WAVE trial
Research type
Research Study
Full title
A UK interventional trial in premature infants With Apnoea of prematurity using a simple, non-invasive Vibratory device to study the Effectiveness in supporting breathing and general stability.
IRAS ID
284919
Contact name
Heike Rabe
Contact email
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The WAVE device is designed to enhance the breathing and general stability of premature babies in the Neonatal Intensive Care Unit. Most of these babies are receiving additional breathing support from ventilation equipment. Babies that are born to soon can experience periods when they pause breathing. These pauses sometimes cause their oxygen levels to drop, it can impact on their heart rate and interferes with their sleep.
We believe that this device can help reducing the degree of ventilation support and its side-effects such as lung damage. Also, Wave has the potential to decrease the amount of oxygen that the babies require, reducing its potential side effects such as eye problems and lung damage. A small study done in the USA on neonatal patients has already demonstrated that Wave device improves the quality of breathing in babies.
WAVE is a non-invasive therapeutic device with gentle vibration for preterm babies. It is minimal contact device (similar to oxygen saturation monitor) where the small vibration probes are placed on the hand and foot with sensor strap. The babies taking part in the study will receive therapeutic vibratory stimulation over two cycles of 6 hours ON/OFF periods for a total of 24 hours.
We will include premature babies who are stable but require breathing support, have had several breathing pauses and whose parents have consented that they can take part.
During the study, the babies will have all routine monitoring which includes skin and comfort assessments. The observations will be continuously recorded to inform the study. We are looking to gather enough data to demonstrate to regulators and neonatal specialists that this medical device meets all standards for health, safety and environmental protection (eventually obtaining CE marking).
This device has great potential to improve babies long term development and health outcomes.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
20/LO/1098
Date of REC Opinion
22 Oct 2020
REC opinion
Favourable Opinion