Apnea of NewbornWAVENCT04528030
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
A study testing WAVE device in people with Apnea of Newborn and Hypoxia Neonatal, run by Inspiration Healthcare.
Trial 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 multiple pathologies, including retinopathy of prematurity (ROP), sympathetic ganglia injury, impaired pancreatic islet… Read more about this study
- Who is it for?
- Ages 28 to 35 weeks
- Conditions the study is for
- Apnea of Newborn, Hypoxia Neonatal, Bradycardia Neonatal
- What is being tested?
- WAVE device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 35 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
R, A contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Apnea of Newborn, Hypoxia Neonatal, Bradycardia Neonatal
- Being tested
- WAVE device
- Keywords
- cardio-respiratory stability, neonate, premature infant, proprioceptive stimulation, Apnoea of Prematurity, Medical Device
- Medical subject headings
- Asphyxia Neonatorum, Premature Birth, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WAVE deviceDevice
Also called limb proprioceptive stimulation, kinesthetic stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment starting with an on ON cycle | Other | 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. Receives: Device: WAVE device |
| Treatment starting with an on OFF cycle | Other | 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. Receives: Device: WAVE device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the cumulative burden of AoP with or without WAVE stimulation
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.
Measured: 24 hours
Secondary outcomes (8)
Compare the number of AoP events.
To compare the number of AoP events between periods of presence and absence of tactile vibratory device stimulation adjunct to standard of care.
Measured: 24 hours
Compare the number of desaturations (SpO2<86%) events
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.
Measured: 24 hours
Compare the cumulative depth of desaturations.
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.
Measured: 24 hours
Compare the cumulative duration of desaturations (SpO2<86%) events.
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.
Measured: 24 hours
Compare the number of bradycardia events.
To compare the number of bradycardia events between periods of presence and absence of tactile vibratory device stimulation adjunct to standard of care.
Measured: 24 hours
Compare the cumulative depth of bradycardia events.
To compare the cumulative depth of bradycardia events between periods of presence and absence of tactile vibratory device stimulation adjunct to standard of care.
Measured: 24 hours
Compare the cumulative duration of bradycardia events.
To compare the cumulative duration of bradycardia events between periods of presence and absence of tactile vibratory device stimulation adjunct to standard of care.
Measured: 24 hours
Nursing assessment scores -NPASS scoring system (6).
To compare NPASS scores (6) between periods of presence and absence of tactile vibratory device stimulation adjunct to standard of care.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Apr 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Apnea of NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential Assignment In the same subject there were 2 periods: OFF cycles (6 hours x 2): 'No intervention' period (no vibrations) - two 6 hour epochs - total of 12 hours of 'No intervention' ON cycles (6hours x 2). Experimental period (with vibrations) - two 6 hour epochs - total of 12 hours of 'vibration intervention' In the same subjects cardio-respiratory parameters will be continuously monitored through the 24 hour treatment period of 4 cycles- heart rate, respiratory rate and oxygen saturation were compared during the experimental period (vibration) and during the no intervention period (no vibration).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inspiration Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- Brighton and Sussex University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Oana Dr Anton, MBBS MRCPCH, Principal investigator, Brighton and Sussex University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528030
- Sponsor's protocol ID
- CRR-WAVE-122-CIP
- Acronym
- WAVE
- Status last verified
- Feb 2021
- First submitted
- 20 Aug 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication and conference presentation of results planned
Publications
Kesavan K, Frank P, Cordero DM, Benharash P, Harper RM. Neuromodulation of Limb Proprioceptive Afferents Decreases Apnea of Prematurity and Accompanying Intermittent Hypoxia and Bradycardia. PLoS One. 2016 Jun 15;11(6):e0157349. doi: 10.1371/journal.pone.0157349. eCollection 2016.
PubMed 27304988Martin RJ, Di Fiore JM, Macfarlane PM, Wilson CG. Physiologic basis for intermittent hypoxic episodes in preterm infants. Adv Exp Med Biol. 2012;758:351-8. doi: 10.1007/978-94-007-4584-1_47.
PubMed 23080182te Pas AB, Davis PG, Kamlin CO, Dawson J, O'Donnell CP, Morley CJ. Spontaneous breathing patterns of very preterm infants treated with continuous positive airway pressure at birth. Pediatr Res. 2008 Sep;64(3):281-5. doi: 10.1203/PDR.0b013e31817d9c35.
PubMed 18458652Robertson CM, Watt MJ, Dinu IA. Outcomes for the extremely premature infant: what is new? And where are we going? Pediatr Neurol. 2009 Mar;40(3):189-96. doi: 10.1016/j.pediatrneurol.2008.09.017.
