None listed
Conditions
Brief summary
There is no consensus as to which nasogastric fluid regime (continuous or intermittent-bolus fluids) should be prescribed for patients with bronchiolitis who cannot maintain oral hydration. We will perform a randomised controlled trial (RCT) in the future comparing intermittent bolus and continuous nasogastric fluids for patients with bronchiolitis that require nasogastric fluids, with the aim of determining which fluid regime leads to a quicker return to normal oral feeding. Prior to this, we will conduct a pilot RCT, in order to test and refine the study procedures prior to beginning the main trial and to identify the feasibility, power calculation and sample size for the main trial. This pilot study is the one currently being conducted, not the main RCT. The main RCT will occur in the future after the results of this current pilot study are analysed and reported.
Interventions
Intermittent Bolus Nasogastric Fluids. Bronchiolitis is a viral infection that affects the lungs and respiratory tract in children less than 12 months of age. It is the leading cause of hospital admission during the first year of life. Patients with bronchiolitis often work harder to breathe and as a result can have trouble feeding effectively, and are therefore at risk of dehydration, which can lead to a longer length of stay in hospital. Approximately a third of patients with bronchiolitis require fluid replacement. For patients with bronchiolitis who cannot maintain hydration orally, fluid replacement can be accomplished by nasogastric fluids (fluids delivered through a tube which goes through the patients nose directly into the patients’ stomach). There are two Nasogastric fluid hydration regimes used; intermittent bolus fluids (when a patient has the same volume delivered through the nasogastric tube over a 1-hour period that they would typically have in a normal oral feed) or continuous fluids (when a patient has the same bolus fluid amount delivered through the nasogastric tube, however given at a slow continuous rate). There is no consensus as to which nasogastric fluid regime should be prescribed for patients with bronchiolitis. In our trial, patients with bronchiolitis that require nasogastric fluids will be consented by a trial research assistant, and randomised to receive either intermittent bolus (3- hourly), or continuous nasogastric fluids. The precise amount of fluid administered to patients on the trial is calculated based on the patients age and weight using the below formula as per the Australasian PREDICT Bronchiolitis guideline for calculating a patients Total Fluid Requirement (TFR): -->0-3 months -150ml/kg/day -->3-6 months -120ml/kg/day -->6-12 months - 100ml/kg/day As per clinical recommendations from the Australasian Bronchiolitis Guideline, all patients on the trial will be prescribed 2/3 (67%) of their TFR For patients receiving intermittent bolus fluids, their TFR is divided by 8 to give them a 3- hourly fluid quota. For patients receiving continuous fluids, their TFR is divided by 24 to give them their hourly fluid rate. The nasogastric fluid used will be either -->expressed breast milk- for babies that are normally breast-fed or normally given expressed breast milk bottles -->formula milk- for babies that are normally fed formula milk -->Oral Rehydration Solution (such as Hydralyte or Gastrolyte)- for babies that are normally breastfed, but are not able to express breast milk The allocated nasogastric fluid regime will then be prescribed by the patients treating doctor and administered by the patients treating nurse. Their nasogastric fluid regime will continue until the patient has achieved adequate oral feeding. The patient's nasogastric fluids can be discontinued when the patient has tolerated adequate oral feeding (which we have defined as 2 tolerated oral feeds of at least 50% of the patients pre-morbid oral feeding quota). A dedicated NOBRO trial research nurse will monitor adherence to study protocols and collect data outcomes.
Sponsors
Study design
Eligibility
Inclusion criteria
• Inclusion criteria o Patient under 12 months (and 0 days) chronological age o Patient diagnosed with bronchiolitis (regardless of the severity) as their primary diagnosis for hospital admission o Patient deemed by their treating clinician to require nasogastric fluids due to poor oral feeding
Exclusion criteria
1. Nasogastric tube, or other gastric feeding device in situ already in situ for normal feeds in the pre-morbid state 2. Requiring > 2L/kg of Highflow oxygen at the time of initiating nasogastric fluids 3. Receiving non invasive mask ventilation (CPAP or BIPAP) at the time of initiating nasogastric fluids 4. Intubated and requiring mechanical ventilation at the time of initiating nasogastric fluids High clinical suspicion of the need for escalated respiratory support (ie. Above 2L/kg of highflow oxygen) within the next 24 hours 5. Patients transferred to Gold Coast University Hospital from a peripheral hospital, or with a plan for backtransfer to a peripheral hospital