Preterm InfantNCT03551314
Effects of Two Modalities of Non-invasive Ventilation After Extubation in Very Low Birth Weight Neonates
A study testing Nasal Intermittent Positive Pressure and Continuous Positive Airway Pressure in people with Preterm Infant, run by Federal University of Minas Gerais at 2 sites in Brazil.
Trial summary
The objective of this study is to evaluate the effects of continuous positive airway pressure and nasal intermittent positive pressure ventilation on breathing pattern variables of very low birth weight neonates immediately after extubation. Read more about this study
- Who is it for?
- Ages Up to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Infant
- What is being tested?
- Nasal Intermittent Positive Pressure and Continuous Positive Airway Pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesBrazil
- Study dates
- 26 May 2017to 26 Jul 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 Up to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Presented gestational age less than or equal to 32 weeks and weight less than or equal to 1,500 g;
- Stability from an hemodynamic point of view (without use of amines);
- Have undergone invasive mechanical ventilation;
- Absence of congenital heart diseases and / or other congenital anomalies (myelomeningocele, gastroschisis and / or omphalocele) or chromosomal abnormalities;
- Absence of any condition that requires surgery in the neonatal period.
Who cannot join
- Presented air leak syndrome (pneumothorax, pneumomediastinum); upper airway obstruction after extubation and non-scheduled extubation.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital das Clínicas da UFMG
Belo Horizonte, Minas Gerais, 30130-100
Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG
Belo Horizonte, Minas Gerais, 31270-901
About this study
Official title: Effects of Two Modalities of Non-invasive Ventilation on Breathing Pattern Variables of Preterm Neonates of Very Low Weight After Extubation
The objective of this study is to evaluate the effects of continuous positive airway pressure and nasal intermittent positive pressure ventilation on breathing pattern variables of very low birth weight neonates immediately after extubation.
Read the detailed description
The effects of non-invasive ventilation on the respiratory function of neonates have not been fully elucidated. Currently, two modalities of non invasive ventilation are commonly used in Brazilian neonatal intensive care units: continuous positive airway pressure (CPAP) and nasal intermittent positive pressure ventilation (NIPPV). In this study, it was hypothesized that NIPPV will improve tidal volume when compared to CPAP. The objective of this study is to evaluate the effects of continuous positive airway pressure and nasal intermittent positive pressure ventilation on breathing pattern variables of very low birth weight neonates immediately after extubation. Soon after extubation, the neonates will be randomized into the CPAP-NIPPV (sequence 1) or the NIPPV-CPAP (sequence 2). The sequence will be assigned at random using sealed envelopes. Respiratory inductive plethysmography will be used to evaluate the breathing pattern (tidal volume, respiratory rate, minute ventilation, mean inspiratory flow) and chest wall motion (labor breathing index, inspiratory phase relation, expiratory phase relation, total phase relation and phase angle). Student t tests for paired samples will be used and the Wilcoxon test according to the data distribution. A significance level of 5% will be adopted. The analyzes will be performed by StatisticalPackage software for the Social Sciences® (SPSS, Chicago, IL, USA), version 17.0 for Windows.
- Conditions
- Preterm Infant
- Being tested
- Nasal Intermittent Positive Pressure, Continuous Positive Airway Pressure
- Keywords
- Non-invasive ventilation, Preterm infant, Breathing pattern
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Intermittent Positive PressureOther
- NIPPV The following parameters: inspiratory pressure = 15 cmH2O / final expiratory positive pressure = 6 cmH2O / inspiratory time = 0.40 / flow = 6-8 L.min-1 / respiratory rate = 24.
Respiratory inductive plethysmography is used to evaluate breathing pattern (tidal volume, respiratory rate, minute ventilation, mean inspiratory flow) and chest wall motion (labor breathing index - LBI, phase relation in inspiratory breathing - PhRIB, phase relation in expiratory breathing - PhREB, total phase relation - PhRTB and phase angle).
Continuous Positive Airway PressureOther
- CPAP The following parameters: pressure of 6 cmH2O, with flow of 6-8L/min.
Respiratory inductive plethysmography is used to evaluate breathing pattern (tidal volume, respiratory rate, minute ventilation, mean inspiratory flow) and chest wall motion (labor breathing index - LBI, phase relation in inspiratory breathing - PhRIB, phase relation in expiratory breathing - PhREB, total phase relation - PhRTB and phase angle).
| Study group | Role | What they receive |
|---|---|---|
| Nasal Intermittent Positive Pressure | Active comparator | In this group, soon after extubation, the newborns will be studied initially in NIPPV for one hour. Infants will be studied in supine while in their incubator.
