新生児の低体温症を予防するためのビニール袋の使用の評価-パートI
発展途上国における新生児の低体温症を予防するためのビニール袋の使用に関する無作為化評価 - パート I
The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.
調査の概要
状態
詳細な説明
This study will compare the incidence of hypothermia during the first hour after birth in preterm/low birth weight infants randomized to receive WHO thermoregulation care and a plastic bag (without drying) covering the torso and lower extremities (control group) or WHO thermoregulation care and a plastic bag (without drying) covering the torso, upper and lower extremities, and a portion of their head (intervention group). The axillary temperature of each infant will be taken initially within 15 minutes of birth and later at 1 hour after birth as the infant is removed from the plastic bag. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 41% and a 21% absolute risk reduction (51% relative risk reduction), a sample size of 182 will be used to have a power of 80% and a confidence interval of 95%.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Lusaka、ザンビア
- University Teaching Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Estimated gestational age 29-36 6/7weeks or birth weight 1,400-2500g
- Delivery in the hospital
Exclusion Criteria:
- Infant admitted to the NICU
- Birth weight less than 1,400g
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
研究計画
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：Resuscitation-torso plastic bag
Resuscitation with plastic bag covering torso and lower extremities for first hour to assist with temperature regulation. |
Infant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth. |
|
アクティブコンパレータ：Resuscitation-partial-head plastic bag
Resuscitation with plastic bag covering torso, upper and lower extremities, and a portion of the head for first hour after birth to assist with temperature regulation. |
Infant's torso, extremities, and portion of the head (face will be exposed) will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth. |
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 |
|---|---|---|
|
Axillary temperature < 36.5 degrees Celsius
時間枠：1-72 hours after birth
|
Temperature taken per axilla at one hour after birth. Temperatures 36.0-36.4 will be classified as mild hypothermia, 32.0-35.9 will be classified as moderate hypothermia, and < 32.0 will be classified as severe hypothermia |
1-72 hours after birth
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Seizure
時間枠：Up to 4 weeks
|
Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done. |
Up to 4 weeks
|
|
Respiratory Distress Syndrome (RDS)
時間枠：Up to 4 weeks
|
Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant |
Up to 4 weeks
|
|
Pneumothorax
時間枠：Up to 4 weeks
|
Either chest radiograph documentation or clinical deterioration consistent with air leak |
Up to 4 weeks
|
|
Sepsis
時間枠：Up to 4 weeks
|
Culture proven or culture negative clinically treated course consistent with sepsis |
Up to 4 weeks
|
|
Necrotizing enterocolitis or intestinal perforation
時間枠：Up to 4 weeks
|
Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocolitis per Bell's classification stage greater than one. |
Up to 4 weeks
|
|
Death
時間枠：Up to 4 weeks
|
Cardiorespiratory failure |
Up to 4 weeks
|
|
Hyperthermia
時間枠：Up to 4 weeks
|
Axillary temperature > 38 degrees Celsius per temperature taken per axilla for one minute |
Up to 4 weeks
|
|
Temperature and humidity
時間枠：1-72 hours after birth
|
A recording of the room temperature and humidity will be obtained with each axillary temperature measurement |
1-72 hours after birth
|
協力者と研究者
捜査官
- 主任研究者：Waldemar A Carlo, MD、University of Alabama at Birmingham
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。