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NCT01946308 · ClinicalTrials.gov registry record · NA
Sleep Organization in Premature Infants With Feeding Difficulties
A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT01946308 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 25 participants.
The verdict
NCT01946308, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
Babies born too soon, premature babies, can have complications following birth because their systems are immature. Hospitals help prevent deformities and delays in motor development by using therapeutic positioning to provide containment as they would experience in the womb. They also often have trouble eating. They have discomfort, are irritable, refuse to eat and cry because their digestive system is immature. The neonatal intensive unit can create stress and disrupt their sleep. Going from active to deep sleep is essential for infant brain development, learning and memory formation. Their sleep states early in life predict their developmental outcome. The purpose is to determine whether a conformational positioning system, one that can mold to the baby and contain him or her, will allow more time asleep in premature infants with feeding problems compared to the standard crib mattress. We hypothesize that the number of total sleep time will be longer and the number of arousals out of sleep lower when they are sleeping on the conformational positioning system compared to the mattress.
Interventions
- OTHER Conformational positioning system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01946308
The ClinicalTrials.gov registry entry for NCT01946308 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Conformational positioning system is the first listed.
NCT01946308 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01946308 about?
NCT01946308 is a clinical study titled "Sleep Organization in Premature Infants With Feeding Difficulties". Babies born too soon, premature babies, can have complications following birth because their systems are immature. Hospitals help prevent deformities and delays in motor development by using therapeutic positioning to provide containment as they would experience in the womb. They also often have tro...
What is the current status of trial NCT01946308?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2011-09. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01946308?
The interventions under investigation include: Conformational positioning system (OTHER).
Who is sponsoring clinical trial NCT01946308?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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