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International Fetal Anesthesia Database (iFAD)

Baylor College of Medicine logo

Baylor College of Medicine

Status

Active, not recruiting

Conditions

Determination of Neurological Outcomes

Treatments

Procedure: Fetal intervention

Study type

Observational

Funder types

Other

Identifiers

NCT02591745
H- 35126

Details and patient eligibility

About

This registry aims to gather anesthetic medications administered to fetuses directly as well as those administered via the mother during fetal intervention procedures. The goal is to assesss short and medium term outcomes as well as long term outcomes of these babies whao have received medication in utero. The long term outcomes will include but are not limited to neurodevelopmental outcomes.

Full description

Advances in technology have allowed for an increase in procedures performed on the fetus in utero; these procedures involve the administration of different anesthetics (sedative- hypnotic agents and or volatile agents) to the mother and sometimes directly to the fetus in order for succesful completion of the procedure. Very few instiututions in the world perform these procedures in any significant number. The establishment of this database will serve to consolidate information regarding anesthetic drugs administered for these procedures, thereby helping to establish best practice guidelines, determine medium and short term outcomes or complications and also facilitate long term neurodevelopmental assessment of children that have undergone these procedures in utero with 5 and 10 year neurodevelopmental assessment.

Enrollment

2,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Pregnant women, fetuses and children

Exclusion Criteria: Non-pregnant women

Trial contacts and locations

1

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Central trial contact

Margaret Owens-Stuberfield; Titilopemi Aina, M.D., M.P.H.

Data sourced from clinicaltrials.gov

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