Changes in Respiratory Effort in Preterm Infants

Not Applicable

Completed

• Conditions: Premature Birth
• Interventions: Procedure: High Flow Nasal Cannulae (HFNC); Procedure: Continuous Positive Airway Pressure (CPAP)

• Registration Number: NCT02014493
• Lead Sponsor: St. Olavs Hospital

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".

Study Timeline

• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-18
• Study Start: 2014-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Neural control of respiration	4 months	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

Name	Time	Method
Respiratory signs	4 months	Observation scale inspired by Silverman- Anderson retraction score. Observation of chest movement, intercostal retraction and xiphoid retraction.

Trial Locations

Locations (1)

Newborn Intensive Care Unit, St Olavs Hospital; 🇳🇴 Trondheim, Norway