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
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:
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|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.|
|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|
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
- 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
- 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)
- 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)
- 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)
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
|Contact: Georg Schmolzer, MD, PhDfirstname.lastname@example.org|
|Contact: Sylvia van Os||7807354647||Sylvia.Vanos@albertahealthservices.ca|
|Australia, New South Wales|
|University of Sydney||Recruiting|
|Sydney, New South Wales, Australia|
|Contact: Ju-Lee OEI email@example.com|
|Principal Investigator: Ju-Lee OEI, MD, PhD|
|Royal Alexandra Hospital||Recruiting|
|Edmonton, Alberta, Canada, T5H 3V9|
|Contact: Georg SCHMOLZER 7807354660 firstname.lastname@example.org|
|Principal Investigator: Georg Schmolzer|
|Sub-Investigator: Sylvia van Os|
|Sub-Investigator: Caroline Fray|
|Sub-Investigator: Avneet Mangat|
|Radboudumc Nijmegen||Not yet recruiting|
|Contact: Djien Liem Djien.Liem@radboudumc.nl|
|Principal Investigator: Djien Liem, MD|
|Principal Investigator:||Georg Schmolzer, MD, PhD||University of Alberta|