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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Koen Huysentruyt, Universitair Ziekenhuis Brussel.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Koen Huysentruyt, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT02316015
First received: December 5, 2014
Last updated: June 15, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Bronchiolitis Dietary Supplement: Infatrini® or Infatrini Peptisorb®

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Protein-energy Enriched Milk for Infants With Bronchiolitis

Further study details as provided by Koen Huysentruyt, Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • Evolution of nutritional status during hospitalization [ Time Frame: Hospital stay (mean 5 days) ]

    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 [ Time Frame: 1 week after discharge ]
    - Change in WFA z-score, weight for height z-score, MUAC z-score and TSF (mm)


Other Outcome Measures:
  • The Quality of life at outpatient follow-up [ Time Frame: 1 week after discharge ]
    The ITQOL-SF47 questionnaire will be used to assess quality of life

  • Duration of hospital stay [ Time Frame: Hospital stay (mean 5 days) ]
    Number of days of hospitalization

  • Time of oxygen support [ Time Frame: Hospital stay (mean 5 days) ]
    Number of hours of oxygen support during hospital stay

  • Rate of antibiotic use [ Time Frame: Hospital stay (mean 5 days) ]
    Number of children in which antibiotics is commenced during their hospitalization

  • Re-admission rate [ Time Frame: 1 week after discharge ]
    Number of children that are re-admitted to the hospital in the first two months after discharge

  • Persistence of wheezing [ Time Frame: 1 week after discharge ]
    This will be assessed using the respiratory distress assessment instrument (Langley et al., 2005)


Estimated Enrollment: 44
Study Start Date: December 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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

Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02316015

Contacts
Contact: Koen Huysentruyt, MD +3224763717 koen.huysentruyt@uzbrussel.be
Contact: Klaar Vergaelen, MD +3224774389 Klaar.vergaelen@uzbrussel.be

Locations
Belgium
UZ Brussel Recruiting
Jette, Belgium, 1090
Contact: Koen Huysentuyt, MD       koen.huysentruyt@uzbrussel.be   
Contact: Klaar Vergaelen, MD       klaar.vergaelen@uzbrussel.be   
Principal Investigator: Koen Huysentruyt, MD         
Sub-Investigator: Klaar Vergaelen, MD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
Principal Investigator: Yvan Vandenplas, MD, PhD UZBrussel
  More Information

Responsible Party: Koen Huysentruyt, Dr., Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02316015     History of Changes
Other Study ID Numbers: B.U.N. 143201422489
Study First Received: December 5, 2014
Last Updated: June 15, 2015

Keywords provided by Koen Huysentruyt, Universitair Ziekenhuis Brussel:
Child, Hospitalized
Nutritional status

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 18, 2017