Protein-energy Enriched Milk for Infants With Bronchiolitis

NCT02316015 | Unknown

• 1 other identifier: B.U.N. 143201422489
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

Child, Hospitalized; Nutritional status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evolution of nutritional status at outpatient follow-up

  1 week after discharge

Other Outcomes (6)

• The Quality of life at outpatient follow-up

  1 week after discharge

• Duration of hospital stay

  Hospital stay (mean 5 days)

• Time of oxygen support

  Hospital stay (mean 5 days)

Study Arms (2)

Intervention group

EXPERIMENTAL

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®

Control group

NO INTERVENTION

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).

Interventions

Infatrini® or Infatrini Peptisorb® DIETARY_SUPPLEMENT

Intervention group

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children hospitalized at the paediatric wards of UZ Brussel with the diagnosis of moderate to severe bronchiolitis
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Yvan Vandenplas, MD, PhD

  UZBrussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koen Huysentruyt, MD

CONTACT

+3224763717; koen.huysentruyt@uzbrussel.be

Klaar Vergaelen, MD

CONTACT

+3224774389; Klaar.vergaelen@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 12, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 16, 2015

Record last verified: 2015-06

Locations

BE (1)