Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123, United States
NCT Number: NCT03798093
Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing data collection. As part of the data collection, an optional echocardiogram will be performed if the parent consents.
Looking for future studies?
Notify Me35 week–42 week
All sexes
Interventional
Not applicable
San Diego, California, 92123, United States
Non-vigorous infants enrolled in the MINVI trial will be approached for consent for ongoing data collection. As part of the data collection, an optional echocardiogram will be performed if the parent consents. The consent will have a check box to indicate if they consent to the additional test.
Echocardiographic measurements will be performed on all infants at 12 hours +/- 6 hours of age by our research sonographers who are blinded to infant randomization. Measurements will be taken according to a standard operating procedure to assess systemic blood flow, by superior vena cava (SVC) flow (ml/kg/min), right ventricular output (ml/kg/min), left ventricular output (LVO) (ml/kg/min), measures of left and right ventricular tissue Doppler and strain imaging. These measurements will be performed offline at a later time. Data will be entered into REDCap.
If any structural abnormalities are found, the attending pediatrician will be notified of the abnormal echocardiogram. The consent will clearly state that this echo is not for diagnostic purposes. Any additional studies including an official complete echocardiogram and or cardiology consultation will be left to the discretion of the attending pediatrician, as he/she deems necessary
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.
The umbilical cord is clamped within 60 seconds of delivery.
Time frame: 12 ± 6 hours of life
Left ventricular output measurements taken by cardiac ultrasound.
Time frame: 12 ± 6 hours of life
Obtained from the modified short axis view of the neonatal echocardiogram performed at 12 hours of life ± 6 hours.
Time frame: 12 ± 6 hours of life
superior vena cava (SVC) flow (Diameter obtained from the infraclavicular view (hybrid view) and doppler assessment from the subcostal view of the neonatal echocardiogram exam performed at 12 hours of life ± 6 hours.
Time frame: 12 ± 6 hours of life
This measurement reflects the deformation (strain) of the heart muscle during systole (the phase of the heartbeat when the heart contracts) relative to its original length. More negative values indicate better myocardial function while values closer to 0 suggest impaired myocardial function.
Time frame: 12 ± 6 hours of life
Measure of left and right ventricular peak systolic tissue doppler velocity on neonatal echocardiogram performed at 12 hours of life ± 6 hours.
Time frame: 12 ± 6 hours of life
Assessment of tricuspid annular plane systolic excursion in the neonate by echocardiogram performed at 12 hours of life ± 6 hours
Time frame: 12 ± 6 hours of life
Diagnosis of patent ductus arteriosus in neonate by echocardiogram with diameter measurement and direction of flow.
Time frame: 12 ± 6 hours of life
Direction of ductal shunt in neonate assessed by echocardiogram which was performed at 12 hours of life ± 6 hours.
Sharp HealthCare
Other
Hemodynamic Changes With Umbilical Cord Milking in Nonvigorous Newborns
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05349175
Asphyxia Neonatorum, Birth Asphyxia
Boston, Massachusetts, United States
View Trial DetailsNCT05707962
Asphyxia Neonatorum, Birth Asphyxia
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT05854745
Asphyxia Neonatorum, Birth Asphyxia
Jimma, Ethiopia
View Trial DetailsNCT03631940
Asphyxia Neonatorum, Birth Asphyxia
Davis, California, United States
View Trial Details