Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Dec 6, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called Feto-Endoscopic Tracheal Occlusion (FETO), which aims to help unborn babies with a condition known as congenital diaphragmatic hernia (CDH). In CDH, a hole in the diaphragm allows organs to move into the chest, which can hinder lung development. The trial is specifically looking at babies who have severe lung issues related to this condition. If you are pregnant and your baby has been diagnosed with isolated left-sided CDH, and you meet certain criteria, you may be eligible to participate.

To qualify for this trial, you need to be at least 18 years old and have a single pregnancy. The procedure is considered for women whose pregnancy is between 27 to 31 weeks along and who have a specific type of lung condition as indicated by ultrasound. Participants will undergo the FETO procedure, which involves placing a small balloon in the baby’s trachea to help improve lung growth before birth. Throughout the trial, you will be closely monitored, and support will be provided to help you understand the process and any potential risks involved. It’s important to know that this trial is currently recruiting participants, so if you think you might be eligible, you can ask your doctor for more information.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Isolated CDH with liver up
• • Severe pulmonary hypoplasia with ultrasound O/E LHR \<25% at the time of surgery
• • Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days
• • Moderate pulmonary hypoplasia with ultrasound O/E LHR \<30% and liver-up at the time of surgery
• • Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category
• • Maternal age greater than or equal to 18 years
• • Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category
• • Normal karyotype or FISH
• • Normal fetal echocardiogram
• • Singleton pregnancy
• • Willing to remain in the greater Cincinnati area for remainder of pregnancy
• • Family considered and decline option of termination of the pregnancy at less than 24 weeks 0 days
• • Family meets psychosocial criteria
• Exclusion Criteria:
• • Patient \< 18 years old
• • Multi-fetal pregnancy
• • Rubber latex allergy
• • Preterm labor, cervix shortened (\<15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa
• • Bilateral CDH, isolated left sided CDH with an O/E \> 30%
• • Additional fetal anomaly by ultrasound, MRI, or echocardiogram
• • Chromosomal abnormalities
• • Maternal contraindications to fetoscopic surgery or severe maternal condition in pregnancy
• • Incompetent cervix with or without a cerclage
• • Placental abnormalities known at time of enrollment
• • Maternal HIV, Hepatits B, Hepatitis C
• • Maternal uterine anomaly
• • No safe or technically feasible fetoscopic approach to balloon placement
• • Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy