Protein-energy Enriched Milk for Infants With Bronchiolitis (PEMIB)

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.

Study Overview

• Status: Unknown
• Conditions: Bronchiolitis
• Intervention / Treatment: Dietary supplement: Infatrini® or Infatrini Peptisorb®

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.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Koen Huysentruyt, MD; Phone Number: +3224763717; Email: koen.huysentruyt@uzbrussel.be
• Study Contact Backup: Name: Klaar Vergaelen, MD; Phone Number: +3224774389; Email: Klaar.vergaelen@uzbrussel.be

Study Locations

• Belgium
  • Jette, Belgium, 1090
    • Recruiting
    • UZ Brussel
    • Contact: Koen Huysentuyt, MD; Email: koen.huysentruyt@uzbrussel.be
    • Contact: Klaar Vergaelen, MD; Email: klaar.vergaelen@uzbrussel.be
    • Principal Investigator: Koen Huysentruyt, MD
    • Sub-Investigator: Klaar Vergaelen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Children in the intervention group will receive a protein-energy enriched milk (Infatrini®, or in the case of children on a partial or fully hydrolized milk Infatrini Peptisorb®). The volume of milk offered will be the same quantity as they usually drink at home (within the limits of 120-170 ml/kg/day). The intervention will be carried out during the first 7 days of hospitalisation, or until the day of discharge (if hospitalized for less than 7 days).	Dietary supplement: Infatrini® or Infatrini Peptisorb®
No Intervention: Control group; Children in the control group will receive their regular milk. The volume of milk offered will be the same quantity as they usually drink at home (within the limits of 120-170 ml/kg/day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Quality of life at outpatient follow-up	The ITQOL-SF47 questionnaire will be used to assess quality of life	1 week after discharge
Duration of hospital stay	Number of days of hospitalization	Hospital stay (mean 5 days)
Time of oxygen support	Number of hours of oxygen support during hospital stay	Hospital stay (mean 5 days)
Rate of antibiotic use	Number of children in which antibiotics is commenced during their hospitalization	Hospital stay (mean 5 days)
Re-admission rate	Number of children that are re-admitted to the hospital in the first two months after discharge	1 week after discharge
Persistence of wheezing	This will be assessed using the respiratory distress assessment instrument (Langley et al., 2005)	1 week after discharge

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Yvan Vandenplas, MD, PhD, UZBrussel

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: December 5, 2014
• First Submitted That Met QC Criteria: December 11, 2014
• First Posted (Estimate): December 12, 2014

Study Record Updates

• Last Update Posted (Estimate): June 16, 2015
• Last Update Submitted That Met QC Criteria: June 15, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Nutritional status; Child, Hospitalized
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: B.U.N. 143201422489