Pilot Study Comparing Different Modes of Non-invasive Ventilation for the Oral Feeding of Preterm Infants
Condition: Feeding Behavior; Chronic Lung Disease
MeSH terms: Lung Diseases
Study type: Interventional

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.
    

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.
    

Intervention name(s): Fisher & Paykel heated humidified high flow nasal cannula; InfantFlow/RAM nasal continuous positive airway pressure
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment