Bronchiolitis
Conditions
Keywords
Child, Hospitalized, Nutritional status
Brief summary
The aim of this study is to investigate if a standardized nutritional intervention with a protein and energy enriched milk could help overcome the catabolic state in children hospitalized with a bronchiolitis and thus creating a better nutritional state during hospitalization and at outpatient follow-up. The investigators also want to assess the clinical repercussion on the number of hospitalization days, the duration of oxygen support and the quality of life at ouptatient follow-up.
Detailed description
In this study, the investigators aim to assess the effect protein-energy enriched milk to reverse the catabolic state (weight loss, change in mid-upper arm circumference and tricpes skin fold) on the short term and failure to thrive (degree of weight recovery, change in arm circumference) one week after discharge in infants with moderate to severe bronchiolitis. The secondary short term aims are to investigate the effect on the length of hospital stay, days of oxygen support and the rate of antibiotic use. Secondary long term outcomes are the re-admission rate, the persistence of wheezing and the number of work days missed by the parents. The investigators hypothesize that in those children who received a protein-energy enriched milk during hospitalization the catabolic state will be reversed more quickly by the intervention and will need less hospitalisation days, less oxygen support, less antibiotic use, less re-admission rate, less persistent wheezing and less work days missed by the parents. The investigators also hypothesize that the effects of the nutritional intervention on the proposed outcome parameters will be greater in children screened at high nutritional risk.
Interventions
DIETARY_SUPPLEMENTInfatrini® or Infatrini Peptisorb®
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
Inclusion criteria
* All children hospitalized at the paediatric wards of UZ Brussel with the diagnosis of moderate to severe bronchiolitis * Not meeting their normal oral intake are eligible for inclusion between the beginning of December and the end of February 2014 * Bronchiolitis will be defined as a constellation of clinical symptoms and signs that typically begin with rhinitis and cough, and may progress to tachypnea, wheezing, rales, use of accessory muscles and/or nasal flaring
Exclusion criteria
* Children admitted to the paediatric intensive care unit * Children in whom it is unsafe to place a nasogastric tube (e.g. severe mucositis, platelet count \<50.000/µl) * Children unwilling or unable to participate * Children that are breast fed * Children over the age of 12 months * Children with an underlying malabsorption disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of nutritional status during hospitalization | Hospital stay (mean 5 days) | The change in followong parameters will be assessed: * Change in weight for age z-score * Change in mid upper arm circumference z-score * Change in triceps skin fold (mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of nutritional status at outpatient follow-up | 1 week after discharge | \- Change in WFA z-score, weight for height z-score, MUAC z-score and TSF (mm) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time of oxygen support | Hospital stay (mean 5 days) | Number of hours of oxygen support during hospital stay |
| Rate of antibiotic use | Hospital stay (mean 5 days) | Number of children in which antibiotics is commenced during their hospitalization |
| The Quality of life at outpatient follow-up | 1 week after discharge | The ITQOL-SF47 questionnaire will be used to assess quality of life |
| Persistence of wheezing | 1 week after discharge | This will be assessed using the respiratory distress assessment instrument (Langley et al., 2005) |
| Re-admission rate | 1 week after discharge | Number of children that are re-admitted to the hospital in the first two months after discharge |
| Duration of hospital stay | Hospital stay (mean 5 days) | Number of days of hospitalization |
Countries
Belgium
Contacts
Primary ContactKoen Huysentruyt, MD
Backup ContactKlaar Vergaelen, MD
Outcome results
None listed