PubMed 19218032Henderson-Smart DJ, Steer PA. Caffeine versus theophylline for apnea in preterm infants. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD000273. doi: 10.1002/14651858.CD000273.pub2.
PubMed 20091506Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
PubMed 30974433Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008 Jan;28(1):55-60. doi: 10.1038/sj.jp.7211861. Epub 2007 Oct 25.
PubMed 18165830Randerath W, Verbraecken J, Andreas S, Arzt M, Bloch KE, Brack T, Buyse B, De Backer W, Eckert DJ, Grote L, Hagmeyer L, Hedner J, Jennum P, La Rovere MT, Miltz C, McNicholas WT, Montserrat J, Naughton M, Pepin JL, Pevernagie D, Sanner B, Testelmans D, Tonia T, Vrijsen B, Wijkstra P, Levy P. Definition, discrimination, diagnosis and treatment of central breathing disturbances during sleep. Eur Respir J. 2017 Jan 18;49(1):1600959. doi: 10.1183/13993003.00959-2016. Print 2017 Jan.
PubMed 27920092Shevtsova NA, Marchenko V, Bezdudnaya T. Modulation of Respiratory System by Limb Muscle Afferents in Intact and Injured Spinal Cord. Front Neurosci. 2019 Mar 26;13:289. doi: 10.3389/fnins.2019.00289. eCollection 2019.
PubMed 30971888Potts JT, Rybak IA, Paton JF. Respiratory rhythm entrainment by somatic afferent stimulation. J Neurosci. 2005 Feb 23;25(8):1965-78. doi: 10.1523/JNEUROSCI.3881-04.2005.
PubMed 15728836Dekker J, Martherus T, Cramer SJE, van Zanten HA, Hooper SB, Te Pas AB. Tactile Stimulation to Stimulate Spontaneous Breathing during Stabilization of Preterm Infants at Birth: A Retrospective Analysis. Front Pediatr. 2017 Apr 3;5:61. doi: 10.3389/fped.2017.00061. eCollection 2017.
PubMed 28421171Solkoff N, Matuszak D. Tactile stimulation and behavioral development among low-birthweight infants. Child Psychiatry Hum Dev. 1975 Fall;6(1):33-7. doi: 10.1007/BF01434430.
PubMed 1238237Lovell JR, Eisenfeld L, Rosow E, Adam J, Lapin C, Bronzino JD. Vibrotactile stimulation for treatment of neonatal apnea: a preliminary study. Conn Med. 1999 Jun;63(6):323-5. No abstract available.
PubMed 10432764Pichardo R, Adam JS, Rosow E, Bronzino J, Eisenfeld L. Vibrotactile stimulation system to treat apnea of prematurity. Biomed Instrum Technol. 2003 Jan-Feb;37(1):34-40. doi: 10.2345/0899-8205(2003)37[34:VSSTTA]2.0.CO;2.
PubMed 12613292Pietravalle A, Cavallin F, Opocher A, Madella S, Cavicchiolo ME, Pizzol D, Putoto G, Trevisanuto D. Neonatal tactile stimulation at birth in a low-resource setting. BMC Pediatr. 2018 Sep 20;18(1):306. doi: 10.1186/s12887-018-1279-4.
PubMed 30236090
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04528030
- Acronym / sponsor ID
- WAVE / CRR-WAVE-122-CIP
- Conditions
- Apnea of Newborn, Hypoxia Neonatal, Bradycardia Neonatal
- Keywords
- cardio-respiratory stability, neonate, premature infant, proprioceptive stimulation, Apnoea of Prematurity, Medical Device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Inspiration HealthcareUniversity, hospital or other
- Collaborators
- Brighton and Sussex University Hospitals NHS Trust
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Sequential Assignment In the same subject there were 2 periods: OFF cycles (6 hours x 2): 'No intervention' period (no vibrations) - two 6 hour epochs - total of 12 hours of 'No intervention' ON cycles (6hours x 2). Experimental period (with vibrations) - two 6 hour epochs - total of 12 hours of 'vibration intervention' In the same subjects cardio-respiratory parameters will be continuously monitored through the 24 hour treatment period of 4 cycles- heart rate, respiratory rate and oxygen saturation were compared during the experimental period (vibration) and during the no intervention period (no vibration).
| Arm | Type | Receives |
|---|---|---|
| Treatment starting with an on ON cycle | Other | Device: WAVE deviceThe 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. |
| Treatment starting with an on OFF cycle | Other | Device: WAVE deviceThe 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. |
Who may qualify
- Ages
- 28 to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WAVE deviceAlso: limb proprioceptive stimulation, kinesthetic stimulationWAVE 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. | Device | Treatment starting with an on OFF cycle, Treatment starting with an on ON cycle |
Primary outcome
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.
