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NCT04301453 · ClinicalTrials.gov registry record · NA
The Effect of Maternal Scent on Sleep Wake States
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 78
- Enrollment target
NCT04301453: Completed NA study, sponsored by Columbia University.
NCT04301453 is a NA study that has completed, run by Columbia University. The registered enrollment target is 78 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04301453, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 78 participants
- Enrollment target
Study Summary
This study will be a prospective, randomized controlled study, which aims to determine if a maternal scent intervention improves the sleep wake states, brain maturation, and heart rate variability in premature infants admitted to the neonatal intensive care unit (NICU). Infants will be randomized to either 24 hours of exposure to maternal scent or standard of care. Sleep wake states will be obtained using behavioral coding. Brain maturation will be measured using several electroencephalogram (EEG) parameters. Heart rate variability will be collected as part of vital sign collection.
Primary Outcome
Active sleep, quiet sleep, and indeterminate sleep will be behaviorally coded to determine the total amount of time spent in quiet sleep.
Interventions
- OTHER Maternal Scent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2019-10-30 |
| Est. Completion | 2021-05-27 |
| Phase | NA |
What the finished NCT04301453 record still lists
NCT04301453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Maternal Scent is the first listed.
NCT04301453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04301453 about?
NCT04301453 is a clinical study titled "The Effect of Maternal Scent on Sleep Wake States". This study will be a prospective, randomized controlled study, which aims to determine if a maternal scent intervention improves the sleep wake states, brain maturation, and heart rate variability in premature infants admitted to the neonatal intensive care unit (NICU). Infants will be randomized to...
What is the current status of trial NCT04301453?
This trial is currently completed. It is a NA study. The enrollment target is 78 participants. The study started on 2019-10-30. Estimated completion is 2021-05-27.
What interventions are being tested in trial NCT04301453?
The interventions under investigation include: Maternal Scent (OTHER).
Who is sponsoring clinical trial NCT04301453?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04301453's enrollment target sits among peer trials
78 1060th of 2000 higher than 939 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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