CompletedNot Applicable

Cardiac and Cerebral Hemodynamics With Umbilical Cord Milking Compared With Early Cord Clamping

United States, Canada34 participantsStarted 2019-01-07

Plain-language summary

3 clinical sites enrolling in the primary MINVI trial (NCT03631940) will collect Near Infrared Spectroscopy (NIRS) data in the first 10 minutes of life on a subset of 200 non-vigorous term and near-term infants enrolled in the trial.

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 * Born at NIRS Sub-study site 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 Avulsion * 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

StO2 in the First 10 Minutes of Life

Timeframe: birth to 10 minutes of life

Trial details

NCT IDNCT03621956

SponsorSharp HealthCare

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-01

Results submitted2024-01-02

View on ClinicalTrials.gov More Birth Asphyxia With Neurologic Involvement trials