Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy 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

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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This is a multi center parallel group three arm randomized controlled clinical trial investigating cardiorespiratory stability in stable preterm infants receiving NHF.

Currently, NCPAP remains the gold standard for administration of prolonged non-invasive ventilatory support in very preterm infants. NHF is a promising method for tailored, less invasive long-term ventilatory support for preterm infants. If ventilatory support with NHF is similarly effective to conventional NCPAP in stable preterm infants, clinicians are likely to adopt this method for widespread clinical use because of its improved comfort and potential other benefits. Primary aim of this trial is to examine cardiorespiratory stability in preterm infants treated with two commonly used NHF flowrates (Interventional group 1 and 2) in comparison to NCPAP (Comparator). Secondary aim is to examine potential comfort-related beneficial effects of NHF.

Conditions

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Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Due to the nature of the study design masking is not possible.

Study Groups

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NHF high

Nasal high flow therapy 8L/min

Group Type EXPERIMENTAL

NHF high

Intervention Type OTHER

Nasal high flow therapy 8L/min.

NHF low

Nasal high flow therapy 6L/min

Group Type EXPERIMENTAL

NHF low

Intervention Type OTHER

Nasal high flow therapy 6L/min.

NCPAP

Nasal continuous positive airway pressure 6 cm H20

Group Type ACTIVE_COMPARATOR

NCPAP

Intervention Type OTHER

Nasal continuous positive airway pressure 6 cm H20

Interventions

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NHF high

Nasal high flow therapy 8L/min.

Intervention Type OTHER

NHF low

Nasal high flow therapy 6L/min.

Intervention Type OTHER

NCPAP

Nasal continuous positive airway pressure 6 cm H20

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Inclusion if all apply.

* Preterm infants up to 31+6 weeks GA admitted to the Division of Neonatology at Inselspital Bern, Switzerland or Division of Neonatology at the University Medical Center of the Johannes Gutenberg-University Mainz, Germany (inborn or outborn)
* \>2nd day of life (defined as date day)
* Stable on NCPAP 6 cm H2O for ≥ 24 hours, defined as:

* ≤ 2 apneas with concomitant bradycardias (\<100/min) per hour for the previous 6 hours
* FiO2 ≤ 0.3 and not increasing
* No significant chest recessions (Silverman Score \< 5)
* Respiratory rate ≤ 60/min
* No need for intermittent positive pressure ventilation
* Parents with an age 18+ years
* Written parental informed consent (or other legal representative)

Exclusion Criteria

Exclusion if any applies.

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

Minimum Eligible Age

23 Weeks

Maximum Eligible Age

31 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No