{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T15:15:17Z","timestamp":1787238917882,"version":"build-2736575974"},"reference-count":53,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100021570","name":"Strategy for Patient-Oriented Research","doi-asserted-by":"publisher","award":["145104"],"award-info":[{"award-number":["145104"]}],"id":[{"id":"10.13039\/100021570","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100005627","name":"Thrasher Research Fund","doi-asserted-by":"publisher","award":["13161"],"award-info":[{"award-number":["13161"]}],"id":[{"id":"10.13039\/100005627","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Ultrasound in Obstet &amp;amp; Gyne"],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Fetuses with single ventricle physiology (SVP) exhibit reductions in fetal cerebral oxygenation, with associated delays in fetal brain growth and neurodevelopmental outcomes. Maternal supplemental oxygen (MSO) has been proposed to improve fetal brain growth, but current evidence on dosing, candidacy and outcomes is limited. In this pilot study, we evaluated the safety and feasibility of continuous low\u2010dose MSO in the setting of SVP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      This single\u2010center, open\u2010label, pilot phase\u20101 safety and feasibility clinical trial included 25 pregnant individuals with a diagnosis of fetal SVP. Participants self\u2010administered continuous MSO using medical\u2010grade oxygen concentrators for up to 24\u2009h per day from the second half of gestation until delivery. The primary aim was the evaluation of the safety profile and feasibility of MSO. A secondary preliminary analysis was performed to assess the impact of MSO on the fetal circulation using echocardiography and late\u2010gestation cardiovascular magnetic resonance imaging. Early outcomes were assessed, including perinatal growth and preoperative brain injury, and neurodevelopmental outcomes were assessed at 18\u2009months using    the Bayley Scales of Infant and Toddler Development 3\n                      <jats:sup>rd<\/jats:sup>\n                      edition, and compared with those of a contemporary fetal SVP cohort (n\u2009=\u2009217) that received the normal standard of care (SOC).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among the 25 participants, the median maternal age at conception was 35\u2009years, and fetal SVP diagnoses included 16 with right ventricle dominant, eight with left ventricle dominant and one with indeterminate ventricular morphology. Participants started the trial at approximately 29\u2009+\u20092\u2009weeks' gestation and self\u2010administered MSO for a median of 16.1\u2009h per day for 63\u2009days, accumulating a median of  1029\u2009h of oxygen intake from enrolment until delivery. The only treatment\u2010associated adverse events were nasal complications that were resolved typically by attaching a humidifier unit to the oxygen concentrator. No premature closure of the ductus arteriosus or unexpected fetal demise was observed. In the secondary analysis, MSO was not associated with any changes in fetal growth, middle cerebral artery pulsatility index, cerebroplacental ratio or head\u2010circumference\u2010to\u2010abdominal\u2010circumference ratio\n                      <jats:italic>Z<\/jats:italic>\n                      \u2010scores over gestation compared with SOC. Although MSO was associated with changes in umbilical artery pulsatility index\n                      <jats:italic>Z<\/jats:italic>\n                      \u2010score over the study period compared with SOC (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009=\u20090.02), this was probably due to initial baseline differences in placental resistance. At late\u2010gestation cardiovascular magnetic resonance imaging, MSO was not associated with an increase in fetal cerebral oxygen delivery. Similarly, no differences were observed in neonatal outcomes, including  preoperative brain weight\n                      <jats:italic>Z<\/jats:italic>\n                      \u2010score and brain injury, mortality by 18\u2009months  of age and neurodevelopmental outcomes at 18\u2009months of age.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This pilot phase\u20101 clinical trial indicates that low\u2010dose MSO therapy is safe and well tolerated in pregnancies diagnosed with fetal SVP. However, our protocol was not associated with an increase in fetal cerebral oxygen delivery or improvements in early neurological or neurodevelopmental outcomes. \u00a9 2024 International Society of Ultrasound in Obstetrics and Gynecology.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/uog.27657","type":"journal-article","created":{"date-parts":[[2024,4,17]],"date-time":"2024-04-17T06:45:37Z","timestamp":1713336337000},"page":"493-503","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Safety and feasibility pilot study of continuous low\u2010dose maternal supplemental oxygen in fetal single ventricle heart disease"],"prefix":"10.1002","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6327-2834","authenticated-orcid":false,"given":"F.\u2010T.","family":"Lee","sequence":"first","affiliation":[{"name":"Department of Physiology, Temerty Faculty of Medicine University of Toronto  Toronto Canada"},{"name":"Division of Cardiology, Department of Pediatrics The Hospital for Sick Children, University of Toronto  Toronto Canada"},{"name":"Translational Medicine Program SickKids Research Institute  Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2517-6398","authenticated-orcid":false,"given":"L.","family":"Sun","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Pediatrics The Hospital for Sick Children, University of Toronto  Toronto Canada"},{"name":"Translational Medicine Program SickKids Research Institute  Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Szabo","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Pediatrics The Hospital for Sick Children, University of Toronto  Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N.","family":"Milligan","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Pediatrics The Hospital for Sick Children, University of Toronto  Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Saini","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Pediatrics The Hospital for Sick Children, University of Toronto  Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D.","family":"Chetan","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Pediatrics The Hospital for Sick Children, University of Toronto  Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.\u2010L.","family":"Hunt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. K.","family":"Macgowan","sequence":"additional","affiliation":[{"name":"Translational Medicine Program SickKids Research Institute  Toronto Canada"},{"name":"Department of Medical Biophysics, Temerty Faculty of Medicine University of Toronto  Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1221-081X","authenticated-orcid":false,"given":"L.","family":"Freud","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Pediatrics The Hospital for Sick Children, University of Toronto  Toronto Canada"},{"name":"Translational Medicine Program SickKids Research Institute  Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9012-6592","authenticated-orcid":false,"given":"E.","family":"Jaeggi","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Department of Pediatrics The Hospital for Sick Children, University of Toronto  Toronto Canada"},{"name":"Translational Medicine Program SickKids Research Institute  Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T.","family":"Van Mieghem","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Mount Sinai Hospital University of Toronto  Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Kingdom","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Mount Sinai Hospital University of Toronto  Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S. P.","family":"Miller","sequence":"additional","affiliation":[{"name":"Department of Pediatrics BC Children's Hospital and University of British Columbia  Vancouver Canada"},{"name":"Department of Pediatrics, The Hospital for Sick Children University of Toronto  Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Seed","sequence":"additional","affiliation":[{"name":"Department of Physiology, Temerty Faculty of Medicine University of Toronto  Toronto Canada"},{"name":"Division of Cardiology, Department of Pediatrics The Hospital for Sick Children, University of Toronto  Toronto Canada"},{"name":"Translational Medicine Program SickKids Research Institute  Toronto Canada"},{"name":"Department of Diagnostic Imaging, The Hospital for Sick Children University of Toronto  Toronto Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,10]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cjca.2022.04.021"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.118.036821"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2021.03.012"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIR.0b013e318265ee8a"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/dmcn.14512"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa067393"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtcvs.2008.10.025"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/braincomms\/fcab046"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.109.865568"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/ana.25940"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2023.08.013"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.121.056305"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.114.013051"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e31829bfdcf"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.115.019881"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/uog.24927"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1159\/000489123"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.281053"},{"key":"e_1_2_8_20_1","unstructured":"ICH Harmonised Guideline.Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2).2016."},{"key":"e_1_2_8_21_1","volume-title":"Adaptive Designs for Clinical Trials of Drugs and Biologics. Guidance for Industry","author":"Food and Drug Administration","year":"2019"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/echo.13722"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.21037\/tp-20-226"},{"key":"e_1_2_8_24_1","article-title":"Maternal oxygen administration for suspected impaired fetal growth","author":"Say L","year":"2003","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1469-0705.1994.04010034.x"},{"key":"e_1_2_8_26_1","first-page":"356","volume-title":"Autopsy Pathology: A Manual and Atlas","year":"2016"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.cir.0000437597.44550.5d"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.echo.2023.04.014"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1186\/1532-429X-17-S1-W13"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1159\/000505091"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.3233\/NPM-210942"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9378(03)00911-6"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2018.02.068"},{"key":"e_1_2_8_34_1","doi-asserted-by":"publisher","DOI":"10.1161\/circ.148.suppl_1.14220"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1038\/pr.2017.275"},{"key":"e_1_2_8_36_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtcvs.2021.01.065"},{"key":"e_1_2_8_37_1","doi-asserted-by":"publisher","DOI":"10.1002\/uog.18919"},{"key":"e_1_2_8_38_1","doi-asserted-by":"publisher","DOI":"10.1148\/radiol.2019190751"},{"key":"e_1_2_8_39_1","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.120.018777"},{"key":"e_1_2_8_40_1","doi-asserted-by":"publisher","DOI":"10.1002\/uog.22024"},{"key":"e_1_2_8_41_1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.202009-3608ST"},{"key":"e_1_2_8_42_1","doi-asserted-by":"publisher","DOI":"10.1016\/0002-9378(71)90639-9"},{"key":"e_1_2_8_43_1","article-title":"Respiratory gas exchange in the placenta","author":"Longo L","year":"2011","journal-title":"Comprehensive Physiology"},{"key":"e_1_2_8_44_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.317.7161.798"},{"key":"e_1_2_8_45_1","doi-asserted-by":"publisher","DOI":"10.4187\/respcare.01963"},{"key":"e_1_2_8_46_1","doi-asserted-by":"publisher","DOI":"10.1203\/00006450-199108000-00007"},{"key":"e_1_2_8_47_1","doi-asserted-by":"publisher","DOI":"10.1093\/bja\/aeg104"},{"key":"e_1_2_8_48_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41390-019-0604-4"},{"key":"e_1_2_8_49_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1469-0705.1993.03020115.x"},{"key":"e_1_2_8_50_1","doi-asserted-by":"publisher","DOI":"10.1242\/dmm.049077"},{"key":"e_1_2_8_51_1","doi-asserted-by":"publisher","DOI":"10.1038\/s42003-023-05132-2"},{"key":"e_1_2_8_52_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamanetworkopen.2024.12291"},{"key":"e_1_2_8_53_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamapediatrics.2019.5316"},{"key":"e_1_2_8_54_1","doi-asserted-by":"publisher","DOI":"10.1017\/S1047951121004030"}],"container-title":["Ultrasound in Obstetrics &amp; Gynecology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/uog.27657","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,12,2]],"date-time":"2024-12-02T06:55:21Z","timestamp":1733122521000},"score":1,"resource":{"primary":{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/10.1002\/uog.27657"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10]]},"references-count":53,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2024,10]]}},"alternative-id":["10.1002\/uog.27657"],"URL":"https:\/\/doi.org\/10.1002\/uog.27657","archive":["Portico"],"relation":{},"ISSN":["0960-7692","1469-0705"],"issn-type":[{"value":"0960-7692","type":"print"},{"value":"1469-0705","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,10]]},"assertion":[{"value":"2023-12-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-03-16","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-10-01","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}