Actively Recruiting

Phase Not Applicable
Age: 23Weeks - 31Weeks
All Genders
NCT05908227

Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-02-21

150

Participants Needed

2

Research Sites

135 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Premature babies often need help breathing for a longer period of time. Traditionally, this is done with a breathing aid called NCPAP (nasal continuous positive airway pressure). This treatment is safe and effective, but it is very time-consuming and can sometimes have side effects. In the present research project, the investigators want to find out whether another type of breathing aid called NHF (nasal high flow therapy) is just as effective for stable premature babies. The investigators suspect that NHF is just as effective, but easier to use and more comfortable.

CONDITIONS

Official Title

Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants

Who Can Participate

Age: 23Weeks - 31Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm infants up to 31 weeks and 6 days gestational age admitted to the specified neonatal units in Switzerland or Germany
  • Older than 2 days of life
  • Stable on NCPAP 6 cm H2O for at least 24 hours with no more than 2 apneas with bradycardia per hour in the last 6 hours
  • Oxygen need (FiO2) 0.3 or less and not increasing
  • No significant chest recessions (Silverman Score less than 5)
  • Respiratory rate 60 breaths per minute or less
  • No need for intermittent positive pressure ventilation
  • Parents aged 18 years or older
  • Written parental informed consent obtained
Not Eligible

You will not qualify if you...

  • Significant fetal anomalies
  • Receiving primary palliative care
  • Stable on NCPAP 6 cm H2O for more than 120 hours according to stability criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University Medical Center of the Johannes Gutenberg-University Mainz

Mainz, Rhineland-Palatinate, Germany, 55131

Actively Recruiting

2

Department of Pediatrics, Inselspital

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

L

Lisa Marie Bünte

CONTACT

A

André Kidszun, Prof. Dr. med.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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