8 secondary outcomes
Compare the number of AoP events.
Time frame: 24 hours
Compare the number of desaturations (SpO2<86%) events
Time frame: 24 hours
Compare the cumulative depth of desaturations.
Time frame: 24 hours
Compare the cumulative duration of desaturations (SpO2<86%) events.
Time frame: 24 hours
Compare the number of bradycardia events.
Time frame: 24 hours
Compare the cumulative depth of bradycardia events.
Time frame: 24 hours
Compare the cumulative duration of bradycardia events.
Time frame: 24 hours
Nursing assessment scores -NPASS scoring system (6).
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Background: PubMed 27304988Kesavan K, Frank P, Cordero DM, Benharash P, Harper RM. Neuromodulation of Limb Proprioceptive Afferents Decreases Apnea of Prematurity and Accompanying Intermittent Hypoxia and Bradycardia. PLoS One. 2016 Jun 15;11(6):e0157349. doi: 10.1371/journal.pone.0157349. eCollection 2016.
- Background: PubMed 23080182Martin RJ, Di Fiore JM, Macfarlane PM, Wilson CG. Physiologic basis for intermittent hypoxic episodes in preterm infants. Adv Exp Med Biol. 2012;758:351-8. doi: 10.1007/978-94-007-4584-1_47.
- Background: PubMed 18458652te Pas AB, Davis PG, Kamlin CO, Dawson J, O'Donnell CP, Morley CJ. Spontaneous breathing patterns of very preterm infants treated with continuous positive airway pressure at birth. Pediatr Res. 2008 Sep;64(3):281-5. doi: 10.1203/PDR.0b013e31817d9c35.
- Background: PubMed 19218032Robertson CM, Watt MJ, Dinu IA. Outcomes for the extremely premature infant: what is new? And where are we going? Pediatr Neurol. 2009 Mar;40(3):189-96. doi: 10.1016/j.pediatrneurol.2008.09.017.
- Background: PubMed 20091506Henderson-Smart DJ, Steer PA. Caffeine versus theophylline for apnea in preterm infants. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD000273. doi: 10.1002/14651858.CD000273.pub2.
- Background: PubMed 30974433Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
- Background: PubMed 18165830Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008 Jan;28(1):55-60. doi: 10.1038/sj.jp.7211861. Epub 2007 Oct 25.
- Background: PubMed 27920092Randerath W, Verbraecken J, Andreas S, Arzt M, Bloch KE, Brack T, Buyse B, De Backer W, Eckert DJ, Grote L, Hagmeyer L, Hedner J, Jennum P, La Rovere MT, Miltz C, McNicholas WT, Montserrat J, Naughton M, Pepin JL, Pevernagie D, Sanner B, Testelmans D, Tonia T, Vrijsen B, Wijkstra P, Levy P. Definition, discrimination, diagnosis and treatment of central breathing disturbances during sleep. Eur Respir J. 2017 Jan 18;49(1):1600959. doi: 10.1183/13993003.00959-2016. Print 2017 Jan.
- Background: PubMed 30971888Shevtsova NA, Marchenko V, Bezdudnaya T. Modulation of Respiratory System by Limb Muscle Afferents in Intact and Injured Spinal Cord. Front Neurosci. 2019 Mar 26;13:289. doi: 10.3389/fnins.2019.00289. eCollection 2019.
- Background: PubMed 15728836Potts JT, Rybak IA, Paton JF. Respiratory rhythm entrainment by somatic afferent stimulation. J Neurosci. 2005 Feb 23;25(8):1965-78. doi: 10.1523/JNEUROSCI.3881-04.2005.
- Background: PubMed 28421171Dekker J, Martherus T, Cramer SJE, van Zanten HA, Hooper SB, Te Pas AB. Tactile Stimulation to Stimulate Spontaneous Breathing during Stabilization of Preterm Infants at Birth: A Retrospective Analysis. Front Pediatr. 2017 Apr 3;5:61. doi: 10.3389/fped.2017.00061. eCollection 2017.
- Background: PubMed 1238237Solkoff N, Matuszak D. Tactile stimulation and behavioral development among low-birthweight infants. Child Psychiatry Hum Dev. 1975 Fall;6(1):33-7. doi: 10.1007/BF01434430.
- Sponsor websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Publication and conference presentation of results planned
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Neonatal Resuscitation, Apnea Neonatal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R, A contact
Oana Dr Anton, MBBS MRCPCH principal investigator
Brighton and Sussex University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing WAVE device in people with Apnea of Newborn and Hypoxia Neonatal, run by Inspiration Healthcare.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline van Druten, BScMedHons (07407614698, jacqueline.vandruten@inspiration-healthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the cumulative burden of AoP with or without WAVE stimulation (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04528030, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.