Sleep Organization in Premature Infants With Feeding Difficulties
Completed · Not applicable
Conditions studied: Premature Infant Sleep
In brief
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.
Key facts
- Study ID
- NCT01946308
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 25
- Starts
- 2011-09-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2020-01-29
Who can join
Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Gestational age of < 37 weeks
- Feeding difficulty due to prematurity or a medical condition
- Not taking sedative medications for 24 hours before sleep study
- Post-surgery
- Sufficiently medically stable to undergo procedures
You may not qualify if…
- Gestational age equal to or greater than 37 weeks
- Clinical apnea
- Require mechanical ventilatory support
- Received sedative medications 24 hours before sleep study
- Brain injury or neurological condition that limits movement
- Orthopedic conditions requiring fixed positioning
- Arthrogryposis
- Osteogenesis imperfecta
- Medically unstable such that procedures cannot be tolerated
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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