Fetal Tracheal Balloon Study in Diaphragmatic Hernia

NCT00966823 | Terminated Phase 2 Results DMC

• 1 other identifier: G080077
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this phase 2 limited study is to examine whether prenatal intervention correct the lung underdevelopment associated with severe diaphragmatic hernia.

Conditions

Diaphragmatic Hernia; Lung Disease

Keywords

Diaphragm; Trachea; Lung development; Lung growth; Tracheal occlusion; ECMO; Neonatal death

Outcome Measures

Primary Outcomes (1)

• Newborn Survival at Birth

  Newborn period (1 day)

Secondary Outcomes (4)

• Newborn Survival at 30 Days

  30 days

• Maternal Complications

  Intervention to 30 days postpartum

• Fetal Morbidity

  Intervention to delivery

• Number of Participants With In Utero Lung Growth (LHR) >1.4

  Intervention to 2 weeks post-intervention

Study Arms (1)

Detachable balloon

EXPERIMENTAL

Intervention: Fetuses treated with endoscopic tracheal occlusion

Device: Fetal tracheal obstruction with detachable balloon (device)

Interventions

Fetal tracheal obstruction with detachable balloon (device) DEVICE

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.

Also known as: Goldvalve Balloon, nFocus Neuromedical, Inc.

Detachable balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton pregnancies
• Isolated congenital diaphragmatic hernia
• Normal karyotype (amniocentesis)
• Initial diagnosis before 26 weeks gestation
• Competent cervix
• Severity of CDH: lung-to-head ratio (LHR) ≤0.8 at 22-26 weeks gestation
• Liver herniation in the chest
• Informed consent

You may not qualify if:

• Preterm labor, premature rupture of membranes or amniotic leak
• Significant maternal morbidity
• Minor (\<18 years)

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital/Women & Infants' Hospital of Rhode Island

Providence, Rhode Island, 02903, United States

Location

Related Publications (13)

• Bealer JF, Skarsgard ED, Hedrick MH, Meuli M, VanderWall KJ, Flake AW, Adzick NS, Harrison MR. The 'PLUG' odyssey: adventures in experimental fetal tracheal occlusion. J Pediatr Surg. 1995 Feb;30(2):361-4; discussion 364-5. doi: 10.1016/0022-3468(95)90590-1.

  PMID: 7738765 BACKGROUND

• Luks FI, Roggin KK, Wild YK, Piasecki GJ, Rubin LP, Lesieur-Brooks AM, De Paepe ME. Effect of lung fluid composition on type II cellular activity after tracheal occlusion in the fetal lamb. J Pediatr Surg. 2001 Jan;36(1):196-201. doi: 10.1053/jpsu.2001.20051.

  PMID: 11150464 BACKGROUND

• Luks FI, Wild YK, Piasecki GJ, De Paepe ME. Short-term tracheal occlusion corrects pulmonary vascular anomalies in the fetal lamb with diaphragmatic hernia. Surgery. 2000 Aug;128(2):266-72. doi: 10.1067/msy.2000.107373.

  PMID: 10923003 BACKGROUND

• Wild YK, Piasecki GJ, De Paepe ME, Luks FI. Short-term tracheal occlusion in fetal lambs with diaphragmatic hernia improves lung function, even in the absence of lung growth. J Pediatr Surg. 2000 May;35(5):775-9. doi: 10.1053/jpsu.2000.6067.

  PMID: 10813348 BACKGROUND

• De Paepe ME, Johnson BD, Papadakis K, Luks FI. Lung growth response after tracheal occlusion in fetal rabbits is gestational age-dependent. Am J Respir Cell Mol Biol. 1999 Jul;21(1):65-76. doi: 10.1165/ajrcmb.21.1.3511.

  PMID: 10385594 BACKGROUND

• De Paepe ME, Papadakis K, Johnson BD, Luks FI. Fate of the type II pneumocyte following tracheal occlusion in utero: a time-course study in fetal sheep. Virchows Arch. 1998 Jan;432(1):7-16. doi: 10.1007/s004280050128.

  PMID: 9463582 BACKGROUND

• De Paepe ME, Johnson BD, Papadakis K, Sueishi K, Luks FI. Temporal pattern of accelerated lung growth after tracheal occlusion in the fetal rabbit. Am J Pathol. 1998 Jan;152(1):179-90.

  PMID: 9422535 BACKGROUND

• Papadakis K, Luks FI, De Paepe ME, Piasecki GJ, Wesselhoeft CW Jr. Fetal lung growth after tracheal ligation is not solely a pressure phenomenon. J Pediatr Surg. 1997 Feb;32(2):347-51. doi: 10.1016/s0022-3468(97)90208-6.

  PMID: 9044151 BACKGROUND

• Luks FI, Deprest JA, Gilchrist BF, Peers KH, van der Wildt B, Steegers EA, Vandenberghe K. Access techniques in endoscopic fetal surgery. Eur J Pediatr Surg. 1997 Jun;7(3):131-4. doi: 10.1055/s-2008-1071072.

  PMID: 9241495 BACKGROUND

• Jani JC, Nicolaides KH, Gratacos E, Valencia CM, Done E, Martinez JM, Gucciardo L, Cruz R, Deprest JA. Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2009 Sep;34(3):304-10. doi: 10.1002/uog.6450.

  PMID: 19658113 BACKGROUND

• Deprest JA, Flemmer AW, Gratacos E, Nicolaides K. Antenatal prediction of lung volume and in-utero treatment by fetal endoscopic tracheal occlusion in severe isolated congenital diaphragmatic hernia. Semin Fetal Neonatal Med. 2009 Feb;14(1):8-13. doi: 10.1016/j.siny.2008.08.010. Epub 2008 Oct 8.

  PMID: 18845492 BACKGROUND

• Yang SH, Nobuhara KK, Keller RL, Ball RH, Goldstein RB, Feldstein VA, Callen PW, Filly RA, Farmer DL, Harrison MR, Lee H. Reliability of the lung-to-head ratio as a predictor of outcome in fetuses with isolated left congenital diaphragmatic hernia at gestation outside 24-26 weeks. Am J Obstet Gynecol. 2007 Jul;197(1):30.e1-7. doi: 10.1016/j.ajog.2007.01.016.

  PMID: 17618746 BACKGROUND

• Luks FI, Carr SR, Muratore CS, O'Brien BM, Tracy TF. The pediatric surgeons' contribution to in utero treatment of twin-to-twin transfusion syndrome. Ann Surg. 2009 Sep;250(3):456-62. doi: 10.1097/SLA.0b013e3181b45794.

  PMID: 19644353 BACKGROUND

MeSH Terms

Conditions

Hernia, Diaphragmatic; Lung Diseases; Tracheal Diseases; Perinatal Death

Condition Hierarchy (Ancestors)

Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Respiratory Tract Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes

Results Point of Contact

• Title: Francois I. Luks, MD, PhD
• Organization: Rhode Island Hospital

Francois_Luks@brown.edu

401-228-0556

Study Officials

• Francois I Luks, MD, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Francois I. Luks, MD, PhD

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: September 1, 2008
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 30, 2017
• Results First Posted: May 30, 2017

Record last verified: 2017-05

Locations

US (1)