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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03650621




Registration number
NCT03650621
Ethics application status
Date submitted
26/06/2018
Date registered
29/08/2018
Date last updated
15/04/2019

Titles & IDs
Public title
Magnetic Non-Invasive Acupuncture For Infant Comfort A Pilot Study in Preterm Infants Requiring Eye-exam for Retinopathy of Prematurity
Scientific title
Magnetic Non-Invasive Acupuncture For Infant Comfort A Pilot Study in Preterm Infants Requiring Eye-exam for Retinopathy of Prematurity
Secondary ID [1] 0 0
Pro00080714
Universal Trial Number (UTN)
Trial acronym
MAGNIFIC-ROP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinopathy of Prematurity 0 0
Pain 0 0
Acupuncture 0 0
Premature Infant 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Magnetic acupuncture
Treatment: Devices - stickers (magnets removed)

Experimental: Intervention - Magnetic acupuncture - Infants randomized to the intervention arm will have 5 magnetic stickers placed on both ears approximately 1 hour before the eye-exam and will stay in place for approximately 1 hour after the eye-exam.
Total duration of study 2.5-3 hours

Placebo Comparator: Control - Placebo control - In this arm the infants will have 5 stickers (magnets removed) placed on their ear approximately 1 hour before the eye-exam and will stay in place for approximately 1 hour after the eye-exam.
Total duration of study 2.5-3 hours


Treatment: Devices: Magnetic acupuncture
5 magnetic acupuncture stickers will be placed on the infants ear

Treatment: Devices: stickers (magnets removed)
in this group 5 stickers (magnets removed) will be placed on the infants ear

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in Premature Infant Pain Profile (PIPP) scores - Mean pain scores on the Premature Infant Pain Profile (PIPP) scores
Timepoint [1] 0 0
Comparison of baseline (= 1 hour before eye-exam) and after eye-exam (1 hour after)
Secondary outcome [1] 0 0
Heart rate changes - During eye-exam - which will take 5min (comparison between baseline before eye-exam and mean value during eye-exam)
Timepoint [1] 0 0
changes in heart rate in beats per minute 1 hour before and 1 hour after eye-exam
Secondary outcome [2] 0 0
Changes in oxygen saturation - During eye-exam - which will take 5min (comparison between baseline before eye-exam and mean value during eye-exam)
Timepoint [2] 0 0
changes in oxygen saturation in % 1 hour before and 1 hour after eye-exam
Secondary outcome [3] 0 0
changes in cerebral oxygenation - During eye-exam - which will take 5min (comparison between baseline before eye-exam and mean value during eye-exam)
Timepoint [3] 0 0
changes in cerebral oxygenation % 1 hour before and 1 hour after eye-exam

Eligibility
Key inclusion criteria
- Infants weighing less than 1250g at birth admitted into the NICU at the Royal
Alexandra Hospital will require routine,regularly scheduled ROP eye-exams beginning at
32 weeks corrected age. We will not enroll any infant who meets any exclusion
criteria.
Minimum age
29 Weeks
Maximum age
36 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Chronic pain stimuli (e.g. infants who have had recent surgery)

2. Neurological problems that could impair pain perception (e.g. diagnosis of
intraventricular hemorrhages Grade III or greater)

3. Cardiorespiratory problems that could impair oxygenation (e.g. any infant who is
intubated and requiring mechanical ventilation)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Netherlands
State/province [2] 0 0
Nijmegen

Funding & Sponsors
Primary sponsor type
Other
Name
University of Alberta
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose is to investigate whether non-invasive acupuncture - NIA (i.e. acupuncture
without needles) will help reduce pain for babies in the Neonatal Intensive Care Unit (NICU)
during their routine weekly eye-exam for Retinopathy of prematurity. Retinopathy of
prematurity (ROP) is an eye disease most commonly affecting premature babies born weighing
less than 1250 grams. Retinopathy of prematurity occurs because these premature babies
require oxygen because of their immature lungs. The oxygen then stimulates the growth of
blood vessels in the retina, causing the retina to be detached from the eye, which causes
vision impairment.

To examine if the vessels grow at the back of the eye, an eye-doctor visits bi-weekly once
the baby is 32 weeks corrected age to assess if the blood vessels change. If there is a lot
of growth, the eye-doctor would use a laser to treat the eye to prevent further growth.

During the bi-weekly eye-exam, the premature infant receives sucrose (a type of sugar) for
pain management. The investigator will assess pain a premature babies experience during this
exam and found that there are extremely high scores of pain despite sucrose and the
investigator believe this pain and stress caused by these procedures could be reduced by
adding:

Magnetic Acupuncture

Also, untreated pain causes stress (lower oxygen levels, higher heart rates), discomfort and
poorer long term outcomes.

Finding the best treatment and prevention for the pain caused by procedures in the NICU is
therefore extremely important for any baby.
Trial website
https://clinicaltrials.gov/show/NCT03650621
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Georg Schmolzer, MD, PhD
Address 0 0
University of Alberta
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Georg Schmolzer, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
7807354647
Fax 0 0
Email 0 0
georg.schmoelzer@me.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03650621