Feeding Behavior Clinical Trial
— CHOMPOfficial 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
NCT number | NCT02055339 |
Other study ID # | MountSinaiH |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2014 |
Est. completion date | December 2016 |
Verified date | November 2018 |
Source | Mount Sinai Hospital, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | December 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 32 Weeks to 34 Weeks |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Mount Sinai Hospital NICU | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Mount Sinai Hospital, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to reach full oral feeds | 2 months | ||
Secondary | Time on non-invasive ventilation or oxygen | 2 months | ||
Secondary | Occurrence of feeding intolerance or reflux | 2 months | ||
Secondary | Occurrence of apneas/bradycardias/desaturations above baseline | 2 months | ||
Secondary | Weight gain | 2 months |
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