Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05767385
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2023-03-01
Brief Title:
Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Determine 1 the impact of abnormal fetal cerebrovascular physiology with neurodevelopmental delay ND outcomes and 2 how this relationship is modified by patient and environmental factors such as chronic congenital heart disease CCHD lesion maternal-fetal environment and social determinants of heath SDOH in a diverse population using a multicenter design
Pregnant women will be approached during one of their fetal cardiology clinic visits
Pregnant women will be approached during one of their fetal cardiology clinic visits
Detailed Description:
Aim 1
Determine the association of baseline cerebrovascular resistance and reactivity and pre-operative neurobehavior in neonates with complex congenital heart disease CCHD
Exposures The baseline middle cerebral artery pulsatility index MCA-PI and change in MCA-PI
Analyses Our principal analyses for Aim 1 will use separate linear regression models to relate the Neonatal Intensive Care Unit Network Neurobehavioral Scale NNNS attention score to 1 the baseline MCA-PI while controlling for maternal age infant sex raceethnicity and SDOH measures maternal education socioeconomic status SES insurance status and clinical site and 2 the change in MCA-PI adjusted for baseline MCA-PI while controlling for the same set of covariates If the NNNS attention score distribution is skewed we will consider transformations so that model residual plots achieve approximate normality The covariates in the above regression analyses exclude factors that may potentially lie on the causal pathway from the MCA-PI to the attention score to avoid risk of over adjustment In secondary analyses 2 regression analyses will be repeated after additional adjustment for the maternal-fetal environment indicators CCHD category and age at NNNS evaluation As a secondary analysis we will evaluate the interaction between baseline MCA-PI and change in MCA-PI For this analysis we will consider dichotomizing baseline MCA-PI to facilitate interpretation of the interaction effect
Aim 2
Determine the impact of patient and environmental factors on cerebrovascular resistance and reactivity Exposures Patient factors including CCHD category indicators of the maternal-fetal environment and SDOH
Analysis The primary analysis for Aim 2 will investigate the joint relationship of the MCA-PI with SDOH measures and the maternal-fetal comorbidity indicator while accounting for the CCHD category defined as Left sided obstructive lesion Right sided obstructive lesion Dextro-Transposition of the Great Arteries and Other We will apply multiple linear regression to relate the MCA-PI to the SDOH measures and a maternal-fetal comorbidity indicator for the presence of any of maternal hypertension diabetes pre-eclampsia eclampsia and abruption prematurity and small for gestational age The CCHD category will also be a covariate in the regression model Additional exploratory regression analyses will include pairwise interaction terms between the maternal-fetal comorbidity indicators with the SDOH measures to assess if the association of the maternal-fetal environment indicators with the MCA-PI varies across the different levels of the SDOH measures We will perform a separate multiple regression with the change in the MCA-PI as the outcome and with the baseline MCA-PI as an additional covariate
Determine the association of baseline cerebrovascular resistance and reactivity and pre-operative neurobehavior in neonates with complex congenital heart disease CCHD
Exposures The baseline middle cerebral artery pulsatility index MCA-PI and change in MCA-PI
Analyses Our principal analyses for Aim 1 will use separate linear regression models to relate the Neonatal Intensive Care Unit Network Neurobehavioral Scale NNNS attention score to 1 the baseline MCA-PI while controlling for maternal age infant sex raceethnicity and SDOH measures maternal education socioeconomic status SES insurance status and clinical site and 2 the change in MCA-PI adjusted for baseline MCA-PI while controlling for the same set of covariates If the NNNS attention score distribution is skewed we will consider transformations so that model residual plots achieve approximate normality The covariates in the above regression analyses exclude factors that may potentially lie on the causal pathway from the MCA-PI to the attention score to avoid risk of over adjustment In secondary analyses 2 regression analyses will be repeated after additional adjustment for the maternal-fetal environment indicators CCHD category and age at NNNS evaluation As a secondary analysis we will evaluate the interaction between baseline MCA-PI and change in MCA-PI For this analysis we will consider dichotomizing baseline MCA-PI to facilitate interpretation of the interaction effect
Aim 2
Determine the impact of patient and environmental factors on cerebrovascular resistance and reactivity Exposures Patient factors including CCHD category indicators of the maternal-fetal environment and SDOH
Analysis The primary analysis for Aim 2 will investigate the joint relationship of the MCA-PI with SDOH measures and the maternal-fetal comorbidity indicator while accounting for the CCHD category defined as Left sided obstructive lesion Right sided obstructive lesion Dextro-Transposition of the Great Arteries and Other We will apply multiple linear regression to relate the MCA-PI to the SDOH measures and a maternal-fetal comorbidity indicator for the presence of any of maternal hypertension diabetes pre-eclampsia eclampsia and abruption prematurity and small for gestational age The CCHD category will also be a covariate in the regression model Additional exploratory regression analyses will include pairwise interaction terms between the maternal-fetal comorbidity indicators with the SDOH measures to assess if the association of the maternal-fetal environment indicators with the MCA-PI varies across the different levels of the SDOH measures We will perform a separate multiple regression with the change in the MCA-PI as the outcome and with the baseline MCA-PI as an additional covariate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U24HL135691 | NIH | None | httpsreporternihgovquickSearchU24HL135691 |