Oxygen Therapy for Fetal Heart Defects

Overseen By Mike Seed, MBBS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Complex TGA, Arrhythmia, Non-cardiac lesions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

40 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Oxygen Therapy for Fetal Heart Defects is an effective treatment?

The available research shows that oxygen therapy is commonly used to treat respiratory issues in infants and children, aiming to prevent or treat low oxygen levels in the body. However, there is no specific data provided in the research articles that directly supports the effectiveness of oxygen therapy for fetal heart defects. The articles discuss its use in other conditions like respiratory failure and chronic obstructive pulmonary disease, but not specifically for fetal heart defects. Therefore, based on the information provided, there is no direct evidence supporting its effectiveness for this particular condition. ^{1 2 3 4 5}

What safety data exists for oxygen therapy in fetal heart defects?

The safety data for oxygen therapy, particularly hyperbaric oxygen therapy (HBOT), includes potential adverse events such as otic/sinus barotrauma, confinement anxiety, hypoglycemia, oxygen toxicity, pneumothorax, seizures, and shortness of breath. Oxygen toxicity seizures are a known complication, with incidence related to exposure duration and pressure. Middle ear barotrauma and claustrophobia are common but generally benign side effects. More serious side effects like seizures occur rarely and are associated with higher oxygen pressures. Maternal hyperoxygenation, a potential therapy for fetal heart defects, has been reviewed for safety, but specific intrauterine complications are not detailed in the provided abstracts. ^{6 7 8 9 10}

Is the treatment in the trial 'Oxygen Therapy for Fetal Heart Defects' promising?

Yes, the treatment is promising because it may help fetuses with heart defects by improving their oxygen levels, which can support better development and health outcomes. ^{1 10 11 12 13}

What is the purpose of this trial?

This prospective study will examine whether transient maternal hyperoxygenation is useful as a diagnostic test to more accurately detect TGA patients with poor vs. good neonatal intra-cardiac mixing of blood, based on the in-utero response to oxygen exposure. This study is Health Canada regulated

Research Team

Mike Seed, MD

Principal Investigator

The Hospital for Sick Children, Toronto

Edgar Jaeggi, MD

Principal Investigator

The Hospital for Sick Children, Toronto

Eligibility Criteria

This trial is for pregnant individuals whose fetus has been diagnosed with a heart condition known as Transposition of the Great Arteries (TGA), with or without a small hole in the heart (VSD). Participants should be planning on active management after the baby's birth.

Inclusion Criteria

My unborn baby has been diagnosed with a heart condition involving the transposition of the great arteries, possibly with a small hole in the heart.

Intention of active postnatal management after birth

Exclusion Criteria

I have significant health issues not related to my heart.

My unborn baby has a complex heart condition called TGA.

I cannot have a fetal MRI due to health reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Maternal Hyperoxygenation

Participants undergo transient maternal hyperoxygenation to assess fetal intracardiac and pulmonary blood flow using echocardiography and MRI

1 day

1 visit (in-person)

Follow-up

Participants are monitored for neonatal outcomes from intrauterine demise to hospital discharge, or up to 1 year of age if pulmonary hypertension exists

Up to 1 year

Treatment Details

Interventions

• Oxygen gas

Trial Overview The study is testing if breathing extra oxygen (hyperoxygenation) can help doctors better predict which babies with TGA will have good or poor mixing of blood in their hearts before they are born.

Participant Groups

Group I: Oxygen gas Experimental Treatment 1 Intervention

10-15 L/min of oxygen by face mask for up to 45 minutes for the MRI and up to 30 minutes for the echocardiogram.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Findings from Research

Oxygen therapy is crucial for infants with respiratory failure, aiming to reduce hypoxemia, prevent pulmonary hypertension, and decrease respiratory and cardiac strain, but there is a lack of consensus on its use across different medical centers.

The Spanish Society of Pediatric Pneumology has developed recommendations based on a review of existing literature to standardize oxygen therapy practices, addressing its indications, benefits, risks, and cost-effectiveness, particularly for home oxygen therapy management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oxygen therapy in acute and chronic conditions: Indications, oxygen systems, assessement and follow-up]. Luna Paredes, MC., Asensio de la Cruz, O., Cortell Aznar, I., et al.[2016]

Oxygen therapy is crucial for hospitalized children to prevent or treat tissue hypoxia, but it must be prescribed carefully like any medication to avoid inappropriate use.

The article emphasizes the importance of understanding the indications, administration, monitoring, and potential risks of oxygen therapy to maximize its benefits and minimize toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Oxygen Therapy: A Clinical Update. Haque, A., Rizvi, M., Arif, F.[2018]

Oxygen therapy is crucial for treating hypoxia by increasing the oxygen concentration in the air a patient breathes, which helps improve cellular metabolism.

Helium-oxygen mixtures (heliox) can effectively reduce respiratory effort and enhance gas exchange in patients with airway obstructions, and they do so with minimal adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Medicinal gases: oxygen and heliox]. Rodríguez Núñez, A., Martinón Sánchez, JM., Martinón Torres, F.[2019]

Maternal oxygen therapy in cases of suspected impaired fetal growth was associated with a lower perinatal mortality rate, showing a relative risk reduction of 50%, based on three studies involving 94 women.

However, the observed benefits may be influenced by the higher gestational age of the mothers receiving oxygen, indicating that more research is needed to fully understand the safety and efficacy of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal oxygen administration for suspected impaired fetal growth. Say, L., Gülmezoglu, AM., Hofmeyr, GJ.[2022]

Oxygen therapy is effective in increasing survival rates for patients with chronic obstructive pulmonary disease (COPD) and respiratory failure, but it has not been proven beneficial for patients with moderate hypoxaemia or other chronic respiratory conditions.

The choice of oxygen source and flow rate should be tailored to individual patient needs, considering factors like comfort, adaptability, and cost, to ensure proper oxygen saturation levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous home oxygen therapy. Ortega Ruiz, F., Díaz Lobato, S., Galdiz Iturri, JB., et al.[2016]

In a review of over 1.5 million hyperbaric oxygen therapy treatments, only 0.68% were linked to adverse events, indicating that serious complications are rare.

The most common issues reported were barotrauma and confinement anxiety, while severe events like oxygen toxicity occurred in less than 0.05 per 1000 treatments, suggesting that HBO therapy is a safe and low-risk treatment when following proper protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Retrospective Analysis of Adverse Events in Hyperbaric Oxygen Therapy (2012-2015): Lessons Learned From 1.5 Million Treatments. Jokinen-Gordon, H., Barry, RC., Watson, B., et al.[2022]

In a review of 41,273 hyperbaric oxygen therapy sessions involving 3,737 patients over 20 years, the incidence of oxygen toxicity seizures (OTS) was found to be low at 0.06%, indicating that while OTS is a risk, it is relatively rare.

The study revealed that the rate of OTS increases significantly with higher pressures, particularly above 203 kPa, suggesting that pressure levels during treatment should be carefully monitored to minimize the risk of seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxygen toxicity seizures: 20 years' experience from a single hyperbaric unit. Banham, ND.[2018]

In a study of 1,308 patients receiving hyperbaric oxygen (HBO2) therapy, five seizure episodes were reported during 10,425 treatments, indicating a low but notable risk of seizures, particularly in patients with carbon monoxide poisoning and arterial gas embolism.

Despite the occurrence of seizures, none of the patients experienced lasting effects, suggesting that while seizures can happen during HBO2 therapy, the overall safety profile remains high, and clinicians should be prepared to manage such events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizure during hyperbaric oxygen therapy: experience at a single academic hospital in Korea. Lee, CH., Choi, JG., Lee, JS., et al.[2021]

The most common side effects of hyperbaric oxygen (HBO2) therapy are middle ear barotrauma, affecting up to 2% of patients, which can be managed through techniques like autoinflation or tympanostomy tubes.

While rare, more severe side effects from HBO2 therapy can include oxygen toxicity leading to issues like progressive myopia and pulmonary dyspnea, with serious complications like seizures occurring at higher oxygen pressures, particularly in patients with acidosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of hyperbaric oxygen therapy. Camporesi, EM.[2014]

Maternal hyperoxygenation (MH) therapy in fetuses with congenital heart disease (CHD) showed promising results, with 270 fetuses treated and evidence of increased size in hypoplastic cardiac structures and improved blood flow metrics, indicating potential therapeutic benefits.

No significant adverse events were reported during the therapy, suggesting that MH is a safe intervention; however, further randomized controlled trials are necessary to confirm its efficacy and outcomes for specific types of CHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal hyperoxygenation: A potential therapy for congenital heart disease in the fetuses? A systematic review of the current literature. Co-Vu, J., Lopez-Colon, D., Vyas, HV., et al.[2020]

Hypoxic gas ventilation therapy using a nitrogen gas mixture safely improves cerebral blood supply in patients with congenital heart diseases, as indicated by increased cerebral oxygen saturation and improved middle cerebral artery blood flow.

In a study of 8 patients, cerebral oxygen saturation increased from an average of 67.3% to 70.7% within 24 hours of treatment, demonstrating that this therapy does not compromise oxygen delivery to the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in cerebral oxygen saturation and blood flow during hypoxic gas ventilation therapy in HLHS and CoA/IAA complex with markedly increased pulmonary blood flow. Toiyama, K., Hamaoka, K., Oka, T., et al.[2019]

Oxygen therapy is crucial for the care of premature infants in the NICU, but it poses risks of oxidant injury due to their limited antioxidant defenses, which can lead to serious complications like retinopathy and chronic lung disease.

The article emphasizes the importance of proper oxygen therapy practices for NICU nurses to minimize oxygen-related complications and improve the health outcomes of premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rethinking oxygen therapy for premature infants in terms of oxidative stress]. Yuan, CJ., Hua, YM., Lee, TY.[2013]

Maternal oxygen inhalation during pregnancy and labor may provide benefits to the fetus, suggesting a potential therapeutic role for oxygen therapy in these situations.

The review highlights the ongoing debate about the advantages and disadvantages of oxygen administration, indicating that more research is needed to fully understand its effects on both mother and fetus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of maternal oxygen administration on the fetus. Bartnicki, J., Saling, E.[2019]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Oxygen therapy in acute and chronic conditions: Indications, oxygen systems, assessement and follow-up]. [2016]

2. Pakistan pubmed.ncbi.nlm.nih.gov

Pediatric Oxygen Therapy: A Clinical Update. [2018]

3. Spain pubmed.ncbi.nlm.nih.gov

[Medicinal gases: oxygen and heliox]. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Maternal oxygen administration for suspected impaired fetal growth. [2022]

5. Spain pubmed.ncbi.nlm.nih.gov

Continuous home oxygen therapy. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

A Retrospective Analysis of Adverse Events in Hyperbaric Oxygen Therapy (2012-2015): Lessons Learned From 1.5 Million Treatments. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Oxygen toxicity seizures: 20 years' experience from a single hyperbaric unit. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Seizure during hyperbaric oxygen therapy: experience at a single academic hospital in Korea. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Side effects of hyperbaric oxygen therapy. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Maternal hyperoxygenation: A potential therapy for congenital heart disease in the fetuses? A systematic review of the current literature. [2020]

11. Japan pubmed.ncbi.nlm.nih.gov

Changes in cerebral oxygen saturation and blood flow during hypoxic gas ventilation therapy in HLHS and CoA/IAA complex with markedly increased pulmonary blood flow. [2019]

12. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

[Rethinking oxygen therapy for premature infants in terms of oxidative stress]. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

The influence of maternal oxygen administration on the fetus. [2019]