Level of Continuous Positive Airway Pressure (CPAP) in Preterm Infants After Extubation (L-CPAP Study)

Study Overview
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Brief Summary
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Despite widely used of nasal CPAP in preterm infants, uncertainties regarding aspects of its application remain. Clinical indications vary greatly between institutions, especially when combined with varieties of systems, devices, and techniques available. One of the controversial aspects that needs to be clarified is the level of pressure which should be used. The objective of the study is to compare the effectiveness of two ranges of nCPAP pressure that are within the spectrum of current practice for post-extubation support in very preterm infants.

Detailed Description
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The use of nCPAP has been established as an effective respiratory support to prevent extubation failure and as treatment of other pulmonary diseases. An upsurge in its popularity has resulted in some controversial aspects, including the level of pressure to be used. The level that has been used in very preterm infants after extubation, which mostly came from anecdotal data, varies from 3 to 10 cmH2O. Physiologic studies show higher nCPAP pressures improve lung mechanical properties. Though potential side effects have been of concern in practical application, there is no formal evidence supporting the concept that increased CPAP pressure results in a higher risk of complications. In relatively stable preterm infants, the range of optimal CPAP level needs to be established in order to adequately support the upper airway and lungs, without increasing complications secondary to the pressure applied. Given the uncertainty of the nCPAP pressure that should be used in very preterm infants, we conduct a randomized controlled trial to compare the effectiveness of two ranges of nCPAP pressure for post-extubation support in very preterm infants. The purpose of this trial is to compare the rate of successful extubation of using the nasal CPAP level of 7 to 9 cmH2O compared to level of 4 to 6 cmH2O.

Official Title
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Nasal Continuous Positive Airway Pressure in Preterm Infants After Extubation: Comparison of Different Levels of Pressure

Conditions
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Respiratory Insufficiency of Prematurity

Intervention / Treatment
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* Device: Nasal CPAP, level 7 to 9 cmH2O
* Device: Nasal CPAP, level 4 to 6 cmH2O


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Birth weight 500 - 1,250 g On mechanical ventilation before 7 days of age First extubation before 14 days of age Exclusion Criteria: Presence of lethal anomalies or upper airway abnormalities IVH, grade 3 or 4 Neuromuscular disorders Receiving muscle relaxation at time of extubation Congenital heart disease, except for PDA GI problems resulting in a need to avoid gastric distension

Ages Eligible for Study
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Maximum Age: 14 Days

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Nasal CPAP, level of 7 to 9 cmH2O | Device: Nasal CPAP, level 7 to 9 cmH2O<br>* Apply nasal CPAP pressure of 7-9 H2O for the first 72 hours of extubation<br>* Other names: High pressure nCPAP, 7-9 cmH2O;|
| Active Comparator: 2<br>Nasal CPAP, level 4 to 6 cmH2O | Device: Nasal CPAP, level 4 to 6 cmH2O<br>* Apply nasal CPAP pressure of 4 to 6 cmH2O for the first 72 hours of extubation<br>* Other names: Low pressure CPAP, 4-6 cmH2O;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of successful extubation within 72 hours of extubation |  | within 72 hours after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of successful extubation within 7 days of extubation |  | within 14 days after extubation | 
| Number of days on nCPAP |  | within 14 days after extubation | 
| Occurrence of air leak syndrome |  | within 14 days after extubation | 
| Occurrence of IVH grade 3 or 4 |  | within 14 days after extubation | 
| Occurrence of traumatized nasal septum |  | within 14 days after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory distress syndrome, Preterm infants, Extubation failure, Pneumothorax, Lung injury, Airway pressure