ANZCTR - Registration

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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]

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

Retinopathy of Prematurity

Condition category

Condition code

Eye

Diseases / disorders of the eye

Reproductive Health and Childbirth

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]

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]

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]

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]

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]

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]

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]

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]

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]

30 mins prior to eye drops, 30 mins post eye drops, and 1 hour post ROP screening.

Secondary outcome [3]

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]

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]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Wellington

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Neonatal Trust

Address [1]

Neonatal Intensive Care Unit, Level 4, Wellington Hospital, Riddiford Street, Newtown, Wellington, New Zealand, 6021

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago

Address

23 Mein St, Newtown, Wellington 6242

Country

New Zealand

Secondary sponsor category [1]

Hospital

Name [1]

Wellington Regional Hospital Neonatal Unit

Address [1]

Neonatal Intensive Care Unit, Level 4, Wellington Hospital, Riddiford Street, Newtown, Wellington, New Zealand, 6021

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern B Health and Disability Ethics Committee

Ethics committee address [1]

Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

10/01/2018

Approval date [1]

20/02/2018

Ethics approval number [1]

18/NTB/10

Ethics committee name [2]

Research Advisory Group Maori

Ethics committee address [2]

Wellington Hospital, Riddiford Street, Newtown, Wellington, New Zealand, 6021

Ethics committee country [2]

New Zealand

Date submitted for ethics approval [2]

26/01/2018

Approval date [2]

04/04/2018

Ethics approval number [2]

#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]

/AnzctrAttachments/375003-HDEC Letter - 18NTB10 - Approved Full Application with NSC.pdf (Ethics approval)

Attachments [2]

/AnzctrAttachments/375003-#589 - Endorsement Letter.pdf (Ethics approval)

Attachments [3]

/AnzctrAttachments/375003-Protocol_V2.docx (Protocol)

Attachments [4]

/AnzctrAttachments/375003-ROP study information sheet V2.docx (Participant information/consent)

Contacts

Principal investigator

Name

Dr Angus Goodson

Address

Neonatal Intensive Care Unit, Level 4, Wellington Hospital, Riddiford Street, Newtown, Wellington, New Zealand, 6021

Country

New Zealand

Phone

+64211998263

Fax

angus.goodson@ccdhb.org.nz

Contact person for public queries

Name

Angus Goodson

Address

Neonatal Intensive Care Unit, Level 4, Wellington Hospital, Riddiford Street, Newtown, Wellington, 6021

Country

New Zealand

Phone

+64211998263

Fax

angus.goodson@ccdhb.org.nz

Contact person for scientific queries

Name

Angus Goodson

Address

Neonatal Intensive Care Unit, Level 4, Wellington Hospital, Riddiford Street, Newtown, Wellington, 6021

Country

New Zealand

Phone

+64211998263

Fax

angus.goodson@ccdhb.org.nz

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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