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NCT04528030: WAVE
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
NA trial testing WAVE device in Apnea of Newborn in 17 participants. Status unknown.
31 December 2021
Quick facts
| Lead sponsor | Inspiration Healthcare |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 17 |
| Start date | 1 April 2021 |
| Primary completion | 31 December 2021 |
| Estimated completion | 1 April 2022 |
Drugs / interventions tested
- WAVE device
Conditions studied
- Apnea of Newborn — all drugs for Apnea of Newborn →
- Hypoxia Neonatal — all drugs for Hypoxia Neonatal →
- Bradycardia Neonatal — all drugs for Bradycardia Neonatal →
Sponsor
Inspiration Healthcare
Who can join
Adults 28 Weeks to 35 Weeks, any sex, with Apnea of Newborn or Hypoxia Neonatal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04528030
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Apnea of Newborn
Currently open trials in the same condition.
- NCT06693817 — Advanced Wireless Sensors for Neonatal Care in the Delivery Room · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04528030 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Inspiration Healthcare
- Last refreshed: 18 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04528030.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing