Randomized Trial Investigating Four Nasal CPAP Systems in the Management of Apnea of Prematurity

University Hospital Tuebingen

Status: Terminated

Conditions: Continuous Positive Airway Pressure; Apnea of Prematurity; CPAP

Treatments: Device: Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT00482040

CPAP-I-Study

Details and patient eligibility

About

The purpose of this study is to evaluate four different nasal continuous pressure systems, which are usually applied on our neonatal intensive care unit, with regard of their effect on bradycardia and desaturations in preterm infants.

Full description

BACKGROUND:

Apnea of prematurity (AOP) is a common problem in preterm infants. Nasal respiratory support using either Continuous Positive Airway Pressure (CPAP) or Intermittent Mandatory Ventilation (IMV) are, among others, widely used treatments. Which of the different systems is the most efficient, however, is unclear.

OBJECTIVE:

Efficiency of different CPAP systems on reducing the cumulative percentage of bradycardia and desaturation in preterm infants.

METHODS:

In a prospective, randomized, cross-over trial 32 preterm infants Infants will randomly allocated to receive nasal CPAP delivered by one of the following sys-tems: (1) a conventional IMV-System (Stephanie, Stephan GmbH, Germany with PIP 15 cmH2O, RR 10/min) delivering CPAP via short binasal prongs (Hudson RCI, USA); (2) the Infant-Flow-System (EME Ltd, Great Britain) with CPAP delivery via short binasal prongs; (3) the Infant-Flow-AdvanceTM-System used in the pressure assist mode with PIP 10 cmH2O, RR 10/min; and (4) a nasal underwater bubble CPAP with application via binasal prongs (Hudson RCI, USA).

All systems will be adjusted to achieve an approximate PEEP of 6 cm H2O. Each study lasts 24 hours, during which chest wall and abdominal movements, SaO2, tcPCO2, ECG, esopha-gus pressure and CPAP-/IMV-pressure will be recorded continuously. Infants will be studied in room air in a 15° head tilt prone position while being treated with caffeine (3mg/kg/d).

PRIMARY OUTCOME MEASURE Cumulative percentage of bradycardia (heart rate <80/min) and desaturation (SaO2 <80%) per hour.

Enrollment: 16 patients

Sex: All

Ages: Under 14 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• gestational age at birth < 34 weeks
• postconceptional age and body weight at study ≤38 week and >1000 g
• requirement for N-CPAP to treat AOP as judged by the attending neonatologist

Exclusion criteria

• congenital or chromosomal abnormalities
• acute infections
• intraventricular hemorrhage
• additional inspired oxygen to maintain pulse oximeter saturation SpO2 >92%
• patent ductus arteriosus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind