UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012395
Receipt number R000014493
Scientific Title Clinical Trial of Fetal Endotracheal Occlusion in fetuses with left sided isolated congenital diaphragmatic hernia
Date of disclosure of the study information 2013/11/25
Last modified on 2013/11/25 10:59:34

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Basic information

Public title

Clinical Trial of Fetal Endotracheal Occlusion in fetuses with left sided isolated congenital diaphragmatic hernia

Acronym

Clinical trial of FETO

Scientific Title

Clinical Trial of Fetal Endotracheal Occlusion in fetuses with left sided isolated congenital diaphragmatic hernia

Scientific Title:Acronym

Clinical trial of FETO

Region

Japan


Condition

Condition

Fetal congenital diaphragmatic hernia

Classification by specialty

Obstetrics and Gynecology Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This trial will test whether Fetal Endotracheal Occlusion (FETO) can be performed safely in fetuses with left sided isolated congenital diaphragmatic hernia without any serious maternal side effects and will test survival till 90 postnatal days and will test survival rate till 90 postnatal days after FETO.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1) Complete FETO procedures without serious maternal side effects
2) survival till 90 postnatal days

Key secondary outcomes

1)Developmental milestones at 6 months after birth
2)Neurodevelopmental milestones at 6 months after birth
3)Adverse effects during FETO procedures
4)Unfixed balloon during and after FETO procedures
5)Lung size after FETO
6)Liver position after FETO
7)Stomach position after FETO
8)Preterm delivery after FETO
9)Intra-uterine fetal demise after FETO
10)Survival after FETO
11)Discharge without any serious complications
12)Number of days in neonatal intensive care unit after birth
13)Number of days of ventilatory support
14)Number of days of NO treatment
15)Complete surgery
16)Any other additional side effects


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

A thin walled flexible Teflon cannula (3.3 mm; Performa, Cook, Strombeek Bever, Belgium), loaded with a pyramidal trocar (11650TG, Karl Storz, Germany) should be inserted into the amniotic cavity towards the fetal mouth. The trocar should then be withdrawn and fetoscopic instruments inserted. These include at present a slightly bent 10 Fr sheath loaded with a 1.3 mm fiber endoscope (Karl Storz). The sheath allows insertion of the balloon occlusion system, consisting of a catheter loaded with a detachable latex balloon. It further has a side connector for amnio-infusion with Hartmann's solution heated to body temperature, for improving visualization and assist in dilatation of the vocal cords on entry of the trachea. The endoscope should be introduced into the fetal mouth, following the tongue and palate, uvula, epiglottis and vocal cords as landmarks. Once inside the trachea the carina should be identified to position and deliver the balloon between carina and vocal cords. The balloon should then be inflated with isotonic fluid (Goldball 2; Balt, Paris, France).

Balloon retrieval should be planned at between 34+0 and 34+6 weeks. The options are ultrasound guided puncture and fetoscopic retrieval.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

16 years-old <=

Age-upper limit

45 years-old >

Gender

Female

Key inclusion criteria

1) Between 27 and 31 weeks of gestation
2) Pregnant woman who is between 16 to 45 years old
3) Diagnosed as singleton with left sided isolated CDH
4) Diagnosed as left sided CDH with Liver up in the chest cavity and Stomach mainly in the right chest cavity (Grade 3 of Kitano classification)
5)O/E LHR < 45%
6) No other presence of fetal anomaies
7) No sign of pregnancy induced hypertension
8) No genital bleeding
9) No premature rupture of membrane
10) Greater than or equal to 20 mm of cervical length
11) Agreement of patient and her partner to follow the protocol

Key exclusion criteria

1) Pregnant woman needs treatment for infectious disease.
2) Presence of HIV antibody, HCV antibody, or HBe antigen in pregnant women
3) Pregnant woman needs treatment for psychological problems
4) American Society of Anesthesiology (ASA) Physical Status Classification: Class 3, 4, 5, or 6

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruhiko Sago MD PhD

Organization

National Center for Child Health and Development

Division name

Department of Maternal-Fetal and Neonatal Medicine

Zip code


Address

2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan

TEL

03-3416-0181

Email

sagou-h@ncchd.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Seiji Wada MD PhD

Organization

National Center for Child Health and Development

Division name

Department of Fetal Therapy

Zip code


Address

2-10-1 Okura, Setagaya-ku, Tokyo 157-8535, Japan

TEL

03-3416-0181

Homepage URL


Email

wada-s@ncchd.go.jp


Sponsor or person

Institute

Japan Fetal Therapy Group (Fetus Japan)

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

国立成育医療研究センター


Other administrative information

Date of disclosure of the study information

2013 Year 11 Month 25 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2013 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 25 Day

Last follow-up date

2016 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 11 Month 25 Day

Last modified on

2013 Year 11 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014493


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name