Apnea of PrematurityNCT01643057
Stochastic Resonance Mattress (Physiological Interventions) and Biomarkers for Enhancing Neonatal Health
An observational study of Apnea of Prematurity, run by Wyss Institute at Harvard University at 1 site in United States.
Trial summary
The purpose of this study is to explore physiological interventions and biomarkers for Apnea of Prematurity in newborn infants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Apnea of Prematurity
- What is being tested?
- Stochastic Resonance Mattress
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infants currently inpatient in the Neonatal Intensive Care Unit at Beth Israel Deaconess Medical Center.
Who may be able to join
- Eligible subjects are infants currently inpatient in the NICU at Beth Israel Deaconess Medical Center and:
- Born premature, at a gestational age < 36 weeks
- Demonstrate irregular breathing by having had at least one documented clinical apnea (> 20 seconds), bradycardia (< 100 bpm) and/or desaturation (< 90%)
Who cannot join
- Eligible infants meeting the inclusion criteria above will be excluded from participation in the study if he/she:
- Is at a Post Conceptual Age of > 45 weeks at time of study (Calculated as: weeks of age at birth + weeks of age since birth)
- Has demonstrable pulmonary disease at time of study, i.e. Chronic Lung Disease, Infant Respiratory Distress Syndrome
- Has Hypoxic-Ischemic Encephalopathy including a cord pH of ≤ 7
- Has a congenital abnormality
- Has a genetic syndrome
Show all 11Show fewer
- Has an anatomic brain anomaly
- Has hydrocephalus or intraventricular hemorrhage > Grade 3 or 4
- Is anemic (hemoglobin < 8g/dL)
- Has an infection at time of study
- Is undergoing therapeutic hypothermia
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconness Medical Center
Boston, Massachusetts, 02115
About this study
The purpose of this study is to explore physiological interventions and biomarkers for Apnea of Prematurity in newborn infants.
Read the detailed description
Apnea of prematurity is defined as cessation of breathing that lasts for more than 20 seconds and/or is accompanied by oxygen desaturation or a decrease in heart rate (bradycardia). Because apnea presents itself within a variety of diseases in newborns, its diagnosis is based largely on the exclusion of other findings. The difficulty in relating the manifestation of apnea to its cause can lead to issues regarding appropriate medical management and delays in treatment.
Our exploration of physiological interventions for Apnea of Prematurity begins with stochastic resonance. Stochastic resonance is the introduction of noise to a system, to alter the system's behavior. This technology has been examined in previous medical applications. The hypothesis for this work is that stochastic resonance stimulation, in the form of gentle vibrations, will stabilize immature breathing patterns in infants.
In this research study, we will use an apnea mattress developed by engineers at the Wyss Institute, Harvard University, which provides gentle vibrations to the infant. We will closely follow the research protocol from UMass Medical School. Whilst the infant is on the mattress, clinical care data will be collected to determine effect on breathing patterns. We also hope to collect enough baseline and intervention data signals to be able to identify candidate biomarkers for apnea. This will assist in development of predictive algorithms for apnea in infants.
- Conditions
- Apnea of Prematurity
- Being tested
- Stochastic Resonance Mattress
- Keywords
- Apnea, Prematurity, Biomarkers, Stochastic Resonance, Neonatal
- Medical subject headings
- Apnea, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stochastic Resonance MattressDevice
The infant's isolette mattress will be replaced with a specially designed mattress (non-commercially available, designed by engineers at the Wyss Institute, Harvard University) to provide gentle vibrations and sounds during mattress stimulations.
| Study group | Role | What they receive |
|---|---|---|
| Stochastic Resonance Mattress | The infant's isolette mattress will be replaced with a specially designed mattress (non-commercially available, designed by engineers at the Wyss Institute, Harvard University) to provide gentle vibrations and sounds during mattress stimulations. Receives: Device: Stochastic Resonance Mattress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate effects of mattress intervention on breathing patterns
Focus on inter-breath intervals and oxygen desaturation.
Measured: Each study session may last up to 24 hours. Participants may take part in up to 4 study sessions.
Secondary outcomes (1)
Candidate Biomarkers for Apnea of Prematurity
Candidate biomarkers in cardio-pulmonary, temperature, audiometry, photometry and clinical assessment data.
Measured: Each study session may last up to 24 hours. Participants may take part in up to 4 study sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Apnea of PrematurityStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyss Institute at Harvard University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent C Smith, MD, MPH, Principal investigator, Beth Israel Deaconess Medical CenterDavid Paydarfar, MD, Principal investigator, UMASS Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643057
- Sponsor's protocol ID
- AMD-CS-0015
- Status last verified
- Sep 2015
- First submitted
- 13 Jul 2012
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Smith VC, Kelty-Stephen D, Qureshi Ahmad M, Mao W, Cakert K, Osborne J, Paydarfar D. Stochastic Resonance Effects on Apnea, Bradycardia, and Oxygenation: A Randomized Controlled Trial. Pediatrics. 2015 Dec;136(6):e1561-8. doi: 10.1542/peds.2015-1334.
