Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ramachandra Bhat, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01242462
First received: November 15, 2010
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

Respiratory distress syndrome (RDS) is the most common respiratory disorder in preterm infants. Despite improved survival of extremely premature infants with RDS, complications related to mechanical ventilation still occur. This trial will attempt to maintain adequate gas exchange at a rapid rate, short inspiratory time, low tidal volume, and low peak inspiratory pressure in infants with respiratory distress requiring mechanical ventilation. A cross over design will be used to test the hypothesis whether mid-frequency ventilation in preterm infants with RDS requiring mechanical ventilation will reduce the peak inspiratory pressure requirement when compared to conventional mechanical ventilation.


Condition Intervention Phase
Respiratory Distress Syndrome, Newborn
Procedure: Conventional Pressure Controlled SIMV
Other: Mid-frequency Ventilation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Mid-frequency Ventilation in Newborn Infants With Respiratory Distress Syndrome (RDS): Crossover Pilot Trial

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Average delta pressure [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
    Difference in peak inspiratory pressure (PIP) and peak end expiratory pressure (PEEP) (average delta pressure) during two time periods--time period on conventional synchronized intermittent ventilation (SIMV) and time period on mid-frequency ventilation, randomly assigned.


Secondary Outcome Measures:
  • Average Mean Airway Pressure (MAP) [ Time Frame: Less than 4 hours ] [ Designated as safety issue: Yes ]
    Comparison of mean airway pressure between 2 periods of ventilation--(A)Conventional ventilation strategy and (B)Mid-frequency ventilation

  • Mean arterial pressure [ Time Frame: Less than 4 hours ] [ Designated as safety issue: Yes ]
    Comparison of mean arterial pressure during two periods of mechanical ventilation--(A)Conventional ventilation strategy and (B)Mid-frequency ventilation

  • Average delta pressure [ Time Frame: Less than 4 hours ] [ Designated as safety issue: Yes ]
    Comparison of average delta pressure during the two periods of mechanical ventilation-(A)Conventional ventilation strategy and (B)Mid-frequency ventilation


Enrollment: 12
Study Start Date: October 2011
Study Completion Date: May 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AB
2 hours of treatment with conventional ventilation strategy, then crossover to 2 hours of treatment with mid-frequency ventilation strategy
Procedure: Conventional Pressure Controlled SIMV
Initial ventilatory settings per clinical physician's discretion-tcCO2 & Saturation (SAT) monitoring. Adjust vent setting approximately every 15min with a goal of: SAT 88-95%, tcCO2 45-55, pH greater than or equal to 7.25. Once goals reached, ventilatory strategy will crossed over to other intervention.
Other: Mid-frequency Ventilation
Ventilatory parameters include: max possible rate between 61-150 breaths/min; Shortest inspiration time (Ti) and expiration time (Te), but completed inspiration and expiration on pulmonary graphics. Stepwise weaning of PIP by 1 cm H20 to maintain tcCO2 at baseline. If measured PEEP - delivered PEEP generated is >/= to 1cm H2O, PEEP is reduced to baseline value. Adjustments will be made to PIP, then rate for pH and CO2 changes; FiO2, then PIP for FiO2 changes. Target goal blood gas parameters (same as baseline) Saturations 88-95%; tcCO2 45-55 mmHG; pH >/= 7.25. Maximum period of 2 hours. When goals met, or 2 hours in period, reverted back to SIMV at baseline settings
Active Comparator: BA
2 hours of treatment with mid-frequency ventilation strategy, then crossover to 2 hours of treatment with conventional ventilation strategy
Procedure: Conventional Pressure Controlled SIMV
Initial ventilatory settings per clinical physician's discretion-tcCO2 & Saturation (SAT) monitoring. Adjust vent setting approximately every 15min with a goal of: SAT 88-95%, tcCO2 45-55, pH greater than or equal to 7.25. Once goals reached, ventilatory strategy will crossed over to other intervention.
Other: Mid-frequency Ventilation
Ventilatory parameters include: max possible rate between 61-150 breaths/min; Shortest inspiration time (Ti) and expiration time (Te), but completed inspiration and expiration on pulmonary graphics. Stepwise weaning of PIP by 1 cm H20 to maintain tcCO2 at baseline. If measured PEEP - delivered PEEP generated is >/= to 1cm H2O, PEEP is reduced to baseline value. Adjustments will be made to PIP, then rate for pH and CO2 changes; FiO2, then PIP for FiO2 changes. Target goal blood gas parameters (same as baseline) Saturations 88-95%; tcCO2 45-55 mmHG; pH >/= 7.25. Maximum period of 2 hours. When goals met, or 2 hours in period, reverted back to SIMV at baseline settings

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inborn newborn infants with birthweight greater than or equal to 500gms, with gestational age greater than or equal to 24 weeks but less than or equal to 36 weeks.
  • Postnatal age less than or equal to 7 days.
  • Infant with respiratory distress syndrome (RDS) on mechanical ventilation with less than or equal to 60 breaths/minute, initially requiring greater than or equal to 30% FiO2.
  • Written informed consent.

Exclusion Criteria:

  • Blood culture positive sepsis, life threatening congenital anomalies, cyanotic congenital heart diseases, hydrops fetalis, outborn infants, non viability as determined by the attending physician, and newborns who are considered too unstable for study enrollment as per neonatology attending/fellow.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242462

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35243
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Ramanchandra Bhat, MD University of Alabama at Birmingham
Study Director: Waldemar A Carlo, MD University of Alabama at Birmingham
Principal Investigator: John Kelleher, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Ramachandra Bhat, MD, Fellow Instructor, Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01242462     History of Changes
Other Study ID Numbers: UAB NEO 002
Study First Received: November 15, 2010
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Conventional mechanical ventilation
Mid-frequency ventilation
Respiratory Distress Syndrome
Preterm Newborn Infant
Mean Airway Pressure
Mean Arterial Pressure
Mean Peak Inspiratory Pressure

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014