Maternal Hyperoxygenation in Congenital Heart Disease

NCT03136835 | Completed Phase 1 DMC

• 1 other identifier: 1000048468
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

A pilot study investigating the safety and feasibility of chronic maternal hyperoxygenation in the setting of fetal congenital heart disease

Conditions

Hypoplastic Left Heart Syndrome

Outcome Measures

Primary Outcomes (2)

• The general condition of the child and mother at the time of birth

  The general condition of the child and mother at birth, classified by any maternal or fetal adverse events. Adverse events will also be classified as mild, moderate, severe, life-threatening or disabling, or fatal. The investigators will further define adverse events in terms of their effect on usual daily activities as follows: mild (an awareness of symptoms but easily tolerated), moderate (symptoms interfere with normal daily activities) or severe (symptoms are incapacitating, with the inability to perform daily activities). As unexpected adverse effects are by definition difficult to predict, the investigators use a variety of sources of information to identify possible side effects of the treatment including participant diaries, direct observations, participant reports, laboratory reports and other medical reports.

  2 years

• The duration of oxygen therapy tolerated by the subjects

  This will be as a proportion of the maximum potential duration if the subjects had adhered to the continuous therapy from enrollment to birth. If the treatment is not tolerable by a substantial number (e.g. \>10%) of subjects for significant periods of time (e.g. more than 8 hours a day) in the pilot study then this will be considered a negative result, i.e. that the treatment is not feasible.

  2 years

Study Arms (1)

Pilot

EXPERIMENTAL

Maternal Hyperoxygenation (4L/min via nasal prongs)

Drug: Maternal Hyperoxygenation

Interventions

Maternal Hyperoxygenation DRUG

Oxygen via nasal prongs at up to 4L/min continuously during 2nd and 3rd trimester of pregnancy until birth

Also known as: Oxygen

Pilot

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 20-32 weeks gestation
• Diagnosis of fetus with a single ventricular ventricular heart
• Delivering at Mount Sinai Hospital
• Written informed consent

You may not qualify if:

• Opting for termination of pregnancy/ comfort care
• BMI \>37.0
• Infections/ anemia
• Smoker
• Serious cardiorespiratory co-morbidities

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• Lee FT, Sun L, Szabo A, Milligan N, Saini A, Chetan D, Hunt JL, Macgowan CK, Freud L, Jaeggi E, Van Mieghem T, Kingdom J, Miller SP, Seed M. Safety and feasibility pilot study of continuous low-dose maternal supplemental oxygen in fetal single ventricle heart disease. Ultrasound Obstet Gynecol. 2024 Oct;64(4):493-503. doi: 10.1002/uog.27657.

  PMID: 38629477 DERIVED

MeSH Terms

Conditions

Hypoplastic Left Heart Syndrome

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Mike Seed, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Michael Seed

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: May 2, 2017
• Study Start: February 2, 2018
• Primary Completion: March 22, 2024
• Study Completion: March 22, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

CA (1)