Infant Respiratory Distress SyndromeCRADLNCT02962505
Continuous Regional Analysis Device for Neonate Lung
An observational study of Infant Respiratory Distress Syndrome and Acute Bronchiolitis, run by University Hospital Schleswig-Holstein at 4 sites in 3 countries.
Trial summary
The purpose of the study is to assess whether Electrical Impedance Tomography (EIT) has the potential to optimize the ventilator therapy, validate the effectiveness, efficacy and safety of nursing and medical interventions (endotracheal suctioning, posture changes, surfactant therapy, recruitment manoeuvres, etc.) and… Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Infant Respiratory Distress Syndrome, Acute Bronchiolitis, Acute Respiratory Distress Syndrome
- How many people
- 200 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Nov 2016to 3 Mar 2019
- 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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: This study specifically focuses on the EIT monitoring of preterm and term neonates, small infants and children up to the age of 7 years treated in NICU and PICU as this is the population where the need for regional lung function monitoring tools is most urgently needed to optimize the ventilator therapy, validate the effectiveness, efficacy and safety of nursing and medical interventions (endotracheal suctioning, posture changes, surfactant therapy, alveolar recruitment, etc.) and prevent/minimize the occurrence of acute (pneumothorax, endotracheal tube misplacement) and chronic (chronic lung disease or bronchopulmonary dysplasia) adverse effects.
Who may be able to join
- Written, informed consent of both parents or legal representative
- Admission in the NICU or PICU
- Patients with or at high risk of developing respiratory failure needing respiratory support.
- o i.e. (oxygen need (FiO2>25%) AND noninvasive or invasive respiratory support) AND/OR repeated apnea with desaturations
- Age from birth to 7 years o Initial focus will be on neonates up to 6 kg and 12 months age. Infants of higher weight up to 7 years age will be included as EIT belts for this age group become available.
Who cannot join
- Post menstrual age less than 25 weeks
- Body weight < 600 g
- Electrically active implants
- Thorax skin lesions
- Prior participation for the same diagnosis of lung disease
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Netherlands2 sites
Academic Medical Center
Amsterdam
VU University Medical Center
Amsterdam
About this study
The purpose of the study is to assess whether Electrical Impedance Tomography (EIT) has the potential to optimize the ventilator therapy, validate the effectiveness, efficacy and safety of nursing and medical interventions (endotracheal suctioning, posture changes, surfactant therapy, recruitment manoeuvres, etc.) and for early recognition of complications like pneumothorax and endotracheal tube misplacement. The study design is purely observational.
Read the detailed description
EIT data will be recorded during 72 hours of routine clinical treatment. To prevent any decisions based on EIT information, the clinicians will be blinded to the EIT findings during the study period. Data on clinical interventions and clinical findings will be recorded using a specially adapted graphical user interface on the EIT device in combination with a paper-based case report form (CRF). EIT data analysis will be performed off-line.
- Conditions
- Infant Respiratory Distress Syndrome, Acute Bronchiolitis, Acute Respiratory Distress Syndrome
- Medical subject headings
- Pulmonary Atelectasis, Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aggregate measure of ventilation homogeneity (coefficient of variation and global inhomogeneity index of regional tidal volume) by > 10% compared with baseline
Measured: 72 hours
Change in right-to-left and/or anteroposterior ventilation distribution by >10% compared with baseline
Measured: 72 hours
Time and duration of right-to-left or left-to-right ventilation ratio >2:1
Measured: 72 hours
Percentage of EIT examination time with at least 26 out of 32 sensors exhibiting skin contact impedance of < 700 Ohm
Skin contact impedance will be monitored continuously by the EIT device. If more than 6 sensors exhibit skin contact impedance > 700 Ohm, the examination is no longer suitable for analyzing. To assess the percentage of EIT measurements suitable for analyzing, we will calculate the percentage of EIT examination time with at least 26 out of 32 sensors exhibiting skin contact impedance of less than 700 Ohm.
