Cardboard Cot: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
2021年10月22日 更新者：Colm Travers、University of Alabama at Birmingham
Cardboard Cot in Neonatal Thermoregulation: Prevention of Moderate or Severe Hypothermia in Preterm Infants Assigned to Open Crib
Infants with an estimated gestational age < 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are delivered in a setting where an incubator is not available, will be randomized to either standard protocol of open crib or mylar-lined cardboard cot for the duration of the hospital stay.
Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot or crib, and then once every 24 hours.
All other care is provided as standard of care.
調査の概要
詳細な説明
Following parental consent, preterm infants with an estimated gestational age < 36 6/7 weeks at delivery who have been in an incubator in the newborn ICU for at least 24 hours in settings where an incubator is available, or who are in the newborn ICU in a setting where an incubator is not available, will be randomized to to transfer either standard protocol of open crib or mylar-lined cardboard cot when their temperatures are stable for transfer. The infants will remain in the cot or crib for the duration of the hospital stay. Axillary temperatures will be taken 1 hr, 6 hrs, and 24 hours after being placed in the cot or crib, and then once every 24 hours. All other care is provided as standard of care, including WHO warm chain thermoregulation guidelines of early and exclusive breastfeeding, appropriate bundling and Kangaroo Mother Care as continuously as possible.
If at any point a babies becomes moderately (32.0-35.9° C) or severely hypothermic (< 32.0° C), an extra blanket will be added to their bodies and a hat placed on their heads.
研究の種類
介入
段階
- 適用できない
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
1日～2週間 (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:
- Estimated gestational age < 36 6/7 weeks
- Hospitalized in the newborn ICU at University Teaching Hospital
- Nursed in an incubator for at least 24 hours
- Thought to be ready to be weaned from incubator by the clinical staff
Exclusion Criteria:
- Major congenital anomalies
- Requiring ongoing respiratory support
- Suspected sepsis
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Cardboard Cot Care
Stable infant will be transferred to cardboard cot, lined with reflective film for duration of hospital stay following weaning from radiant warmer.
Infant's axillary temperature will be taken at 1 hour, 6 hours, 24 hours after being placed in the cot or crib, and then once every 24 hours until discharge.
|
When ready to be weaned from radiant warmer, infant will be placed in a reflective film-lined cot for the duration of hospitalization.
Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after placement in cot, and every 24 hours thereafter until discharge.
If temperatures found < 36.0 at any time, an additional blanket and hat will be added to infant to improve temperature.
All other care will be standard of care at University Teaching Hospital, including early and exclusive breastfeeding, appropriate bundling, and Kangaroo Mother Care as continuously as possible.
|
|
プラセボコンパレーター：Open Crib
Stable infant will be transferred to standard of care open crib for duration of hospital stay following weaning from radiant warmer.
Infant's axillary temperature will be taken at 1 hour, 6 hours, 24 hours after being placed in the cot or crib, and then once every 24 hours until discharge.
|
When ready to be weaned from radiant warmer, infant will be placed in a standard of care open crib for the duration of hospitalization.
Axillary temperatures will be taken at 1 hour, 6 hours, and 24 hours after placement in cot, and every 24 hours thereafter until discharge.
If temperatures found < 36.0 at any time, an additional blanket and hat will be added to infant to improve temperature.
All other care will be standard of care at University Teaching Hospital, including early and exclusive breastfeeding, appropriate bundling, and Kangaroo Mother Care as continuously as possible.
|
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 |
時間枠 |
|---|---|
|
Moderate (32.0-35.9° C) or Severe (<32.0° C) Hypothermia at discharge per axillary Temperature
時間枠：Up to 14 days
|
Up to 14 days
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Hypothermia (< 36.0° C) throughout the duration of the intervention measured by axillary temperature
時間枠：Up to14 days
|
Up to14 days
|
|
Mean Axillary Temperatures on All Infants Weaned to Cardboard Cots
時間枠：4 months
|
4 months
|
|
Mean Axillary Temperatures on All Infants Weaned to Open Cribs
時間枠：4 months
|
4 months
|
|
Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary Temperature
時間枠：1 hour after placement in warming device
|
1 hour after placement in warming device
|
|
Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
時間枠：6 hours
|
6 hours
|
|
Moderate Hypothermia (32.0-35.9° C) after placement in warming device measured by axillary temperature
時間枠：24 hours after placement in warming device
|
24 hours after placement in warming device
|
|
Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
時間枠：1 hour after placement in warming device
|
1 hour after placement in warming device
|
|
Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
時間枠：6 hours after placement in warming device
|
6 hours after placement in warming device
|
|
Severe (<32.0° C) Hypothermia after placement in the warming device measured by axillary temperature
時間枠：24 hours after placement in warming device
|
24 hours after placement in warming device
|
|
Rate of Hyperthemia (>38° C) measured by axillary temperature
時間枠：14 days
|
14 days
|
|
Rate of Normothermia (>36.5° C) at discharge measured by axillary temperature
時間枠：Up to 14 days
|
Up to 14 days
|
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：Colm P Travers, MB BCh BAO、University of Alabama at Birmingham
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 (実際)
2019年6月11日
一次修了 (実際)
2021年9月27日
研究の完了 (実際)
2021年9月27日
試験登録日
最初に提出
2017年11月14日
QC基準を満たした最初の提出物
2017年11月14日
最初の投稿 (実際)
2017年11月17日
学習記録の更新
投稿された最後の更新 (実際)
2021年10月26日
QC基準を満たした最後の更新が送信されました
2021年10月22日
最終確認日
2021年10月1日
詳しくは
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。
Cardboard Cot Careの臨床試験
-
University of California, San DiegoNational Cancer Institute (NCI); University of Michigan; Arizona State University; Small Steps Labs...完了
-
linor kennetTel Aviv University完了
-
Johns Hopkins UniversityNational Institute on Disability, Independent Living, and Rehabilitation Research; Rita & Alex...募集
-
Montefiore Medical CenterAmerican Academy of Physical Medicine and Rehabilitation終了しました
-
New York UniversityIndiana University; Moi University完了
-
Duke Universityまだ募集していません満足、患者 | 転倒によるけが | 静脈血栓塞栓症 (VTE) | 滞在日数 | CLABSI - 中心線関連血流感染症 | 看護師 | カテーテル関連尿路感染症 | 再入院率 | 病院は圧力損傷を獲得しましたアメリカ