胎児鏡検査による管腔内気管閉塞 (FETO)
重度の左側先天性横隔膜ヘルニアに対する胎児鏡検査による管腔内気管閉塞
This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Midwest Fetal Care Center, a collaboration between Allina Health and Children's Minnesota. This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant people and their baby who meet study criteria.
調査の概要
詳細な説明
This is a single site pilot trial to assess the feasibility and safety of treating the most severe group of fetuses with left CDH with Fetal Endoluminal Tracheal Occlusion (FETO) using the Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100) at Midwest Fetal Care Center (MWFCC), a collaboration between Allina Health and Children's MN.
Congenital Diaphragmatic Hernia (CDH) is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up in the lungs and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life. The rationale for fetal therapy in severe CDH is to improve fetal lung growth and therefore neonatal survival.
The study will enroll pregnant women that meet study criteria, and their baby. The mother-fetus participant will undergo one procedure for placement of FETO before gestational age 29 weeks 6 days; and a second procedure for removal of the FETO device. The timing for removal of FETO is no later than 35 weeks and 6 days. After delivery, routine care of the baby with CDH will occur within the Children's MN NICU.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ、55404
- Midwest Fetal Care Center
-
-
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:
- A subject is defined as a female (18 years or older) who is pregnant.
- The pregnancy must be a singleton pregnancy.
- The CDH must be left-sided.
- The CDH must be severe (Observed to Expected Lung to Head Ratio - O/E LHR - < 25% from U/S measurements).
- No associated lethal anomalies (other than the CDH), no pathogenic variants on microarray, and no pathologic findings on karyotype.
- Fetal echocardiogram with changes expected with CDH and no major structural cardiac defects.
- Gestational age at time of balloon placement between and including 27 weeks 0 days and 29 weeks 6 days.
- Cervix length longer than 20 mm at pre-balloon placement evaluation.
- Acceptance of responsibility to stay locally (within 15 minutes) of MWFCC and Children's Minnesota - Minneapolis.
- Written consent must be obtained.
- Must meet psychosocial criteria including appropriate family/friend support during stay with balloon in place (cannot stay without additional helper), no current illicit drug use, no over-the-counter drug abuse, and no ineffectively treated DSM-IV diagnoses.
Exclusion Criteria:
- Twin or higher order gestation
- Not able to consent
- Right-sided or bilateral CDH
- Additional fetal or genetic abnormalities that would impact care after delivery or be known to have an impact on outcome
- Maternal isoimmunization or neonatal alloimmune thrombocytopenia
- Balloon not able to be placed prior to 30 weeks gestation
- CDH O/E LHR 25% or greater
- Maternal factors precluding safe fetal surgery (maternal cardiac findings not safe for anesthesia, maternal morbid obesity precluding safe usage of the equipment required for entry into the uterus, spontaneous preterm delivery prior to 36 weeks)
- Maternal HIV, Hepatitis B with positive surface antigen, Hepatitis C with presence of virus in maternal blood due to risks of fetal transmission during procedures
- Short cervix (20 mm or less)
- History of incompetent cervix or uterine anomaly predisposing to preterm labor
- Significant placental abnormalities (abruption, chorioangioma, accrete) known at the time of enrollment and/or surgery
- History of natural rubber latex allergy
- No safe or feasible fetoscopic approach to balloon placement
- Inability to relocate to within 15 minutes of MWFCC/Children's Minnesota
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：デバイスの実現可能性
- 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：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 |
|---|---|
|
実験的：FETO therapy
FETO therapy |
placement of FETO prior to 29 weeks 6 days GA; and removal of the FETO device no later than 35 weeks and 6 days
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 |
|---|---|---|
|
Successful placement of Balt Goldbal2 balloon
時間枠：Prior to 29 weeks 6 days Gestational Age (GA)
|
Successful completion of balloon insertion in fetuses with severe CDH defined as direct visualization of balloon above the carina at the time of FETO procedure. |
Prior to 29 weeks 6 days Gestational Age (GA)
|
|
Successful removal of Balt Goldbal2 balloon
時間枠：Prior to 35 weeks 6 days GA
|
Removal of the balloon |
Prior to 35 weeks 6 days GA
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in fetal lung growth
時間枠：Immediately after intervention (device removal)
|
Prenatal ultrasound will measure the observed-to-expected lung to head ratio (o/e LHR) at weekly visits while the balloon is in place and after balloon removal. Fetal lung growth will be calculated as the difference between the o/e LHR pre-balloon placement and the o/e LHR after balloon removal. |
Immediately after intervention (device removal)
|
|
Gestational age at delivery
時間枠：Measured at time of delivery
|
Gestational age at delivery will be recorded. |
Measured at time of delivery
|
|
Infant survival
時間枠：Birth - 24 months
|
Infant survival will be recorded from delivery to NICU discharge, and at 6, 12, and 24 months of age |
Birth - 24 months
|
|
Number of infants requiring extra corporeal membrane oxygenation (ECMO) support
時間枠：Birth to 6 months
|
Use of ECMO will be collected from medical chart review. |
Birth to 6 months
|
|
Number of infants requiring tracheostomy while in the NICU
時間枠：up to 2 years of age
|
Tracheostomy information will be collected from medical chart review. |
up to 2 years of age
|
|
Number of infants requiring home oxygen support upon discharge from the NICU
時間枠：up to 2 years of age
|
Oxygen support will be collected from medical chart review. |
up to 2 years of age
|
|
Time to pulmonary hypertension resolution
時間枠：up to 2 years of age
|
pulmonary hypertension will be collected from medical chart review. |
up to 2 years of age
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 1397678; 2021-055
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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