Respiratory Insufficiency Syndrome of NewbornPhase 1/2NCT03109613
PEEP and V/Q Mismatch in Premature Infants
A Phase 1/2 study testing Positive end-expiratory pressure (PEEP) in people with Respiratory Insufficiency Syndrome of Newborn and Infant, Premature, Diseases, run by Children's Hospital of Philadelphia at 3 sites in United States.
Trial summary
Positive end-expiratory pressure (PEEP) is used in premature infants receiving mechanical ventilation to maintain lungs open and facilitate gas exchange. When ventilation/perfusion mismatch is present, areas of the lung that are open for gas exchange do not match up with areas of the lung that are receiving blood for… Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Respiratory Insufficiency Syndrome of Newborn, Infant, Premature, Diseases
- What is being tested?
- Positive end-expiratory pressure (PEEP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Apr 2016to 8 Aug 2018
- Phase
- Phase 1/2
- 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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm birth before 32 weeks gestational age by best obstetric estimate, determined by the clinical obstetric team during antepartum admission
- Birth weight less than 1500 grams, as measured by the clinical team at neonatal admission.
- Presence of endotracheal intubation and invasive mechanical ventilation
- Less than or equal to 28 days chronologic age
- Supplemental oxygen requirement, with a fraction of inspired oxygen (FiO2) equal to or greater than 0.25 as documented on the bedside infant flow sheet.
Who cannot join
- Congenital anomalies, as determined by the clinical supervising physician
- Current of prior air leak syndrome, as determined by the clinical supervising physician.
- Non-English speaking parents
- Non-viable birth, as determined by the clinical supervising physician
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Christiana Care Health System
Newark, Delaware, 19713
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Selecting PEEP in Ventilated Premature Infants by Reducing Ventilation/Perfusion Mismatch: a Pilot Feasibility Study
Positive end-expiratory pressure (PEEP) is used in premature infants receiving mechanical ventilation to maintain lungs open and facilitate gas exchange. When ventilation/perfusion mismatch is present, areas of the lung that are open for gas exchange do not match up with areas of the lung that are receiving blood for gas exchange. This study measures the feasibility of enrolling and completing study maneuvers in premature infants for a prospective study measuring the responsiveness of V/Q mismatch to changes in the amount (or level) of PEEP.
- Being tested
- Positive end-expiratory pressure (PEEP)
- Keywords
- Positive end-expiratory pressure, PEEP, Bronchopulmonary Dysplasia, Ventilator Induced Lung Injury, V/Q mismatch
- Medical subject headings
- Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive end-expiratory pressure (PEEP)Device
level changes as per arm description
| Study group | Role | What they receive |
|---|---|---|
| Positive end-expiratory pressure (PEEP) level changes | Experimental | Sequential changes in PEEP level within range of 4-8 cm H2O followed by measurement of V/Q mismatch at each level. Receives: Device: Positive end-expiratory pressure (PEEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed by rate of successfully study enrollment and completion
Rate of successfully study enrollment and completion
Measured: Full enrollment (12 subjects)
Secondary outcomes (1)
Ventilation/perfusion mismatch
Measured by non-invasive computerized technique based of curvilinear characteristics generated by a best-fit curve connection the fractional inspired oxygen and corresponding peripheral oxygen saturation pairs
Measured: 10-20 minutes following each PEEP level change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start11 Apr 2016
- Primary completion8 Aug 2018
- Study completion8 Aug 2018
Why it stopped: Inadequate enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Insufficiency Syndrome of NewbornStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Christiana Care Health Services
- Responsible party
- Sponsor
- Investigators
- Haresh Kirpalani, BM, MSc, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109613
- Sponsor's protocol ID
- 17-013702
- Status last verified
- Nov 2020
- First submitted
- 6 Apr 2017
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selecting PEEP in Ventilated Premature Infants by Reducing Ventilation/Perfusion Mismatch: a Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT03109613
- Acronym / sponsor ID
- 17-013702
- Keywords
- Positive end-expiratory pressure, PEEP, Bronchopulmonary Dysplasia, Ventilator Induced Lung Injury, V/Q mismatch
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate enrollment
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Christiana Care Health Services
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 12 Apr 2017 (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.
Positive end-expiratory pressure (PEEP) is used in premature infants receiving mechanical ventilation to maintain lungs open and facilitate gas exchange. When ventilation/perfusion mismatch is present, areas of the lung that are open for gas exchange do not match up with areas of the lung that are receiving blood for gas exchange. This study measures the feasibility of enrolling and completing study maneuvers in premature infants for a prospective study measuring the responsiveness of V/Q mismatch to changes in the amount (or level) of PEEP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Positive end-expiratory pressure (PEEP) level changes | Experimental | Device: Positive end-expiratory pressure (PEEP)Sequential changes in PEEP level within range of 4-8 cm H2O followed by measurement of V/Q mismatch at each level. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preterm birth before 32 weeks gestational age by best obstetric estimate, determined by the clinical obstetric team during antepartum admission
- Birth weight less than 1500 grams, as measured by the clinical team at neonatal admission.
- Presence of endotracheal intubation and invasive mechanical ventilation
- Less than or equal to 28 days chronologic age
- Supplemental oxygen requirement, with a fraction of inspired oxygen (FiO2) equal to or greater than 0.25 as documented on the bedside infant flow sheet.
Key exclusion criteria (4 listed)
- Congenital anomalies, as determined by the clinical supervising physician
- Current of prior air leak syndrome, as determined by the clinical supervising physician.
- Non-English speaking parents
- Non-viable birth, as determined by the clinical supervising physician
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 |
|---|---|---|
| Positive end-expiratory pressure (PEEP)level changes as per arm description | Device | Positive end-expiratory pressure (PEEP) level changes |
Primary outcome
Feasibility assessed by rate of successfully study enrollment and completion
Time frame: Full enrollment (12 subjects)
Rate of successfully study enrollment and completion
1 secondary outcome
Ventilation/perfusion mismatch
Time frame: 10-20 minutes following each PEEP level change
Results and safety
The study was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Haresh Kirpalani, BM, MSc principal investigator
University of Pennsylvania
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Positive end-expiratory pressure (PEEP) in people with Respiratory Insufficiency Syndrome of Newborn and Infant, Premature, Diseases, run by Children's Hospital of Philadelphia at 3 sites 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 17 Nov 2020. 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 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.
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?
Feasibility assessed by rate of successfully study enrollment and completion (time frame: Full enrollment (12 subjects)). 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 17 Nov 2020.