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CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure (NICA)

Primary Purpose

Prematurity, Respiratory Distress Syndrome, Apnea of Prematurity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
continuous positive airway pressure
nasal intermittent positive pressure ventilation
Sponsored by
Women and Infants Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prematurity focused on measuring Continuous positive airway pressure, Nasal intermittent positive pressure ventilation, Mean airway pressure, Apnea, Bradycardia, Prematurity

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Gestational Age 23-34 completed weeks
  • Stable on non- invasive respiratory support for at least 24h
  • CPAP level of 7-12 cmH2O or NIPPV with MAP 7-12 cmH2O
  • FiO2 requirement of <0.40

Exclusion Criteria:

  • Clinical instability as judged by the clinical team
  • FiO2 requirement of > 0.40 for more than 60 min.
  • >10 apnea/bradycardia/desaturation events in past 24 h requiring moderate or vigorous stimulation.
  • Anticipated intubation within next 24 h.
  • Active abdominal pathology (Spontaneous Intestinal Perforation, confirmed or suspected Necrotizing Enterocolitis, bowel obstruction).
  • Hemodynamically significant patent ductus arteriosus (PDA)
  • Anticipated weaning off non-invasive support in the next 24 h.
  • Any major congenital anomalies, congenital heart disease (other than PDA, atrial septal defect or ventricular septal defect) and cardiac arrhythmias
  • Lack of study equipment or personnel
  • Lack of parental consent

Sites / Locations

  • Women and Infants Hospital of Rhode IslandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CPAP first

NIPPV first

Arm Description

The intervention is application of continuous positive airway pressure (CPAP). The order of the two interventions of this crossover study is randomized but each subject will be exposed to both interventions. The period of CPAP will be compared to the period of NIPPV.

The intervention is application of nasal intermittent positive pressure ventilation (NIPPV). The order of the two interventions of this crossover study is randomized but each subject will be exposed to both interventions. The period of CPAP will be compared to the period of NIPPV.

Outcomes

Primary Outcome Measures

Number of Apnea/bradycardia events
Number of episodes of apnea and/or bradycardia that trigger alarm on the bedside monitor

Secondary Outcome Measures

Number of of desaturation events
Number of episodes of pulse oximetry readings that trigger alarm on the bedside monitor
Mean oxygen saturation by pulse oximetry and proportion of time below 88%
Mean oxygen saturation by pulse oximetry and proportion of time at saturation <88%
Mean transcutaneous PCO2 and proportion of time >55 torr
Mean transcutaneous PCO2 and proportion of time at PCO2 > 55 torr
Mean fraction of inspired oxygen
Mean fraction of inspired oxygen (FIO2)
Mean respiratory rate
Mean respiratory rate
Mean degrees of phase lag by RIP
Estimate of work of breathing based on phase angle as determined by respiratory inductive plethysmography
Number of episodes of feeding intolerance
number of instances of interruption of feeding, abdominal radiographs
Instances of treatment failure
Inability to tolerate assigned treatment by pre-defined criteria

Full Information

First Posted
September 12, 2018
Last Updated
May 26, 2020
Sponsor
Women and Infants Hospital of Rhode Island
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1. Study Identification

Unique Protocol Identification Number
NCT03670732
Brief Title
CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure
Acronym
NICA
Official Title
Nasal Intermittent Positive Pressure Ventilation vs. Nasal Continuous Positive Airway Pressure at Equivalent Mean Airway Pressure in Preterm Infants: Effect on Oxygenation, CO2 Elimination, Work of Breathing and Frequency of Cardio-respiratory Events.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2017 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women and Infants Hospital of Rhode Island

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
This study seeks to determine if standard continuous positive airway pressure, known as CPAP is as effective as a more complicated approach that generates intermittent increases in airway pressure applied to the nostrils via a breathing machine. The latter is known as NIPPV and requires costly equipment to operate. Previous studies did not ensure that the average pressure applied to the lungs was equal and thus did not make for a fair comparison. The investigators believe that when the same average pressure is applied with the two techniques, CPAP is just as effective as NIPPV and may have fewer side effects, such as blowing air into the stomach. Each baby will receive CPAP or NIPPV in a random sequence for a period of 12 hours, followed by 12 hours on the alternate technique.
Detailed Description
This is a pilot clinical trial to evaluate the comparative effectiveness of two commonly used types of non-invasive respiratory support. Preterm infants < 34 weeks gestational age, who are stable on either of the two modalities of support will be studied in a cross-over study design, such that each subject acts as his/her own control. The study will assess the relative efficacy of these modalities when used with equal mean airway pressure comparing measures of oxygenation, CO2 removal, apnea/bradycardia/desaturation events and work of breathing. The initial phase of the study is complete and preliminary analysis supports the hypothesis that there is no difference between the modalities when the mean airway pressure is equal. However we recognized that use of the RAM cannula, which does not transmit pressure effectively is an important study limitation. The findings are valid, but may only be applicable to this interface, which is widely used, but increasingly recognized as flawed. We are now extending the study to determine if the findings will be the same when short bi-nasal prongs are used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Respiratory Distress Syndrome, Apnea of Prematurity
Keywords
Continuous positive airway pressure, Nasal intermittent positive pressure ventilation, Mean airway pressure, Apnea, Bradycardia, Prematurity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover non-inferiority trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPAP first
Arm Type
Active Comparator
Arm Description
The intervention is application of continuous positive airway pressure (CPAP). The order of the two interventions of this crossover study is randomized but each subject will be exposed to both interventions. The period of CPAP will be compared to the period of NIPPV.
Arm Title
NIPPV first
Arm Type
Active Comparator
Arm Description
The intervention is application of nasal intermittent positive pressure ventilation (NIPPV). The order of the two interventions of this crossover study is randomized but each subject will be exposed to both interventions. The period of CPAP will be compared to the period of NIPPV.
Intervention Type
Other
Intervention Name(s)
continuous positive airway pressure
Other Intervention Name(s)
CPAP
Intervention Description
Continuous positive airway pressure is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study
Intervention Type
Other
Intervention Name(s)
nasal intermittent positive pressure ventilation
Other Intervention Name(s)
NIPPV
Intervention Description
NIPPV is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study
Primary Outcome Measure Information:
Title
Number of Apnea/bradycardia events
Description
Number of episodes of apnea and/or bradycardia that trigger alarm on the bedside monitor
Time Frame
Duration of intervention (12 hours)
Secondary Outcome Measure Information:
Title
Number of of desaturation events
Description
Number of episodes of pulse oximetry readings that trigger alarm on the bedside monitor
Time Frame
Duration of intervention (12 hours)
Title
Mean oxygen saturation by pulse oximetry and proportion of time below 88%
Description
Mean oxygen saturation by pulse oximetry and proportion of time at saturation <88%
Time Frame
Duration of intervention (12 hours)
Title
Mean transcutaneous PCO2 and proportion of time >55 torr
Description
Mean transcutaneous PCO2 and proportion of time at PCO2 > 55 torr
Time Frame
Duration of intervention (12 hours)
Title
Mean fraction of inspired oxygen
Description
Mean fraction of inspired oxygen (FIO2)
Time Frame
Duration of intervention (12 hours)
Title
Mean respiratory rate
Description
Mean respiratory rate
Time Frame
Duration of intervention (12 hours)
Title
Mean degrees of phase lag by RIP
Description
Estimate of work of breathing based on phase angle as determined by respiratory inductive plethysmography
Time Frame
Duration of intervention (12 hours)
Title
Number of episodes of feeding intolerance
Description
number of instances of interruption of feeding, abdominal radiographs
Time Frame
Duration of intervention (12 hours)
Title
Instances of treatment failure
Description
Inability to tolerate assigned treatment by pre-defined criteria
Time Frame
Duration of intervention (12 hours)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational Age 23-34 completed weeks Stable on non- invasive respiratory support for at least 24h CPAP level of 7-12 cmH2O or NIPPV with MAP 7-12 cmH2O FiO2 requirement of <0.40 Exclusion Criteria: Clinical instability as judged by the clinical team FiO2 requirement of > 0.40 for more than 60 min. >10 apnea/bradycardia/desaturation events in past 24 h requiring moderate or vigorous stimulation. Anticipated intubation within next 24 h. Active abdominal pathology (Spontaneous Intestinal Perforation, confirmed or suspected Necrotizing Enterocolitis, bowel obstruction). Hemodynamically significant patent ductus arteriosus (PDA) Anticipated weaning off non-invasive support in the next 24 h. Any major congenital anomalies, congenital heart disease (other than PDA, atrial septal defect or ventricular septal defect) and cardiac arrhythmias Lack of study equipment or personnel Lack of parental consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Keszler, MD
Phone
401 274 1122
Ext
47490
Email
mkeszler@wihri.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Grady, MD
Phone
401 274 1122
Email
LGrady@wihri.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Shaw, PhD
Organizational Affiliation
Brown University
Official's Role
Study Director
Facility Information:
Facility Name
Women and Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Keszler, MD
Phone
401-274-1122
Ext
47490
Email
mkeszler@wihri.org
First Name & Middle Initial & Last Name & Degree
Ashish Gupta, MD
Phone
401 274 1122
Ext
47466
Email
AKGupta@wihri.org

12. IPD Sharing Statement

Plan to Share IPD
No

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CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure

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