試験ID UMIN000002912
最終情報更新日：2011年4月7日
Early weaning from incubator and early discharge of preterm infants
基本情報
| 試験ID | UMIN000002912 | |
|---|---|---|
| 研究名称 / Scientific Title（Acronym） | Early weaning from incubator and early discharge of preterm infants | Early weaning from incubator and early discharge of preterm infants |
| 平易な研究名称 / Public Title（Acronym） | Early weaning of preterm infants to open crib | Early weaning from incubator and early discharge of preterm infants |
| 試験進捗状況/Recruitment status | 試験終了 | Complete: follow-up complete |
| 登録日時 | 2009年12月16日 | |
| 最終情報更新日 | 2011年4月7日 | |
| 試験開始日（予定日） | ||
| 試験終了日（予定日） | ||
| 組入れ開始日 / Date of first enrollment | 2008年1月1日 | |
試験概要
| 試験実施地域 / Region | 欧州 | Europe |
|---|---|---|
| 実施都道府県 | ||
| 目標症例数/Target sample size | 94 | |
| 対象疾患 / Health condition(s) or Problem(s) studied | Prematurity | Prematurity |
| 試験のタイプ / Study type | 介入 | Interventional |
| 試験デザイン / Study design | 並行群間比較 | |
| ランダム化 / Randomization | ランダム化 | |
| 主要評価項目 / Primary outcomes | Total length of stay lower for infants transferred to an open crib at 1600 grams | Total length of stay lower for infants transferred to an open crib at 1600 grams |
| 副次評価項目 / Secondary outcomes | Number of infants requiring hospital readmissions during the first week after discharge not significantly higher for infants transferred to an open cot at 1600 g than for infants transferred at 1800 g. | Number of infants requiring hospital readmissions during the first week after discharge not significantly higher for infants transferred to an open cot at 1600 g than for infants transferred at 1800 g. |
適格性
| 年齢（下限）/ Age minimum | Not applicable | |
|---|---|---|
| 年齢（上限）/ Age maximum | Not applicable | |
| 性別 / Gender | 男女両方 | Male and Female |
| 選択基準 / Include criteria | Preterm infants whit birth weight < 1600 grams. Weight > 1600 grams at enrollment, medically stable, stable or increasing weight > 48 hours | |
| 除外基準 / Exclude criteria | Major congenital abnormality; respiratory support (CPAP or oxygen) | Major congenital abnormality; respiratory support (CPAP or oxygen) |
責任研究者
| 責任研究者 / Name of lead principal investigator | Enrico Zecca | Enrico Zecca |
|---|---|---|
| 組織名 / Organization | Catholic University of the Sacred Heart | |
| 部署名 / Division | Neonatology | Catholic University of the Sacred Heart Neonatology |
| 住所 / Address | Largo Gemelli 8, 00168 Rome, Italy | Largo Gemelli 8, 00168 Rome, Italy |
| 電話 / Telephone | +81-039630154169 | +81-039630154169 |
| 実施責任組織 / Affiliation | Division of Neonatology, Department of Pediatrics, Catholic University of the Sacred Heart | Catholic University of the Sacred Heart Neonatology |
| 研究費提供組織 / Funding Source | Catholic University of the Sacred Heart | Catholic University of the Sacred Heart |
| 共同実施組織 / Funding Source | ||
| 受付ID |
試験問い合わせ窓口
| 住所 / Address | Largo Gemelli 8, 00168 Rome, Italy | Largo Gemelli 8, 00168 Rome, Italy |
|---|---|---|
| 電話 / Telephone | +81-039630154169 | +81-039630154169 |
| ホームページURL | ||
| enrizecca@rm.unicatt.it | enrizecca@rm.unicatt.it | |
| 担当者 / Name of contact person | Enrico Zecca |