurity screening.

Multi-site NIRS system (Nonin SenSmartTM Model X-100) with non-adhesive regional oximetry sensors will be used (EQUANOX Advanced 9004CB-NA Paediatric/Neonatal). The Paediatric/Neonatal sensors have the advantage of having a completely flat surface to avoid pressure-related injury on fragile skin of infants. They will be attached to infants using soft elastic bandages or a Tegaderm, which are routinely used in clinical practice.

The sensors will be positioned using a standard template to minimise inter-observer variability in sensor placement. The following organ systems will be studied:

Brain: Left fronto-parietal area of infant’s head. Two lateral LED emitters should avoid the midline (to avoid interference by the sagittal sinus) and hair.

Somatic (splanchnic bed): Anterior abdominal wall in the midline 2cm below the umbilicus

Cardiorespiratory stability
1. Heart rate and peripheral arterial saturation will be recorded using a pulse oximeter for 1 hour prior to retinopathy screening, during instillation if eye drops, during ophthalmic examination and for 3 hours post examination.
2. Non-invasive, intermittent blood pressure monitoring will be performed using a neonatal blood pressure cuffs for prior to retinopathy screening, after instillation of eye drops, and after eye examination.
3. Ultrasound doppler will be used to measure abdominal blood flow velocities in the coeliac trunk.

Position of infants
Infants will be placed supine during data collection unless medically indicated for them to lie in other positions (sleep position of infants will be recorded as part of study). This is because sleep position is known to affect parameters of cardiorespiratory stability.
Intervention code [1] 301047 0
Early Detection / Screening
Comparator / control treatment
All trial entrants will be monitored according to the trial protocol prior to, during, and after retinopathy of prematurity screening. Each case is therefore its own control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305707 0
cerebral regional oxygenation as assessed by near-infrared spectroscopy.

The regional oxygenation will be measured by a Multi-site NIRS system (Nonin SenSmartTM Model X-100) with non-adhesive regional oximetry sensors (EQUANOX Advanced 9004CB-NA Paediatric/Neonatal)
Timepoint [1] 305707 0
Measurement will commence 1 hour prior to the instillation of eye drops, during retinopathy of prematurity screening, and for 3 hours post screening. total measurement time is approx. 5 hours.
Primary outcome [2] 305794 0
gastrointestinal regional oxygenation as assessed by near-infrared spectroscopy.

The regional oxygenation will be measured by a Multi-site NIRS system (Nonin SenSmartTM Model X-100) with non-adhesive regional oximetry sensors (EQUANOX Advanced 9004CB-NA Paediatric/Neonatal)
Timepoint [2] 305794 0
Measurement will commence 1 hour prior to the instillation of eye drops, during retinopathy of prematurity screening, and for 3 hours post screening. total measurement time is approx. 5 hours.
Secondary outcome [1] 346209 0
Peripheral arterial oxygen saturation

peripheral arterial saturation will be recorded using a pulse oximeter. Multi-site NIRS system (Nonin SenSmartTM Model X-100) with pulse oximeter.
Timepoint [1] 346209 0
Measurement will commence 1 hour prior to instillation of eye drops and continue until 3 hours post completion of screening. Total measurement time is approx. 5 hours.
Secondary outcome [2] 346277 0
Abdominal blood flow velocities as measured by Doppler of the coeliac trunk

Ultrasound doppler will be used to measure abdominal blood flow velocities in the coeliac trunk.
Timepoint [2] 346277 0
30 mins prior to eye drops, 30 mins post eye drops, and 1 hour post ROP screening.
Secondary outcome [3] 346571 0
Heart Rate

Heart rate will be recorded using a pulse oximeter. Multi-site NIRS system (Nonin SenSmartTM Model X-100) with pulse oximeter.
Timepoint [3] 346571 0
Measurement will commence 1 hour prior to instillation of eye drops and continue until 3 hours post completion of screening. Total measurement time is approx. 5 hours.
Secondary outcome [4] 346572 0
Peripheral Blood pressure

Peripheral blood pressure will be measured using a Philips #2 soft neonatal blood pressure cuff with Philips Intellivue X2 monitor
Timepoint [4] 346572 0
30 mins prior to eye drops, 30 mins post eye drops, and 1 hour post ROP screening.

Eligibility
Key inclusion criteria
Infants will be considered for recruitment into the study if they meet the criteria for screening for ROP

Eye checks are performed on

• All infants <1301 grams birth weight and all infants <31 weeks gestation at birth. [one criteria only needs to be met]
• Infants >1300 grams and >31 weeks will be referred for ROP screening only if the clinical course has been unstable and the infant is felt to be at high risk for ROP e.g. an infant who has required high Heart Rate and concentrations of oxygen

Timing of the first examination

• Infants, 27 weeks at birth [i.e. up to 26+6] : first exam at 30-31 weeks post menstrual age
• Infants 27 weeks or beyond: first exam at 4-5 weeks [29-35 days ] post natal age
Minimum age
No limit
Maximum age
2 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If the clinicians caring for the baby consider that participation in the trial would be detrimental to the neonate or compromise the care being provided to the neonate then the patient would not be considered eligible.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Power analysis: We calculated that a sample size of at least 30 infants is required to detect a significant increase of 10% in somatic regional oxygenation 24hrs post transfusion with 80% power using p-value of 0.05 and the margin of error of +/- 4%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
24/04/2018
Date of last participant enrolment
Anticipated
27/11/2018
Actual
Date of last data collection
Anticipated
30/11/2018
Actual
Sample size
Target
30
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 10358 0
New Zealand
State/province [1] 10358 0
Wellington

