Comparison of two methods of continuous positive airway pressure (CPAP) to support successful extubation of infants of birth weights less than or equal to 1500 grams (C2CPAP)

Category Primary study
Registry of TrialsANZCTR
Year 2005
INTERVENTION: When the clinical team has made the decision that an infant will be extubated to CPAP parents will be approached regarding this study. If parents are willing to receive information, it will be given at this time, and all questions answered. The recruiter will then withdraw to allow parents to consider participation privately, returning at a mutually agreeable time to receive parents decision. If parents agree to this study this will be documented on the infants chart and members of the clinical team will be notified. Immediately before extubation the infant will be randomized to Bubble CPAP (experimental group) or to receive Infant Flow System (IFS) CPAP (standard group). The respiratory therapist (RRT) on duty will pick the next randomization card in the appropriate size group (less than1000 g and 1001 to 1500 g). If randomized to the bubble CPAP (experimental arm of this study), an infant upon extubation, will be placed on a bubble CPAP system. A CPAP level of 5 cm H2O will be initiated. The bubble CPAP system will consist of a humidified, blended (oxygen and air) gas source delivered through a heated wire disposable circuit. The CPAP will be delivered by placing the expiratory limb of the patient circuit in a container of water to the desired depth. The expiratory portion of the circuit will be placed five centimetres under water, which will deliver 5 cmH2O of CPAP. There will be eight centimeters of water in the container to ensure that an excessive CPAP level cannot be accidentally attained. A flow of 6 to 8 lpm will be used to meet the inspiratory flow demand of the infant and to ensure a consistent bubbling of H2O in the system. The interface between the infant and the bubble CPAP will be Hudson dual nasal prongs. These prongs come in different sizes and the appropriate size of prong will be used as recommended by the manufacturer and as judged by the bedside clinician to ensure a comfortable and effective seal. If randomized to the IFS CPAP (standard treatment arm of this study), an infant upon extubation will be placed on an IFS CPAP system. A CPAP level of 5 cm H2O will be initiated, a flow adequate to achieve this level of CPAP will be used CONDITION: It has been shown that premature infants are successfully extubated using CPAP. This study compares two popular methods of delivering CPAP to determine if one is more successful at supporting extubation in infants less than or equal to 1500 gram infants. PRIMARY OUTCOME: The failure of extubation as defined by the following: pH less than 7.25 and PCO2 greater than 65 (or an increase of 15 mmHg from pre extubation), a sustained (greater than 1 hour) increase in FiO2 of .15 (as compared to pre extubation) or significant apnoea and bradycardia requiring manual resuscitation at anytime. If these criteria are met within 7 days post extubation this will be considered failure of extubation. SECONDARY OUTCOME: Average weight gain on CPAP Corrected gestational age at cessation of CPAP Length of time in days on CPAP Pain Reintubation The presence of nasal tissue damage will also be documented but only as an exploratory question. INCLUSION CRITERIA: 1) Intubated infant 2) less than or equal to 1500 grams at birth 3) Decision to extubate to CPAP made by the clinical team 4) Written informed consent obtained. 8 lpm as suggested by the manufacturer. Nasal prongs of an appropriate size as recommended by the manufacturer and judged by the bedside clinician will be used to provide the interface between the infant and the IFS. A Premature Infant Pain Profile (PIPP) Score will be evaluated within the 24 hours post initiation of CPAP device. An infant will remain on CPAP unless failure criteria are met or specific criteria are met to wean infant off CPAP. If the infant does not meet reintubation criteria within 7 days of extubation, extubation will be considered successful. If an infant is reintubated the reason for reintubation will be documented. An infant may be removed from CPAP if the following criteria are met FiO2 < 0.30, respiratory rate <80 and < than one per hour apnoea or bradycardia episodes requiring stimulation in the previous 12 hours. If the infant needs to go back onto CPAP this will not be considered a negative outcome.
Epistemonikos ID: 8418922151fccf28a2a4d9b46d0f83efb7fb1117
First added on: Aug 21, 2024