Respiratory Distress Syndrome, NewbornNCT00810186
Continuous Monitoring of Lung Ventilation
An observational study of Respiratory Distress Syndrome, Newborn and Pulmonary Ventilation; Newborn, Abnormal, run by Pneumedicare Ltd. at 3 sites in Israel.
Trial summary
Background: Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further deterioration due to complications induced by progression of lung disease or the mechanical ventilation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Pulmonary Ventilation; Newborn, Abnormal, Apnea
- How many people
- 77 participants
- Where
- 3 sitesIsrael
- Study dates
- Apr 2009to Aug 2015
- 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 that require tight monitoring of lung ventilation admited to the Neonatal Intensive Care Unit.
Who may be able to join
- Infants that require tight monitoring of lung ventilation.
- Parents that understand and read Hebrew or Russian or Arabic.
Who cannot join
- Parental refusal to participate in the study.
- Premature babies under 700 grams.
- Prematurity below 26 weeks gestation.
- Severe edematous babies (Hydrops fetalis).
- Severe Hypoxic Ischemic Encephalopathy, initial brain injury or severe intracranial bleeding.
- Skin reactions to the adhesive patches.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Bnai Zion Medical Center
Haifa
Department of Neonatology, Carmel Medical Center
Haifa
Rambam Health Care Campus
Haifa
About this study
Official title: Continuous Monitoring of Lungs Ventilation Dynamics by Small Surface Patches That Include Safe Mechanical Sensors. A Multicenter Study.
Background: Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further deterioration due to complications induced by progression of lung disease or the mechanical ventilation. The complications usually develop in a progressive manner, but are currently detected relatively late, when there is already severe and life threatening deterioration in patient oxygenation and sometimes irreversible damages.
Objective:To measure chest wall dynamics, derived from sensors placed on the chest and abdomen.
Methods: The system comprises of patches attached to the chest wall and upper abdomen that include mechanical sensors that measure the mechanics of lung inflation and deflation.
Read the detailed description
Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further life threatening deterioration following the development of mechanical problems related to airway management, development of lung barotrauma or displacement of the endotracheal tube.
Neonates especially need tight and sensitive monitoring of lung ventilation, because of the high prevalence of lung disease and need for ventilatory support in this population.
Methods:
The system comprises of patches attached to the chest wall and to the epigastrium. The patches include sensors that measure the mechanics of the lung inflation and deflation.
Study protocol
- Following parental informed consent, three patches will be placed on both sides of the chest and over the epigastric area in infants that require tight respiratory monitoring.
- The patches will be placed just beside the ECG patches.
- The placement of the patches will be performed by a physician.
- The monitoring can be preformed as long as the baby needs a tight respiratory monitoring. The patches will be replaced according to routine replacement policy of patches in the neonatal intensive care units, and at the regular time defined by the attending staff, and no longer than 24 hours. At the end of the data acquisition, the patches will be removed.
- No additional intervention is required.
- The patient will be inspected by the supervising physician involve in the research.
- It will not provide any data that may alter the treatment and will not interfere or influence the other monitoring devices that are used to evaluate the clinical status of the patient.
- The other parameters that are regularly monitored, that are displayed on the bedside monitor and respirator will be recorded by the research assistant. The ventilated baby will be identified by a study number. There will be a separate database for the measurements and the demographic and clinical data. There will be no disclosure of the patient's identity along with the data analysis and publication of the results or communication to authorities or other medical practitioners.
Equipment safety:
The system is safe for the use in human subjects. The whole system is approved for safety according to the acquired standard ICE-60601
- Conditions
- Respiratory Distress Syndrome, Newborn, Pulmonary Ventilation; Newborn, Abnormal, Apnea, Respiration Disorders
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Antisocial Personality Disorder, Apnea, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Newborns needing respiratory monitoring | Premature and term newborn infants (male/female) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A data-bank of the recordings obtained at various clinical settings acquired by the sensors
Measured: one year
Secondary outcomes (1)
Establishment of a novel data bank that includes clinical cases of changes in ventilation and the comparison between the different monitored parameters.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startApr 2009
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pneumedicare Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carmel Medical Center, Bnai Zion Medical Center, Rambam Health Care Campus
- Responsible party
- Sponsor
- Investigators
- Dan Waisman, MD, Study director, Department of Neonatology Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810186
- Sponsor's protocol ID
- NEO-01/2008
- Status last verified
- Mar 2016
- First submitted
- 15 Dec 2008
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring of Lungs Ventilation Dynamics by Small Surface Patches That Include Safe Mechanical Sensors. A Multicenter Study.
- ClinicalTrials.gov ID
- NCT00810186
- Acronym / sponsor ID
- NEO-01/2008
- Conditions
- Respiratory Distress Syndrome, Newborn, Pulmonary Ventilation; Newborn, Abnormal, Apnea, Respiration Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Pneumedicare Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Carmel Medical Center, Bnai Zion Medical Center, Rambam Health Care Campus
- Study start
- Apr 2009
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Dec 2008 (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.
Background: Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further deterioration due to complications induced by progression of lung disease or the mechanical ventilation. The complications usually develop in a progressive manner, but are currently detected relatively late, when there is already severe and life threatening deterioration in patient oxygenation and sometimes irreversible damages.
Objective:To measure chest wall dynamics, derived from sensors placed on the chest and abdomen.
Methods: The system comprises of patches attached to the chest wall and upper abdomen that include mechanical sensors that measure the mechanics of lung inflation and deflation.
Detailed description
Patients that suffer from respiratory failure and need mechanical ventilation are at risk of further life threatening deterioration following the development of mechanical problems related to airway management, development of lung barotrauma or displacement of the endotracheal tube.
Neonates especially need tight and sensitive monitoring of lung ventilation, because of the high prevalence of lung disease and need for ventilatory support in this population.
Methods:
The system comprises of patches attached to the chest wall and to the epigastrium. The patches include sensors that measure the mechanics of the lung inflation and deflation.
Study protocol
- Following parental informed consent, three patches will be placed on both sides of the chest and over the epigastric area in infants that require tight respiratory monitoring.
- The patches will be placed just beside the ECG patches.
- The placement of the patches will be performed by a physician.
- The monitoring can be preformed as long as the baby needs a tight respiratory monitoring. The patches will be replaced according to routine replacement policy of patches in the neonatal intensive care units, and at the regular time defined by the attending staff, and no longer than 24 hours. At the end of the data acquisition, the patches will be removed.
- No additional intervention is required.
- The patient will be inspected by the supervising physician involve in the research.
- It will not provide any data that may alter the treatment and will not interfere or influence the other monitoring devices that are used to evaluate the clinical status of the patient.
- The other parameters that are regularly monitored, that are displayed on the bedside monitor and respirator will be recorded by the research assistant. The ventilated baby will be identified by a study number. There will be a separate database for the measurements and the demographic and clinical data. There will be no disclosure of the patient's identity along with the data analysis and publication of the results or communication to authorities or other medical practitioners.
Equipment safety:
The system is safe for the use in human subjects. The whole system is approved for safety according to the acquired standard ICE-60601
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newborns needing respiratory monitoring | – | –Premature and term newborn infants (male/female) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants that require tight monitoring of lung ventilation admited to the Neonatal Intensive Care Unit.
Key inclusion criteria (2 listed)
- Infants that require tight monitoring of lung ventilation.
- Parents that understand and read Hebrew or Russian or Arabic.
Key exclusion criteria (6 listed)
- Parental refusal to participate in the study.
- Premature babies under 700 grams.
- Prematurity below 26 weeks gestation.
- Severe edematous babies (Hydrops fetalis).
- Severe Hypoxic Ischemic Encephalopathy, initial brain injury or severe intracranial bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A data-bank of the recordings obtained at various clinical settings acquired by the sensors
Time frame: one year
1 secondary outcome
Establishment of a novel data bank that includes clinical cases of changes in ventilation and the comparison between the different monitored parameters.
Time frame: one year
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 22 Mar 2016.
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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.
Dan Waisman, MD study director
Department of Neonatology Carmel Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Newborn and Pulmonary Ventilation; Newborn, Abnormal, run by Pneumedicare Ltd. at 3 sites in Israel.
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 2 inclusion and 6 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 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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?
A data-bank of the recordings obtained at various clinical settings acquired by the sensors (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2016; AzTrials last refreshed its copy on 7 Nov 2026.