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Flow-synchronized Nasal IMV in Preterm Infants

Primary Purpose

Premature Infant Disease, Respiratory Insufficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
non-synchronized NIMV
Synchronized NIMV
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Premature Infant Disease focused on measuring nasal ventilation, premature infants, synchronized ventilation, non-invasive respiratory support

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Preterm infants of 30 or less weeks of gestational age
  • Receiving NIMV
  • Requiring Fi02 > 0.21 to keep Sp02 > 90%
  • Parental written informed consent

Exclusion Criteria:

  • Major congenital anomalies
  • Proven sepsis within 72 hours of the study
  • Hypotension requiring pressors within 72 hours of the study
  • Pneumothorax or pneumomediastinum within 72 hours of the study
  • Current suspected necrotizing enterocolitis, spontaneous perforation or severe abdominal distention

Sites / Locations

  • Holtz Childrens Hospital-Jackson Health System-University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

NIMV followed by S-NIMV

S-NIMV followed by NIMV

Arm Description

During the study infants assigned to this arm will undergo a 2-hour period of non-synchronized NIMV followed by a 2-hour period of Synchronized-NIMV.

During the study infants assigned to this arm will undergo a 2-hour period of synchronized NIMV followed by a 2-hour period of non-synchronized NIMV.

Outcomes

Primary Outcome Measures

Minute Ventilation
Measurements of minute ventilation (VE in ml-units/min/Kg) by respiratory inductance plethysmography during flow synchronized-NIMV will be compared to measurements during non-synchronized-NIMV
Ttidal volume (VT)
Measurements of tidal volume (VT in ml-units/Kg) by respiratory inductance plethysmography during flow synchronized-NIMV will be compared to measurements during non-synchronized-NIMV

Secondary Outcome Measures

Arterial oxygen saturation
Measurements of arterial oxygen saturation (%) by pulse oximetry obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
fraction of inspired oxygen
Required fraction of inspired oxygen during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
transcutaneous carbon dioxide tension
Measurements of transcutaneous carbon dioxide tension (mmHg) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV

Full Information

First Posted
March 10, 2014
Last Updated
May 9, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT02085499
Brief Title
Flow-synchronized Nasal IMV in Preterm Infants
Official Title
Effects of Flow-synchronized Nasal Intermittent Mandatory Ventilation in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

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 use of non-invasive methods of respiratory support to reduce complications of prolonged invasive mechanical ventilation in preterm infants has increased. The most common mode is nasal intermittent mandatory ventilation (NIMV). In NIMV, the interval between mechanical breaths is fixed and is determined by the frequency dialed by the clinician. Asynchrony between the infant's spontaneous breathing may exist since mechanical breaths delivered at fixed intervals can occur at different times over the inspiratory or expiratory phases of the infant's spontaneous breathing. Synchronized-NIMV is a mode similar to NIMV where the ventilator cycle is delivered in synchrony with the infant's spontaneous inspiration. This has been achieved by using techniques to detect the infant's spontaneous inspiration. The advantages or disadvantages of synchronized compared to non-synchronized NIMV remain to be determined. This study seeks to evaluate the effect of synchronized NIMV versus non-synchronized NIMV on ventilation and gas exchange in premature infants who require supplemental oxygen. The hypothesis is that the use of flow synchronized nasal intermittent mandatory ventilation (S-NIMV) in comparison to non-synchronized NIMV will improve ventilation and gas exchange and reduce breathing effort. The objective of the study is to compare the effect of flow synchronized-NIMV to non-synchronized-NIMV on tidal volume (VT), minute ventilation (VE), gas exchange, breathing effort, apnea and chest wall distortion in preterm neonates with lung disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infant Disease, Respiratory Insufficiency
Keywords
nasal ventilation, premature infants, synchronized ventilation, non-invasive respiratory support

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIMV followed by S-NIMV
Arm Type
Other
Arm Description
During the study infants assigned to this arm will undergo a 2-hour period of non-synchronized NIMV followed by a 2-hour period of Synchronized-NIMV.
Arm Title
S-NIMV followed by NIMV
Arm Type
Other
Arm Description
During the study infants assigned to this arm will undergo a 2-hour period of synchronized NIMV followed by a 2-hour period of non-synchronized NIMV.
Intervention Type
Other
Intervention Name(s)
non-synchronized NIMV
Intervention Description
During the study each infant will undergo a 2-hour period of NIMV at a frequency of 30 cycles per minute. NIMV will be provided by a time cycled, pressure limited neonatal ventilator (Puritan Bennett 840, Covidien, Boulder, CO).
Intervention Type
Other
Intervention Name(s)
Synchronized NIMV
Intervention Description
During the study each infant will undergo a 2-hour period of S-NIMV at a frequency of 30 cycles per minute. S-NIMV will be provided by a time cycled, pressure limited neonatal ventilator, with leak compensation capacity and nasal flow triggered ventilation (Puritan Bennett 840, Covidien, Boulder, CO). Synchronization will be achieved by the leak compensation software and the internal sensor of the ventilator.
Primary Outcome Measure Information:
Title
Minute Ventilation
Description
Measurements of minute ventilation (VE in ml-units/min/Kg) by respiratory inductance plethysmography during flow synchronized-NIMV will be compared to measurements during non-synchronized-NIMV
Time Frame
4 hours
Title
Ttidal volume (VT)
Description
Measurements of tidal volume (VT in ml-units/Kg) by respiratory inductance plethysmography during flow synchronized-NIMV will be compared to measurements during non-synchronized-NIMV
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Arterial oxygen saturation
Description
Measurements of arterial oxygen saturation (%) by pulse oximetry obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Time Frame
4 hours
Title
fraction of inspired oxygen
Description
Required fraction of inspired oxygen during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Time Frame
4 hours
Title
transcutaneous carbon dioxide tension
Description
Measurements of transcutaneous carbon dioxide tension (mmHg) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Time Frame
4 hours
Other Pre-specified Outcome Measures:
Title
Inspiratory breathing effort
Description
Measurements of inspiratory breathing effort obtained by esophageal manometry (cmH2O) during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Time Frame
4 hours
Title
Chest wall distortion by Tcd/Vt ratio
Description
Measurements of inspiratory chest wall distortion (Tcd/Vt ratio) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Time Frame
4 hours
Title
Chest wall distortion by phase lag
Description
Measurements of inspiratory chest wall distortion (phase lag in degrees) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Time Frame
4 hours
Title
apnea frequency
Description
Measurements of apneic respiratory pauses (#/hour) obtained during flow synchronized-NIMV will be compared to measurements obtained during non-synchronized-NIMV
Time Frame
4 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preterm infants of 30 or less weeks of gestational age Receiving NIMV Requiring Fi02 > 0.21 to keep Sp02 > 90% Parental written informed consent Exclusion Criteria: Major congenital anomalies Proven sepsis within 72 hours of the study Hypotension requiring pressors within 72 hours of the study Pneumothorax or pneumomediastinum within 72 hours of the study Current suspected necrotizing enterocolitis, spontaneous perforation or severe abdominal distention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelson Claure, MSc, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eduardo Bancalari, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holtz Childrens Hospital-Jackson Health System-University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Flow-synchronized Nasal IMV in Preterm Infants

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