Acupuncture for Preterm Infants Requiring Eye-exam

NCT03650621 | Completed

• 1 other identifier: Pro00080714
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 3

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.

Conditions

Retinopathy of Prematurity; Pain; Acupuncture; Premature Infant

Outcome Measures

Primary Outcomes (1)

• Changes in Premature Infant Pain Profile (PIPP) scores

  Mean pain scores on the Premature Infant Pain Profile (PIPP) scores

  Comparison of baseline (= 1 hour before eye-exam) and after eye-exam (1 hour after)

Secondary Outcomes (3)

• Heart rate changes

  changes in heart rate in beats per minute 1 hour before and 1 hour after eye-exam

• Changes in oxygen saturation

  changes in oxygen saturation in % 1 hour before and 1 hour after eye-exam

• changes in cerebral oxygenation

  changes in cerebral oxygenation % 1 hour before and 1 hour after eye-exam

Study Arms (2)

Intervention - Magnetic acupuncture

EXPERIMENTAL

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

Control - Placebo control

PLACEBO COMPARATOR

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)

Interventions

Magnetic acupuncture DEVICE

5 magnetic acupuncture stickers will be placed on the infants ear

Intervention - Magnetic acupuncture

stickers (magnets removed) DEVICE

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

Control - Placebo control

Eligibility Criteria

• Age: 29 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Chronic pain stimuli (e.g. infants who have had recent surgery)
• Neurological problems that could impair pain perception (e.g. diagnosis of intraventricular hemorrhages Grade III or greater)
• Cardiorespiratory problems that could impair oxygenation (e.g. any infant who is intubated and requiring mechanical ventilation)

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (3)

University of Sydney

Sydney, New South Wales, Australia

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

University of Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Related Publications (1)

• Gan KML, Oei JL, Quah-Smith I, Kamar AA, Lordudass AAD, Liem KD, Lindrea KB, Daly M, Gaunker N, Mangat AK, Yaskina M, Schmolzer GM. Magnetic Non-invasive Auricular Acupuncture During Eye-Exam for Retinopathy of Prematurity in Preterm Infants: A Multicentre Randomized Controlled Trial. Front Pediatr. 2020 Dec 23;8:615008. doi: 10.3389/fped.2020.615008. eCollection 2020.

  PMID: 33425820 DERIVED

MeSH Terms

Conditions

Retinopathy of Prematurity; Pain; Premature Birth

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Georg Schmolzer, MD, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: patients are preterm infants and therefore mask, health care providers will be masked as well as outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: this is a 2-arm parallel design randomized controlled trial with 3 sites recruiting infants

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: August 29, 2018
• Study Start: August 24, 2018
• Primary Completion: September 30, 2019
• Study Completion: April 30, 2020
• Last Updated: September 19, 2024

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: once study has been completed
• Access Criteria: email to PI

Locations

AU (1); MY (1); CA (1)