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NCT04559620 · ClinicalTrials.gov registry record · NA
Mother's Recorded Voice for Preterm Infants
A NA study, sponsored by AdventHealth.
- Completed
- Registry status
- NA
- Development phase
- 67
- Enrollment target
NCT04559620: Completed NA study, sponsored by AdventHealth.
NCT04559620 is a NA study that has completed, run by AdventHealth. The registered enrollment target is 67 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04559620, a NA study, has completed, sponsored by AdventHealth.
- COMPLETED
- Registry status
- NA
- Development phase
- 67 participants
- Enrollment target
Study Summary
The early birth of a premature baby can be a devastating and unplanned situation for parents. Often, their baby cannot be readily held; they can be very sick and fragile. Parents can feel helpless; bonding may be more difficult, parental control is superseded by medical necessity and parents can feel tremendous guilt whenever they are unable to be present at their baby's bedside. The investigators believe that giving parents an opportunity to provide comfort in the form of the mother's voice, pre-recorded and played to her baby, will improve her feeling about her baby in the NICU. The investigators hypothesize that playing the mother's recorded voice to her extremely preterm infant while in the incubator when she cannot be present will improve the depression, anxiety and stress as well as overall feeling about her baby. The investigators will assess the change in depression, anxiety and stress with the use of a validated tool (the DASS21), as a result of the intervention. The investigators will also assess the improvement of her feelings with a questionnaire () to be administered before and after the intervention. The investigators predict that her depression, anxiety and stress as well as positive feeling will increase after the intervention. The investigators also predict that the infant's vital signs will remain stable and/or improve when the recording is played.
Primary Outcome
(DASS is a 1-21 questionnaire where a higher score=worse outcome)
Interventions
- OTHER Maternal voice
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2021-03-25 |
| Est. Completion | 2024-01-09 |
| Phase | NA |
What the finished NCT04559620 record still lists
NCT04559620 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Maternal voice is the first listed.
NCT04559620 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04559620 about?
NCT04559620 is a clinical study titled "Mother's Recorded Voice for Preterm Infants". The early birth of a premature baby can be a devastating and unplanned situation for parents. Often, their baby cannot be readily held; they can be very sick and fragile. Parents can feel helpless; bonding may be more difficult, parental control is superseded by medical necessity and parents can fee...
What is the current status of trial NCT04559620?
This trial is currently completed. It is a NA study. The enrollment target is 67 participants. The study started on 2021-03-25. Estimated completion is 2024-01-09.
What interventions are being tested in trial NCT04559620?
The interventions under investigation include: Maternal voice (OTHER).
Who is sponsoring clinical trial NCT04559620?
This trial is sponsored by AdventHealth, which has 95 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04559620's enrollment target sits among peer trials
67 1139th of 2000 higher than 862 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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