Premature Infant DiseaseNCT02085499
Flow-synchronized Nasal IMV in Preterm Infants
A study testing non-synchronized NIMV and Synchronized NIMV in people with Premature Infant Disease and Respiratory Insufficiency, run by University of Miami at 1 site in United States.
Trial summary
The use of non-invasive methods of respiratory support to reduce complications of prolonged invasive mechanical ventilation in preterm infants has increased. The most common mode is nasal intermittent mandatory ventilation (NIMV). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Infant Disease, Respiratory Insufficiency
- What is being tested?
- non-synchronized NIMV and Synchronized NIMV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 1 Jun 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm infants of 30 or less weeks of gestational age
- Receiving NIMV
- Requiring Fi02 > 0.21 to keep Sp02 > 90%
- Parental written informed consent
Who cannot join
- Major congenital anomalies
- Proven sepsis within 72 hours of the study
- Hypotension requiring pressors within 72 hours of the study
- Pneumothorax or pneumomediastinum within 72 hours of the study
- Current suspected necrotizing enterocolitis, spontaneous perforation or severe abdominal distention
Trial locations and contacts
1 site in 1 country.
United States1 site
Holtz Childrens Hospital-Jackson Health System-University of Miami
Miami, Florida, 33136
About this study
Official title: Effects of Flow-synchronized Nasal Intermittent Mandatory Ventilation in Preterm Infants
The use of non-invasive methods of respiratory support to reduce complications of prolonged invasive mechanical ventilation in preterm infants has increased.
The most common mode is nasal intermittent mandatory ventilation (NIMV). In NIMV, the interval between mechanical breaths is fixed and is determined by the frequency dialed by the clinician. Asynchrony between the infant's spontaneous breathing may exist since mechanical breaths delivered at fixed intervals can occur at different times over the inspiratory or expiratory phases of the infant's spontaneous breathing. Synchronized-NIMV is a mode similar to NIMV where the ventilator cycle is delivered in synchrony with the infant's spontaneous inspiration. This has been achieved by using techniques to detect the infant's spontaneous inspiration.
Read more
The advantages or disadvantages of synchronized compared to non-synchronized NIMV remain to be determined.
This study seeks to evaluate the effect of synchronized NIMV versus non-synchronized NIMV on ventilation and gas exchange in premature infants who require supplemental oxygen.
The hypothesis is that the use of flow synchronized nasal intermittent mandatory ventilation (S-NIMV) in comparison to non-synchronized NIMV will improve ventilation and gas exchange and reduce breathing effort.
The objective of the study is to compare the effect of flow synchronized-NIMV to non-synchronized-NIMV on tidal volume (VT), minute ventilation (VE), gas exchange, breathing effort, apnea and chest wall distortion in preterm neonates with lung disease.
- Being tested
- non-synchronized NIMV, Synchronized NIMV
- Keywords
- nasal ventilation, premature infants, synchronized ventilation, non-invasive respiratory support
- Medical subject headings
- Respiratory Insufficiency, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-synchronized NIMVOther
During the study each infant will undergo a 2-hour period of NIMV at a frequency of 30 cycles per minute.
NIMV will be provided by a time cycled, pressure limited neonatal ventilator (Puritan Bennett 840, Covidien, Boulder, CO).
Synchronized NIMVOther
During the study each infant will undergo a 2-hour period of S-NIMV at a frequency of 30 cycles per minute.
S-NIMV will be provided by a time cycled, pressure limited neonatal ventilator, with leak compensation capacity and nasal flow triggered ventilation (Puritan Bennett 840, Covidien, Boulder, CO). Synchronization will be achieved by the leak compensation software and the internal sensor of the ventilator.
| Study group | Role | What they receive |
|---|---|---|
| NIMV followed by S-NIMV | Other | During the study infants assigned to this arm will undergo a 2-hour period of non-synchronized NIMV followed by a 2-hour period of Synchronized-NIMV. Receives: Other: non-synchronized NIMV; Other: Synchronized NIMV |
| S-NIMV followed by NIMV | Other | During the study infants assigned to this arm will undergo a 2-hour period of synchronized NIMV followed by a 2-hour period of non-synchronized NIMV. Receives: Other: non-synchronized NIMV; Other: Synchronized NIMV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minute Ventilation
Measurements of minute ventilation (VE in ml-units/min/Kg) by respiratory inductance plethysmography during flow synchronized-NIMV will be compared to measurements during non-synchronized-NIMV
Measured: 4 hours
Ttidal volume (VT)
Measurements of tidal volume (VT in ml-units/Kg) by respiratory inductance plethysmography during flow synchronized-NIMV will be compared to measurements during non-synchronized-NIMV
Measured: 4 hours
Secondary outcomes (3)
Arterial oxygen saturation
Measurements of arterial oxygen saturation (%) by pulse oximetry obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Measured: 4 hours
fraction of inspired oxygen
Required fraction of inspired oxygen during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Measured: 4 hours
transcutaneous carbon dioxide tension
Measurements of transcutaneous carbon dioxide tension (mmHg) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Infant DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelson Claure, University of Miami
- Investigators
- Nelson Claure, MSc, PhD, Principal investigator, University of MiamiEduardo Bancalari, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085499
- Sponsor's protocol ID
- 20130844
- Status last verified
- May 2024
- First submitted
- 10 Mar 2014
- Last updated
- 16 May 2024
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Flow-synchronized Nasal Intermittent Mandatory Ventilation in Preterm Infants
- ClinicalTrials.gov ID
- NCT02085499
- Acronym / sponsor ID
- 20130844
- Keywords
- nasal ventilation, premature infants, synchronized ventilation, non-invasive respiratory support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 13 Mar 2014 (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 use of non-invasive methods of respiratory support to reduce complications of prolonged invasive mechanical ventilation in preterm infants has increased.
The most common mode is nasal intermittent mandatory ventilation (NIMV). In NIMV, the interval between mechanical breaths is fixed and is determined by the frequency dialed by the clinician. Asynchrony between the infant's spontaneous breathing may exist since mechanical breaths delivered at fixed intervals can occur at different times over the inspiratory or expiratory phases of the infant's spontaneous breathing. Synchronized-NIMV is a mode similar to NIMV where the ventilator cycle is delivered in synchrony with the infant's spontaneous inspiration. This has been achieved by using techniques to detect the infant's spontaneous inspiration.
The advantages or disadvantages of synchronized compared to non-synchronized NIMV remain to be determined.
This study seeks to evaluate the effect of synchronized NIMV versus non-synchronized NIMV on ventilation and gas exchange in premature infants who require supplemental oxygen.
The hypothesis is that the use of flow synchronized nasal intermittent mandatory ventilation (S-NIMV) in comparison to non-synchronized NIMV will improve ventilation and gas exchange and reduce breathing effort.
The objective of the study is to compare the effect of flow synchronized-NIMV to non-synchronized-NIMV on tidal volume (VT), minute ventilation (VE), gas exchange, breathing effort, apnea and chest wall distortion in preterm neonates with lung disease.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIMV followed by S-NIMV | Other | Other: non-synchronized NIMV, Other: Synchronized NIMVDuring the study infants assigned to this arm will undergo a 2-hour period of non-synchronized NIMV followed by a 2-hour period of Synchronized-NIMV. |
| S-NIMV followed by NIMV | Other | Other: non-synchronized NIMV, Other: Synchronized NIMVDuring the study infants assigned to this arm will undergo a 2-hour period of synchronized NIMV followed by a 2-hour period of non-synchronized NIMV. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Preterm infants of 30 or less weeks of gestational age
- Receiving NIMV
- Requiring Fi02 > 0.21 to keep Sp02 > 90%
- Parental written informed consent
Key exclusion criteria (5 listed)
- Major congenital anomalies
- Proven sepsis within 72 hours of the study
- Hypotension requiring pressors within 72 hours of the study
- Pneumothorax or pneumomediastinum within 72 hours of the study
- Current suspected necrotizing enterocolitis, spontaneous perforation or severe abdominal distention
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 |
|---|---|---|
| non-synchronized NIMVDuring the study each infant will undergo a 2-hour period of NIMV at a frequency of 30 cycles per minute. NIMV will be provided by a time cycled, pressure limited neonatal ventilator (Puritan Bennett 840, Covidien, Boulder, CO). | Other | NIMV followed by S-NIMV, S-NIMV followed by NIMV |
| Synchronized NIMVDuring the study each infant will undergo a 2-hour period of S-NIMV at a frequency of 30 cycles per minute. S-NIMV will be provided by a time cycled, pressure limited neonatal ventilator, with leak compensation capacity and nasal flow triggered ventilation (Puritan Bennett 840, Covidien, Boulder, CO). Synchronization will be achieved by the leak compensation software and the internal sensor of the ventilator. | Other | NIMV followed by S-NIMV, S-NIMV followed by NIMV |
Primary outcome
Minute Ventilation
Time frame: 4 hours
Measurements of minute ventilation (VE in ml-units/min/Kg) by respiratory inductance plethysmography during flow synchronized-NIMV will be compared to measurements during non-synchronized-NIMV
Ttidal volume (VT)
Time frame: 4 hours
Measurements of tidal volume (VT in ml-units/Kg) by respiratory inductance plethysmography during flow synchronized-NIMV will be compared to measurements during non-synchronized-NIMV
3 secondary outcomes
Arterial oxygen saturation
Time frame: 4 hours
fraction of inspired oxygen
Time frame: 4 hours
transcutaneous carbon dioxide tension
Time frame: 4 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 16 May 2024.
- 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.
Nelson Claure, MSc, PhD principal investigator
University of Miami
Eduardo Bancalari, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-synchronized NIMV and Synchronized NIMV in people with Premature Infant Disease and Respiratory Insufficiency, run by University of Miami 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 4 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 16 May 2024. 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?
Minute Ventilation (time frame: 4 hours). The study lists 2 primary outcomes in all. 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 16 May 2024; AzTrials last refreshed its copy on 30 Oct 2026.