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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age23-31
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

≤ 2 apneas with concomitant bradycardias (<100/min) per hour for the previous 6 hours

FiO2 ≤ 0.3 and not increasing

Disqualifiers

Significant fetal anomalies

Primary palliative care

Stable on NCPAP 6 cm H2O according to stability criteria for more than 120 hours

Trial design

Design model

Parallel

Treatments tested in this trial

  • NHF high

    Other intervention

    Nasal high flow therapy 8L/min.

  • NHF low

    Other intervention

    Nasal high flow therapy 6L/min.

  • NCPAP

    Other intervention

    Nasal continuous positive airway pressure 6 cm H20

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: NHF highExperimental treatment 1 intervention
Group B: NHF lowExperimental treatment 1 intervention
Group C: NCPAPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Treatment failure

Treatment failure is a composite outcome defined as meeting one of the following treatment failure criteria within 24 hours of starting of intervention: 1. \>2 apneas with concomitant bradycardias (\<100/min) per hour for \> 1 hour or 2. FiO2 \> 0.3 consistently for \> 1 hour or 3. Significant chest recessions (Silverman Score ≥ 5) for \> 1 hour or 4. Respiratory rate \> 60/min consistently for \> 1 hour or 5. Any need for intermittent positive pressure ventilation The presence of "Treatment failure" within 24 hours of starting of intervention will be documented (dichotomous outcome; yes/no).

Time frame
24 hours

Secondary outcomes

1

Apneas and bradycardias

The total frequency of apneas and bradycardias (\<100/min) within 24 hours of starting of intervention will be documented.

Time frame
24 hours
2

Respiratory rate (RR)

The mean RR within 24 hours of starting of intervention will be documented.

Time frame
24 hours
3

Heart rate (HR)

The mean HR within 24 hours of starting of intervention will be documented.

Time frame
24 hours
4

Oxygen saturation (SpO2) and fraction of inspired oxygen (FiO2)

The mean SpO2/FiO2 ratio within 24 hours of starting of intervention will be documented.

Time frame
24 hours

Other outcomes

Sponsors and contacts

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