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Intravenous Fluids Versus Naso/Orogastric-tube Feeding in Hospitalized Infants With Bronchiolitis

This study has been completed.
Information provided by (Responsible Party):
Bnai Zion Medical Center Identifier:
First received: August 23, 2010
Last updated: February 5, 2013
Last verified: December 2009
Oro- or nasogastric tube feeding is safe and may be more physiologic than intravenous (IV) fluids in hospitalized infants with acute viral bronchiolitis.

Condition Intervention
Viral Bronchiolitis
Procedure: IV fluids
Procedure: Naso/oro gastric tube feedings

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravenous Fluids vs. Naso/Orogastric-tube Feeding in Hospitalized Infants With Acute Viral Bronchiolitis: a Randomized, Controlled, Prospective Clinical Trial

Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • Clinical outcomes [ Time Frame: 3 winters ]
    Will compare clinical outcomes between the groups: Length of stay, need for oxygen, time to full feeds etc.

Secondary Outcome Measures:
  • Possible side effects of each method (IV vs. Oro/nasogastric feedings) [ Time Frame: 3 winters ]
    Local or systemic signs of infection, "para"infusion, discomfort while inserting the IV, electrolyte abnormalitis (as part of routine care) vs. aspiration, discomfort with naso/oro gastric tube.

Enrollment: 35
Study Start Date: December 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV fluids
Infants will get IV fluids whem indicated until able to tolerate full oral feedings
Procedure: IV fluids
Infants will be allocated to IV fluids
Experimental: Oro/naso gastric tube feeding
Infants will get oro/naso gastric tube feeding whem indicated until able to tolerate full oral feedings
Procedure: Naso/oro gastric tube feedings
Infants will be allocated to naso/oro gastric tube feedings


Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Infants with bronchiolitis < 6 months who need to be hospitalized and are not able to eat per os.

Exclusion Criteria:

  • Infants with severe bronchiolitis not allowed to get any gastric feeds or those that their parents will not sign an informed consent.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01189149

Pediatric Department
Haifa, Israel
Sponsors and Collaborators
Bnai Zion Medical Center
Principal Investigator: Amir Kugelman, MD Bnai Zion Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bnai Zion Medical Center Identifier: NCT01189149     History of Changes
Other Study ID Numbers: 115/08
Study First Received: August 23, 2010
Last Updated: February 5, 2013

Additional relevant MeSH terms:
Bronchiolitis, Viral
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases processed this record on May 25, 2017