Effects of Two Modalities of Non-invasive Ventilation After Extubation in Very Low Birth Weight Neonates
Primary Purpose
Preterm Infant
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Nasal Intermittent Positive Pressure
Continuous Positive Airway Pressure
Sponsored by
About this trial
This is an interventional treatment trial for Preterm Infant focused on measuring Non-invasive ventilation, Preterm infant, Breathing pattern
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Presented air leak syndrome (pneumothorax, pneumomediastinum); upper airway obstruction after extubation and non-scheduled extubation.
Sites / Locations
- Hospital das Clínicas da UFMG
- Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nasal Intermittent Positive Pressure
Continuous Positive Airway Pressure
Arm Description
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
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
Outcomes
Primary Outcome Measures
Tidal volume
Defined as the volume of air entering or exiting the lungs during each breath - in millilitres.
Secondary Outcome Measures
Respiratory rate
Breaths per minute
Minute ventilation
Computed from tidal volume multiplied by respiratory rate, in liters/minute
Mean inspiratory flow
Is a estimation of respiratory center drive activity. The higher its value, the greater the drive and vice-versa.
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.
Phase relation in inspiratory breathing (PhRIB)
This express the percentage agreement between direction of ribcage and abdomen movements during the inspiratory phase of breath.
Phase relation in expiratory breathing
This express the percentage agreement between direction of ribcage and abdomen movements during the expiratory phase of breath.
Phase relation in total breathing
This express the percentage agreement between direction of ribcage and abdomen movements during the entire breath cycle.
Phase angle
The phase angle is computed from Lissajous loops between ribcage and abdomen excursions on a breath by breath basis.
Full Information
NCT ID
NCT03551314
First Posted
May 15, 2018
Last Updated
February 20, 2019
Sponsor
Federal University of Minas Gerais
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT03551314
Brief Title
Effects of Two Modalities of Non-invasive Ventilation After Extubation in Very Low Birth Weight Neonates
Official Title
Effects of Two Modalities of Non-invasive Ventilation on Breathing Pattern Variables of Preterm Neonates of Very Low Weight After Extubation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 26, 2017 (Actual)
Primary Completion Date
July 26, 2018 (Actual)
Study Completion Date
July 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant
Keywords
Non-invasive ventilation, Preterm infant, Breathing pattern
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nasal Intermittent Positive Pressure
Arm Type
Active Comparator
Arm Description
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
Arm Title
Continuous Positive Airway Pressure
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Nasal Intermittent Positive Pressure
Intervention Description
- 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).
Intervention Type
Other
Intervention Name(s)
Continuous Positive Airway Pressure
Intervention Description
- 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).
Primary Outcome Measure Information:
Title
Tidal volume
Description
Defined as the volume of air entering or exiting the lungs during each breath - in millilitres.
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.
Secondary Outcome Measure Information:
Title
Respiratory rate
Description
Breaths per minute
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.
Title
Minute ventilation
Description
Computed from tidal volume multiplied by respiratory rate, in liters/minute
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.
Title
Mean inspiratory flow
Description
Is a estimation of respiratory center drive activity. The higher its value, the greater the drive and vice-versa.
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.
Title
Labored Breathing Index (LBI)
Description
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.
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.
Title
Phase relation in inspiratory breathing (PhRIB)
Description
This express the percentage agreement between direction of ribcage and abdomen movements during the inspiratory phase of breath.
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.
Title
Phase relation in expiratory breathing
Description
This express the percentage agreement between direction of ribcage and abdomen movements during the expiratory phase of breath.
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.
Title
Phase relation in total breathing
Description
This express the percentage agreement between direction of ribcage and abdomen movements during the entire breath cycle.
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.
Title
Phase angle
Description
The phase angle is computed from Lissajous loops between ribcage and abdomen excursions on a breath by breath basis.
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.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Presented air leak syndrome (pneumothorax, pneumomediastinum); upper airway obstruction after extubation and non-scheduled extubation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Verônica F Parreira, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas da UFMG
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-100
Country
Brazil
Facility Name
Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
31270-901
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Two Modalities of Non-invasive Ventilation After Extubation in Very Low Birth Weight Neonates
We'll reach out to this number within 24 hrs