ClinicalTrials.gg
CompletedNCT01189149Updated Feb 6, 2013

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

An interventional study of IV fluids and Naso/oro gastric tube feedings in Viral Bronchiolitis, sponsored by Bnai Zion Medical Center. Completed at 1 site in Israel. Open to participants aged 1 Day to 6 Months. Per ClinicalTrials.gov, last updated 2013-02-06.

Sponsored by Bnai Zion Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
1 Day to 6 Months
Sex
All
01

Study summary

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

02

Conditions studied

  • Viral Bronchiolitis

Browse trials for

03

In context

Bronchiolitis, Viral

30 studies on the registry are indexed under Bronchiolitis, Viral; 2 are open to participants now.

This study's enrollment of 35 is below the median of 85 across 25 interventional studies indexed under Bronchiolitis, Viral.

Browse Bronchiolitis, Viral studies →

Lead sponsor

Bnai Zion Medical Center is the lead sponsor of 104 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 6 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Infants with severe bronchiolitis not allowed to get any gastric feeds or those that their parents will not sign an .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    IV fluids

    Infants will get IV fluids whem indicated until able to tolerate full oral feedings

    Procedure: 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

Interventions

  • ProcedureIV fluids

    Infants will be allocated to IV fluids

  • ProcedureNaso/oro gastric tube feedings

    Infants will be allocated to naso/oro gastric tube feedings

06

What researchers measure

Primary outcomes

  1. Clinical outcomes

    Will compare clinical outcomes between the groups: Length of stay, need for oxygen, time to full feeds etc.

    Time frame: 3 winters

Secondary outcomes

  1. 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.

    Time frame: 3 winters

07

Study locations

1 site
  • Pediatric Department
    Haifa, Israel
08

References and documents

Publications

  • 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. PubMed 23260101 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01189149
Responsible party
Sponsor
First posted
Aug 26, 2010
Start date
Dec 2008
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Feb 6, 2013

Study contacts

Amir Kugelman, MD
principal investigator · Bnai Zion Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion