Echocardiography Sub-Study of the Umbilical Cord Milking in Non-Vigorous Infants Trial (MINVI)

Birth Asphyxia Clinical Trial

Official title: Hemodynamic Changes With Umbilical Cord Milking in Nonvigorous Newborns

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 venitricular 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 ;

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Asphyxia

• NCT number: NCT03798093
• Study type: Interventional
• Source: Sharp HealthCare
• Status: Completed
• Phase: N/A
• Start date: January 7, 2019
• Completion date: November 4, 2022