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New treatment option for Respiratory Distress Syndrome
Official title Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants
ClinicalTrials.gov ID: NCT05908227
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 23 to 31
You may be able to join if
- 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...
- \>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
You likely can't join if
- 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
See the full eligibility 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...
- \>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 if any applies.
- Significant fetal anomalies
- Primary palliative care
- Stable on NCPAP 6 cm H2O according to stability criteria for more than 120 hours
The study team makes the final eligibility decision.
Where it's taking place
- Mainz, Rhineland-Palatinate, Germany
- Bern, Switzerland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 23 weeks to 31 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mainz, Rhineland-Palatinate, Germany; Bern, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.