Changes in Respiratory Effort in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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".

Conditions

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Premature Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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HFNC first

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

Group Type ACTIVE_COMPARATOR

High Flow Nasal Cannulae (HFNC)

Intervention Type PROCEDURE

HFNC 6 l/pr.min

CPAP first

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

Group Type ACTIVE_COMPARATOR

Continuous Positive Airway Pressure (CPAP)

Intervention Type PROCEDURE

CPAP 6 l/pr.min

Interventions

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High Flow Nasal Cannulae (HFNC)

HFNC 6 l/pr.min

Intervention Type PROCEDURE

Continuous Positive Airway Pressure (CPAP)

CPAP 6 l/pr.min

Intervention Type PROCEDURE

Eligibility Criteria

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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