Trial Outcomes & Findings for Fetal Tracheal Balloon Study in Diaphragmatic Hernia (NCT NCT00966823)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Newborn period (1 day)

Results posted on

2017-05-30

Participant Flow

1 participant met inclusion criteria and was enrolled, but was excluded immediately before intervention (active labor), and was therefore excluded from the trial.

Participant milestones

Participant milestones
Measure	Detachable Balloon Fetuses treated with endoscopic tracheal occlusion Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation. \- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation.
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fetal Tracheal Balloon Study in Diaphragmatic Hernia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Detachable Balloon n=2 Participants Fetuses treated with endoscopic tracheal occlusion Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation. \- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	2 participants n=93 Participants

PRIMARY outcome

Timeframe: Newborn period (1 day)

Outcome measures

Outcome measures
Measure	Detachable Balloon n=2 Participants Fetuses treated with endoscopic tracheal occlusion Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation. \- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation.
Newborn Survival at Birth	1 Participants

SECONDARY outcome

Timeframe: 30 days

Population: 1 of 2 enrolled participants (fetuses) survived until birth (Primary outcome). This 1 participant (infant) also survived at 30 days (secondary outcome).

Outcome measures

Outcome measures
Measure	Detachable Balloon n=2 Participants Fetuses treated with endoscopic tracheal occlusion Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation. \- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation.
Newborn Survival at 30 Days	1 Participants

SECONDARY outcome

Timeframe: Intervention to 30 days postpartum

Outcome measures

Outcome measures
Measure	Detachable Balloon n=2 Participants Fetuses treated with endoscopic tracheal occlusion Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation. \- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation.
Maternal Complications	0 occurrences

SECONDARY outcome

Timeframe: Intervention to delivery

Fetal morbidity, fetal mortality

Outcome measures

Outcome measures
Measure	Detachable Balloon n=2 Participants Fetuses treated with endoscopic tracheal occlusion Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation. \- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation.
Fetal Morbidity	1 Participants

SECONDARY outcome

Timeframe: Intervention to 2 weeks post-intervention

Inclusion criterion for the study is LHR\<0.9 (extreme pulmonary hypoplasia). Given that LHR is relatively constant during 2nd and 3rd trimester of gestation, "In utero lung growth" is defined as LHR\>1.4 (definition of mild/moderate pulmonary hypoplasia) within 2 weeks of intervention. Outcome measure = number of participants with LHR\>1.4 at 2 weeks post-intervention

Outcome measures

Outcome measures
Measure	Detachable Balloon n=1 Participants Fetuses treated with endoscopic tracheal occlusion Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation. \- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation.
Number of Participants With In Utero Lung Growth (LHR) >1.4	1 Participants

Adverse Events

Detachable Balloon

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Francois I. Luks, MD, PhD

Rhode Island Hospital

Phone: 401-228-0556

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place