Sleep Organization in Premature Infants With Feeding Difficulties

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Completed

CT.gov ID

NCT01946308

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Infant Sleep	Other: Conformational positioning system	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Sleep Organization in Premature Infants With Feeding Difficulties

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: conformational positioner & mattress conformational positioner & mattress, five hours on each	Other: Conformational positioning system The conformational positioning system will be compared to the standard infant crib mattress. Other Names: therapeutic positioner fluidized bed positioner

Arm

Intervention/Treatment

Experimental: conformational positioner & mattress

conformational positioner & mattress, five hours on each

Other: Conformational positioning system

The conformational positioning system will be compared to the standard infant crib mattress.

Other Names:

therapeutic positioner

fluidized bed positioner

Outcome Measures

Primary Outcome Measures

Sleep organization defined as efficiency, active sleep time, quiet sleep time, number of arousals, measured by polysomnography [Overnight, 10.5 hour standard EEG sleep study]
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.

Secondary Outcome Measures

Sleep state by behavioral observation [Two 30-minute periods, one on each treatment, during the EEG sleep study]
Nurses trained in the techniques of premature infant behavioral state determination will observe the infant for two 30-minute periods while the EEG sleep study is being conducted. One nurse will observe when the subject is on the standard mattress and the other will observe when the subject is on the conformational positioning system. They will record specific behaviors observed in 2-minute intervals during the 30-minute period.

Other Outcome Measures

Impact of prior surgery on sleep organization [Overnight, 10-hour sleep study]
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. The sleep organization and behaviorally observed sleep state will be compared for the subjects grouped as having had surgery prior to the study or not having had surgery to ascertain the impact of surgery while controlling for the treatment effects.