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

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Jun 8, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a new breathing aid called Nasal High Flow Therapy (NHF) for premature babies who have Respiratory Distress Syndrome. Traditionally, these infants are treated with a method called NCPAP, which helps keep their airways open, but it can be time-consuming and may cause some side effects. The researchers believe that NHF could be just as effective as NCPAP while being easier to use and more comfortable for the babies.

To participate in the trial, infants need to be born prematurely (up to about 32 weeks) and have been stable on the NCPAP treatment for at least 24 hours. They should also meet certain health criteria, such as having a low number of breathing pauses and not needing additional breathing support. Parents must be at least 18 years old and provide written consent for their baby to take part. If eligible, families can expect their child to receive either NHF or continue with NCPAP, and the researchers will closely monitor their breathing and overall stability during the study.

Gender

ALL

Eligibility criteria

• 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