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

Primary Purpose

Respiratory Distress Syndrome, Newborn

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Conventional Pressure Controlled SIMV
Mid-frequency Ventilation
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn focused on measuring Conventional mechanical ventilation, Mid-frequency ventilation, Respiratory Distress Syndrome, Preterm Newborn Infant, Mean Airway Pressure, Mean Arterial Pressure, Mean Peak Inspiratory Pressure

Eligibility Criteria

1 Hour - 7 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AB

BA

Arm Description

2 hours of treatment with conventional ventilation strategy, then crossover to 2 hours of treatment with mid-frequency ventilation strategy

2 hours of treatment with mid-frequency ventilation strategy, then crossover to 2 hours of treatment with conventional ventilation strategy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Average Mean Airway Pressure (MAP)
Comparison of mean airway pressure between 2 periods of ventilation--(A)Conventional ventilation strategy and (B)Mid-frequency ventilation
Mean arterial pressure
Comparison of mean arterial pressure during two periods of mechanical ventilation--(A)Conventional ventilation strategy and (B)Mid-frequency ventilation
Average delta pressure
Comparison of average delta pressure during the two periods of mechanical ventilation-(A)Conventional ventilation strategy and (B)Mid-frequency ventilation

Full Information

First Posted
November 15, 2010
Last Updated
May 29, 2014
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT01242462
Brief Title
Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial
Official Title
Feasibility of Mid-frequency Ventilation in Newborn Infants With Respiratory Distress Syndrome (RDS): Crossover Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn
Keywords
Conventional mechanical ventilation, Mid-frequency ventilation, Respiratory Distress Syndrome, Preterm Newborn Infant, Mean Airway Pressure, Mean Arterial Pressure, Mean Peak Inspiratory Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AB
Arm Type
Active Comparator
Arm Description
2 hours of treatment with conventional ventilation strategy, then crossover to 2 hours of treatment with mid-frequency ventilation strategy
Arm Title
BA
Arm Type
Active Comparator
Arm Description
2 hours of treatment with mid-frequency ventilation strategy, then crossover to 2 hours of treatment with conventional ventilation strategy
Intervention Type
Procedure
Intervention Name(s)
Conventional Pressure Controlled SIMV
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mid-frequency Ventilation
Intervention Description
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
Primary Outcome Measure Information:
Title
Average delta pressure
Description
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.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Average Mean Airway Pressure (MAP)
Description
Comparison of mean airway pressure between 2 periods of ventilation--(A)Conventional ventilation strategy and (B)Mid-frequency ventilation
Time Frame
Less than 4 hours
Title
Mean arterial pressure
Description
Comparison of mean arterial pressure during two periods of mechanical ventilation--(A)Conventional ventilation strategy and (B)Mid-frequency ventilation
Time Frame
Less than 4 hours
Title
Average delta pressure
Description
Comparison of average delta pressure during the two periods of mechanical ventilation-(A)Conventional ventilation strategy and (B)Mid-frequency ventilation
Time Frame
Less than 4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramanchandra Bhat, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Waldemar A Carlo, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John Kelleher, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28049742
Citation
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.
Results Reference
derived

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

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