Randomized Control Trial: Synchronized Non-invasive Positive Pressure Ventilation Versus Non Synchronized Non Invasive Positive Pressure Ventilation in Extremely Low Birth Weight Infants

Related Clinical Trial
The Budesonide in Babies (BiB) Trial Follow-up Results of Newborns With Tracheostomy Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia Prolonged Outcomes After Nitric Oxide (PrONOx) A Study of Tobacco Smoke and Children With Respiratory Illnesses Delivery Room CPAP in Extremely Low Birth Weight Infants Dexamethasone Therapy in VLBW Infants at Risk of CLD Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children Estimating Length of Endotracheal Tube Insertion Using Gestational Age or Nasal-Tragus Length in Newborn Infants MRI as a Means to Measure Lung Function: Non-Invasive Imaging in Neonates and Children Seattle-PAP Bubble Nasal CPAP and Work of Breathing High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Blood Oxygenation and Stability of Oxygenation Comparing Two Different Modes of Ventilation in Pretem Neonates Bilevel VG and PRVC High Frequency Ventilation in Premature Infants (HIFI) Early Caffeine in Preterm Neonates High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Lung Volume Monitored by Electric Tomography Impedance. Functional and Lymphocytic Markers of Respiratory Morbidity in Hyperoxic Preemies Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants Non-invasive Respiratory Support in Preterm Infants Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants. The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS Work of Breathing During Non-invasive Ventilation in Premature Neonates Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants Intratracheal Budesonide/Surfactant Prevents BPD Bronchopulmonary Disease (BPD) Patient Registry Premature Birth and Its Sequelae in Women Inhaled NO in Prevention of Chronic Lung Disease The Effects of Position on the Oxygenation Instability of Premature Infants as Documented by SpO2 Histograms Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide Continuous Positive Airway Pressure Via Binasal Prong vs Nasal Mask: a Randomised Controlled Trial Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome Continuous Versus Intermittent Bolus Feeding in Very Preterm Infants – Effect on Respiratory Morbidity Feasibility and Impact of Volume Targeted Ventilation in the Delivery Room Growth of Airways and Lung Tissues in Premature and Healthy Infants Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants Assessment of Lung Structure and Function of Infants Born Prematurely Post-hospitalization Nursing Effectiveness (PHONE) Study Assessment of the Pulmonary Diffusion Capacity in Healthy Infants and Infants With Chronic Lung Disease NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS) Neurotrophin Expression in Infants as a Predictor of Respiratory and Neurodevelopmental Outcomes Inhaled Beclomethasone to Prevent Chronic Lung Disease Work of Breathing in Premature Infants at Discharge Efficacy of Recombinant Human Clara Cell 10 Protein (rhCC10) Administered to Premature Neonates With Respiratory Distress Syndrome Hydrocortisone for BPD Clinic Features and Outcome of BPD (SGBPD) Neolifes Heart – Pulmonary Hypertension in Preterm Children Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia Management of Hyponatremia in Preterm Infants on Diuretics Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial Respiratory Outcome at Adolescence of Very Low Birthweight Infants Surfactant Administration During Spontaneous Breathing Determining the Effect of Spironolactone on Electrolyte Supplementation in Preterm Infants With Chronic Lung Disease Developmental Sequelae of Severe Chronic Lung Disorders Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study Indoor Air Quality and Respiratory Morbidity in School-Aged Children With BPD Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator Improving Prematurity-Related Respiratory Outcomes at Vanderbilt Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease – The AD-ON Study Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns Azithromycin in the Prevention of Lung Injury in Premature Newborn Randomized Control Trial: Synchronized Non-invasive Positive Pressure Ventilation Versus Non Synchronized Non Invasive Positive Pressure Ventilation in Extremely Low Birth Weight Infants Neurally Adjusted Ventilatory Assist vs Proportional Assist Ventilation MRI in BPD Subjects A Safety Study of IV Stem Cell-derived Extracellular Vesicles (UNEX-42) in Preterm Neonates at High Risk for BPD Hypercapnia and Its Association With Long-term Respiratory Morbidities in Premature Infants With Chronic Lung Disease Early Versus Late Caffeine for ELBW Newborns Assessment of Lung Aeration at Birth MRI of Lung Structure and Function in Preterm Children BPD Saturation TARgeting Use of Human Milk Cream to Decrease Length of Stay in Extremely Premature Infants Effect of Synchronized vs. Continuous HFNC Using NAVA on WOB in Infants With BPD Antecedents of Bronchopulmonary Dysplasia Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood Aerosolized Albuterol Use in Severe BPD Late Sequelae of Bronchopulmonary Dysplasia Montelukast in Very Low Birthweight Infants Preterm Infant Inhaled Albuterol Dosing 129Xe MRI in Pediatric Population With BPD Investigation of Polymorphisms in Bronchopulmonary Dysplasia In Turkish Population Pulmonary MRI of Ex-preterm Children With and Without BPD To Understand Risk of Emphysematous Changes Comparison of Classification Standards of BPD in Premature Infants Inhaled Corticosteroids for Treatment of Bronchopulmonary Dysplasia Safety of Sildenafil in Premature Infants Phase II Pilot Study of Early Cortisol Replacement to Prevent Bronchopulmonary Dysplasia Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia Phase III Randomized, Double-Blind Study of Dexamethasone Vs Dexamethasone/Methylprednisolone Vs Placebo for Bronchopulmonary Dysplasia Impact of an Exercise Program for Children Aged 4 to 6 Years With Bronchopulmonary Dysplasia Trial II of Lung Protection With Azithromycin in the Preterm Infant Forced Oscillometry in Infants With Bronchopulmonary Dysplasia The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia L-citrulline and Pulmonary Hypertension Associated With Bronchopulmonary Dysplasia The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia Fluid Filled Lung Oxygenation Assistance Trial Trial of Late Surfactant for Prevention of Bronchopulmonary Dysplasia Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia Risk Factors in Bronchopulmonary Dysplasia (Newborn Lung Project) Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants. Bronchopulmonary Dysplasia: From Neonatal Chronic Lung Disease to Early Onset Adult COPD Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia Physiologic Definition of Bronchopulmonary Dysplasia Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) – a US Study Inhaled Nitric Oxide for Pulmonary Hypertension and Bronchopulmonary Dysplasia Human Mesenchymal Stem Cells For Infants At High Risk For Bronchopulmonary Dysplasia SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants. Safety of Furosemide in Premature Infants at Risk of Bronchopulmonary Dysplasia (BPD) Mesenchymal Stem Cells for The Treatment of Bronchopulmonary Dysplasia in Infants p16Ink4a in Bronchopulmonary Dysplasia in Children Transpyloric Feeding in Severe Bronchopulmonary Dysplasia Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia Phase 1 Intravenous Citrulline for the Prevention of Bronchopulmonary Dysplasia in Preterm Infants Epidemiological Study for Bronchopulmonary Dysplasia (BPD) in China PREMILOC Trial to Prevent Bronchopulmonary Dysplasia in Very Preterm Neonates Stem Cells for Bronchopulmonary Dysplasia Hydrotherapy in Premature Infants With Bronchopulmonary Dysplasia Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants Prospective Study on Plasma Pro-endothelin-1 in Predicting Bronchopulmonary Dysplasia Interest of Pulmonary Ultrasound to Predict Evolution Towards Bronchopulmonary Dysplasia in Premature Infants at Gestational Age Less Than or Equal to 34 Weeks of Gestation Safety and Efficacy Evaluation of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD) Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia Study to Justify Steroid Use in Preterm Neonates to Prevent Bronchopulmonary Dysplasia Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia. Human Mesenchymal Stem Cells For Bronchopulmonary Dysplasia Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia Genetic Susceptibility for Bronchopulmonary Dysplasia in Preterm Infants Respiratory Management of Preterm Infants and Bronchopulmonary Dysplasia

Brief Title

Randomized Control Trial: Synchronized Non-invasive Positive Pressure Ventilation Versus Non Synchronized Non Invasive Positive Pressure Ventilation in Extremely Low Birth Weight Infants

Official Title

Randomized Control Trial: Synchronized Non-Invasive Positive Pressure Ventilation (sNIPPV) With Neurally-Assisted Ventilatory Assist (NAVA) Versus NIPPV in Extremely Low Birth Weight Infants

Brief Summary

      Infants delivered weighing less than 1 kg at birth (ELBW) are at high risk for the
      development of bronchopulmonary dysplasia (BPD) and Ventilator-Induced Lung Injury (VILI), in
      part because of the need for mechanical ventilation utilizing an endotracheal tube (MVET). In
      spite of strategies to minimize the need for MVET, the incidence of BPD in ELBW infants
      continues to be 20-80%. The hypothesis is that synchronized NIPPV will decrease the need for
      MVET and reduce BPD in ELBW infants as compared to NIPPV.
    

Detailed Description

      Hypothesis:

      The hypothesis is that sNIPPV will decrease the need for MVET and reduce BPD in ELBW infants
      as compared to NIPPV.

      Specific Aims:

      The specific aims are to determine whether:

        1. sNIPPV results in a decreased need for MVET at 7days of life and 28 days of life in ELBW
           infants compared to NIPPV.

        2. sNIPPV reduces BPD in ELBW infants compared to NIPPV. Research design and methods: ELBW
           infants will be enrolled in this study at the RNICU at MFCH of WMC following informed
           written parental consent.

      Randomization:

      ELBW infants will be randomized to either sNIPPV group or NIPPV group using a
      computer-generated scheme.

      Extubation criteria:

        1. Infant is receiving caffeine.

        2. Infants can be extubated at any point, but must be extubated following a 12-hour period
           of clinical stability when the ventilator settings have met all the following criteria:

             -  mean airway pressure (MAP) < 8cmH20,

             -  FiO2 < 0.4,

             -  pH > 7.2, and

             -  pCO2 < 70.

      Intubation criteria:

      Infants must be intubated if any of the following criteria occur:

        1. One apneic event requiring positive pressure ventilation (PPV).

        2. More than 6 apneic events requiring stimulation within a 6-hour period.

        3. A deterioration in respiratory status as noted by any of the following criteria:

             -  pH < 7.2,

             -  pCO2 > 70,

             -  FiO2 > 0.6,

        4. Or, if in the opinion of the attending neonatologist, the baby is failing either
           non-invasive strategy.

      Data Collection:

      Demographic and outcome data will be collected from source data, and then the patient will be
      given a unique identifier, without reference to MRN or birthdate.

      Tracheal aspirates will be collected per routine nursing care to look for inflammatory
      cytokine markers (IL8, IL6 and TNF alpha). This may help to determine if certain infants
      remained intubated due to a pro-inflammatory mechanism (if their TA cytokines were elevated
      early compared to those who may have been more successfully extubated because of low levels
      of cytokines).

      During hospital stay, DNA and RNA samples will be extracted from buccal swabs, as certain
      babies are more susceptible to BPD based on their genetic foundations.

      Charts will be reviewed to determine the duration of oxygen therapy as well as the duration
      of MVET.

      MVET will be assessed at 7 days of life and 28 days of life as primary outcome. BPD, as
      defined as oxygen requirement at 36 weeks PMA, is a secondary outcome. Initial statistical
      analysis will be performed using chi square for categorical data; and t-test or Mann Whitney
      for continuous data that is normally or non-normally distributed (respectively), with
      statistical significance when P < 0.05.

      Power analysis:

      Based on the investigators' NICU data that NIPPV has MVET rate at 7 days of life of 84% for
      ELBWs, it was hypothesized that sNIPPV will decrease the need for MVET at 7 days of life by
      40%. For a power of 80%, and an alpha value of 0.05, the sample size is 27 infants in each
      group. Anticipating a 10% dropout rate, this gives 30 as the sample size for each group.

      Anticipated timeline:

      With 80-100 ELBW infants admitted each year, enrollment is anticipated to be completed in 1
      year.

      The clinical implications of this study will determine if synchronized NIPPV in ELBW infants
      will reduce the need for mechanical ventilation and ultimately BPD.

      There are no procedures, situations, or materials that will be hazardous to personnel. There
      are no courses planned which support the research training experience. This research will not
      include the use of experimental drugs or treatments.
    


Study Type

Interventional


Primary Outcome

The need for Mechanical Ventilation via ET tube ( MVET) at 7 days of life

Secondary Outcome

 Incidence of BPD or need for supplemental O2 at 36 weeks corrected age

Condition

BPD - Bronchopulmonary Dysplasia

Intervention

NAVA technology to synchronize NIPPV

Study Arms / Comparison Groups

 NIPPV
Description:  non synchronized non invasive positive pressure ventilation

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

60

Start Date

April 26, 2018

Completion Date

April 26, 2019

Primary Completion Date

April 26, 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Babies born less than 1kg.

          2. Babies born at 24-30 weeks gestation.

          3. Babies who qualify for surfactant administration within 90mins of birth:

               -  FiO2 > 0.4,

               -  nCPAP > 6, with

               -  Increased work of breathing as noted by grunting; and/or inter-, sub-, or
                  supra-sternal retractions.

        Exclusion Criteria:

          1. Babies with Grade 3-4 IVH (may not be known prior to randomization).

          2. Babies with congenital anomalies including neuromuscular disorder.

          3. Babies who do not require intubation until 7 days of life.
      

Gender

All

Ages

24 Weeks - 30 Weeks

Accepts Healthy Volunteers

No

Contacts

Lance Parton, MD, 9144938558, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03613987

Organization ID

L12,175


Responsible Party

Sponsor

Study Sponsor

New York Medical College


Study Sponsor

Lance Parton, MD, Principal Investigator, Westchester Medical Center


Verification Date

July 2018