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

Viral Bronchiolitis Clinical Trial

Official title:

Intravenous Fluids vs. Naso/Orogastric-tube Feeding in Hospitalized Infants With Acute Viral Bronchiolitis: a Randomized, Controlled, Prospective Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189149
• Other study ID #: 115/08
• Status: Completed
• Phase: N/A
• First received: August 23, 2010
• Last updated: February 5, 2013
• Start date: December 2008
• Est. completion date: March 2012

Study information

• Verified date: December 2009
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Oro- or nasogastric tube feeding is safe and may be more physiologic than intravenous (IV) fluids in hospitalized infants with acute viral bronchiolitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis, Viral
• Viral Bronchiolitis

Intervention

Procedure:
• IV fluids
Infants will be allocated to IV fluids
• Naso/oro gastric tube feedings
Infants will be allocated to naso/oro gastric tube feedings

Locations

Country	Name	City	State
Israel	Pediatric Department	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcomes	Will compare clinical outcomes between the groups: Length of stay, need for oxygen, time to full feeds etc.	3 winters	No
Secondary	Possible side effects of each method (IV vs. Oro/nasogastric feedings)	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.	3 winters	Yes