Clinical Trial: Early FETO for Severe Congenital Diaphragmatic Hernia

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

Official Title: "Early" Versus "Standard" Fetal Endoscopic Tracheal Occlusion for Severe Congenital Diaphragmatic Hernia - a Randomized Controlled Trial

Brief Summary:

Congenital diaphragmatic hernia (CDH) is associated high mortality and morbidity, mainly in those cases with severe forms where there are extremely reduced lung volumes, liver herniation and decreased abnormal pulmonary vascularization. Fetal endoscopic tracheal occlusion performed between 26 and 30 weeks (standard FETO) has been shown to increase fetal pulmonary size and vascularity, and to improve infant survival in isolated severe CDH. Fetal pulmonary response followed FETO can be used to predict outcome and is dependent on the size of the fetal lung prior to the procedure.

We hypothesize that performing an earlier FETO, between 22-24 weeks, fetuses with severe form of CDH will have a better fetal pulmonary response and higher chance of surviving.

Detailed Summary: We pretend to investigate if "early FETO" will improve the survival rate and the fetal pulmonary response, by conducting a randomized controlled trial comparing the results with those fetuses that undergo to "standard FETO" (between 26-28 weeks).
Sponsor: University of Sao Paulo General Hospital

Current Primary Outcome: Infant survival rate [ Time Frame: 6 months of life ]

Original Primary Outcome:

• Neonatal survival rate [ Time Frame: 30 days of life ]
  Survivors at 30 days of life (after birth)
• Infant survival rate [ Time Frame: 6 months of life ]
  Percentage of survivors at 6 months of life

Current Secondary Outcome:

• Postnatal severe pulmonary arterial hypertension (PAH) [ Time Frame: 30 days of life ]
  Severe PAH will be considered when the neonate presents with profound cyanosis associated with echocardiographic continuous right-to-left shunting through a persistent 'ductus arteriosus' and a persistent difference in pre- to postductal saturation gradient >20%, despite the use of intake Nitric Oxide (iNO).
• Respiratory morbidity [ Time Frame: 6 months of life ]
  Need for ventilatory support and/or oxygen dependency.

Original Secondary Outcome: Same as current

Information By: University of Sao Paulo General Hospital

Dates:
Date Received: November 14, 2012
Date Started: June 2014
Date Completion: December 2016
Last Updated: December 16, 2013
Last Verified: November 2012