Status:
COMPLETED
Echocardiography Sub-Study of the Umbilical Cord Milking in Non-Vigorous Infants Trial (MINVI)
Lead Sponsor:
Sharp HealthCare
Collaborating Sponsors:
Sharp Mary Birch Hospital for Women & Newborns
Conditions:
Birth Asphyxia
Eligibility:
All Genders
35-42 years
Phase:
NA
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- • Non-vigorous newborns born between 35-42 weeks gestation.
Exclusion
- Known major congenital or chromosomal anomalies of newborn.
- Known cardiac defects other than small atrial septal defect (ASD), ventricular septal defect (VSD) and patent ductus arteriosus (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.
Key Trial Info
Start Date :
January 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2022
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT03798093
Start Date
January 7 2019
End Date
November 4 2022
Last Update
March 25 2025
Active Locations (1)
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1
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States, 92123