Randomised crossover trial of different nasal support systems for the treatment of apnea of prematurity

Randomised crossover trial of different nasal support systems for the treatment of apnea of prematurity - NASUS

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005387

Enrollment

Registered

2013-11-12

Start date

2013-12-16

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

P28.4

Interventions

Group 1: Nasal CPAP via variable flow device (Infant Flow

Electro Medical Equipment, Brighton, UK) (PEEP 6 cm H2O) Group 2: Nasal CPAP using a conventional respirator (Stephanie

Stephan, Gackenbach, Germany) with application of respiratory support by Hudson prongs and additional background support, synchronisation via Graseby Respiration Sensor placed on the abdomen (SIMV f=2

Stephan, Gackenbach, Germany) with application of respiratory support by Hudson prongs and additional background support via high frequency ventilation (variable amplitude, P osz.: 15 cm H2O, MAP: 6 c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Gestational age at birth = 34 0/7 weeks; age at study performance = 38 0/7 weeks; persistent apneas despite administration of caffeine; apnea-score = 6 (a score used routinely at our neonatal intensive care unit to monitor the frequency and severity of apneas); parental approval and written informed parental consent

Exclusion criteria

Exclusion criteria: Congenital severe dysplasia (e.g. congenital heart defect, chromosome abnormality); symptomatic apnea due to sepsis, epileptic seizure, hypoglycemia or intracerebral haemorrhage; neuromuscular, muscular or skeletal disease; necessity of changing the dosis of caffeine or doxapram; necessity of intubation and mechanical ventilation

Design outcomes

Primary

Measure	Time frame
Combined rate of intermittent hypoxia (SpO2 <80%) and bradycardia (pulse rate <80/min.) per hour. The recording of aterial oxygen saturation is carried out using a Vitaguard 300 (Getemed, Teltow, Germany) monitor for a period of 48 hours (each intervention for 8 hours, then the last one for another 24 hours).	—

Secondary

Measure	Time frame
Mean FiO2, mean tcPCO2 and change of abdominal girth during the particular 8-hour interval (documentation through nursing staff).	—

Countries

Germany

Contacts

Public ContactAnette Poets

Universitätsklinik für Kinder- und Jugendmedizin, Abt. IV Neonatologie

anette.poets at med.uni-tuebingen.de07071/2980877

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026