N/A
N=106
Echocardiography Sub-Study of the Umbilical Cord Milking in Non-Vigorous Infants Trial (MINVI)
Birth Asphyxia
Bottom Line
View on ClinicalTrials.gov: NCT03798093 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Left Ventricular Output — 225; 187 mL/kg/min — p=0.08
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Umbilical Cord Milking (Procedure); Early Cord Clamping (Procedure)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sharp HealthCare
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Left Ventricular Output |
225; 187 | 0.08 |
| SECONDARY Neonatal Right Ventricular Output |
284; 222 | — |
| SECONDARY Neonatal Superior Vena Cava Flow |
100; 86 | — |
| SECONDARY Neonatal Peak Systolic Strain |
-17; -22 | — |
| SECONDARY Neonatal Peak Systolic Velocity |
.06; .07 | — |
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.
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT03798093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.