A UK Interventional Trial in Premature Infants With Apnea of Prematurity Using a Simple, Non-invasive Vibratory Device to Study the Effectiveness in Supporting Breathing and General Stability (WAVE)

February 17, 2021 updated by: Inspiration Healthcare

WAVE Trial in Premature Infants With Apnea of Prematurity Using a Simple, Non-invasive Vibratory Device to Study the Effectiveness in Supporting Breathing and General Stability

Purpose of Study: Apnoea of Prematurity (AOP) is common, affecting the majority of infants born <34 weeks gestational age (GA). Apnea is accompanied by intermittent hypoxia (IH), which contributes to multiple pathologies, including retinopathy of prematurity (ROP), sympathetic ganglia injury, impaired pancreatic islet cell and bone development, and neurodevelopmental disabilities. Standard of care for AOP/IH includes prone positioning, positive pressure ventilation, and caffeine therapy. The objective of this device is to provide an adjunct to current AoP treatment to support breathing in premature infants by using a simple, non-invasive vibratory device placed over limb proprioceptor fibers, an intervention using the principle that limb movements facilitate breathing.

Methods Used: Premature infants (27+6 - 34+6 weeks GA) with clinical confirmed weeks with diagnosis of Apnoea of Prematurity. Caffeine therapy was not a reason for exclusion. Small vibration devices were placed on one hand and one foot and activated in a 6 hour ON/OFF sequence for a total of 24 hours. Heart rate, respiratory rate, oxygen saturation (SpO2), and breathing pauses were continuously collected.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Aim: To study the effect of (WAVE Device) limb proprioceptive stimulation using a vibratory device on AoP events, intermittent hypoxic episodes (SpO2≤85%) and bradycardias(≤100bpm) in a premature infant with confirmed clinical diagnosis of apnea of prematurity (AoP).

The objective of the WAVE device is to provide an adjunct to current care to provide support in apnea of prematurity (AOP). Recurrent apnea and accompanying resultant intermittent hypoxic (IH) episodes are significant concerns commonly encountered in premature infants, and optimal management is a challenge to neonatologists. AoP is defined as >20s breathing pause OR breathing pause of 10-20sec with clinical signs of Bradycardia (≤100bpm) and/or desaturation (≤85% SpO2) in infants born less than 37 weeks of gestation. When these pauses are longer (> 20s), they are frequently prolonged by obstructed inspiratory efforts, most likely secondary to loss of upper airway tonic activity. In extremely low birth weight (ELBW) infants, the incidence of IH progressively increases over the first 4 weeks of postnatal life, followed by a plateau and subsequent decline between 6-8 weeks.

The incidence of AOP correlates inversely with gestational age and birth weight. Nearly all infants born <29 weeks gestation or <1,000 g, 54% at 30 to 31 weeks, 15% at 32 to 33 weeks, and 7% at 34 to 35 weeks gestation exhibit AOP (2). Both animal and human evidence show that immature or impaired respiratory control and the resultant IH exposure contribute to a variety of pathophysiologic issues via pro-inflammatory and/or pro-oxidant cascade as well as cellular mechanisms, e.g., apoptosis, leading to acute and chronic morbidities (e.g. retinopathy of prematurity, altered growth and cardiovascular regulation, disrupting zinc homeostasis which hampers insulin production and there by predisposing to diabetes in later life, cerebellar injuries and neurodevelopmental disabilities).

Current standard of care for AOP includes prone positioning, continuous positive airway pressure (CPAP) or nasal intermittent positive pressure ventilation (NIPPV) to prevent pharyngeal collapse and alveolar atelectasis, and methylxanthine therapy (caffeine, theophylline), which is the mainstay of treatment of central apnea. Apart from prone positioning, none of these interventions are optimal for early development. CPAP masks will distort the bony facial structure in early development, and methylxanthine interventions pose serious questions of neural development interactions.

Study Type

Interventional

Enrollment (Anticipated)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 8 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • Gestational age > 27+6weeks, < 34+1 weeks
  • Diagnosis of apnoea of prematurity (AOP) on clinical observations (atleast 4 AoP episodes and atleast one ABD event (equal and less 85% SpO2)- define clearly).
  • Caffeine treatment will not be an exclusion. If babies are on caffeine they need on maintenance dose for atleats 48 hours. (72hours after first dose of caffeine (Infant must be on maintenance dose)
  • During screening baby must demonstrate >4 AoP/1 ABD events
  • Minimum 48 hours after extubation.