PubMed 26598451
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stochastic Resonance Mattress (Physiological Interventions) and Biomarkers for Enhancing Neonatal Health
- ClinicalTrials.gov ID
- NCT01643057
- Acronym / sponsor ID
- AMD-CS-0015
- Conditions
- Apnea of Prematurity
- Keywords
- Apnea, Prematurity, Biomarkers, Stochastic Resonance, Neonatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Wyss Institute at Harvard UniversityUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, University of Massachusetts, Worcester
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 17 Jul 2012 (estimated)
- 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.
The purpose of this study is to explore physiological interventions and biomarkers for Apnea of Prematurity in newborn infants.
Detailed description
Apnea of prematurity is defined as cessation of breathing that lasts for more than 20 seconds and/or is accompanied by oxygen desaturation or a decrease in heart rate (bradycardia). Because apnea presents itself within a variety of diseases in newborns, its diagnosis is based largely on the exclusion of other findings. The difficulty in relating the manifestation of apnea to its cause can lead to issues regarding appropriate medical management and delays in treatment.
Our exploration of physiological interventions for Apnea of Prematurity begins with stochastic resonance. Stochastic resonance is the introduction of noise to a system, to alter the system's behavior. This technology has been examined in previous medical applications. The hypothesis for this work is that stochastic resonance stimulation, in the form of gentle vibrations, will stabilize immature breathing patterns in infants.
In this research study, we will use an apnea mattress developed by engineers at the Wyss Institute, Harvard University, which provides gentle vibrations to the infant. We will closely follow the research protocol from UMass Medical School. Whilst the infant is on the mattress, clinical care data will be collected to determine effect on breathing patterns. We also hope to collect enough baseline and intervention data signals to be able to identify candidate biomarkers for apnea. This will assist in development of predictive algorithms for apnea in infants.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stochastic Resonance Mattress | – | Device: Stochastic Resonance MattressThe infant's isolette mattress will be replaced with a specially designed mattress (non-commercially available, designed by engineers at the Wyss Institute, Harvard University) to provide gentle vibrations and sounds during mattress stimulations. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants currently inpatient in the Neonatal Intensive Care Unit at Beth Israel Deaconess Medical Center.
Key inclusion criteria (3 listed)
- Eligible subjects are infants currently inpatient in the NICU at Beth Israel Deaconess Medical Center and:
- Born premature, at a gestational age < 36 weeks
- Demonstrate irregular breathing by having had at least one documented clinical apnea (> 20 seconds), bradycardia (< 100 bpm) and/or desaturation (< 90%)
Key exclusion criteria (11 listed)
- Eligible infants meeting the inclusion criteria above will be excluded from participation in the study if he/she:
- Is at a Post Conceptual Age of > 45 weeks at time of study (Calculated as: weeks of age at birth + weeks of age since birth)
- Has demonstrable pulmonary disease at time of study, i.e. Chronic Lung Disease, Infant Respiratory Distress Syndrome
- Has Hypoxic-Ischemic Encephalopathy including a cord pH of ≤ 7
- Has a congenital abnormality
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 |
|---|---|---|
| Stochastic Resonance MattressThe infant's isolette mattress will be replaced with a specially designed mattress (non-commercially available, designed by engineers at the Wyss Institute, Harvard University) to provide gentle vibrations and sounds during mattress stimulations. | Device | Stochastic Resonance Mattress |
Primary outcome
Investigate effects of mattress intervention on breathing patterns
Time frame: Each study session may last up to 24 hours. Participants may take part in up to 4 study sessions.
Focus on inter-breath intervals and oxygen desaturation.
1 secondary outcome
Candidate Biomarkers for Apnea of Prematurity
Time frame: Each study session may last up to 24 hours. Participants may take part in up to 4 study sessions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2015.
- Derived from this study: PubMed 26598451Smith VC, Kelty-Stephen D, Qureshi Ahmad M, Mao W, Cakert K, Osborne J, Paydarfar D. Stochastic Resonance Effects on Apnea, Bradycardia, and Oxygenation: A Randomized Controlled Trial. Pediatrics. 2015 Dec;136(6):e1561-8. doi: 10.1542/peds.2015-1334.
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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.
Vincent C Smith, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
David Paydarfar, MD principal investigator
UMASS Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea of Prematurity, run by Wyss Institute at Harvard University at 1 site in United States.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 10 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate effects of mattress intervention on breathing patterns (time frame: Each study session may last up to 24 hours. Participants may take part in up to 4 study sessions.). 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 NCT01643057, which also lists 1 linked publication.
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 10 Sep 2015; AzTrials last refreshed its copy on 7 Nov 2026.