Single Arm for Congenital Heart Disease Complex
Phase-Based Progress Estimates
Effectiveness
Safety
University of California San Francisco, San Francisco, CACongenital Heart Disease Complex+3 MoreNeonatal Neurobehavioral Scale - Procedure
Study Summary
This trial investigates how factors like CCHD, the mother-fetus environment, and social determinants of health affect a baby's brain development.
Eligible Conditions
- Congenital Heart Disease Complex
- Congenital Heart Disease
- Hypoxia
- Neurodevelopmental Disorders
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: <=30 days of life
Day 30
Baseline MCA-PI and change in MCA-PI with Maternal Hyperoxia
<=30 days of life
Pre-operative Neonatal Network Neurobehavioral Scale (NNNS) attention scores
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
1 Treatment Group
Single Arm
1 of 1
Experimental Treatment
150 Total Participants · 1 Treatment Group
Primary Treatment: Single Arm · No Placebo Group · Phase 2 & 3
Single ArmExperimental Group · 2 Interventions: Neonatal Neurobehavioral Scale, Single Arm · Intervention Types: Procedure, Procedure
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: <=30 days of life
Who is running the clinical trial?
University of UtahLead Sponsor
1,008 Previous Clinical Trials
1,787,232 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,616 Previous Clinical Trials
47,118,046 Total Patients Enrolled
Primary Children's HospitalOTHER
18 Previous Clinical Trials
14,054 Total Patients Enrolled
Eligibility Criteria
Age No minimum age - 52 · Female Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Women aged 18 and over who are pregnant with one baby, suspected or known to have congenital heart disease, and needing attention or surgery within 30 days of delivery.
References
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- Donofrio MT, Duplessis AJ, Limperopoulos C. Impact of congenital heart disease on fetal brain development and injury. Curr Opin Pediatr. 2011 Oct;23(5):502-11. doi: 10.1097/MOP.0b013e32834aa583.
- McQuillen PS, Miller SP. Congenital heart disease and brain development. Ann N Y Acad Sci. 2010 Jan;1184:68-86. doi: 10.1111/j.1749-6632.2009.05116.x.
- Limperopoulos C, Tworetzky W, McElhinney DB, Newburger JW, Brown DW, Robertson RL Jr, Guizard N, McGrath E, Geva J, Annese D, Dunbar-Masterson C, Trainor B, Laussen PC, du Plessis AJ. Brain volume and metabolism in fetuses with congenital heart disease: evaluation with quantitative magnetic resonance imaging and spectroscopy. Circulation. 2010 Jan 5;121(1):26-33. doi: 10.1161/CIRCULATIONAHA.109.865568. Epub 2009 Dec 21.
- Peyvandi S, Xu D, Wang Y, Hogan W, Moon-Grady A, Barkovich AJ, Glenn O, McQuillen P, Liu J. Fetal Cerebral Oxygenation Is Impaired in Congenital Heart Disease and Shows Variable Response to Maternal Hyperoxia. J Am Heart Assoc. 2021 Jan 5;10(1):e018777. doi: 10.1161/JAHA.120.018777. Epub 2020 Dec 21.
- Dimitropoulos A, McQuillen PS, Sethi V, Moosa A, Chau V, Xu D, Brant R, Azakie A, Campbell A, Barkovich AJ, Poskitt KJ, Miller SP. Brain injury and development in newborns with critical congenital heart disease. Neurology. 2013 Jul 16;81(3):241-8. doi: 10.1212/WNL.0b013e31829bfdcf. Epub 2013 Jun 14.
- Vesoulis ZA, Mathur AM. Cerebral Autoregulation, Brain Injury, and the Transitioning Premature Infant. Front Pediatr. 2017 Apr 3;5:64. doi: 10.3389/fped.2017.00064. eCollection 2017.
- Oros D, Figueras F, Cruz-Martinez R, Padilla N, Meler E, Hernandez-Andrade E, Gratacos E. Middle versus anterior cerebral artery Doppler for the prediction of perinatal outcome and neonatal neurobehavior in term small-for-gestational-age fetuses with normal umbilical artery Doppler. Ultrasound Obstet Gynecol. 2010 Apr;35(4):456-61. doi: 10.1002/uog.7588.
- Hogan WJ, Moon-Grady AJ, Zhao Y, Cresalia NM, Nawaytou H, Quezada E, Brook M, McQuillen P, Peyvandi S. Fetal cerebrovascular response to maternal hyperoxygenation in congenital heart disease: effect of cardiac physiology. Ultrasound Obstet Gynecol. 2021 May;57(5):769-775. doi: 10.1002/uog.22024. Epub 2021 Apr 13.
- Donofrio MT, Bremer YA, Schieken RM, Gennings C, Morton LD, Eidem BW, Cetta F, Falkensammer CB, Huhta JC, Kleinman CS. Autoregulation of cerebral blood flow in fetuses with congenital heart disease: the brain sparing effect. Pediatr Cardiol. 2003 Sep-Oct;24(5):436-43. doi: 10.1007/s00246-002-0404-0.
- Williams IA, Tarullo AR, Grieve PG, Wilpers A, Vignola EF, Myers MM, Fifer WP. Fetal cerebrovascular resistance and neonatal EEG predict 18-month neurodevelopmental outcome in infants with congenital heart disease. Ultrasound Obstet Gynecol. 2012 Sep;40(3):304-9. doi: 10.1002/uog.11144. Epub 2012 Aug 2.
- Hahn E, Szwast A, Cnota J 2nd, Levine JC, Fifer CG, Jaeggi E, Andrews H, Williams IA. Association between fetal growth, cerebral blood flow and neurodevelopmental outcome in univentricular fetuses. Ultrasound Obstet Gynecol. 2016 Apr;47(4):460-5. doi: 10.1002/uog.14881. Epub 2016 Feb 18.
- Szwast A, Putt M, Gaynor JW, Licht DJ, Rychik J. Cerebrovascular response to maternal hyperoxygenation in fetuses with hypoplastic left heart syndrome depends on gestational age and baseline cerebrovascular resistance. Ultrasound Obstet Gynecol. 2018 Oct;52(4):473-478. doi: 10.1002/uog.18919. Epub 2018 Sep 3.
- Sanapo L, Al-Shargabi T, Ahmadzia HK, Schidlow DN, Donofrio MT, Hitchings L, Khoury A, Larry Maxwell G, Baker R, Bulas DI, Gomez LM, du Plessis AJ. Fetal acute cerebral vasoreactivity to maternal hyperoxia in low-risk pregnancies: a cross-sectional study. Prenat Diagn. 2020 Jun;40(7):813-824. doi: 10.1002/pd.5694. Epub 2020 Apr 20.
- Rasanen J, Wood DC, Debbs RH, Cohen J, Weiner S, Huhta JC. Reactivity of the human fetal pulmonary circulation to maternal hyperoxygenation increases during the second half of pregnancy: a randomized study. Circulation. 1998 Jan 27;97(3):257-62. doi: 10.1161/01.cir.97.3.257.
- Hogan WJ, Winter S, Pinto NM, Weng C, Sheng X, Conradt E, Wood J, Puchalski MD, Tani LY, Miller TA. Neurobehavioral evaluation of neonates with congenital heart disease: a cohort study. Dev Med Child Neurol. 2018 Dec;60(12):1225-1231. doi: 10.1111/dmcn.13912. Epub 2018 May 10.
- Gakenheimer-Smith L, Glotzbach K, Ou Z, Presson AP, Puchalski M, Jones C, Lambert L, Delgado-Corcoran C, Eckhauser A, Miller T. The Impact of Neurobehavior on Feeding Outcomes in Neonates with Congenital Heart Disease. J Pediatr. 2019 Nov;214:71-78.e2. doi: 10.1016/j.jpeds.2019.06.047. Epub 2019 Aug 8.
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- Whitnee Hogan, MD (Assistant Professor) 2021. "Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05767385.
Frequently Asked Questions
To whom is access to this clinical trial open?
"Eligibility for this trial is contingent on being between the ages of 0 and 52, as well as displaying signs of hypoxia. 150 participants in total need to be enrolled." - Anonymous Online Contributor
Unverified Answer
Are individuals aged 40 and above being enrolled into this research study?
"As indicated in the eligibility requirements, participants must be between 0 and 52 years of age. There are 173 studies for minors and 358 for those over 65." - Anonymous Online Contributor
Unverified Answer
Are there any vacant slots to join this research study?
"According to official records found on clinicaltrials.gov, the search for participants is still ongoing at this time. The trial was initially published on December 17th 2021 and had its last update posted March 1st 2023." - Anonymous Online Contributor
Unverified Answer
What is the current cohort size of participants enrolled in this trial?
"Affirmative. Clinicaltrials.gov alludes to this clinical trial's current demands for participants, which commenced on the 17th of December 2021 and was most recently modified on March 1st 2023. The study plan necessitates 150 recruits from 5 different medical centres." - Anonymous Online Contributor
Unverified Answer
How many physical sites are currently administering this research project?
"At present, 5 different sites across the US have opened their doors to enrolling patients in this trial. These locations are situated in Washington, Scarborough and Salt Lake City amongst other cities. It is advisable for participants to choose a center closest to them so that travel demands can be minimized if they decide to join the study." - Anonymous Online Contributor
Unverified Answer