NIPPV: Nasal Intermittent Positive Pressure Ventilation Receives: Other: Nasal Intermittent Positive Pressure |
| Continuous Positive Airway Pressure | Active comparator | In this group, soon after extubation, the newborns will be studied initially in CPAP for one hour. Infants will be studied in supine while in their incubator.
CPAP: Continuous Positive Airway Pressure Receives: Other: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume
Defined as the volume of air entering or exiting the lungs during each breath - in millilitres.
Measured: Measure during the two non-invasive ventilation strategies. Tidal volume will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Secondary outcomes (8)
Respiratory rate
Breaths per minute
Measured: Measure during the two non-invasive ventilation strategies. Respiratory rate will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Minute ventilation
Computed from tidal volume multiplied by respiratory rate, in liters/minute
Measured: Measure during the two non-invasive ventilation strategies. Minute ventilation will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Mean inspiratory flow
Is a estimation of respiratory center drive activity. The higher its value, the greater the drive and vice-versa.
Measured: Measure during the two non-invasive ventilation strategies. Mean inspiratory flow will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Labored Breathing Index (LBI)
This is a measure of chest wall coordination. This is the Labored Breathing Index (LBI) of a breath that takes into account phase and amplitude of the ribcage and abdomen traces. It is computed as the ratio of the sum of the integrals of the absolut values of the derivatives of the inspiratory limbs of ribcage and abdomen excursions divided by the corresponding integral of the derivative of the inspiratory limb of the tidal volume deflection. This measure of thoracoabdominal coordination is computed on a breath by breath basis. Perfect thoracoabdominal coordination produces an LBI of 1.0. In babies or adults who are relaxed and awake or in Quiet State, LBI lies between 1.0 and 1.2 but no systematic study of the normal values of LBI as a function of sleep stage and body posture has yet been undertaken. In Active State, thoracoabdominal discoordination generally is associated with elevated LBI values.
Measured: Measure during the two non-invasive ventilation strategies. Labor breathing index (LBI) will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Phase relation in inspiratory breathing (PhRIB)
This express the percentage agreement between direction of ribcage and abdomen movements during the inspiratory phase of breath.
Measured: Measure during the two non-invasive ventilation strategies. Phase relation in inspiratory breathing will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Phase relation in expiratory breathing
This express the percentage agreement between direction of ribcage and abdomen movements during the expiratory phase of breath.
Measured: Measure during the two non-invasive ventilation strategies. Phase relation in expiratory breathing will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Phase relation in total breathing
This express the percentage agreement between direction of ribcage and abdomen movements during the entire breath cycle.
Measured: Measure during the two non-invasive ventilation strategies. Phase relation in total breathing will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Phase angle
The phase angle is computed from Lissajous loops between ribcage and abdomen excursions on a breath by breath basis.
Measured: Measure during the two non-invasive ventilation strategies. Phase angle will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start26 May 2017
- Primary completion26 Jul 2018
- Study completion26 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Veronica Franco Parreira, Federal University of Minas Gerais
- Investigators
- Verônica F Parreira, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551314
- Sponsor's protocol ID
- CAAE: 67787917.7.0000.5149
- Status last verified
- Feb 2019
- First submitted
- 15 May 2018
- Last updated
- 21 Feb 2019
- 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 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Modalities of Non-invasive Ventilation on Breathing Pattern Variables of Preterm Neonates of Very Low Weight After Extubation
- ClinicalTrials.gov ID
- NCT03551314
- Acronym / sponsor ID
- CAAE: 67787917.7.0000.5149
- Conditions
- Preterm Infant
- Keywords
- Non-invasive ventilation, Preterm infant, Breathing pattern
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 26 May 2017 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 26 Jul 2018 (actual)
- First posted
- 11 Jun 2018 (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.
The objective of this study is to evaluate the effects of continuous positive airway pressure and nasal intermittent positive pressure ventilation on breathing pattern variables of very low birth weight neonates immediately after extubation.
