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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798093
• Other study ID #: MINVI Echo Study
• Status: Completed
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: November 4, 2022

Study information

• Verified date: June 2024
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: November 4, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Weeks to 42 Weeks

Eligibility

Inclusion Criteria:

• Non-vigorous newborns born between 35-42 weeks gestation.

Exclusion Criteria:

• Known major congenital or chromosomal anomalies of newborn.

• Known cardiac defects other than small ASD, VSD and PDA

• Complete placental abruption/cutting through the placenta at time of delivery.

• Monochorionic multiples

• Cord anomaly (i.e. cord avulsion or true knot)

• Presence of non-reducible nuchal cord

• Perinatal providers unaware of the protocol

• Incomplete delivery data

• Infants born in extremis, for whom additional treatment will not be offered.

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Asphyxia

Intervention

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.
• Early Cord Clamping
The umbilical cord is clamped within 60 seconds of delivery.

Locations

Country	Name	City	State
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Sharp HealthCare	Sharp Mary Birch Hospital for Women & Newborns

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Output	Cardiac Output measured by Left Ventricular Output	12 +/- 6 hours of life
Secondary	Right Ventricular Output	Obtained from the modified short axis view of Cardiac Ultrasound	12 +/- 6 hours of life
Secondary	SVC Flow	SVC flow (Diameter obtained from the infaclavicular view (hybrid view), Doppler from the subcostal view)	12 +/- 6 hours of life
Secondary	Peak Systolic Strain and Strain rate	Measures of Left and Right Ventricular Strain and Strain rate	12 +/- 6 hours of life
Secondary	Peak Systolic Tissue Doppler	Measure of left and right ventricular peak systolic Tissue Doppler velocity	12 +/- 6 hours of life