Level of CPAP in Preterm Infants After Extubation (L-CPAP Study) - Full Text View

Sponsored by:	Hamilton Health Sciences
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00636324

Purpose

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.

Condition	Intervention	Phase
Respiratory Insufficiency of Prematurity	Device: Nasal CPAP, level 7 to 9 cmH2O Device: Nasal CPAP, level 4 to 6 cmH2O	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Nasal Continuous Positive Airway Pressure in Preterm Infants After Extubation: Comparison of Different Levels of Pressure

Further study details as provided by McMaster University:

Primary Outcome Measures:

The rate of successful extubation within 72 hours of extubation [ Time Frame: within 72 hours after extubation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The rate of successful extubation within 7 days of extubation [ Time Frame: within 14 days after extubation ] [ Designated as safety issue: Yes ]
Number of days on nCPAP [ Time Frame: within 14 days after extubation ] [ Designated as safety issue: Yes ]
Occurrence of air leak syndrome [ Time Frame: within 14 days after extubation ] [ Designated as safety issue: Yes ]
Occurrence of IVH grade 3 or 4 [ Time Frame: within 14 days after extubation ] [ Designated as safety issue: Yes ]
Occurrence of traumatized nasal septum [ Time Frame: within 14 days after extubation ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	180
Study Start Date:	July 2007
Estimated Study Completion Date:	June 2010
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Nasal CPAP, level of 7 to 9 cmH2O	Device: Nasal CPAP, level 7 to 9 cmH2O Apply nasal CPAP pressure of 7-9 H2O for the first 72 hours of extubation
2: Active Comparator Nasal CPAP, level 4 to 6 cmH2O	Device: Nasal CPAP, level 4 to 6 cmH2O Apply nasal CPAP pressure of 4 to 6 cmH2O for the first 72 hours of extubation

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	up to 14 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636324

Contacts

Contact: Guilherme M SantAnna, MD	905 521 2100 ext 76487	santang@mcmaster.ca
Contact: Ratchada Kitsommart, MD	905 521 2100 ext 75612	rkitsommart@hotmail.com

Locations

Canada, Ontario
Division of Neonatology, Hamilton Health Sciences	Recruiting
Hamilton, Ontario, Canada, L8P 3Z5
Contact: Guilherme M SantAnna, MD 905 521 2100 ext 76487 santang@mcmaster.ca
Contact: Ratchada Kitsommart, MD 905 521 2100 ext 75612 rkitsommart@hotmail.com

Sponsors and Collaborators

Hamilton Health Sciences

Investigators

Principal Investigator:

Giulherme M SantAnna, MD

Hamilton Health Sciences

More Information

Responsible Party:	Hamilton Health Sciences ( Guilherme Mendes Sant'Anna )
Study ID Numbers:	REB project # 07-047
Study First Received:	March 7, 2008
Last Updated:	March 13, 2008
ClinicalTrials.gov Identifier:	NCT00636324
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McMaster University:

Respiratory distress syndrome
Preterm infants
Extubation failure

Pneumothorax
Lung injury
Airway pressure

Study placed in the following topic categories:

Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders
Pneumothorax

ClinicalTrials.gov processed this record on January 16, 2009