Pilot Study Comparing Different Modes of Non-invasive Ventilation for the Oral Feeding of Preterm Infants (CHOMP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02055339|
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : November 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Feeding Behavior Chronic Lung Disease||Device: Fisher & Paykel heated humidified high flow nasal cannula Device: InfantFlow/RAM nasal continuous positive airway pressure||Not Applicable|
The primary objective of this study is to assess whether a baby born at less than 28 weeks gestation who at 34 weeks corrected gestational age, will reach full oral feeds faster on the current practice of nasal continuous positive airway pressure (nCPAP) and low flow oxygen (LFO2) or the new intervention of heated, humidified high flow nasal cannula (HHHFNC).
The specific aim of this study is to investigate the effectiveness and safety of using nCPAP and LFO2 versus HHHFNC for reaching full oral feeds in premature infants.
We hypothesize that the use of HHHFNC at the initiation of oral feeding will allow babies to reach full feeds sooner as compared with nCPAP and LFO2.
Babies born at extreme prematurity (<28 weeks gestation), are at risk of chronic lung disease due to lung immaturity. A proportion of preterm infants remains dependent on non-invasive ventilation at the corrected gestational age when they are at the neurodevelopmental stage of oral feeds. If oral feeds are not initiated in a timely manner, delays in progression of oral feeds and oral aversion may occur, resulting in longer hospital stays and/or gastrostomy tube insertions. Those that are nCPAP dependant are unable to orally feed due to safety concerns so are placed on a low pressure system of low flow nasal cannula during feeds. This may lead to microatelectasis in those babies needing a higher pressure to maintain gas exchange. HHHFNC is another method of non-invasive ventilation and it can be changed from a high pressure system (in litres per minute) to a low pressure system by turning a dial, and not having to disconnect the baby from the respiratory system.
Randomized controlled trial consisting of two arms: 1) The CPAP/LFO2 arm in which the babies will be maintained on nCPAP until the time of oral feeds wherein they will have their circuits exchanged for a low flow cannula. 2) The HHHFNC arm in which babies will be maintained on 5 lpm of HHHFNC until the time of oral feeds, wherein they will have their flows turned down to 2 lpm. The study will be conducted in a level III neonatal intensive care unit (NICU) in Mount Sinai hospital. The study subjects are 40 preterm babies that were born before 28 weeks gestational age who are now 34 weeks corrected gestational age (CGA), which are dependent on non-invasive ventilation and are receiving full feeds via nasogastric tube. The randomization will occur at 33+6/7 weeks CGA. Demographic characteristics will be compared between groups using Chi-square test or Fisher's exact test for categorical variables. Differences between continuous variables will be assessed using Student's t-test or Mann-Whitney U test for non-normally distributed variables. The primary outcome (time to full oral feeds) is a binary outcome and will be compared between groups using Chi-square test or Fisher's exact test. A difference of a p-value of <0.05 will be considered significant.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Nasal Continuous Positive Airway Pressure With Low Flow Oxygen Versus Heated, Humidified High Flow Nasal Cannula for Oral Feeding of the Premature Infant (CHOMP Trial): A Pilot Study|
|Actual Study Start Date :||March 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Fisher & Paykel heated humidified high flow nasal cannula
For neonates randomized to HHHFNC, they will be placed on a flow rate equivalent to the pressures of nCPAP they were originally receiving based on a published chart, or stay on the same flow rate prior to randomization. When it is time for oral feeds, the Registered Nurse (RN) will turn the dial of the high flow circuit down to 2 lpm. The baby will then proceed to feed for up to one hour, and afterwards, will be turned back up to the flow rate they were on prior to feeds.
Device: Fisher & Paykel heated humidified high flow nasal cannula
Active Comparator: InfantFlow/RAM nasal continuous positive airway pressure
Neonates randomized to the nCPAP arm will remain on the nCPAP pressures they were on before recruitment into the study or match the flow rate they were receiving on high flow based on a published chart. The nCPAP circuit will only be removed when it is time for oral feeds. The respiratory therapist (RT) will exchange the circuit for a low flow nasal cannula which will be set at the flow that is optimal for the baby's gestational age saturations. The baby will then proceed to feed for up to one hour, and afterwards, will be changed back to the nCPAP circuit.
Device: InfantFlow/RAM nasal continuous positive airway pressure
- Time to reach full oral feeds [ Time Frame: 2 months ]
- Time on non-invasive ventilation or oxygen [ Time Frame: 2 months ]
- Occurrence of feeding intolerance or reflux [ Time Frame: 2 months ]
- Occurrence of apneas/bradycardias/desaturations above baseline [ Time Frame: 2 months ]
- Weight gain [ Time Frame: 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055339
|Mount Sinai Hospital NICU|
|Toronto, Ontario, Canada|
|Principal Investigator:||Sandra Leibel, MD||MOUNT SINAI HOSPITAL|