Clinical trial NCT01946308: Sleep Organization in Premature Infants With Feeding Difficulties
Official title: Sleep Organization in Premature Infants With Feeding Difficulties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infant Sleep
Keywords: sleep
sleep efficiency
active sleep
quiet sleep
arousals
premature infant
conformational positioning
mattress
feeding difficulty
neonatal intensive care unit
sleep state
behavioral observation
stress behavior
self-regulatory behavior
surgery
gastrointestinal
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 25
Sex: ALL
Minimum age (years): 26
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Premature infants are at risk for complications due to the immaturity of motor, gastrointestinal, respiratory, cutaneous and behavioral systems. Therapeutic positioning is routinely used to provide containment, maintain a flexed position and prevent skeletal deformities and delays in motor development. Premature infants have feeding difficulties and frequently experience gastroesophageal reflux, discomfort, refusal to feed, irritability, and crying. The neonatal intensive care environment can create stress and disrupts sleep-wake cycles and self-regulatory behaviors. Cycling from active to deep sleep states is required for neurosensory processing, learning, memory formation and brain plasticity. Sleep and waking states for premature infants are predictive of neurodevelopmental outcomes. The purpose of the study is to determine whether the use of conformational positioning will be associated with greater total sleep time in premature infants with a history feeding difficulty compared to positioning on a mattress alone. We hypothesize that the number of arousals and total sleep time will be affected by the support surface. Specifically, the number of arousals will be lower and total sleep time will be greater for infants when they are on a conformational positioning (CP) device compared to when they are on the standard positioning system (mattress) (SP). The use of CP will reduce the number of arousals, increase the total sleep time, and bring about behavioral states that are conducive to regulation of attention, state and motor response relative to SP.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Sleep organization defined as efficiency, active sleep time, quiet sleep time, number of arousals, measured by polysomnography
timeFrame: Overnight, 10.5 hour standard EEG sleep study
Secondary outcomes:
measure: Sleep state by behavioral observation
timeFrame: Two 30-minute periods, one on each treatment, during the EEG sleep study
Other outcomes:
measure: Impact of prior surgery on sleep organization
timeFrame: Overnight, 10-hour sleep study
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Marty O Visscher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.