Intravenous Fluids Versus Naso/Orogastric-tube Feeding in Hospitalized Infants With Bronchiolitis
Intravenous Fluids vs. Naso/Orogastric-tube Feeding in Hospitalized Infants With Acute Viral Bronchiolitis: a Randomized, Controlled, Prospective Clinical Trial
1 other identifier
interventional
35
1 country
1
Brief Summary
Oro- or nasogastric tube feeding is safe and may be more physiologic than intravenous (IV) fluids in hospitalized infants with acute viral bronchiolitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 23, 2010
CompletedFirst Posted
Study publicly available on registry
August 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFebruary 6, 2013
December 1, 2009
3.2 years
August 23, 2010
February 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical outcomes
Will compare clinical outcomes between the groups: Length of stay, need for oxygen, time to full feeds etc.
3 winters
Secondary Outcomes (1)
Possible side effects of each method (IV vs. Oro/nasogastric feedings)
3 winters
Study Arms (2)
IV fluids
EXPERIMENTALInfants will get IV fluids whem indicated until able to tolerate full oral feedings
Oro/naso gastric tube feeding
EXPERIMENTALInfants will get oro/naso gastric tube feeding whem indicated until able to tolerate full oral feedings
Interventions
Infants will be allocated to naso/oro gastric tube feedings
Eligibility Criteria
You may qualify if:
- Infants with bronchiolitis \< 6 months who need to be hospitalized and are not able to eat per os.
You may not qualify if:
- Infants with severe bronchiolitis not allowed to get any gastric feeds or those that their parents will not sign an informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pediatric Department
Haifa, Israel
Related Publications (1)
Kugelman A, Raibin K, Dabbah H, Chistyakov I, Srugo I, Even L, Bzezinsky N, Riskin A. Intravenous fluids versus gastric-tube feeding in hospitalized infants with viral bronchiolitis: a randomized, prospective pilot study. J Pediatr. 2013 Mar;162(3):640-642.e1. doi: 10.1016/j.jpeds.2012.10.057. Epub 2012 Dec 20.
PMID: 23260101DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amir Kugelman, MD
Bnai Zion Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2010
First Posted
August 26, 2010
Study Start
December 1, 2008
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
February 6, 2013
Record last verified: 2009-12