Protein-energy Enriched Milk for Infants With Bronchiolitis (PEMIB)
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|ClinicalTrials.gov Identifier: NCT02316015|
Recruitment Status : Unknown
Verified June 2015 by Koen Huysentruyt, Universitair Ziekenhuis Brussel.
Recruitment status was: Recruiting
First Posted : December 12, 2014
Last Update Posted : June 16, 2015
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 or disease||Intervention/treatment||Phase|
|Bronchiolitis||Dietary Supplement: Infatrini® or Infatrini Peptisorb®||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|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|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||April 2016|
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).
- 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)
- 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)
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02316015
|Contact: Koen Huysentruyt, MDfirstname.lastname@example.org|
|Contact: Klaar Vergaelen, MD||+3224774389||Klaar.email@example.com|
|Jette, Belgium, 1090|
|Contact: Koen Huysentuyt, MD firstname.lastname@example.org|
|Contact: Klaar Vergaelen, MD email@example.com|
|Principal Investigator: Koen Huysentruyt, MD|
|Sub-Investigator: Klaar Vergaelen, MD|
|Principal Investigator:||Yvan Vandenplas, MD, PhD||UZBrussel|