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NCT02214589 · ClinicalTrials.gov registry record · NA
Non-pharmacological Interventions for Procedural Pain in Premature Neonates
A NA study, sponsored by Loma Linda University.
- Completed
- Registry status
- NA
- Development phase
- 203
- Enrollment target
NCT02214589: Completed NA study, sponsored by Loma Linda University.
NCT02214589 is a NA study that has completed, run by Loma Linda University. The registered enrollment target is 203 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02214589, a NA study, has completed, sponsored by Loma Linda University.
- COMPLETED
- Registry status
- NA
- Development phase
- 203 participants
- Enrollment target
Study Summary
A. Specific Aims Premature infants 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) known to cause pain \[1\]. Through funding from NINR, the investigators found that TDPs not only caused pain but also increased markers of ATP degradation and oxidative stress\[2\[. The TDP was tape removal, a commonly performed procedure in the NICU2. Based on this finding, the investigators sought to determine if interventions that relieve pain also reduce biochemical markers of ATP degradation and oxidative stress. The investigators first examined the effect of oral sucrose, a commonly used intervention, when given before a heel lance. The investigators chose heel lance because it is the most predominant painful procedure in the NICU, as shown in 29 different clinical trials\[3\]. The investigators hypothesized that since oral sucrose is documented to significantly reduce pain scores, then administration of this analgesic will also decrease markers of ATP degradation and oxidative stress. However,the investigators observed the opposite effect. Although a single dose of oral sucrose reduced behavioral markers of pain, it significantly increased biochemical markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) over time\[4\]. More importantly, the effect of oral sucrose on breakdown markers of ATP were enhanced and were significantly higher in neonates that were intubated or were receiving more than 30% FiO25. These findings lead to the question: If oral sucrose does not effectively reduce the biochemical effects of procedural pain, what intervention or groups of intervention will decrease both behavioral markers of procedural pain and reduce ATP utilization and oxidative stress in premature neonates? For this RO1 renewal, the investigators propose to test the individual and additive effects of two commonly used interventions
Primary Outcome
A decrease in pain score will be quantified using the validated tool Premature Infant Pain Profile, which will be scored by a neonatologist blinded to group assignment.
Interventions
- OTHER Oral glucose, facilitated tucking, NNS
- OTHER Oral glucose and NNS
- OTHER Facilitated tucking and NNS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2014-08 |
| Est. Completion | 2019-12 |
| Phase | NA |
What the finished NCT02214589 record still lists
NCT02214589 is an interventional study that assigns participants to a tested intervention. The registered 203 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 (86% lower).
The record links to 0 conditions, and to 3 interventions - of which Oral glucose, facilitated tucking, NNS is the first listed.
NCT02214589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02214589 about?
NCT02214589 is a clinical study titled "Non-pharmacological Interventions for Procedural Pain in Premature Neonates". A. Specific Aims Premature infants 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) known to cause pain \[1\]. Through funding from NINR, the investigators found that TDPs no...
What is the current status of trial NCT02214589?
This trial is currently completed. It is a NA study. The enrollment target is 203 participants. The study started on 2014-08. Estimated completion is 2019-12.
What interventions are being tested in trial NCT02214589?
The interventions under investigation include: Oral glucose, facilitated tucking, NNS (OTHER), Oral glucose and NNS (OTHER), Facilitated tucking and NNS (OTHER).
Who is sponsoring clinical trial NCT02214589?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02214589's enrollment target sits among peer trials
203 504th of 2000 higher than 1,496 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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