Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01894659 · ClinicalTrials.gov registry record · NA
Oral Sucrose Versus Glucose for Procedural Pain in Premature Neonates
A NA study, sponsored by Loma Linda University.
- Completed
- Registry status
- NA
- Development phase
- 51
- Enrollment target
NCT01894659 is a NA study that has completed, run by Loma Linda University. The registered enrollment target is 51 participants.
The verdict
NCT01894659, a NA study, has completed, sponsored by Loma Linda University.
- COMPLETED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
Study Summary
Premature neonates admitted to the neonatal intensive care unit (NICU) require up to several hundred procedures during their hospitalization. Many of these are tissue-damaging procedures (TDPs) that cause pain. Through our NIH funded research, we made the novel observation that exposure to a single TDP can significantly increase ATP utilization and oxidative stress, as evidenced by increased plasma levels of hypoxanthine, uric acid and malondialdehyde in neonates exposed to TDPs as compared to controls (no TDP). Because neonates are exposed to numerous TDPs, it is relevant to explore the energy costs of repeated exposures to painful procedures, an important information that is currently not known, as the effect of this cumulative metabolic dysfunction could result in potentially treatable or preventable cell injury. Oral sucrose analgesia is frequently given to relieve procedural pain in neonates on the basis of its effect on behavioral and physiological pain scores. However, we found, through our prospective, randomized, double blind study funded by NIH, that although oral sucrose significantly reduced pain scores, its administration before a single TDP (heel lance) significantly increased ATP utilization. This is evidenced by higher plasma concentrations of hypoxanthine and uric acid in neonates given sucrose compared to control neonates (no TDP, no sucrose) or neonates just given a pacifier. These novel findings raise concern because preterm neonates have limited ATP stores and are susceptible to cell injury due to ATP depletion. In addition, it raises the relevant concern: If a single dose of oral sucrose can alter ATP metabolism, what are the effects of exposure to multiple doses of oral sucrose? More importantly, what is the effect of multiple TDPs and/or multiple oral sucrose dosages on ATP utilization, oxidative stress and cell injury? This application will also explore the effect of 30% oral glucose, another sweet solution currently used to relieve pain, o
Interventions
- OTHER 24% oral sucrose
- OTHER 30% oral glucose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2014-02 |
| Est. Completion | 2020-07-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01894659
The ClinicalTrials.gov registry entry for NCT01894659 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loma Linda University, which has 237 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which 24% oral sucrose is the first listed.
NCT01894659 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01894659 about?
NCT01894659 is a clinical study titled "Oral Sucrose Versus Glucose for Procedural Pain in Premature Neonates". Premature neonates admitted to the neonatal intensive care unit (NICU) require up to several hundred procedures during their hospitalization. Many of these are tissue-damaging procedures (TDPs) that cause pain. Through our NIH funded research, we made the novel observation that exposure to a single ...
What is the current status of trial NCT01894659?
This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2014-02. Estimated completion is 2020-07-31.
What interventions are being tested in trial NCT01894659?
The interventions under investigation include: 24% oral sucrose (OTHER), 30% oral glucose (OTHER).
Who is sponsoring clinical trial NCT01894659?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.