Measured: 72 hours
Secondary outcomes (12)
Relationship between time of onset/end of non-invasive respiratory support and EIT findings
Measured: 72 hours
Relationship between time of intubation/extubation and EIT findings
Measured: 72 hours
Relationship between time of suctioning and EIT findings
Measured: 72 hours
Relationship between time and type of posture change and EIT findings
Measured: 72 hours
Relationship between time of surfactant administration and EIT findings
Measured: 72 hours
Relationship between time of clinically indicated radiological examination and EIT findings
Measured: 72 hours
Relationship between time of recruitment manoeuvre and EIT findings
Measured: 72 hours
Relationship between time of confirmed pneumothorax and EIT findings
Measured: 72 hours
Relationship between time of confirmed endotracheal tube malposition and EIT findings
Measured: 72 hours
Relationship between primary cause of respiratory failure and EIT findings
Measured: 72 hours
Relationship between fraction of inspired oxygen over time and EIT findings
Measured: 72 hours
Relationship between saturation of peripheral oxygen over time and EIT findings
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion3 Mar 2019
- Study completion3 Mar 2019
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 Infant Respiratory Distress SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Middlesex University London, University College, London, NICU of Makarios III Hospital-The Ministry of Health for the Republic of Cyprus, Bio-Medical Research Foundation, University of Geneva, Switzerland, Linneuniversitetet, SWISSTOM AG, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Studio Fifield, Panaxea
- Responsible party
- Principal investigator, Inez Frerichs, University Hospital Schleswig-Holstein
- Investigators
- Inez Frerichs, MD, Study chair, University Medical Center SH, Kiel , Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962505
- Sponsor's protocol ID
- 668259
- Acronym
- CRADL
- Status last verified
- Mar 2019
- First submitted
- 3 Nov 2016
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Becher TH, Miedema M, Kallio M, Papadouri T, Karaoli C, Sophocleous L, Rahtu M, van Leuteren RW, Waldmann AD, Strodthoff C, Yerworth R, Dupre A, Benissa MR, Nordebo S, Khodadad D, Bayford R, Vliegenthart R, Rimensberger PC, van Kaam AH, Frerichs I. Prolonged Continuous Monitoring of Regional Lung Function in Infants with Respiratory Failure. Ann Am Thorac Soc. 2022 Jun;19(6):991-999. doi: 10.1513/AnnalsATS.202005-562OC.
PubMed 34898392
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Regional Analysis Device for Neonate Lung
- ClinicalTrials.gov ID
- NCT02962505
- Acronym / sponsor ID
- CRADL / 668259
- Conditions
- Infant Respiratory Distress Syndrome, Acute Bronchiolitis, Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- Middlesex University London, University College, London, NICU of Makarios III Hospital-The Ministry of Health for the Republic of Cyprus, Bio-Medical Research Foundation, University of Geneva, Switzerland, Linneuniversitetet, SWISSTOM AG, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Studio Fifield, Panaxea
- Study start
- Nov 2016
- Primary completion
- 3 Mar 2019 (actual)
- Study completion
- 3 Mar 2019 (actual)
- First posted
- 11 Nov 2016 (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 the study is to assess whether Electrical Impedance Tomography (EIT) has the potential to optimize the ventilator therapy, validate the effectiveness, efficacy and safety of nursing and medical interventions (endotracheal suctioning, posture changes, surfactant therapy, recruitment manoeuvres, etc.) and for early recognition of complications like pneumothorax and endotracheal tube misplacement. The study design is purely observational.
Detailed description
EIT data will be recorded during 72 hours of routine clinical treatment. To prevent any decisions based on EIT information, the clinicians will be blinded to the EIT findings during the study period. Data on clinical interventions and clinical findings will be recorded using a specially adapted graphical user interface on the EIT device in combination with a paper-based case report form (CRF). EIT data analysis will be performed off-line.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study specifically focuses on the EIT monitoring of preterm and term neonates, small infants and children up to the age of 7 years treated in NICU and PICU as this is the population where the need for regional lung function monitoring tools is most urgently needed to optimize the ventilator therapy, validate the effectiveness, efficacy and safety of nursing and medical interventions (endotracheal suctioning, posture changes, surfactant therapy, alveolar recruitment, etc.) and prevent/minimize the occurrence of acute (pneumothorax, endotracheal tube misplacement) and chronic (chronic lung disease or bronchopulmonary dysplasia) adverse effects.
Key inclusion criteria (5 listed)
- Written, informed consent of both parents or legal representative
- Admission in the NICU or PICU
- Patients with or at high risk of developing respiratory failure needing respiratory support.
- o i.e. (oxygen need (FiO2>25%) AND noninvasive or invasive respiratory support) AND/OR repeated apnea with desaturations
- Age from birth to 7 years o Initial focus will be on neonates up to 6 kg and 12 months age. Infants of higher weight up to 7 years age will be included as EIT belts for this age group become available.
Key exclusion criteria (5 listed)
- Post menstrual age less than 25 weeks
- Body weight < 600 g
- Electrically active implants
- Thorax skin lesions
- Prior participation for the same diagnosis of lung disease
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
Change in aggregate measure of ventilation homogeneity (coefficient of variation and global inhomogeneity index of regional tidal volume) by > 10% compared with baseline
Time frame: 72 hours
Change in right-to-left and/or anteroposterior ventilation distribution by >10% compared with baseline
Time frame: 72 hours
Time and duration of right-to-left or left-to-right ventilation ratio >2:1
Time frame: 72 hours
Percentage of EIT examination time with at least 26 out of 32 sensors exhibiting skin contact impedance of < 700 Ohm
Time frame: 72 hours
Skin contact impedance will be monitored continuously by the EIT device. If more than 6 sensors exhibit skin contact impedance > 700 Ohm, the examination is no longer suitable for analyzing. To assess the percentage of EIT measurements suitable for analyzing, we will calculate the percentage of EIT examination time with at least 26 out of 32 sensors exhibiting skin contact impedance of less than 700 Ohm.
12 secondary outcomes
Relationship between time of onset/end of non-invasive respiratory support and EIT findings
Time frame: 72 hours
Relationship between time of intubation/extubation and EIT findings
Time frame: 72 hours
Relationship between time of suctioning and EIT findings
Time frame: 72 hours
Relationship between time and type of posture change and EIT findings
Time frame: 72 hours
Relationship between time of surfactant administration and EIT findings
Time frame: 72 hours
Relationship between time of clinically indicated radiological examination and EIT findings
Time frame: 72 hours
Relationship between time of recruitment manoeuvre and EIT findings
Time frame: 72 hours
Relationship between time of confirmed pneumothorax and EIT findings
Time frame: 72 hours
Relationship between time of confirmed endotracheal tube malposition and EIT findings
Time frame: 72 hours
Relationship between primary cause of respiratory failure and EIT findings
Time frame: 72 hours
Relationship between fraction of inspired oxygen over time and EIT findings
Time frame: 72 hours
Relationship between saturation of peripheral oxygen over time and EIT findings
Time frame: 72 hours
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 21 Mar 2019.
- Derived from this study: PubMed 34898392Becher TH, Miedema M, Kallio M, Papadouri T, Karaoli C, Sophocleous L, Rahtu M, van Leuteren RW, Waldmann AD, Strodthoff C, Yerworth R, Dupre A, Benissa MR, Nordebo S, Khodadad D, Bayford R, Vliegenthart R, Rimensberger PC, van Kaam AH, Frerichs I. Prolonged Continuous Monitoring of Regional Lung Function in Infants with Respiratory Failure. Ann Am Thorac Soc. 2022 Jun;19(6):991-999. doi: 10.1513/AnnalsATS.202005-562OC.
- Individual participant dataSharing planned: No
Related trials for Infant Respiratory Distress Syndrome
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RecruitingObservational study
Pulmonary Immune Cell-microbiome Interactions in ARDS
ARDS, Human
RecruitingPhase 2
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome, Infections
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruitingObservational study
Right Heart Injury Monitoring on ECMO
Acute Respiratory Distress Syndrome (ARDS), Acute Respiratory Failure (ARF)
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.
Inez Frerichs, MD study chair
University Medical Center SH, Kiel , Germany
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Respiratory Distress Syndrome and Acute Bronchiolitis, run by University Hospital Schleswig-Holstein at 4 sites in 3 countries.
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 5 inclusion and 5 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 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Cyprus, Finland. 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?
Change in aggregate measure of ventilation homogeneity (coefficient of variation and global inhomogeneity index of regional tidal volume) by > 10% compared with baseline (time frame: 72 hours). The study lists 4 primary outcomes in all. 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 NCT02962505, 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 21 Mar 2019.