NCT03650621: MAGNIFIC-ROP

Acupuncture for Preterm Infants Requiring Eye-exam

Completed NA Last updated 19 September 2024

What this trial tests

NA trial testing Magnetic acupuncture in Retinopathy of Prematurity in 100 participants. Completed in 30 April 2020.

Timeline

24 August 2018

Primary endpoint
30 September 2019

30 April 2020

Quick facts

Lead sponsor	University of Alberta
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	100
Start date	24 August 2018
Primary completion	30 September 2019
Estimated completion	30 April 2020
Sites	3 locations across Canada, Australia, Malaysia

Drugs / interventions tested

• Magnetic acupuncture
• stickers (magnets removed)

Conditions studied

• Retinopathy of Prematurity — all drugs for Retinopathy of Prematurity →
• Pain — all drugs for Pain →
• Acupuncture — all drugs for Acupuncture →
• Premature Infant — all drugs for Premature Infant →

Sponsor

University of Alberta

Who can join

Adults 29 Weeks to 36 Weeks, any sex, with Retinopathy of Prematurity or Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Magnetic Non-invasive Auricular Acupuncture During Eye-Exam for Retinopathy of Prematurity in Preterm Infants: A Multicentre Randomized Controlled Trial.
   Gan KML, Oei JL, Quah-Smith I, Kamar AA, et al · · 2020 · cited 12× · PMID 33425820 · DOI 10.3389/fped.2020.615008
2. Literature Watch.
   Litscher G. · · 2021 · PMID 35003489 · DOI 10.1089/acu.2021.29167.lit