Clinical trial NCT02316015: Protein-energy Enriched Milk for Infants With Bronchiolitis
Official title: Protein-energy Enriched Milk for Infants With Bronchiolitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchiolitis
Keywords: Child, Hospitalized
Nutritional status
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 44
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evolution of nutritional status during hospitalization
timeFrame: Hospital stay (mean 5 days)
Secondary outcomes:
measure: Evolution of nutritional status at outpatient follow-up
timeFrame: 1 week after discharge
Other outcomes:
measure: The Quality of life at outpatient follow-up
timeFrame: 1 week after discharge
measure: Duration of hospital stay
timeFrame: Hospital stay (mean 5 days)
measure: Time of oxygen support
timeFrame: Hospital stay (mean 5 days)
measure: Rate of antibiotic use
timeFrame: Hospital stay (mean 5 days)
measure: Re-admission rate
timeFrame: 1 week after discharge
measure: Persistence of wheezing
timeFrame: 1 week after discharge
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: UZBrussel
name: Yvan Vandenplas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: