CompletedNot Applicable

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

United States227 participantsStarted 2019-01-07

Plain-language 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.

Who can participate

Age range35 Weeks – 42 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Left Ventricular Output

Timeframe: 12 ± 6 hours of life

Trial details

NCT IDNCT03798093

SponsorSharp HealthCare

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-01

Results submitted2024-07-18

View on ClinicalTrials.gov More Birth Asphyxia trials