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NCT03370757 · ClinicalTrials.gov registry record · NA
Very Low Birth Weight Preterm Infant Bundled Care in the NICU
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 49
- Enrollment target
NCT03370757: Completed NA study, sponsored by Duke University.
NCT03370757 is a NA study that has completed, run by Duke University. The registered enrollment target is 49 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03370757, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 49 participants
- Enrollment target
Study Summary
The purpose of this study is to explore the impact of bundling nursing care activities on the overall health of Very Low Birthweight (VLBW) preterm infants who receive bundled care in a Level IV Neonatal Intensive Care Unit (NICU). The study will evaluate differences in infant health when diaper changes occur at 3- versus 6-hours during 3-hour bundled care. Differences in infant skin health between 3- and 6-hour bundled care diapering at two sites (buttocks and chest) will also be evaluated.
Primary Outcome
Heart rate instability was defined as having a mean heart rate value during a bundled care event that was ≥1 standard deviation above or below the mean heart rate value during the 90 minutes before the event started. In addition, clinically meaningful parameters were added to indicate exceptions to this definition. For HR, mean values ≥ one standard deviation below the mean was categorized as physiologically unstable only if the mean value was \< 100. Based on these criteria, each observation wa
Interventions
- OTHER 3-hour bundled care
- OTHER 6-hour bundled care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2018-02-02 |
| Est. Completion | 2019-08-23 |
| Phase | NA |
What the finished NCT03370757 record still lists
NCT03370757 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which 3-hour bundled care is the first listed.
NCT03370757 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03370757 about?
NCT03370757 is a clinical study titled "Very Low Birth Weight Preterm Infant Bundled Care in the NICU". The purpose of this study is to explore the impact of bundling nursing care activities on the overall health of Very Low Birthweight (VLBW) preterm infants who receive bundled care in a Level IV Neonatal Intensive Care Unit (NICU). The study will evaluate differences in infant health when diaper cha...
What is the current status of trial NCT03370757?
This trial is currently completed. It is a NA study. The enrollment target is 49 participants. The study started on 2018-02-02. Estimated completion is 2019-08-23.
What interventions are being tested in trial NCT03370757?
The interventions under investigation include: 3-hour bundled care (OTHER), 6-hour bundled care (OTHER).
Who is sponsoring clinical trial NCT03370757?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03370757's enrollment target sits among peer trials
49 1379th of 2000 higher than 620 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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