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試験進捗状況 一般募集中/Open public recruiting
UMIN試験ID UMIN000036066
受付番号 R000041084
科学的試験名
一般公開日(本登録希望日) 2019/09/30
最終更新日 2021/03/03

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Effects of early respiratory physiotherapy techniques on spontaneous respiratory
activity of preterm infants: a randomized controlled trial
一般向け試験名略称/Acronym
Early Neonatal Respiratory Physiotherapy
科学的試験名/Scientific Title
Effects of early respiratory physiotherapy techniques on spontaneous respiratory
activity of preterm infants: a randomized controlled trial
科学的試験名略称/Scientific Title:Acronym
Early Neonatal Respiratory Physiotherapy
試験実施地域/Region
欧州/Europe

対象疾患/Condition
対象疾患名/Condition
pretermn infants with respiratory insufficence with/without BPD
疾患区分1/Classification by specialty
呼吸器内科学/Pneumology 小児科学/Pediatrics
集中治療医学/Intensive care medicine リハビリテーション医学/Rehabilitation medicine
小児/Child
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
To evaluate the efficacy of respiratory facilitation physiotherapy technique according to reflex stimulations, applied early to the preterm infant. This intervention is aimed at promoting spontaneous respiratory activity and reducing work of breathing, avoiding or minimizing the use of invasive respiratory support.
目的2/Basic objectives2 安全性・有効性/Safety,Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Incidence of intubation and mechanical ventilation (MV) in the first week of life (excluding the intubation necessary for surfactant administration). This will represent the primary outcome for non-intubated infants in the delivery room.
副次アウトカム評価項目/Key secondary outcomes
- duration of MV during the hospital stay (only for the babies not intubated in the
delivery room);
- duration of O 2 -therapy during the hospital stay;
- development of BPD (O 2 -dependence at 36 weeks of postmenstrual age);
- incidence of atelectasis,
- duration of non-invasive ventilation (NIV) during the hospital stay;
- post-conceptional age attainment of complete respiratory autonomy (absence of any
kind of respiratory support and oxygen);
- length of the hospital stay
- survival.

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 無治療対照/No treatment
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 予防・検診・検査/Prevention
介入の種類/Type of intervention
手技/Maneuver
介入1/Interventions/Control_1
In the Study Group the physiotherapist will perform the technique of respiratory facilitation according to the reflex stimulations, experience already conducted in the neonates and modified for the preterm infant. The newborn is placed in supine decubitus and a slight digital pressure is exerted on a hemithorax, more precisely between the 7 th and the 8 th rib (area corresponding to the insertion of the diaphragm muscle) at the level of the mammillary line, pressing from top to bottom (in direction of the support plane) and obliquely (in the direction of the vertebral column). We will define this as a "trigger point". Stimulating the trigger point will stimulate the respiratory activity by determining a compression on the stimulation side with consequent increase of the ipsilateral
pulmonary ventilation / minute and the facilitation of the contralateral pulmonary expansion (thoracic expansion of the ribcage). This mechanism will determine the concatenation of input to all anatomical structures in direct and indirect relation to the area being treated, on the basis of the
mechanical-neurological-fluidic links of the human body. The above-mentioned maneuver will determine three different consequences at a distance that will positively influence the respiratory dynamics of the preterm infant.The respiratory facilitation technique will be performed for about three minutes and repeated for a total of 4/6 times in sequence: 7th right hemitoraceous space for three minutes, 7th left hemithorax space for three minutes, 7th right space for a further three minutes, 7th left space for a further three minutes. In case of secretions the respiratory facilitation technique will be associated with the prolonged slow expired technique for the preterm infant. This program will be performed 3 times a day until spontaneous respiratory activity is achieved.
介入2/Interventions/Control_2
The Control Group Infants will perform exclusively the Individualized Postural Care program.
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
24 週/weeks-old より上/<
年齢(上限)/Age-upper limit
31 週/weeks-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
Preterm newborns with a gestational age less than or equal 30 weeks requiring invasive or non-invasive respiratory support.
除外基準/Key exclusion criteria
- Outborn
- Presence of major congenital malformations and/or genetic syndromes
- Fetal hydrops
- Inherited disorders of metabolism
- Persistent Pulmonary Hypertension of Newborn
- Severe circulatory shock (prolonged capillary filling, reduced strength of peripheral pulses, cool skin, lethargy, hypotension, oliguria, increasing lactate concentrations and metabolic
acidosis)
- Others unstable clinical conditions at the time of randomization for which the newborn can not perform the physiotherapy treatment required by the study.
目標参加者数/Target sample size 132

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム


ミドルネーム
Milena Tana
所属組織/Organization
Foundation Policlinico University A. Gemelli IRCCS, Catholic University of the Sacred Heart, Rome, Italy.
所属部署/Division name
Division of Neonatology
郵便番号/Zip code
住所/Address
Largo A. Gemelli 8, 00168, Rome, Italy
電話/TEL 00393288446775
Email/Email milenatana@yahoo.it

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム


ミドルネーム
Giovanni Vento
組織名/Organization
Foundation P. University A. Gemelli IRCCS
部署名/Division name
Division of Neonatology
郵便番号/Zip code
住所/Address
Largo A. Gemelli 8, 00168, Rome, Italy
電話/TEL 00390630153237
試験のホームページURL/Homepage URL
Email/Email giovanni.vento@unicatt.it

実施責任組織/Sponsor
機関名/Institute その他 Foundation Policlinico University A. Gemelli IRCCS, Catholic University of the Sacred Heart, Rome, Italy.
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Foundation Policlinico University A. Gemelli IRCCS, Catholic University of the Sacred Heart, Rome, Italy.
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 財団/Non profit foundation
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization

住所/Address

電話/Tel
Email/Email

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2019 09 30

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 一般募集中/Open public recruiting
プロトコル確定日/Date of protocol fixation
2018 04 01
倫理委員会による承認日/Date of IRB
2019 01 01
登録・組入れ開始(予定)日/Anticipated trial start date
2018 04 08
フォロー終了(予定)日/Last follow-up date
2019 01 01
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2019 03 01
最終更新日/Last modified on
2021 03 03


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041084
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041084

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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