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Completed

NCT Number: NCT03798093

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

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.

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Key information

Age range

35 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

About this study

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 ventricular 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Umbilical Cord Milking

Procedure

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

Procedure

The umbilical cord is clamped within 60 seconds of delivery.

Primary outcomes

  1. Left Ventricular Output

    Time frame: 12 ± 6 hours of life

    Left ventricular output measurements taken by cardiac ultrasound.

Secondary outcomes

  1. Neonatal Right Ventricular Output

    Time frame: 12 ± 6 hours of life

    Obtained from the modified short axis view of the neonatal echocardiogram performed at 12 hours of life ± 6 hours.

  2. Neonatal Superior Vena Cava Flow

    Time frame: 12 ± 6 hours of life

    superior vena cava (SVC) flow (Diameter obtained from the infraclavicular view (hybrid view) and doppler assessment from the subcostal view of the neonatal echocardiogram exam performed at 12 hours of life ± 6 hours.

  3. Neonatal Peak Systolic Strain

    Time frame: 12 ± 6 hours of life

    This measurement reflects the deformation (strain) of the heart muscle during systole (the phase of the heartbeat when the heart contracts) relative to its original length. More negative values indicate better myocardial function while values closer to 0 suggest impaired myocardial function.

  4. Neonatal Peak Systolic Velocity

    Time frame: 12 ± 6 hours of life

    Measure of left and right ventricular peak systolic tissue doppler velocity on neonatal echocardiogram performed at 12 hours of life ± 6 hours.

Other outcomes

  1. Tricuspid Annular Plane Systolic Excursion Measurement in Neonate

    Time frame: 12 ± 6 hours of life

    Assessment of tricuspid annular plane systolic excursion in the neonate by echocardiogram performed at 12 hours of life ± 6 hours

  2. Number of Neonates With a Patent Ductus Arteriosus

    Time frame: 12 ± 6 hours of life

    Diagnosis of patent ductus arteriosus in neonate by echocardiogram with diameter measurement and direction of flow.

  3. Neonatal Direction of Ductal Shunt

    Time frame: 12 ± 6 hours of life

    Direction of ductal shunt in neonate assessed by echocardiogram which was performed at 12 hours of life ± 6 hours.

Sponsors and collaborators

Lead sponsor

Sharp HealthCare

Other

Collaborators

  • Sharp Mary Birch Hospital for Women & Newborns

Registry information

Official study title

Hemodynamic Changes With Umbilical Cord Milking in Nonvigorous Newborns

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 9, 2019
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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