Hypoxia Clinical Trial
Official title:
Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior
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.
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, race/ethnicity, 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 indicator(s), 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 indicator(s) with the SDOH measures to assess if the association of the maternal-fetal environment indicator(s) 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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04498598 -
Structural Modification In Supraglottic Airway Device
|
N/A | |
| Completed |
NCT05532670 -
N600X Low Saturation Accuracy Validation
|
||
| Enrolling by invitation |
NCT04106401 -
Intravascular Volumes in Hypoxia During Antarctic Confinement
|
N/A | |
| Recruiting |
NCT05883137 -
High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
|
||
| Not yet recruiting |
NCT05817448 -
Hypoxia-induced Autophagy in the Pathogenesis of MAP
|
||
| Recruiting |
NCT02661152 -
DAHANCA 30: A Randomized Non-inferiority Trial of Hypoxia-profile Guided Hypoxic Modification of Radiotherapy of HNSCC.
|
Phase 3 | |
| Terminated |
NCT02801162 -
Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard
|
N/A | |
| Not yet recruiting |
NCT02201875 -
Intrinsic Periodic Pattern of Breathing
|
N/A | |
| Completed |
NCT02943863 -
Regional Ventilation During High Flow Nasal Cannula and Conventional Nasal Cannula in Patients With Hypoxia
|
N/A | |
| Completed |
NCT02105298 -
Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
|
N/A | |
| Completed |
NCT01922401 -
Inverse Ratio Ventilation on Bariatric Operation
|
N/A | |
| Active, not recruiting |
NCT01681238 -
Goal-directed Therapy in High-risk Surgery
|
N/A | |
| Completed |
NCT01463527 -
Using Capnography to Reduce Hypoxia During Pediatric Sedation
|
N/A | |
| Completed |
NCT01507623 -
Value of Capnography During Nurse Administered Propofol Sedation (NAPS)
|
N/A | |
| Withdrawn |
NCT00638040 -
The Gene Expression Studies of the Role of Tumor Microenvironments in Tumor Progression
|
N/A | |
| Active, not recruiting |
NCT06097754 -
Intermittent Exogenous Ketosis (IEK) at High Altitude
|
N/A | |
| Completed |
NCT04589923 -
The VISION-Acute Study
|
||
| Completed |
NCT05044585 -
Evaluation of RDS MultiSense® in Desaturation Analysis in Healthy Volunteers
|
N/A | |
| Completed |
NCT03659513 -
The Effect of ECMO on the Pharmacokinetics of the Drugs and Their Clinical Efficacy
|
||
| Completed |
NCT03221387 -
Sleep and Daytime Use of Humidified Nasal High-flow Oxygen in COPD Outpatients
|
N/A |