Feeding BehaviorCHOMPNCT02055339
Pilot Study Comparing Different Modes of Non-invasive Ventilation for the Oral Feeding of Preterm Infants
A study testing Fisher & Paykel heated humidified high flow nasal cannula and InfantFlow/RAM nasal continuous positive airway pressure in people with Feeding Behavior and Chronic Lung Disease, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Preterm infants born before 28 weeks gestation are at risk for lung disease and require oxygen and pressure to keep their lungs open. This usually involves a device called nasal continuous positive airway pressure (nCPAP). Read more about this study
- Who is it for?
- Ages 32 to 34 weeks
- Conditions the study is for
- Feeding Behavior, Chronic Lung Disease
- What is being tested?
- Fisher & Paykel heated humidified high flow nasal cannula and InfantFlow/RAM nasal continuous positive airway pressure
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age of <28 weeks (24+0 to 27+6) with corrected gestational age of 34 weeks
- Neonates requiring respiratory support in the form of nCPAP or HHHFNC at any pressure at 34 weeks corrected gestational age and failing a trial of low flow oxygen or room air
- Full enteral feeding tolerated through a nasogastric tube
Who cannot join
- Gestational age > 28 weeks
- Neonate requiring biphasic nCPAP
- Mother never at the bedside and no consent for bottle feeds
- Severe nasal breakdown or genetic/neurologic abnormalities which impair oral feeding
Trial locations and contacts
1 site in 1 country.
About this study
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
Preterm infants born before 28 weeks gestation are at risk for lung disease and require oxygen and pressure to keep their lungs open. This usually involves a device called nasal continuous positive airway pressure (nCPAP). When preterm babies reach a certain age, they are ready to begin to feed by mouth, but for those on nCPAP, oral feeds are usually not started due to concerns for choking. This may cause them to miss their window of learning and may lead to a longer hospital stay or oral aversion. Sometimes babies are switched from nCPAP to low flow oxygen (LFO2) for a short time for oral feeds, but this may not provide enough support for their lungs. Heated, humidified high flow nasal cannula (HHHFNC) is another mode of providing oxygen and pressure. It is equal to nCPAP in small babies transitioning off of ventilators, but no studies have been done in older babies. We plan to compare the feeding of babies orally using either nCPAP with LFO2 or HHHFNC in preterm babies born before 28 weeks gestation who are now 34 weeks corrected gestational age. The goal will be the fastest time to full oral feeds.
Read the detailed description
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.
- Conditions
- Feeding Behavior, Chronic Lung Disease
- Being tested
- Fisher & Paykel heated humidified high flow nasal cannula, InfantFlow/RAM nasal continuous positive airway pressure
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fisher & Paykel heated humidified high flow nasal cannulaDevice
InfantFlow/RAM nasal continuous positive airway pressureDevice
| Study group | Role | What they receive |
|---|---|---|
| Fisher & Paykel heated humidified high flow nasal cannula | Experimental | 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. Receives: Device: Fisher & Paykel heated humidified high flow nasal cannula |
| InfantFlow/RAM nasal continuous positive airway pressure | Active comparator | 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. Receives: Device: InfantFlow/RAM nasal continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach full oral feeds
Measured: 2 months
Secondary outcomes (4)
Time on non-invasive ventilation or oxygen
Measured: 2 months
Occurrence of feeding intolerance or reflux
Measured: 2 months
Occurrence of apneas/bradycardias/desaturations above baseline
Measured: 2 months
Weight gain
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feeding BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Leibel, Mount Sinai Hospital, Canada
- Investigators
- Sandra Leibel, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055339
- Sponsor's protocol ID
- MountSinaiH
- Acronym
- CHOMP
- Status last verified
- Nov 2018
- First submitted
- 3 Feb 2014
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Leibel SL, Castro M, McBride T, Hassall K, Sarmiento K, Ye XY, Shah V. Comparison of Continuous positive airway pressure versus High flow nasal cannula for Oral feeding Preterm infants (CHOmP): randomized pilot study. J Matern Fetal Neonatal Med. 2022 Mar;35(5):951-957. doi: 10.1080/14767058.2020.1735339. Epub 2020 Mar 5.
PubMed 32138561
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02055339
- Acronym / sponsor ID
- CHOMP / MountSinaiH
- Conditions
- Feeding Behavior, Chronic Lung Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preterm infants born before 28 weeks gestation are at risk for lung disease and require oxygen and pressure to keep their lungs open. This usually involves a device called nasal continuous positive airway pressure (nCPAP). When preterm babies reach a certain age, they are ready to begin to feed by mouth, but for those on nCPAP, oral feeds are usually not started due to concerns for choking. This may cause them to miss their window of learning and may lead to a longer hospital stay or oral aversion. Sometimes babies are switched from nCPAP to low flow oxygen (LFO2) for a short time for oral feeds, but this may not provide enough support for their lungs. Heated, humidified high flow nasal cannula (HHHFNC) is another mode of providing oxygen and pressure. It is equal to nCPAP in small babies transitioning off of ventilators, but no studies have been done in older babies. We plan to compare the feeding of babies orally using either nCPAP with LFO2 or HHHFNC in preterm babies born before 28 weeks gestation who are now 34 weeks corrected gestational age. The goal will be the fastest time to full oral feeds.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fisher & Paykel heated humidified high flow nasal cannula | Experimental | Device: Fisher & Paykel heated humidified high flow nasal cannulaFor 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. |
| InfantFlow/RAM nasal continuous positive airway pressure | Active comparator | Device: InfantFlow/RAM nasal continuous positive airway pressureNeonates 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. |
Who may qualify
- Ages
- 32 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age of <28 weeks (24+0 to 27+6) with corrected gestational age of 34 weeks
- Neonates requiring respiratory support in the form of nCPAP or HHHFNC at any pressure at 34 weeks corrected gestational age and failing a trial of low flow oxygen or room air
- Full enteral feeding tolerated through a nasogastric tube
Key exclusion criteria (4 listed)
- Gestational age > 28 weeks
- Neonate requiring biphasic nCPAP
- Mother never at the bedside and no consent for bottle feeds
- Severe nasal breakdown or genetic/neurologic abnormalities which impair oral feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fisher & Paykel heated humidified high flow nasal cannula | Device | Fisher & Paykel heated humidified high flow nasal cannula |
| InfantFlow/RAM nasal continuous positive airway pressure | Device | InfantFlow/RAM nasal continuous positive airway pressure |
Primary outcome
Time to reach full oral feeds
Time frame: 2 months
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Derived from this study: PubMed 32138561Leibel SL, Castro M, McBride T, Hassall K, Sarmiento K, Ye XY, Shah V. Comparison of Continuous positive airway pressure versus High flow nasal cannula for Oral feeding Preterm infants (CHOmP): randomized pilot study. J Matern Fetal Neonatal Med. 2022 Mar;35(5):951-957. doi: 10.1080/14767058.2020.1735339. Epub 2020 Mar 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Leibel, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fisher & Paykel heated humidified high flow nasal cannula and InfantFlow/RAM nasal continuous positive airway pressure in people with Feeding Behavior and Chronic Lung Disease, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to reach full oral feeds (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02055339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018.