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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Continuous Positive Airway Pressure, Apnea of Prematurity, CPAP

Intervention / Treatment
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* Device: Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 14 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Stephanie (TM), Infant Flow (TM), Infant Flow advance (TM), Bubble CPAP|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative percentage of bradycardia (heart rate <80 beats/min) and desaturation (SaO2 <80%) per hour |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Event rates for central apneas, desaturations and bradycardias calculated as the number of respective events per hour of artefact free recording time - relative cumulative event time - baseline heart rate, respiratory rate and oxygen saturation |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPAP, Preterm, Prematurity, Apnea of prematurity