Clinical Trial: Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Randomized Clinical Trial in Order to Assess the Effect of Fetoscopic Tracheal Balloon Occlusion on the Postnatal Disease Course in Neonates With Left Congenital Diaphragmatic He

Brief Summary:

Left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung failure due to lung underdevelopment and pulmonary hypertension. In severe cases, extracorporeal membrane oxygenation (ECMO) is used as a life-saving intensive care means to enable survival of severely affected infants.

Clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls.

Therefore, the purpose of this randomized clinical trial in a less severely affected subgroup of patients is whether by fetoscopic tracheal occlusion, the intensity of postnatal intensive care therapy might be reduced. Primary outcome measure is the need for postnatal ECMO therapy.


Detailed Summary:
Sponsor: University Hospital, Bonn

Current Primary Outcome: Need for postnatal ECMO therapy [ Time Frame: First two days of life ]

Original Primary Outcome: Need for postnatal ECMO therapy

Current Secondary Outcome:

  • Survival to discharge from hospital [ Time Frame: Days to discharge ]
  • Maternal morbidity [ Time Frame: Until maternal discharge ]
  • Fetal / Neonatal morbidity [ Time Frame: Overall & at discharge from hospital ]
  • Premature preterm rupture of membranes [ Time Frame: Following the interventions over the remainder of gestation ]
  • Unintended preterm delivery [ Time Frame: Following the interventions before scheduled elective delivery ]
  • Days in intensive care [ Time Frame: Number of day until discharge from ICU ]
  • Days in hospital [ Time Frame: Number of days until discharge from hospital ]
  • Oxygen dependency on discharge [ Time Frame: Days until discharge ]


Original Secondary Outcome:

  • Survival to discharge from hospital
  • Maternal morbidity
  • Fetal morbidity
  • Premature preterm rupture of membranes
  • Unintended preterm delivery
  • Days in intensive care
  • Days in hospital
  • Oxygen dependency on discharge


Information By: University Hospital, Bonn

Dates:
Date Received: September 6, 2006
Date Started: January 2009
Date Completion: July 2014
Last Updated: January 5, 2009
Last Verified: January 2009