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Magnetic Non-Invasive Acupuncture For Infant Comfort A Pilot Study in Preterm Infants Requiring Eye-exam for Retinopathy of Prematurity (MAGNIFIC-ROP)

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ClinicalTrials.gov Identifier: NCT03650621
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
University of Alberta

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.


Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Pain Acupuncture Premature Infant Device: Magnetic acupuncture Device: stickers (magnets removed) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: this is a two arm parallel design randomized controlled trial with 3 sites recruiting infants at a (40 infants in Edmonton, 40 infants in Sydney, and10 infants Nijmegen)
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: patients are preterm infants and therefore mask, care provider will balsa masked as well as outcome assessor.
Primary Purpose: Treatment
Official Title: Magnetic Non-Invasive Acupuncture For Infant Comfort A Pilot Study in Preterm Infants Requiring Eye-exam for Retinopathy of Prematurity
Actual Study Start Date : August 24, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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

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

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




Primary Outcome Measures :
  1. Changes in Premature Infant Pain Profile (PIPP) scores [ Time Frame: Comparison of baseline (= 1 hour before eye-exam) and after eye-exam (1 hour after) ]
    Mean pain scores on the Premature Infant Pain Profile (PIPP) scores


Secondary Outcome Measures :
  1. Heart rate changes [ Time Frame: changes in heart rate in beats per minute 1 hour before and 1 hour after eye-exam ]
    During eye-exam - which will take 5min (comparison between baseline before eye-exam and mean value during eye-exam)

  2. Changes in oxygen saturation [ Time Frame: changes in oxygen saturation in % 1 hour before and 1 hour after eye-exam ]
    During eye-exam - which will take 5min (comparison between baseline before eye-exam and mean value during eye-exam)

  3. changes in cerebral oxygenation [ Time Frame: changes in cerebral oxygenation % 1 hour before and 1 hour after eye-exam ]
    During eye-exam - which will take 5min (comparison between baseline before eye-exam and mean value during eye-exam)



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Ages Eligible for Study:   29 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650621


Contacts
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Contact: Georg Schmolzer, MD, PhD 7807354647 georg.schmoelzer@me.com
Contact: Sylvia van Os 7807354647 Sylvia.Vanos@albertahealthservices.ca

Locations
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Australia, New South Wales
University of Sydney Recruiting
Sydney, New South Wales, Australia
Contact: Ju-Lee OEI       j.oei@unsw.edu.au   
Principal Investigator: Ju-Lee OEI, MD, PhD         
Canada, Alberta
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Georg SCHMOLZER    7807354660    georg.schmoelzer@me.com   
Principal Investigator: Georg Schmolzer         
Sub-Investigator: Sylvia van Os         
Sub-Investigator: Caroline Fray         
Sub-Investigator: Avneet Mangat         
Netherlands
Radboudumc Nijmegen Not yet recruiting
Nijmegen, Netherlands
Contact: Djien Liem       Djien.Liem@radboudumc.nl   
Principal Investigator: Djien Liem, MD         
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Georg Schmolzer, MD, PhD University of Alberta

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03650621     History of Changes
Other Study ID Numbers: Pro00080714
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: once study has been completed
Access Criteria: email to PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Diseases
Retinopathy of Prematurity
Premature Birth
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases