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Changes in Respiratory Effort in Preterm Infants

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
High Flow Nasal Cannulae (HFNC)
Continuous Positive Airway Pressure (CPAP)
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Birth focused on measuring Respiration, Noninvasive Ventilation, Work of breathing, Infant, premature, Electromyography, Diaphragm

Eligibility Criteria

28 Weeks - 34 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Preterm infants who are stable on Nasal Continuous Positive Airway Pressure (nCPAP) with flow 8l/min
  • <34 and >28 gestational weeks, respiratory stable last 72 hours.
  • 1 kilo
  • Fi02< 30%
  • C02<9
  • written informed consent by parents/caregivers

Exclusion Criteria:

  • need for sedation
  • damage on the phrenic nerve
  • anomalies in the upper airways

Sites / Locations

  • Newborn Intensive Care Unit, St Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HFNC first

CPAP first

Arm Description

4 hours with High Flow Nasal Cannulae (HFNC) 6 l/pr.min, then 4 hours with Continuous Positive Airway Pressure (CPAP) 6l/pr.min.

4 hours Continuous Positive Airway Pressure (CPAP) 6 l/pr.min, then 4 hours High Flow Nasal Cannulae (HFNC) 6 l/pr.min.

Outcomes

Primary Outcome Measures

Neural control of respiration
reflected by electrical activity of the diaphragm (Edi): inspiratory drive (Edi peak) and tonic activity (Edi min). A nasogastric feeding tube with ten microsensors will measure action potentials from the phrenic nerve to the diaphragm.

Secondary Outcome Measures

Respiratory signs
Observation scale inspired by Silverman- Anderson retraction score. Observation of chest movement, intercostal retraction and xiphoid retraction.

Full Information

First Posted
December 4, 2013
Last Updated
March 6, 2018
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02014493
Brief Title
Changes in Respiratory Effort in Preterm Infants
Official Title
Respiratory Effort in Preterm Infants in the Transition From Continuous Positive Airway Pressure (CPAP) to High Flow Nasal Cannulae (HFNC)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Continuous Positive Airway Pressure (CPAP) is used to treat preterm infants with an immature respiratory center and having respiratory distress. CPAP requires intensive care monitoring and special qualified staff. Continuous positive pressure makes a constant noise around the child and can lead to an uncomfortable environment.The fixture of the binasal prongs can cause nasal trauma after to tight attachment.Minimizing the time on CPAP is considered important for the child. Recently High-Flow Nasal Cannula (HFNC) has become widely used in modern newborn intensive care units.HFNC is considered to be easy to apply and a more comfortable respiratory support for the preterm infant with mild and moderate respiratory distress. HFNC gives warm humified air with high flow through a nasal cannulae. HFNC is used as part of withdrawal from intensive respiratory support, to prevent respiratory distress and as a respiratory support after extubation. There is still uncertainty about safety and effectiveness of HFNC. The aim of this study is to investigate the preterm infants respiratory effort by measuring electrical activity in diaphragm (Edi max and Edi min), respiratory parameters and a clinical observation using a scoring system inspired by Silverman- Andersen retraction score. It is expected that measured electrical activity in the diaphragm, measured respiratory parameters combined with bedside observations provide applicable knowledge about preterm infants respiratory effort in transition from CPAP to HFNC.
Detailed Description
Data material will be stored on a separate computer in a sheltered home Directory. All data will be anonymous. Edi signals are transported from Servo-I ventilator with neural access through a communication port to a personal computer.Respiratory parameters will be stored in Picis (High Performance Hospital Information System). For the Statistical analyzes a T-test will be carried out, and data from the pilot study will decide the power to see whether we reject or retain the 0 hypothesis: " There are no changes in the preterm infants respiratory effort in transition from CPAP to HFNC".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
Respiration, Noninvasive Ventilation, Work of breathing, Infant, premature, Electromyography, Diaphragm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HFNC first
Arm Type
Active Comparator
Arm Description
4 hours with High Flow Nasal Cannulae (HFNC) 6 l/pr.min, then 4 hours with Continuous Positive Airway Pressure (CPAP) 6l/pr.min.
Arm Title
CPAP first
Arm Type
Active Comparator
Arm Description
4 hours Continuous Positive Airway Pressure (CPAP) 6 l/pr.min, then 4 hours High Flow Nasal Cannulae (HFNC) 6 l/pr.min.
Intervention Type
Procedure
Intervention Name(s)
High Flow Nasal Cannulae (HFNC)
Intervention Description
HFNC 6 l/pr.min
Intervention Type
Procedure
Intervention Name(s)
Continuous Positive Airway Pressure (CPAP)
Intervention Description
CPAP 6 l/pr.min
Primary Outcome Measure Information:
Title
Neural control of respiration
Description
reflected by electrical activity of the diaphragm (Edi): inspiratory drive (Edi peak) and tonic activity (Edi min). A nasogastric feeding tube with ten microsensors will measure action potentials from the phrenic nerve to the diaphragm.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Respiratory signs
Description
Observation scale inspired by Silverman- Anderson retraction score. Observation of chest movement, intercostal retraction and xiphoid retraction.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preterm infants who are stable on Nasal Continuous Positive Airway Pressure (nCPAP) with flow 8l/min <34 and >28 gestational weeks, respiratory stable last 72 hours. 1 kilo Fi02< 30% C02<9 written informed consent by parents/caregivers Exclusion Criteria: need for sedation damage on the phrenic nerve anomalies in the upper airways
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Håkon Bergseng, MD PhD
Organizational Affiliation
St. Olavs Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Newborn Intensive Care Unit, St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
29504671
Citation
Brenne H, Grunewaldt KH, Follestad T, Bergseng H. A randomised cross-over study showed no difference in diaphragm activity during weaning from respiratory support. Acta Paediatr. 2018 Oct;107(10):1726-1732. doi: 10.1111/apa.14303. Epub 2018 Apr 4.
Results Reference
result

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Changes in Respiratory Effort in Preterm Infants

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