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

Primary Purpose

Bronchiolitis

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Infatrini® or Infatrini Peptisorb®
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bronchiolitis focused on measuring Child, Hospitalized, Nutritional status

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZ BrusselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Evolution of nutritional status at outpatient follow-up
- Change in WFA z-score, weight for height z-score, MUAC z-score and TSF (mm)

Full Information

First Posted
December 5, 2014
Last Updated
June 15, 2015
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT02316015
Brief Title
Protein-energy Enriched Milk for Infants With Bronchiolitis
Acronym
PEMIB
Official Title
Protein-energy Enriched Milk for Infants With Bronchiolitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Child, Hospitalized, Nutritional status

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Infatrini® or Infatrini Peptisorb®
Primary Outcome Measure Information:
Title
Evolution of nutritional status during hospitalization
Description
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)
Time Frame
Hospital stay (mean 5 days)
Secondary Outcome Measure Information:
Title
Evolution of nutritional status at outpatient follow-up
Description
- Change in WFA z-score, weight for height z-score, MUAC z-score and TSF (mm)
Time Frame
1 week after discharge
Other Pre-specified Outcome Measures:
Title
The Quality of life at outpatient follow-up
Description
The ITQOL-SF47 questionnaire will be used to assess quality of life
Time Frame
1 week after discharge
Title
Duration of hospital stay
Description
Number of days of hospitalization
Time Frame
Hospital stay (mean 5 days)
Title
Time of oxygen support
Description
Number of hours of oxygen support during hospital stay
Time Frame
Hospital stay (mean 5 days)
Title
Rate of antibiotic use
Description
Number of children in which antibiotics is commenced during their hospitalization
Time Frame
Hospital stay (mean 5 days)
Title
Re-admission rate
Description
Number of children that are re-admitted to the hospital in the first two months after discharge
Time Frame
1 week after discharge
Title
Persistence of wheezing
Description
This will be assessed using the respiratory distress assessment instrument (Langley et al., 2005)
Time Frame
1 week after discharge

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koen Huysentruyt, MD
Phone
+3224763717
Email
koen.huysentruyt@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Klaar Vergaelen, MD
Phone
+3224774389
Email
Klaar.vergaelen@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvan Vandenplas, MD, PhD
Organizational Affiliation
UZBrussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koen Huysentuyt, MD
Email
koen.huysentruyt@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Klaar Vergaelen, MD
Email
klaar.vergaelen@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Koen Huysentruyt, MD
First Name & Middle Initial & Last Name & Degree
Klaar Vergaelen, MD

12. IPD Sharing Statement

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Protein-energy Enriched Milk for Infants With Bronchiolitis

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