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Changes in Respiratory Effort in Preterm Infants

NCT02014493 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-03-08

No results posted yet for this study

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.

Conditions

  • Premature Birth

Interventions

PROCEDURE

High Flow Nasal Cannulae (HFNC)

HFNC 6 l/pr.min

PROCEDURE

Continuous Positive Airway Pressure (CPAP)

CPAP 6 l/pr.min

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    collaborator OTHER

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Håkon Bergseng, MD PhD · St. Olavs Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
28 Weeks
Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02014493 on ClinicalTrials.gov