Funding & Sponsors
Funding source category [1] 299351 0
Charities/Societies/Foundations
Name [1] 299351 0
Neonatal Trust
Country [1] 299351 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
23 Mein St, Newtown, Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 298627 0
Hospital
Name [1] 298627 0
Wellington Regional Hospital Neonatal Unit
Address [1] 298627 0
Neonatal Intensive Care Unit, Level 4, Wellington Hospital, Riddiford Street, Newtown, Wellington, New Zealand, 6021
Country [1] 298627 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300256 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 300256 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 300256 0
New Zealand
Date submitted for ethics approval [1] 300256 0
10/01/2018
Approval date [1] 300256 0
20/02/2018
Ethics approval number [1] 300256 0
18/NTB/10
Ethics committee name [2] 300257 0
Research Advisory Group Maori
Ethics committee address [2] 300257 0
Wellington Hospital, Riddiford Street, Newtown, Wellington, New Zealand, 6021
Ethics committee country [2] 300257 0
New Zealand
Date submitted for ethics approval [2] 300257 0
26/01/2018
Approval date [2] 300257 0
04/04/2018
Ethics approval number [2] 300257 0
#589

Summary
Brief summary
Retinopathy of Prematurity (ROP) is the abnormal development of blood vessels in the eye. ROP can occur in premature babies, mainly affecting those born before 31 weeks gestation or with a birthweight under 1300 grams. Not all of these babies will be affected but all at risk babies are routinely checked by an ophthalmologist whilst still in the neonatal unit.
The retina lines the inside of the eye. It receives rays of light and sends images to the brain where they are converted into what we see. As the eye develops, tiny blood vessels grow throughout the retina. The blood vessels start developing at 16 weeks of pregnancy and complete growing approximately one month after birth.

With ROP, these blood vessels may grow in the wrong direction or stop growing too early. The blood vessels are very fragile and there is a high risk of blood leaking from them. This bleeding can result in scarring and damage to the retina. If there are abnormal blood vessels they can be effectively treated with lasers which is why screening is so important.

Baby’s eyes will be examined by a specialist eye doctor known as an ophthalmologist. In order for the ophthalmologist to be able to properly examine the retina, eye drops are needed to enlarge the pupils. These drops are given approximately one hour before the screening.

The screening for ROP can result in some babies showing signs of stress. There is also some evidence that ROP screening can cause disruption to a baby’s ability to handle feeds for a short period and may make them more vulnerable to developing infections related to the gastrointestinal tract. For this reason, feeding is paused at the time of screening.

This study aims to better understand the underlying changes that lead to these effects and determine whether they are related to changes in blood flow to the gastrointestinal tract. This study further seeks to identify during which stage of the ROP screening process these changes occur and whether it is related to the eye drops used in the screening process.

The early detection of ROP is vital in protecting the future vision of premature neonates. This study aims to contribute to ensuring that the screening process is as safe as possible.

This study measure physiological parameters (heart rate, blood pressure, pulse oximetry) as well as regional oxygenation using near-infrared spectroscopy and coeliac ultrasound dopplers.. These measurements are taken before, during, and for 3 hours after screening.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2648 2648 0 0
/AnzctrAttachments/375003-HDEC Letter - 18NTB10 - Approved Full Application with NSC.pdf (Ethics approval)
Attachments [2] 2649 2649 0 0
/AnzctrAttachments/375003-#589 - Endorsement Letter.pdf (Ethics approval)
Attachments [3] 2650 2650 0 0
/AnzctrAttachments/375003-Protocol_V2.docx (Protocol)
Attachments [4] 2651 2651 0 0
/AnzctrAttachments/375003-ROP study information sheet V2.docx (Participant information/consent)

Contacts
Principal investigator
Name 83070 0
Dr Angus Goodson
Address 83070 0
Neonatal Intensive Care Unit, Level 4, Wellington Hospital, Riddiford Street, Newtown, Wellington, New Zealand, 6021
Country 83070 0
New Zealand
Phone 83070 0
+64211998263
Fax 83070 0
Email 83070 0
[email protected]
Contact person for public queries
Name 83071 0
Dr Angus Goodson
Address 83071 0
Neonatal Intensive Care Unit, Level 4, Wellington Hospital, Riddiford Street, Newtown, Wellington, 6021
Country 83071 0
New Zealand
Phone 83071 0
+64211998263
Fax 83071 0
Email 83071 0
[email protected]
Contact person for scientific queries
Name 83072 0
Dr Angus Goodson
Address 83072 0
Neonatal Intensive Care Unit, Level 4, Wellington Hospital, Riddiford Street, Newtown, Wellington, 6021
Country 83072 0
New Zealand
Phone 83072 0
+64211998263
Fax 83072 0
Email 83072 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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