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

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Brief Title

Acupuncture for Preterm Infants Requiring Eye-exam

Official Title

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

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.
    

Detailed Description

      Background: Infants in neonatal intensive care units (NICU) may experience as many as 14
      painful and stressful procedures every day. Even common and seemingly innocuous procedures
      like routine eye exams can cause relatively severe pain that is only marginally alleviated by
      powerful analgesics like morphine. Infants subject to severe and repeated episodes of pain
      are at risk of immediate and long-term sequelae, including intraventricular hemorrhage,
      impaired neurodevelopment, poor postnatal growth, cognitive and motor dysfunction and
      emotional dysregulation. Pharmacological analgesia is often used in the NICU to either
      prevent or alleviate procedural pain but none are completely effective and almost all have
      potentially detrimental side-effects. Non-pharmacological measures (e.g., kangaroo care and
      breastfeeding) are also used but these methods may not be feasible in very sick infants or if
      pain is extremely severe. Methods to provide safe and effective analgesia for babies in the
      NICU are therefore needed. Acupuncture has been used for thousands of years to prevent and
      treat pain and various health conditions. There are many forms of acupuncture, including
      needling, electrical currents, laser, and pressure, all of which aim to modulate activity of
      key nociceptive structures, neurotransmitter secretions and parasympathetic function. The
      investigator have reported about the safety and efficacy of auricular magnetic acupuncture
      (MA) in the NICU environment during heel pricks or neonatal withdrawal. One of the most
      common and painful procedure preterm infants experience during their NICU stay is their
      weekly eye-exam to assess for Retinopathy of Prematurity. Currently, during the eye exam
      infants receive sucrose for analgesia, which has very limited effects on pain release. The
      investigator propose to examine if using auricular MA will reduce pain during their eye-exam.

      Research question: Does auricular MA decrease pain in preterm infants compared to placebo
      with control.

      Aim: To determine if auricular MA will reduce pain compared to placebo with control in
      preterm infants during their eye exam.

      Hypothesis: The investigator hypotheses that auricular MA will reduce pain compared to
      placebo with control in preterm infants during their eye exam.

      Methods: Infants who will require their routine eye exam (beginning at 32 weeks corrected
      age) will be randomized to either auricular MA or auricular placebo/sucrose after parental
      informed consent. Five auricular MA or placebo stickers will be placed on acupuncture sites
      on both ears for 1 hour prior to the eye-exam by a non-blinded investigator. Pain responses
      will be assessed with the Premature Infant Pain Profile (PIPP) by blinded clinicians before,
      during and after each eye-exam. The study will be conducted in the NICU at the Royal
      Alexandra Hospital as a single-blinded randomized, placebo controlled study to investigate
      the safety and feasibility of using magnetic stickers in the NICU environment. The
      randomization sequence will be pre-specified, computer generated into block sizes of 2-4.
      Allocations will be concealed in sequential opaque envelopes stored in a secure location. A
      single unblinded investigator will complete randomization, administer the intervention, but
      will not be involved in data collection. Infants will be randomized to receive either MA or
      placebo stickers that are to be applied bilaterally to the 5 auricular acupuncture points as
      per the Battlefield Acupuncture (BFA) protocol at least 1 hour prior to the eye-exam by the
      unblinded investigator. Placebos will be constructed by removing the magnet ball from pre
      commercially-available MA plasters (Sakamura, Helio Acupuncture, Japan). The magnet site on
      placebo and magnetic stickers will then be concealed with a thick application of white,
      opaque correction fluid. Stickers will be removed 1 hour after the eye-exam. Sucrose for pain
      management can be given as per NICU policy. The ROP eye exams are performed by a dedicated
      group of five physicians therefore consistency will be maintained. Primary outcome: Infant's
      response to the pain during the eye-exam, measured by the PIPP score, a validated,
      quantitative pain assessment tool for use in premature infants.

      Expected outcomes: The proposed study aims to examine if auricular MA compared to placebo
      will decrease pain in premature infants. If validated, the results of the study could be
      translated into NICUs around the world and might benefit a large number of babies each year.
    


Study Type

Interventional


Primary Outcome

Changes in Premature Infant Pain Profile (PIPP) scores

Secondary Outcome

 Heart rate changes

Condition

Retinopathy of Prematurity

Intervention

Magnetic acupuncture

Study Arms / Comparison Groups

 Intervention - Magnetic acupuncture
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

100

Start Date

August 24, 2018

Completion Date

April 30, 2020

Primary Completion Date

September 30, 2019

Eligibility 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)
      

Gender

All

Ages

29 Weeks - 36 Weeks

Accepts Healthy Volunteers

No

Contacts

Georg Schmolzer, MD, PhD, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT03650621

Organization ID

Pro00080714


Responsible Party

Sponsor

Study Sponsor

University of Alberta


Study Sponsor

Georg Schmolzer, MD, PhD, Principal Investigator, University of Alberta


Verification Date

July 2020