NCT05908227

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

2.4 years

First QC Date

May 30, 2023

Last Update Submit

February 19, 2025

Conditions

Respiratory Distress Syndrome

Keywords

Nasal high flow therapyContinuous positive airway pressure

Outcome Measures

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).

    24 hours

Secondary Outcomes (30)

  • Apneas and bradycardias

    24 hours

  • Respiratory rate (RR)

    24 hours

  • Heart rate (HR)

    24 hours

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

    24 hours

  • Frequency of any treatment failure

    Individual study duration: estimated to be between a minimum of 7 days to an (estimated) maximum of 10 weeks.

  • +25 more secondary outcomes

Study Arms (3)

NHF high

EXPERIMENTAL

Nasal high flow therapy 8L/min

Other: NHF high

NHF low

EXPERIMENTAL

Nasal high flow therapy 6L/min

Other: NHF low

NCPAP

ACTIVE COMPARATOR

Nasal continuous positive airway pressure 6 cm H20

Other: NCPAP

Interventions

NHF highOTHER

Nasal high flow therapy 8L/min.

NHF high
NHF lowOTHER

Nasal high flow therapy 6L/min.

NHF low
NCPAPOTHER

Nasal continuous positive airway pressure 6 cm H20

NCPAP

Eligibility Criteria

Age23 Weeks - 31 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Medical Center of the Johannes Gutenberg-University Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

Department of Pediatrics, Inselspital

Bern, 3010, Switzerland

RECRUITING

Related Publications (1)

  • Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available.

    PMID: 11401896RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • André Kidszun, Prof. Dr. med.

    Division of Neonatology, Department of Pediatrics, Inselspital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Marie Bünte

CONTACT

+41 31 632 19 23lisamarie.buente@insel.ch

André Kidszun, Prof. Dr. med.

CONTACT

+41 31 632 14 01andre.kidszun@insel.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the study design masking is not possible.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 18, 2023

Study Start

July 1, 2023

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)DE(1)