Determination of Neurological OutcomesiFADNCT02591745
International Fetal Anesthesia Database
An observational study of Determination of Neurological Outcomes, run by Baylor College of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Determination of Neurological Outcomes
- What is being tested?
- Fetal intervention
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jan 2030
- How long will I take part?
- 18 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mothers whose fetuses require fetal intervention for a variety of conditions. Fetuses who have undergone surgical intervention while in-utero.
Inclusion Criteria: Pregnant women, fetuses and children
Exclusion Criteria: Non-pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Children's Hospital, Baylor College of Medicine
Houston, Texas, 77030
About this study
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.
Read the detailed 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.
- Conditions
- Determination of Neurological Outcomes
- Being tested
- Fetal intervention
- Keywords
- Fetal, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal interventionProcedure or surgery
Type of fetal conditions requiring intervention and medications administered to fetuses undergoing varying types of fetal intervention will be documeted in this database.
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal complications
resuscitation efforts during surgery or peri-operative demise
Measured: Peri-operative
Secondary outcomes (1)
Maternal hypotension or other maternal complications
Measured: Peri-operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2027 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Determination of Neurological OutcomesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 18 Years
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Universitaire Ziekenhuizen KU Leuven, The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, Titilopemi Aina, MD MPH, Baylor College of Medicine
- Investigators
- Titilopemi Aina, M.D., M.P.H., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591745
- Sponsor's protocol ID
- H- 35126
- Acronym
- iFAD
- Status last verified
- Feb 2025
- First submitted
- 28 Oct 2015
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Fetal Anesthesia Database
- ClinicalTrials.gov ID
- NCT02591745
- Acronym / sponsor ID
- iFAD / H- 35126
- Conditions
- Determination of Neurological Outcomes
- Keywords
- Fetal, Anesthesia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Universitaire Ziekenhuizen KU Leuven, The University of Texas Health Science Center, Houston
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 18 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mothers whose fetuses require fetal intervention for a variety of conditions. Fetuses who have undergone surgical intervention while in-utero.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal interventionType of fetal conditions requiring intervention and medications administered to fetuses undergoing varying types of fetal intervention will be documeted in this database. | Procedure or surgery | – |
Primary outcome
Fetal complications
Time frame: Peri-operative
resuscitation efforts during surgery or peri-operative demise
1 secondary outcome
Maternal hypotension or other maternal complications
Time frame: Peri-operative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Titilopemi Aina, M.D., M.P.H. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Determination of Neurological Outcomes, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal complications (time frame: Peri-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.