Status:
UNKNOWN
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
Lead Sponsor:
Inspiration Healthcare
Collaborating Sponsors:
Brighton and Sussex University Hospitals NHS Trust
Conditions:
Apnea of Newborn
Hypoxia Neonatal
Eligibility:
All Genders
28-35 years
Phase:
NA
Brief Summary
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...
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 infa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04528030
Start Date
April 1 2021
End Date
April 1 2022
Last Update
February 18 2021
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