Magnetic non-Invasive acupuncture for Infant comfort during retinopathy of prematurity examination

Retinopathy of Prematurity (ROP) is abnormal blood vessel development in the
retina. It occurs in preterm infants (especially those born <30 weeks
gestational age) because the blood vessels in the eye may stop growing and
become leaky or proliferate from excess oxygen. If undetected and untreated,
ROP can lead to scarring, retinal detachment and blindness. As prevention
preterm infants have their eyes checked for ROP when they reach about 32-34
weeks. When there are signs of starting ROP, then treatment can be started to
prevent progression of ROP.
These ROP examinations are uncomfortable and cause significant stress and pain
for the preterm infants. Despite this, they are usually done without pain
relief and may be repeated for several weeks. Pain relief for ROP examinations
is not usual practice. Sucrose as general pain reliëf for newborn infants has
been proven to be ineffectieve during this ROP examination. The only
medications that are strong enough to treat the discomfort from ROP examination
(opioids) may cause serious side effects (e.g. the infant stops breathing).
Both pain and pain medications in the newborn period increase the risk of poor
neurodevelopmental outcomes. Finding a solution to the pain they
experience is therefore one of the most important tasks we have.
Acupuncture is a form of traditional Chinese therapy that has been used for
thousands of years to prevent and treat pain and other health problems. It can
be applied in multiple ways including the traditional needles, by laser, by
pressure or by magnets.
In a pilot study, it has been shown that non-invasive ear acupuncture, (i.e.
acupuncture without needles) using magnets on 5 ear acupuncture points in
newborn infants, is able to reduce pain during a heel prick for blood tests.
Therefore we would like to investigate whether this non-invasive ear magnetic
acupuncture can reduce pain and stress during ROP examination in preterm
infants.

To investigate whether non-invasive ear magnetic acupuncture will help reduce
pain and stress for preterm infants in the Neonatal Intensive Care Unit (NICU)
during their routine eye examination for Retinopathy of Prematurity (ROP).

Study Design: Randomized control trial
Number of centres: Multi-centre (Edmonton, Canada; Sydney, Australia, Nijmegen,
Netherlands)

Intervention:
Included infants will be randomized to one of the following study arms:
1. Intervention group: Infants will have non-invasive ear magnetic acupuncture
during a ROP-exam.
Four ear magnets will be placed on each ear of the infant at 1 hours before the
ROP-examination by a neonatologist-acupuncturist. The magnets will be placed on
the baby*s ear and removed after the ROP-examination. The magnets will be
replaced if they are displaced before the ROP-exam and removed if there are
complications (e.g. skin reactions, not previously documented on other
patients). The magnets stick to skin with a zelf-adhesive sticker (skin
reactions have not been reported). They are also inert so will be passed out in
stools if ingested.
2. Control group: Infants will have placebo during a ROP-exam.
Four placebo stickers will be placed on each ear of the infant at 1 hours
before the ROP-examination by a neonatologist-acupuncturist. The placebo
stickers will be placed on the baby*s ear and removed after the ROP-exam. The
placebo stickers will be replaced if they are displaced before the ROP-exam and
removed if there are complications (e.g. skin reactions, not previously
documented on other patients). The placebo zelf-adhesive stickers will be
attached to skin (skin reactions have not been reported). They are also inert
so will be passed out in stools if ingested.

Blinding
Nursing staff (pain assessors) will be blinded to the arm that the baby is
randomized to. Only the neonatologist-acupuncturist applying the stickers will
be aware of the allocation the infant has received. The flesh coloured stickers
will conceal the presence of the magnets. Stickers will be replaced if they
fall off and data will continue to be recorded.

Assessment of pain/stress response:
1. Infant vital signs (heart rate/ arterial oxygen saturation / respiratory
rate) before, during and after the procedure will be recorded using the bedside
monitor of the infant
2. The Preterm Infant Pain Profile (PIPP) score before, during after the
procedure will be assessed by the bedside nurse.
3. Pain management will be as per NICU policy. All infants will receive sucrose
prior eye-exam. Further pain management is limited to supportive care (e.g.
swaddling and cuddling, feeding). Data will be collected on pain management
strategies.
4. Event recording: The bedside nurse will record: time and duration of
pain/stress events on a separate data sheet for correlation with vital sign
changes

In addition, common neonatal data including respiratory support at the neonatal
unit, incidence of patent ductus arteriosus, intraventricular hemorrhage,
periventricular leukomalacia, necrotizing enterocolitis, oxygen/respiratory
support at 36 weeks postmenstrual age, neonatal death <28 days, death before
discharge, days on ventilator, age of discontinuation of respiratory support,
age at discharge home, length of during hospital stay, will be recorded from
electronic patient file in order to compare whether both study groups have the
same background characteristics.

Risks
- Stickers:
There are no anticipated risks. The stickers may fall off and need to be
replaced. Skin reactions from the adhesive have not been reported.
- Magnets
Although previously not reported, there is a theoretical risk that the infant
can swallow the magnet. In such cases, the parent will be informed and a chest
and abdominal X-Ray taken to verify where the magnet is. The magnet is inert
and will pass out in the stools in due time.

Benefit
Preterm infants will require ROP-examination to assess development and severity
of ROP. This is accompanied by pain and stress. Pain increases the risk of
adverse neurodevelopmental outcome in later life but unfortunately, so do many
of the medications that are used to prevent or treat pain. If non-invasive
magnetic ear acupuncture can be shown to both reduce pain perception and
improve infant comfort, we will be able to reduce the need for potentially
toxic medications and improve long-term neurological outcomes for hundreds of
preterm infants every year.