Exclusion Criteria:

  • Inotropes
  • Infants with major congenital anomalies/malformations which will influence central nervous system and long-term outcomes in these infants, such as cardiac anomalies (except for Patent Ductus Arteriosus or Ventricular Septal Defect) or major neurological malformations, like meningoencephalocele, holoprosencephaly
  • Neonates who have apnoea from airway issues like laryngomalacia or tracheomalacia.
  • Neonates with a history of hypoxic-ischemic encephalopathy or Grade IV intraventricular haemorrhage
  • Infants that are currently intubated and invasive ventilation
  • Congenital skin malformations, skin conditions due to recurrent illness (microcirculation concerns).
  • Patients being treated for sepsis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Treatment starting with an on ON cycle
The treatment will start ON cycle for 6 hours, followed by OFF cycle for 6 hours, followed by OFF cycle for 6 hours and finished with ON cycle for 6 hours.
Device: WAVE device
WAVE applies a transcutaneous vibration to the soles of the foot and palms of the hand to elicit nerve signalling from pressure and other limb proprioceptor sensors to pontine, cerebellar, and medullary brain areas that coordinate limb movement and reflexively activate brain areas controlling breathing. The WAVE device is a battery-operated product to reduce the episodes of Apnoea of Prematurity by vibratory stimulation to the hand and foot.
Other Names:
  • limb proprioceptive stimulation
  • kinesthetic stimulation
OTHER: Treatment starting with an on OFF cycle
The treatment will start OFF cycle for 6 hours, followed by ON cycle for 6 hours, followed by OFF cycle for 6 hours and finished with ON cycle for 6 hours.
Device: WAVE device
WAVE applies a transcutaneous vibration to the soles of the foot and palms of the hand to elicit nerve signalling from pressure and other limb proprioceptor sensors to pontine, cerebellar, and medullary brain areas that coordinate limb movement and reflexively activate brain areas controlling breathing. The WAVE device is a battery-operated product to reduce the episodes of Apnoea of Prematurity by vibratory stimulation to the hand and foot.
Other Names:
  • limb proprioceptive stimulation
  • kinesthetic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the cumulative burden of AoP with or without WAVE stimulation
Time Frame: 24 hours
The primary objective is to compare the cumulative duration of breathing pauses related to Apnoea of Prematurity (AoP) between periods of presence and absence of tactile vibratory device stimulation as adjunct to standard care.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the number of AoP events.
Time Frame: 24 hours
To compare the number of AoP events between periods of presence and absence of tactile vibratory device stimulation adjunct to standard of care.
24 hours
Compare the number of desaturations (SpO2<86%) events
Time Frame: 24 hours
To compare the number of desaturations (SpO2<86%) events between periods of presence and absence of tactile vibratory device stimulation adjunct to standard of care.
24 hours
Compare the cumulative depth of desaturations.
Time Frame: 24 hours
To compare the cumulative depth of desaturations (SpO2<86%) between periods of presence and absence of tactile vibratory device stimulation adjunct to standard of care.
24 hours
Compare the cumulative duration of desaturations (SpO2<86%) events.
Time Frame: 24 hours
To compare the cumulative duration of desaturations (SpO2<86%) between periods of presence and absence of tactile vibratory device stimulation adjunct to standard of care.
24 hours
Compare the number of bradycardia events.
Time Frame: 24 hours
To compare the number of bradycardia events between periods of presence and absence of tactile vibratory device stimulation adjunct to standard of care.
24 hours
Compare the cumulative depth of bradycardia events.
Time Frame: 24 hours
To compare the cumulative depth of bradycardia events between periods of presence and absence of tactile vibratory device stimulation adjunct to standard of care.
24 hours
Compare the cumulative duration of bradycardia events.
Time Frame: 24 hours
To compare the cumulative duration of bradycardia events between periods of presence and absence of tactile vibratory device stimulation adjunct to standard of care.
24 hours
Nursing assessment scores -NPASS scoring system (6).
Time Frame: 24 hours
To compare NPASS scores (6) between periods of presence and absence of tactile vibratory device stimulation adjunct to standard of care.
24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post trial feedback
Time Frame: up to 24 weeks
To conduct post-trial surveys to gather feedback from bedside nurses and parents/legal guardians.
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inspiration Healthcare

Collaborators

Brighton and Sussex University Hospitals NHS Trust

Investigators

  • Principal Investigator: Oana Dr Anton, MBBS MRCPCH, Brighton and Sussex University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2021

Primary Completion (ANTICIPATED)

December 31, 2021

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

August 20, 2020

First Submitted That Met QC Criteria

August 22, 2020

First Posted (ACTUAL)

August 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRR-WAVE-122-CIP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publication and conference presentation of results planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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