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Non-invasive Ventilation

Pilot Study Comparing Different Modes of Non-invasive Ventilation for the Oral Feeding of Preterm Infants (CHOMP Trial)

N/A
Waitlist Available
Led By Sandra Leibel, MD
Research Sponsored by Mount Sinai Hospital, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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). 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.

Eligible Conditions
  • Lung Disease
  • Feeding Disorders

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Fisher & Paykel heated humidified high flow nasal cannulaExperimental Treatment1 Intervention
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.
Group II: InfantFlow/RAM nasal continuous positive airway pressureActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fisher & Paykel heated humidified high flow nasal cannula
2014
N/A
~30

Find a Location

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor
204 Previous Clinical Trials
69,172 Total Patients Enrolled
Sandra Leibel, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL
1 Previous Clinical Trials
130 Total Patients Enrolled
~2 spots leftby Dec 2025