Bronchiolitis Clinical Trial
Official title:
Protein-energy Enriched Milk for Infants With Bronchiolitis
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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