Premature Infant Sleep Clinical Trial
Official title:
Sleep Organization in Premature Infants With Feeding Difficulties
| NCT number | NCT01946308 |
| Other study ID # | CHMC 2011-1456 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2011 |
| Est. completion date | July 2012 |
| Verified date | September 2013 |
| Source | Children's Hospital Medical Center, Cincinnati |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 26 Weeks to 36 Weeks |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Children's Hospital Medical Center, Cincinnati |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Impact of prior surgery on sleep organization | 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. | Overnight, 10-hour sleep study | |
| Primary | 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 | |
| Secondary | 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. | Two 30-minute periods, one on each treatment, during the EEG sleep study |