NCT03798093

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

Hemodynamic Changes With Umbilical Cord Milking in Nonvigorous Newborns

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Sharp HealthCare · Academic / Other
• Sex: All
• Age: 35 Weeks – 42 Weeks
• Healthy volunteers: Not accepted

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.

Detailed 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 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

Conditions

• Birth Asphyxia

Interventions

Type	Name	Description
PROCEDURE	Umbilical Cord Milking	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.
PROCEDURE	Early Cord Clamping	The umbilical cord is clamped within 60 seconds of delivery.

Timeline

• Start date: 2019-01-07
• Primary completion: 2021-06-01
• Completion: 2022-11-04
• First posted: 2019-01-09
• Last updated: 2025-03-25
• Results posted: 2025-03-25

Locations

1 site across 1 country: United States