Detailed description
The effects of non-invasive ventilation on the respiratory function of neonates have not been fully elucidated. Currently, two modalities of non invasive ventilation are commonly used in Brazilian neonatal intensive care units: continuous positive airway pressure (CPAP) and nasal intermittent positive pressure ventilation (NIPPV). In this study, it was hypothesized that NIPPV will improve tidal volume when compared to CPAP. The objective of this study is to evaluate the effects of continuous positive airway pressure and nasal intermittent positive pressure ventilation on breathing pattern variables of very low birth weight neonates immediately after extubation. Soon after extubation, the neonates will be randomized into the CPAP-NIPPV (sequence 1) or the NIPPV-CPAP (sequence 2). The sequence will be assigned at random using sealed envelopes. Respiratory inductive plethysmography will be used to evaluate the breathing pattern (tidal volume, respiratory rate, minute ventilation, mean inspiratory flow) and chest wall motion (labor breathing index, inspiratory phase relation, expiratory phase relation, total phase relation and phase angle). Student t tests for paired samples will be used and the Wilcoxon test according to the data distribution. A significance level of 5% will be adopted. The analyzes will be performed by StatisticalPackage software for the Social Sciences® (SPSS, Chicago, IL, USA), version 17.0 for Windows.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal Intermittent Positive Pressure | Active comparator | Other: Nasal Intermittent Positive PressureIn this group, soon after extubation, the newborns will be studied initially in NIPPV for one hour. Infants will be studied in supine while in their incubator. NIPPV: Nasal Intermittent Positive Pressure Ventilation |
| Continuous Positive Airway Pressure | Active comparator | Other: Continuous Positive Airway PressureIn this group, soon after extubation, the newborns will be studied initially in CPAP for one hour. Infants will be studied in supine while in their incubator. CPAP: Continuous Positive Airway Pressure |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Presented gestational age less than or equal to 32 weeks and weight less than or equal to 1,500 g;
- Stability from an hemodynamic point of view (without use of amines);
- Have undergone invasive mechanical ventilation;
- Absence of congenital heart diseases and / or other congenital anomalies (myelomeningocele, gastroschisis and / or omphalocele) or chromosomal abnormalities;
- Absence of any condition that requires surgery in the neonatal period.
Key exclusion criteria (1 listed)
- Presented air leak syndrome (pneumothorax, pneumomediastinum); upper airway obstruction after extubation and non-scheduled extubation.
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 |
|---|---|---|
| Nasal Intermittent Positive Pressure- NIPPV The following parameters: inspiratory pressure = 15 cmH2O / final expiratory positive pressure = 6 cmH2O / inspiratory time = 0.40 / flow = 6-8 L.min-1 / respiratory rate = 24. Respiratory inductive plethysmography is used to evaluate breathing pattern (tidal volume, respiratory rate, minute ventilation, mean inspiratory flow) and chest wall motion (labor breathing index - LBI, phase relation in inspiratory breathing - PhRIB, phase relation in expiratory breathing - PhREB, total phase relation - PhRTB and phase angle). | Other | Nasal Intermittent Positive Pressure |
| Continuous Positive Airway Pressure- CPAP The following parameters: pressure of 6 cmH2O, with flow of 6-8L/min. Respiratory inductive plethysmography is used to evaluate breathing pattern (tidal volume, respiratory rate, minute ventilation, mean inspiratory flow) and chest wall motion (labor breathing index - LBI, phase relation in inspiratory breathing - PhRIB, phase relation in expiratory breathing - PhREB, total phase relation - PhRTB and phase angle). | Other | Continuous Positive Airway Pressure |
Primary outcome
Tidal volume
Time frame: Measure during the two non-invasive ventilation strategies. Tidal volume will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Defined as the volume of air entering or exiting the lungs during each breath - in millilitres.
8 secondary outcomes
Respiratory rate
Time frame: Measure during the two non-invasive ventilation strategies. Respiratory rate will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Minute ventilation
Time frame: Measure during the two non-invasive ventilation strategies. Minute ventilation will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Mean inspiratory flow
Time frame: Measure during the two non-invasive ventilation strategies. Mean inspiratory flow will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Labored Breathing Index (LBI)
Time frame: Measure during the two non-invasive ventilation strategies. Labor breathing index (LBI) will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Phase relation in inspiratory breathing (PhRIB)
Time frame: Measure during the two non-invasive ventilation strategies. Phase relation in inspiratory breathing will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Phase relation in expiratory breathing
Time frame: Measure during the two non-invasive ventilation strategies. Phase relation in expiratory breathing will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Phase relation in total breathing
Time frame: Measure during the two non-invasive ventilation strategies. Phase relation in total breathing will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
Phase angle
Time frame: Measure during the two non-invasive ventilation strategies. Phase angle will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.
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 Feb 2019.
- 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.
Verônica F Parreira, PhD principal investigator
Federal University of Minas Gerais
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Intermittent Positive Pressure and Continuous Positive Airway Pressure in people with Preterm Infant, run by Federal University of Minas Gerais at 2 sites in Brazil.
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 1 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 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Tidal volume (time frame: Measure during the two non-invasive ventilation strategies. Tidal volume will be measured for 2 hours, one hour in continuous positive airway pressure and one hour in nasal intermittent positive pressure ventilation.). 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 21 Feb 2019.