SleepNCT05589831
Respiratory Support and Brain Health in Preterm Infants
An observational study of Sleep and Cerebral Oxygenation, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Premature babies often require breathing support during their neonatal intensive care unit stay. This is because their lungs are not fully developed to perform the work of breathing on their own. Read more about this study
- Who is it for?
- Ages 3 days and older
- Conditions the study is for
- Sleep, Cerebral Oxygenation
- What is being tested?
- Non-invasive Neurally Adjusted Ventilatory Assist
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2023to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Preterm infants at tertiary NICU at Mount Sinai Hospital (Toronto, Ontario).
Who may be able to join
- Preterm infants born between 22+0 and 31+6 weeks' GA
- Weight > 500 g at the time of approach for consent
- A minimum of 3 days of age
- Clinically stable for > 24 hours while receiving NIPPV or NIV-NAVA
- Clinical stability will be defined as meeting all the following criteria for a 24 hour period prior to recruitment:
- differences in maximum and minimum fractions of inspired oxygen (FiO2) of <20%
Show all 10Show fewer
- differences in maximum and minimum MAP <4 cm H2O
- no active infection
- no hypotension
- no use of cardioactive medications or medical therapy for patent ductus arteriosus.
Who cannot join
- Infants with IVH of grade 3 or 4
- Birth weight < 3rd percentile
- Genetic or congenital abnormalities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario
Laura Thomas, MSc, 416-586-4800 ext. 172060, laura.thomas@sinaihealth.ca
About this study
Official title: Respiratory Support and Brain Health in Preterm Infants: a Prospective Crossover Study
Premature babies often require breathing support during their neonatal intensive care unit stay. This is because their lungs are not fully developed to perform the work of breathing on their own. Although breathing support can be provided via a breathing tube, it is preferable to provide breathing support non-invasively from a breathing machine which is then connected to a mask or prongs placed on the baby's nose. In premature babies born under 32 weeks gestation, a commonly used mode of non-invasive breathing support is called Non-Invasive Positive Pressure Ventilation (NIPPV). In this mode, the breathing machine provides 2 levels of support: one is the constant distending pressure to keep the lungs open and the other provides additional 'breaths' on top of that distending pressure. This is to mimic regular breathing. These breaths are set at a fixed rate and pressure. Although NIPPV protects the lungs from injury caused by a breathing tube, the breaths are not in sync with the baby's own breathing effort. Another mode of non-invasive breathing support recently being used in premature infants called Neurally Adjusted Ventilatory Assist (NAVA). When NAVA is provided non-invasively using a mask or prongs similar to NIPPV, it is called Non-invasive NAVA (NIV-NAVA). During NIV-NAVA a special feeding tube is used that detects the baby's own breathing movement from the electrical signal of the baby's diaphragm and feeds back to the machine which then provides a 'top-up' to the baby's own breath. This top-up breath also provides only as much pressure as the baby needs on top on their own breathing effort. Therefore, this is thought to be in sync with the baby's own breathing effort. However, it is not known if this mode of ventilation leads to improved sleep, improved brain oxygen levels, reduced discomfort and improved functioning of the diaphragm. The investigators aim to examine these indices in this research project.
Read the detailed description
Rationale: It is imperative to find the optimal method of supporting not only lung development, but also brain development during this critical period of brain growth and development. NIV-NAVA is a more physiologically compatible method of supporting respiration. The investigators hypothesize that this compatibility may increase comfort and restful periods compared to standard NIPPV, and thus, may be more neuroprotective.
Objective and outcomes assessed: The objective is to compare sleep-wake cycling, cerebral oxygenation, heart rate variability and diaphragm function during standard NIPPV and NIV-NAVA modes in preterm neonates born at <32 weeks' gestation who are stable on NIPPV or NIV-NAVA for at least 24 hours and are a minimum of 3 days old.
