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NCT01343758 · ClinicalTrials.gov registry record · NA
Study Investigating the Use of Intravenous Fluids With Dextrose for Dehydrated Children
A NA study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 188
- Enrollment target
NCT01343758: Completed NA study, sponsored by Boston Children's Hospital.
NCT01343758 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 188 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01343758, a NA study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 188 participants
- Enrollment target
Study Summary
Infants and young children often become infected with gastroenteritis leading to vomiting and diarrhea. This can lead to dehydration, one of the most common complaints in the Pediatric Emergency Department. These children are often in need of treatment with intravenous (IV) fluids. While the investigators know that IV fluids work, it is not clear which type or how much fluid is the best amount to give. Currently, the most common type of IV fluid given is salt water, also called normal saline. In contrast to adults, infants and young children with dehydration often have a build up of a certain type of acid in their blood which can perpetuate the nausea, vomiting, and general malaise associated with gastroenteritis. The investigators feel that giving these children IV fluids with lots of sugar (in addition to the salt) reduces the acid more rapidly than giving just salt water alone. In a prior study, the investigators have shown that children who receive lower amounts of sugar in the IV fluids return to the Emergency Department more often for a second visit. Based on this study, the investigators believe that children who receive the sugar-salt solution will do better than children who receive just normal saline. The investigators will determine if the sugar-salt solution is better by giving equal numbers of children the sugar-salt solution and normal saline and then see what happens to each child. The investigators will monitor who needs to be admitted, how much each child vomits, how much each child drinks, and also the level of acid in the blood before and after getting the IV fluid. After the study is completed, the investigators can compare the two different groups (children who received the sugar-salt solution versus children who received normal saline alone) to determine if one group had greater improvement and better clinical outcome than the other.
Primary Outcome
The investigators will measure what percentage of patients in each treatment group are admitted.
Interventions
- OTHER 5% dextrose in normal saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2007-01 |
| Est. Completion | 2011-07 |
| Phase | NA |
What the finished NCT01343758 record still lists
NCT01343758 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which 5% dextrose in normal saline is the first listed.
NCT01343758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01343758 about?
NCT01343758 is a clinical study titled "Study Investigating the Use of Intravenous Fluids With Dextrose for Dehydrated Children". Infants and young children often become infected with gastroenteritis leading to vomiting and diarrhea. This can lead to dehydration, one of the most common complaints in the Pediatric Emergency Department. These children are often in need of treatment with intravenous (IV) fluids. While the investi...
What is the current status of trial NCT01343758?
This trial is currently completed. It is a NA study. The enrollment target is 188 participants. The study started on 2007-01. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01343758?
The interventions under investigation include: 5% dextrose in normal saline (OTHER).
Who is sponsoring clinical trial NCT01343758?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01343758's enrollment target sits among peer trials
188 576th of 2000 higher than 1,422 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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