Protein-energy Enriched Milk for Infants With Bronchiolitis

NCT ID: NCT02316015

Last Updated: 2015-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-04-30

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.

Conditions

Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Infatrini® or Infatrini Peptisorb®

Intervention Type: DIETARY_SUPPLEMENT

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Infatrini® or Infatrini Peptisorb®

Intervention Type: DIETARY_SUPPLEMENT

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

• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Koen Huysentruyt

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yvan Vandenplas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZBrussel

Locations

UZ Brussel

Jette, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Koen Huysentruyt, MD

Role: CONTACT

koen.huysentruyt@uzbrussel.be

+3224763717

Klaar Vergaelen, MD

Role: CONTACT

Klaar.vergaelen@uzbrussel.be

+3224774389

Facility Contacts

Koen Huysentuyt, MD

Role: primary

koen.huysentruyt@uzbrussel.be

Klaar Vergaelen, MD

Role: backup

klaar.vergaelen@uzbrussel.be

Other Identifiers

B.U.N. 143201422489

Identifier Type: -

Identifier Source: org_study_id