- Conditions
- Sleep, Cerebral Oxygenation
- Being tested
- Non-invasive Neurally Adjusted Ventilatory Assist
- Keywords
- Neurally Adjusted Ventilatory Assist, Non-Invasive Positive Pressure Ventilation, Preterm Neonates, Amplitude integrated electroencephalography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Neurally Adjusted Ventilatory AssistDevice
Also called NIV-NAVA
Neurally Adjusted Ventilatory Assist (NAVA) is a new non-invasive ventilation mode that uses the electrical activity of the diaphragm (EAdi) to offer ventilatory assistance in synchrony with patient effort, thus potentially reducing stress and discomfort. It uses electrodes placed on a modified nasogastric feeding tube to detect the electrical activity of the diaphragm (EAdi), such that both the initiation and termination of a breath during each respiratory cycle is in synchrony with the infant's effort
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of uninterrupted sleep-wake cycling (SWC)
An uninterrupted SWC will be defined as a smooth and gradual decrease in the minimum amplitude on aEEG to quiet sleep (QS), followed by a gradual increase to active sleep or awake state (AS). An interrupted SWC will be defined as a sudden or sharp increase in the minimum amplitude during QS with change to AS state that may or may not be followed by a further drop in QS.
Measured: For 24 hours after intervention initiation
Secondary outcomes (7)
Total duration of quiet sleep (QS)
First, high base voltage (HBV) will be defined as the voltage of the lower margin of aEEG during AS. Total QS duration will be calculated as the combined duration of time spent below the HBV in uninterrupted SWC during 24 h.
Measured: For 24 hours after intervention initiation
Cerebral oxygen saturation (CrSO2)
Cerebral fractional tissue oxygen extraction (CFTOE), calculated as (oxygen saturation [SpO2] - CrSO2) / SpO2, will be calculated offline
Measured: For 24 hours after intervention initiation
Newborn Infant Parasympathetic Evaluation (NIPE) index
Measurement of heart rate variability
Measured: For 24 hours after intervention initiation
Diaphragmatic thickness
Measurement of Diaphragmatic thickness (DT) using lung ultrasound
Measured: 1 day during Nasal Intermittent Positive-Pressure Ventilation (NIPPV) period and 1 day during the Non-Invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA) period
Diaphragm thickness fraction
Diaphragmatic thickness fraction (DTF), calculated as ([(inspiratory thickness-expiratory thickness)]) / (expiratory thickness) x 100, will be calculated using diaphragmatic thicknesses obtained from lung ultrasound
Measured: 1 day during Nasal Intermittent Positive-Pressure Ventilation (NIPPV) period and 1 day during the Non-Invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA) period
Diaphragmatic excursion (DE)
Measurement of Diaphragmatic excursion (DE) using lung ultrasound
Measured: 1 day during Nasal Intermittent Positive-Pressure Ventilation (NIPPV) period and 1 day during the Non-Invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA) period
Lung Ultrasound Severity Score (LUSS)
Point score based on qualitative analysis using lung ultrasound. For each lung area, a 0- to 3-point score is given. Where 0 score refer to normal aeration and 3 score refer to severe loss of lung aeration. Total score ranging from 0-18 based on 3 areas on each lung, with low score means good lung aeration and higher means poor lung aeration.
Measured: 1 day during Nasal Intermittent Positive-Pressure Ventilation (NIPPV) period and 1 day during the Non-Invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA) period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start4 Jul 2023
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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 crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Poorva Deshpande, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589831
- Sponsor's protocol ID
- 22-0128-A
- Status last verified
- Mar 2025
- First submitted
- 5 Oct 2022
- Last updated
- 24 Mar 2025
- 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 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Support and Brain Health in Preterm Infants: a Prospective Crossover Study
- ClinicalTrials.gov ID
- NCT05589831
- Acronym / sponsor ID
- 22-0128-A
- Conditions
- Sleep, Cerebral Oxygenation
- Keywords
- Neurally Adjusted Ventilatory Assist, Non-Invasive Positive Pressure Ventilation, Preterm Neonates, Amplitude integrated electroencephalography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 21 Oct 2022 (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.
Premature babies often require breathing support during their neonatal intensive care unit stay. This is because their lungs are not fully developed to perform the work of breathing on their own. Although breathing support can be provided via a breathing tube, it is preferable to provide breathing support non-invasively from a breathing machine which is then connected to a mask or prongs placed on the baby's nose. In premature babies born under 32 weeks gestation, a commonly used mode of non-invasive breathing support is called Non-Invasive Positive Pressure Ventilation (NIPPV). In this mode, the breathing machine provides 2 levels of support: one is the constant distending pressure to keep the lungs open and the other provides additional 'breaths' on top of that distending pressure. This is to mimic regular breathing. These breaths are set at a fixed rate and pressure. Although NIPPV protects the lungs from injury caused by a breathing tube, the breaths are not in sync with the baby's own breathing effort. Another mode of non-invasive breathing support recently being used in premature infants called Neurally Adjusted Ventilatory Assist (NAVA). When NAVA is provided non-invasively using a mask or prongs similar to NIPPV, it is called Non-invasive NAVA (NIV-NAVA). During NIV-NAVA a special feeding tube is used that detects the baby's own breathing movement from the electrical signal of the baby's diaphragm and feeds back to the machine which then provides a 'top-up' to the baby's own breath. This top-up breath also provides only as much pressure as the baby needs on top on their own breathing effort. Therefore, this is thought to be in sync with the baby's own breathing effort. However, it is not known if this mode of ventilation leads to improved sleep, improved brain oxygen levels, reduced discomfort and improved functioning of the diaphragm. The investigators aim to examine these indices in this research project.
Detailed description
Rationale: It is imperative to find the optimal method of supporting not only lung development, but also brain development during this critical period of brain growth and development. NIV-NAVA is a more physiologically compatible method of supporting respiration. The investigators hypothesize that this compatibility may increase comfort and restful periods compared to standard NIPPV, and thus, may be more neuroprotective.
Objective and outcomes assessed: The objective is to compare sleep-wake cycling, cerebral oxygenation, heart rate variability and diaphragm function during standard NIPPV and NIV-NAVA modes in preterm neonates born at <32 weeks' gestation who are stable on NIPPV or NIV-NAVA for at least 24 hours and are a minimum of 3 days old.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Preterm infants at tertiary NICU at Mount Sinai Hospital (Toronto, Ontario).
Key inclusion criteria (10 listed)
- Preterm infants born between 22+0 and 31+6 weeks' GA
- Weight > 500 g at the time of approach for consent
- A minimum of 3 days of age
- Clinically stable for > 24 hours while receiving NIPPV or NIV-NAVA
- Clinical stability will be defined as meeting all the following criteria for a 24 hour period prior to recruitment:
Key exclusion criteria (3 listed)
- Infants with IVH of grade 3 or 4
- Birth weight < 3rd percentile
- Genetic or congenital abnormalities
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-invasive Neurally Adjusted Ventilatory AssistAlso: NIV-NAVANeurally Adjusted Ventilatory Assist (NAVA) is a new non-invasive ventilation mode that uses the electrical activity of the diaphragm (EAdi) to offer ventilatory assistance in synchrony with patient effort, thus potentially reducing stress and discomfort. It uses electrodes placed on a modified nasogastric feeding tube to detect the electrical activity of the diaphragm (EAdi), such that both the initiation and termination of a breath during each respiratory cycle is in synchrony with the infant's effort | Device | – |
Primary outcome
Number of uninterrupted sleep-wake cycling (SWC)
Time frame: For 24 hours after intervention initiation
An uninterrupted SWC will be defined as a smooth and gradual decrease in the minimum amplitude on aEEG to quiet sleep (QS), followed by a gradual increase to active sleep or awake state (AS). An interrupted SWC will be defined as a sudden or sharp increase in the minimum amplitude during QS with change to AS state that may or may not be followed by a further drop in QS.
7 secondary outcomes
Total duration of quiet sleep (QS)
Time frame: For 24 hours after intervention initiation
Cerebral oxygen saturation (CrSO2)
Time frame: For 24 hours after intervention initiation
Newborn Infant Parasympathetic Evaluation (NIPE) index
Time frame: For 24 hours after intervention initiation
Diaphragmatic thickness
Time frame: 1 day during Nasal Intermittent Positive-Pressure Ventilation (NIPPV) period and 1 day during the Non-Invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA) period
Diaphragm thickness fraction
Time frame: 1 day during Nasal Intermittent Positive-Pressure Ventilation (NIPPV) period and 1 day during the Non-Invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA) period
Diaphragmatic excursion (DE)
Time frame: 1 day during Nasal Intermittent Positive-Pressure Ventilation (NIPPV) period and 1 day during the Non-Invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA) period
Lung Ultrasound Severity Score (LUSS)
Time frame: 1 day during Nasal Intermittent Positive-Pressure Ventilation (NIPPV) period and 1 day during the Non-Invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA) period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- 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.
Poorva Deshpande principal investigator
MOUNT SINAI HOSPITAL
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 Sleep and Cerebral Oxygenation, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 10 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 24 Mar 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Poorva Deshpande (416-586-4800 ext. 7213, poorva.deshpande@sinaihealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of uninterrupted sleep-wake cycling (SWC) (time frame: For 24 hours after intervention initiation). 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 24 Mar 2025.