Sleep Organization in Premature Infants With Feeding Difficulties
27. januar 2020 oppdatert av: Children's Hospital Medical Center, Cincinnati
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
25
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Ohio
-
Cincinnati, Ohio, Forente stater, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 måneder til 8 måneder (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: conformational positioner & mattress
conformational positioner & mattress, five hours on each
|
The conformational positioning system will be compared to the standard infant crib mattress.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sleep organization defined as efficiency, active sleep time, quiet sleep time, number of arousals, measured by polysomnography
Tidsramme: 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.
|
Overnight, 10.5 hour standard EEG sleep study
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sleep state by behavioral observation
Tidsramme: 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.
|
Two 30-minute periods, one on each treatment, during the EEG sleep study
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Impact of prior surgery on sleep organization
Tidsramme: 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.
|
Overnight, 10-hour sleep study
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Marty O Visscher, PhD, Children's Hospital Medical Center, Cincinnati
Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2011
Primær fullføring (Faktiske)
1. juli 2012
Studiet fullført (Faktiske)
1. juli 2012
Datoer for studieregistrering
Først innsendt
17. september 2013
Først innsendt som oppfylte QC-kriteriene
18. september 2013
Først lagt ut (Anslag)
19. september 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. januar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. januar 2020
Sist bekreftet
1. september 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CHMC 2011-1456
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