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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infatrini® or Infatrini Peptisorb® | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of nutritional status during hospitalization | The change in followong parameters will be assessed:
| Hospital stay (mean 5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of nutritional status at outpatient follow-up | - Change in WFA z-score, weight for height z-score, MUAC z-score and TSF (mm) | 1 week after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| The Quality of life at outpatient follow-up | The ITQOL-SF47 questionnaire will be used to assess quality of life | 1 week after discharge |
| Duration of hospital stay | Number of days of hospitalization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Koen Huysentruyt, MD | Contact | +3224763717 | koen.huysentruyt@uzbrussel.be | |
| Klaar Vergaelen, MD | Contact | +3224774389 | Klaar.vergaelen@uzbrussel.be |
| Name | Affiliation | Role |
|---|---|---|
| Yvan Vandenplas, MD, PhD | UZBrussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Recruiting | Jette | 1090 | Belgium |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| Hospital stay (mean 5 days) |
| Time of oxygen support | Number of hours of oxygen support during hospital stay | Hospital stay (mean 5 days) |
| Rate of antibiotic use | Number of children in which antibiotics is commenced during their hospitalization | Hospital stay (mean 5 days) |
| Re-admission rate | Number of children that are re-admitted to the hospital in the first two months after discharge | 1 week after discharge |
| Persistence of wheezing | This will be assessed using the respiratory distress assessment instrument (Langley et al., 2005) | 1 week after discharge |
| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |