Maternal Hyperoxygenation in Fetal Left Heart Hypoplasia

NCT05334966 | Unknown

• 1 other identifier: H-33802
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Heart disease is the leading cause of infant death related to birth defects. Congenital heart disease in which the left sided structures of the heart (left heart hypoplasia or LHH) are too small are among the most severe, and have some of the highest death and other complication rates.

Conditions

Left Heart Hypoplasia

Outcome Measures

Primary Outcomes (1)

• Aortic annular dimension

  By fetal echo the size of the aortic annulus in mm

  2 years

Secondary Outcomes (1)

• Mitral annular dimension

  years

Study Arms (4)

Historical LHH Controls

NO INTERVENTION

Previous women with a dx of fetal LHH and whose care was continued at Texas Children's Hospital.

Healthy Fetal Controls

PLACEBO COMPARATOR

Healthy mothers with healthy fetuses that will come in monthly for fetal echcos starting at 20 wks.

Other: Maternal Hyperoxygenation

Chonic Maternal Hyperoxygenation w/ LHH

EXPERIMENTAL

Mothers who have a fetus diagnosed with LHH and elect daily maternal hyperoxygenation therapy.

Other: Maternal Hyperoxygenation

Acute Maternal Hyperoxygenation with LHH

EXPERIMENTAL

Mothers who have a fetus diagnosed with LHH and elect acute maternal hyperoxygenation challenge testing.

Other: Maternal Hyperoxygenation

Interventions

Maternal Hyperoxygenation OTHER

Oxygen is given to mothers at 8L through a non-rebreather mask.

Also known as: Oxygen

Acute Maternal Hyperoxygenation with LHH; Chonic Maternal Hyperoxygenation w/ LHH; Healthy Fetal Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group A, C: Fetuses with hypoplastic left sided structures or at risk of coarctation of the aorta and ALL of the following
• Any mitral annulus, aortic annulus, left ventricular end-diastolic dimension, or aortic diameter z-score less than or equal to 3.0
• Right-left ventricular size discrepancy with no other explanation of discrepancy
• Retrograde blood flow in the aortic arch from the ductus arteriosus
• Left to right flow across the foramen ovale
• Group B: Healthy Fetal controls
• Mothers undergoing screening fetal echo for family history of CHD with a normal echo.
• Mothers undergoing fetal echocardiography for suspected heart disease with a normal echo
• Mothers evaluated in the fetal center with normal ultrasound
• Group D:
• Fetuses with hypoplastic left sided structures or at risk of coarctation of the aorta and any of the following
• Any mitral annulus, aortic annulus, left ventricular end-diastolic dimension, or aortic diameter z-score less than or equal to 2.0
• Right-left ventricular size discrepancy with no other explanation of discrepancy
• Continuous Doppler flow in the aortic arch concerning for coarctation
• Significantly less aortic flow than pulmonary artery flow

You may not qualify if:

• Multiple gestations
• Persistent arrhythmia
• Very poor ultrasound images, defined by the inability to reliably measure/evaluate all included cardiac structures (valve annuli, branch pulmonary arteries, PFO, and arch)
• Major extra cardiac anomalies
• Aneuploidy
• Maternal conditions that may alter fetal hemodynamics, including moderate to severe HTN requiring medication in pregnancy, preeclampsia, major or unrepaired maternal congenital heart disease, obstructive sleep apnea, severe asthma (non-responsive to inhaled steroid therapy), restrictive lung disease, severe anemia, maternal chronic renal disease known placentation abnormality (complete placenta previa, accrete, or percreta), and antiphospholipid ab syndrome

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital Pavilion for Women

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Shaine A Morris, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: April 19, 2022
• Study Start: January 1, 2014
• Primary Completion: April 1, 2024
• Study Completion: December 1, 2025
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

US (1)