NCT01946308|Completed
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Sponsor study identifier
interventional
25
1 country
1
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2012
Actual (reported)Study Completion
July 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2012
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
July 2012
Actual (reported)July 2012
Actual (reported)September 17, 2013
Actual (reported)September 19, 2013
Actual (reported)Sleep organization defined as efficiency, active sleep time, quiet sleep time, number of arousals, measured by polysomnography
Standard polysomnography electrodes are applied to the subject in the evening and the subject is placed on either the standard mattress or the conformational positioning system (assigned at random) for the first 5 hours. The subject is then moved onto the second treatment for the remainder of the study. EEG measures are recorded continuously over the entire period. The EEG data are assessed by trained sleep study physicians and clinical staff.
Overnight, 10.5 hour standard EEG sleep study
Sleep state by behavioral observation
Two 30-minute periods, one on each treatment, during the EEG sleep study
conformational positioner \& mattress, five hours on each
The conformational positioning system will be compared to the standard infant crib mattress.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Visscher MO, Lacina L, Casper T, Dixon M, Harmeyer J, Haberman B, Alberts J, Simakajornboon N. Conformational positioning improves sleep in premature infants with feeding difficulties. J Pediatr. 2015 Jan;166(1):44-8. doi: 10.1016/j.jpeds.2014.09.012. Epub 2014 Oct 12.
Marty O Visscher, PhD
Children's Hospital Medical Center, Cincinnati
25 participants (actual enrollment reported by the registry).
First Submitted
September 17, 2013
First Posted
September 19, 2013
Study Start
September 2011
Date type not reportedThis date has not been verified as actual or estimated.
Impact of prior surgery on sleep organization
Overnight, 10-hour sleep study
Contact the study team to confirm eligibility.
Primary Completion
July 2012
Actual (reported)Study Completion
July 2012
Actual (reported)Last Updated
January 29, 2020
Record last verified: 2013-09
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Source: ClinicalTrials.gov.
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