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Sleep Organization in Premature Infants With Feeding Difficulties

Primary Purpose

Premature Infant Sleep

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conformational positioning system
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Infant Sleep focused on measuring 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

Eligibility Criteria

26 Weeks - 36 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

conformational positioner & mattress

Arm Description

conformational positioner & mattress, five hours on each

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sleep state by behavioral observation
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.

Full Information

First Posted
September 17, 2013
Last Updated
January 27, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT01946308
Brief Title
Sleep Organization in Premature Infants With Feeding Difficulties
Official Title
Sleep Organization in Premature Infants With Feeding Difficulties
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conformational positioner & mattress
Arm Type
Experimental
Arm Description
conformational positioner & mattress, five hours on each
Intervention Type
Other
Intervention Name(s)
Conformational positioning system
Other Intervention Name(s)
therapeutic positioner, fluidized bed positioner
Intervention Description
The conformational positioning system will be compared to the standard infant crib mattress.
Primary Outcome Measure Information:
Title
Sleep organization defined as efficiency, active sleep time, quiet sleep time, number of arousals, measured by polysomnography
Description
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.
Time Frame
Overnight, 10.5 hour standard EEG sleep study
Secondary Outcome Measure Information:
Title
Sleep state by behavioral observation
Description
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.
Time Frame
Two 30-minute periods, one on each treatment, during the EEG sleep study
Other Pre-specified Outcome Measures:
Title
Impact of prior surgery on sleep organization
Description
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.
Time Frame
Overnight, 10-hour sleep study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
26 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marty O Visscher, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25311708
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.
Results Reference
derived

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Sleep Organization in Premature Infants With Feeding Difficulties

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