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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT01189149
First received: August 23, 2010
Last updated: February 5, 2013
Last verified: December 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01189149

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

No publications provided by Bnai Zion Medical Center

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

Additional relevant MeSH terms:
Bronchiolitis
Bronchiolitis, Viral
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 20, 2014