Sleep Organization in Premature Infants With Feeding Difficulties
2020年1月27日 更新者: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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
25
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Ohio
-
Cincinnati、Ohio、アメリカ、45229
- Cincinnati Children's Hospital Medical Center
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
6ヶ月~8ヶ月 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:conformational positioner & mattress
conformational positioner & mattress, five hours on each
|
The conformational positioning system will be compared to the standard infant crib mattress.
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sleep organization defined as efficiency, active sleep time, quiet sleep time, number of arousals, measured by polysomnography
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sleep state by behavioral observation
時間枠: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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Impact of prior surgery on sleep organization
時間枠: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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:Marty O Visscher, PhD、Children's Hospital Medical Center, Cincinnati
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年9月1日
一次修了 (実際)
2012年7月1日
研究の完了 (実際)
2012年7月1日
試験登録日
最初に提出
2013年9月17日
QC基準を満たした最初の提出物
2013年9月18日
最初の投稿 (見積もり)
2013年9月19日
学習記録の更新
投稿された最後の更新 (実際)
2020年1月29日
QC基準を満たした最後の更新が送信されました
2020年1月27日
最終確認日
2013年9月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- CHMC 2011-1456
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。