RecruitingNot Applicable

Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH

United States80 participantsStarted 2025-06-23

Plain-language summary

This registry study aims to confirm that FETO increases neonatal survival to discharge and reduces long-term morbidity in fetuses with isolated left CDH and o/e LHR \< 30%, or isolated right CDH and o/e LHR ≤ 45%, compared to those receiving standard care. This prospective registry plans to enroll 80 pregnant women (40 treatment/40 control) with fetuses diagnosed with isolated CDH, and the children will be followed for up to 24 months.

Who can participate

Age range18 Years

SexFEMALE

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Exclusion criteria

✕. Inability to reside within 30 minutes of Johns Hopkins Hospital Center for Fetal Therapy.
✕. The patient does not have a support person (e.g., spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Johns Hopkins Hospital Center for Fetal Therapy.

What they're measuring

Number of successful placement of FETO device

Timeframe: 10-60 minutes after surgery begins

Number of successful removal of FETO device

Timeframe: Immediately after the procedure (about 1 hour after start of surgery)

Number of FETO procedure complications

Timeframe: End of study (24 months)

Number of neonates that survived

Timeframe: From delivery to hospital discharge

Trial details

NCT IDNCT07166172

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-01

Contact for this trial

Ahmet Baschat, MD

410-502-6561 abascha1@jhmi.edu

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