Viral BronchiolitisNCT01189149
Intravenous Fluids Versus Naso/Orogastric-tube Feeding in Hospitalized Infants With Bronchiolitis
A study testing IV fluids and Naso/oro gastric tube feedings in people with Viral Bronchiolitis, run by Bnai Zion Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 1 day to 6 months
- Conditions the study is for
- Viral Bronchiolitis
- What is being tested?
- IV fluids and Naso/oro gastric tube feedings
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2008to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with bronchiolitis < 6 months who need to be hospitalized and are not able to eat per os.
Who cannot join
- Infants with severe bronchiolitis not allowed to get any gastric feeds or those that their parents will not sign an informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Fluids vs. Naso/Orogastric-tube Feeding in Hospitalized Infants With Acute Viral Bronchiolitis: a Randomized, Controlled, Prospective Clinical Trial
Oro- or nasogastric tube feeding is safe and may be more physiologic than intravenous (IV) fluids in hospitalized infants with acute viral bronchiolitis.
- Conditions
- Viral Bronchiolitis
- Being tested
- IV fluids, Naso/oro gastric tube feedings
- Medical subject headings
- Bronchiolitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV fluidsProcedure or surgery
Infants will be allocated to IV fluids
Naso/oro gastric tube feedingsProcedure or surgery
Infants will be allocated to naso/oro gastric tube feedings
| Study group | Role | What they receive |
|---|---|---|
| IV fluids | Experimental | Infants will get IV fluids whem indicated until able to tolerate full oral feedings Receives: Procedure: IV fluids |
| Oro/naso gastric tube feeding | Experimental | Infants will get oro/naso gastric tube feeding whem indicated until able to tolerate full oral feedings Receives: Procedure: Naso/oro gastric tube feedings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcomes
Will compare clinical outcomes between the groups: Length of stay, need for oxygen, time to full feeds etc.
Measured: 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.
Measured: 3 winters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startDec 2008
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Viral BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Amir Kugelman, MD, Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189149
- Sponsor's protocol ID
- 115/08
- Status last verified
- Dec 2009
- First submitted
- 23 Aug 2010
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Fluids vs. Naso/Orogastric-tube Feeding in Hospitalized Infants With Acute Viral Bronchiolitis: a Randomized, Controlled, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT01189149
- Acronym / sponsor ID
- 115/08
- Conditions
- Viral Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Dec 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 26 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oro- or nasogastric tube feeding is safe and may be more physiologic than intravenous (IV) fluids in hospitalized infants with acute viral bronchiolitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV fluids | Experimental | Procedure: IV fluidsInfants will get IV fluids whem indicated until able to tolerate full oral feedings |
| Oro/naso gastric tube feeding | Experimental | Procedure: Naso/oro gastric tube feedingsInfants will get oro/naso gastric tube feeding whem indicated until able to tolerate full oral feedings |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants with bronchiolitis < 6 months who need to be hospitalized and are not able to eat per os.
Key exclusion criteria (1 listed)
- Infants with severe bronchiolitis not allowed to get any gastric feeds or those that their parents will not sign an informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV fluidsInfants will be allocated to IV fluids | Procedure or surgery | IV fluids |
| Naso/oro gastric tube feedingsInfants will be allocated to naso/oro gastric tube feedings | Procedure or surgery | Oro/naso gastric tube feeding |
Primary outcome
Clinical outcomes
Time frame: 3 winters
Will compare clinical outcomes between the groups: Length of stay, need for oxygen, time to full feeds etc.
1 secondary outcome
Possible side effects of each method (IV vs. Oro/nasogastric feedings)
Time frame: 3 winters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
- Derived from this study: PubMed 23260101Kugelman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Kugelman, MD principal investigator
Bnai Zion Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV fluids and Naso/oro gastric tube feedings in people with Viral Bronchiolitis, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes (time frame: 3 winters). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01189149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2013.