Trial of Maternal Oxygen for Fetal Left Heart Hypoplasia

NCT02965638 | Active Not Recruiting

• 1 other identifier: H37471
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if maternal hyperoxygenation is an effective treatment for fetal left heart hypoplasia versus room air (placebo). This will be determined by measuring how well a baby's heart valves and their surrounding tissue are growing and functioning. In addition the investigators will examine brain growth using fetal ultrasound and MRI, and MRI of the child's brain after they are born to determine if there is greater neonatal brain maturity or mothers receiving oxygen compared to fetuses of mothers not receiving oxygen. Of note, the trial was initially randomized. However, due to low sample size and hesitation about randomization, the trial was converted to an open label study, allowing families opting for oxygen therapy to be in the intervention arm.

Conditions

Fetal Left Heart Hypoplasia

Keywords

LHH

Outcome Measures

Primary Outcomes (2)

• Fetal aortic valve growth

  The rate of growth of the fetal aortic valve using fetal echocardiography during serial echocardiography throughout enrollment during the fetal period

  from study enrollment to delivery

• Fetal mitral valve growth

  The rate of growth of the fetal mitral valve using fetal echocardiography during serial echocardiography throughout enrollment during the fetal period

  from study enrollment to delivery

Secondary Outcomes (4)

• Brain maturation score by cerebral magnetic resonance imaging

  performed after birth prior to cardiac surgery if necessary, which will be within the first 30 days of life

• Neurologic injury on postnatal brain MRI

  performed after birth prior to cardiac surgery if necessary, which will be within the first 30 days of life

• Neurodevelopmental assessments

  at 6 and 12 months

• Change in measured parameters on fetal neurosonography and fetal brain MRI

  from study enrollment to delivery

Study Arms (2)

Oxygen Group

ACTIVE COMPARATOR

The mothers will be asked to be on 4 liter of oxygen through nasal cannula up to 24 hours a day. The subjects will be blinded to their treatment.

Other: Oxygen

Control Group

NO INTERVENTION

These mothers will not undergo CMH therapy

Interventions

Oxygen OTHER

The intervention arm (Oxygen Group) will receive oxygen via nasal cannula at a rate of 4L of FiO2 93-100% from an oxygen concentrator up to 24 hours daily

Oxygen Group

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Mothers carrying fetuses with small left sided structures likely needing neonatal intervention, defined as the following on fetal echocardiography:
• Sum of aortic and mitral valve z-scores (standard deviation based on gestational age) less than -4.5
• Flow across the atrial septum either bidirectional or left to right
• Transverse aortic arch or isthmus z-score less than 2.0.

You may not qualify if:

• Severe fetal aortic stenosis
• Fetal mitral or aortic atresia
• Abnormal fetal atrioventricular or ventriculoarterial relationships, including double inlet left ventricle, double outlet right ventricle, transposition of the great arteries
• Multiple gestations
• Intrauterine growth restriction
• Persistent fetal arrhythmia
• Very poor ultrasound images, defined by the inability to reliably measure/evaluate all included cardiac structures
• Major fetal extracardiac anomalies, specifically lesions that would be expected toi ncrease mortality for the fetus/neonate or would necessitate intervention in the neonatal period, including but not limited to congenital diaphragmatic hernia, omphalocele, gastroschesis, meningomyelocele, lower urinary tract obstruction, and anencephaly
• Aneuploidy (although this is not required to be known to enroll
• Maternal conditions that may alter fetal hemodynamic, including moderate to severe hypertension requiring medication in pregnancy, preeclampsia, major or unrepaired maternal congenital heart disease, obstructive sleep apnea, severe asthma (requiring daily treatment), restrictive lung disease, severe anemia (hemoglobin less than 8 g/dL), maternal chronic renal disease (creatinine greater than 1.2 mg/dL), known placental abnormality (complete placenta previa, accrete, or percreta), and antiphospholipid antibody syndrome.

Sponsors & Collaborators

• Shaine Morris: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Lara DA, Morris SA, Maskatia SA, Challman M, Nguyen M, Feagin DK, Schoppe L, Zhang J, Bhatt A, Sexson-Tejtel SK, Lopez KN, Lawrence EJ, Andreas S, Wang Y, Belfort MA, Ruano R, Ayres NA, Altman CA, Aagaard KM, Becker J. Pilot study of chronic maternal hyperoxygenation and effect on aortic and mitral valve annular dimensions in fetuses with left heart hypoplasia. Ultrasound Obstet Gynecol. 2016 Sep;48(3):365-72. doi: 10.1002/uog.15846.

  PMID: 26700848 BACKGROUND

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Shaine A Morris, MD, MPH

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 17, 2016
• Study Start: September 1, 2015
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)