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Acupuncture for Preterm Infants Requiring Eye-exam

NCT03650621 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Retinopathy of Prematurity
  • Pain
  • Acupuncture
  • Premature Infant

Interventions

DEVICE

Magnetic acupuncture

5 magnetic acupuncture stickers will be placed on the infants ear

DEVICE

stickers (magnets removed)

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

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Georg Schmolzer, MD, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
29 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-24
Primary Completion
2019-09-30
Completion
2020-04-30

Countries

  • Australia
  • Canada
  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03650621 on ClinicalTrials.gov