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

Feasibility of Mid-frequency Ventilation in Newborn Infants With Respiratory Distress Syndrome (RDS): Crossover Pilot Trial

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Newborn
• Intervention / Treatment: Procedure: Conventional Pressure Controlled SIMV; Other: Mid-frequency Ventilation

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 1 week (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average delta pressure	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.	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Mean Airway Pressure (MAP)	Comparison of mean airway pressure between 2 periods of ventilation--(A)Conventional ventilation strategy and (B)Mid-frequency ventilation	Less than 4 hours
Mean arterial pressure	Comparison of mean arterial pressure during two periods of mechanical ventilation--(A)Conventional ventilation strategy and (B)Mid-frequency ventilation	Less than 4 hours
Average delta pressure	Comparison of average delta pressure during the two periods of mechanical ventilation-(A)Conventional ventilation strategy and (B)Mid-frequency ventilation	Less than 4 hours

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Ramanchandra Bhat, MD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• Bhat R, Kelleher J, Ambalavanan N, Chatburn RL, Mireles-Cabodevila E, Carlo WA. Feasibility of Mid-Frequency Ventilation Among Infants With Respiratory Distress Syndrome. Respir Care. 2017 Apr;62(4):481-488. doi: 10.4187/respcare.05157. Epub 2017 Jan 3.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): May 1, 2013

Study Registration Dates

• First Submitted: November 15, 2010
• First Submitted That Met QC Criteria: November 16, 2010
• First Posted (ESTIMATE): November 17, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 2, 2014
• Last Update Submitted That Met QC Criteria: May 29, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Respiratory Distress Syndrome; Conventional mechanical ventilation; Mid-frequency ventilation; Preterm Newborn Infant; Mean Airway Pressure; Mean Arterial Pressure; Mean Peak Inspiratory Pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: UAB NEO 002