Protein-energy Enriched Milk for Infants With Bronchiolitis

Bronchiolitis Clinical Trial

— PEMIB  

Official title:

Protein-energy Enriched Milk for Infants With Bronchiolitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02316015
• Other study ID #: B.U.N. 143201422489
• Status: Recruiting
• Phase: N/A
• First received: December 5, 2014
• Last updated: June 15, 2015
• Start date: December 2014
• Est. completion date: April 2016

Study information

• Verified date: June 2015
• Source: Universitair Ziekenhuis Brussel
• Contact: Koen Huysentruyt, MD
• Phone: +3224763717
• Email: koen.huysentruyt[@]uzbrussel.be
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Dietary Supplement:
• Infatrini® or Infatrini Peptisorb®

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Quality of life at outpatient follow-up	The ITQOL-SF47 questionnaire will be used to assess quality of life	1 week after discharge	No
Other	Duration of hospital stay	Number of days of hospitalization	Hospital stay (mean 5 days)	No
Other	Time of oxygen support	Number of hours of oxygen support during hospital stay	Hospital stay (mean 5 days)	No
Other	Rate of antibiotic use	Number of children in which antibiotics is commenced during their hospitalization	Hospital stay (mean 5 days)	No
Other	Re-admission rate	Number of children that are re-admitted to the hospital in the first two months after discharge	1 week after discharge	No
Other	Persistence of wheezing	This will be assessed using the respiratory distress assessment instrument (Langley et al., 2005)	1 week after discharge	No
Primary	Evolution of nutritional status during hospitalization	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)	Hospital stay (mean 5 days)	No
Secondary	Evolution of nutritional status at outpatient follow-up	- Change in WFA z-score, weight for height z-score, MUAC z-score and TSF (mm)	1 week after discharge	No