An interventional study of Umbilical Cord Milking and Early Cord Clamping in Birth Asphyxia, sponsored by Sharp HealthCare. Completed at 1 site in United States. Open to participants aged 35 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by Sharp HealthCare · Not applicable, Interventional, and Diagnostic
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.
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
106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.
This study's enrollment of 227 is above the median of 173 across 73 interventional studies indexed under Asphyxia Neonatorum.
Browse Asphyxia Neonatorum studies →Sharp HealthCare is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk the entire length of umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for Early Cord Clamping as we have demonstrated in our previous trials.
Procedure: Umbilical Cord Milking
This will occur by clamping the umbilical cord as soon as possible. Since both Early Cord Clamping and Umbilical Cord Milking will occur after a brief assessment, it is important to note that the cord clamping time will be longer than in previously conducted preterm trials (average 20 seconds) which performed the intervention on all subjects regardless of whether or not they were vigorous. In all cases, the cord clamping time will be documented to ensure consistency.
Procedure: Early Cord Clamping
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.
The umbilical cord is clamped within 60 seconds of delivery.
Left Ventricular Output
Left ventricular output measurements taken by cardiac ultrasound.
Time frame: 12 ± 6 hours of life
Neonatal Right Ventricular Output
Obtained from the modified short axis view of the neonatal echocardiogram performed at 12 hours of life ± 6 hours.
Time frame: 12 ± 6 hours of life
Neonatal Superior Vena Cava Flow
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.
Time frame: 12 ± 6 hours of life
Neonatal Peak Systolic Strain
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.
Time frame: 12 ± 6 hours of life
Neonatal Peak Systolic Velocity
Measure of left and right ventricular peak systolic tissue doppler velocity on neonatal echocardiogram performed at 12 hours of life ± 6 hours.
Time frame: 12 ± 6 hours of life
Tricuspid Annular Plane Systolic Excursion Measurement in Neonate
Assessment of tricuspid annular plane systolic excursion in the neonate by echocardiogram performed at 12 hours of life ± 6 hours
Time frame: 12 ± 6 hours of life
Number of Neonates With a Patent Ductus Arteriosus
Diagnosis of patent ductus arteriosus in neonate by echocardiogram with diameter measurement and direction of flow.
Time frame: 12 ± 6 hours of life
Neonatal Direction of Ductal Shunt
Direction of ductal shunt in neonate assessed by echocardiogram which was performed at 12 hours of life ± 6 hours.
Time frame: 12 ± 6 hours of life
Recruitment took place at two maternity hospitals involved in a cluster crossover randomization trial of non-vigorous infants at birth randomized to perform umbilical cord milking in the initial period (January 2019-January 2020) and early cord clamping in the crossover period (February 2020- March 2021). Participants were enrolled in this study upon parental consent for a neonatal echocardiogram in the first 12 hours of life. Participants enrolled in periods 1 \& 2 are unique participants.
| Milestone | Umbilical Cord Milking Then Early Cord Clamping Site Randomization - Neonate | Early Cord Clamping Then Umbilical Cord Milking - Neonate |
|---|---|---|
| Started | 106 | 0 |
| Completed | 106 | 0 |
| Not completed | 0 | 0 |
| Milestone | Umbilical Cord Milking Then Early Cord Clamping Site Randomization - Neonate | Early Cord Clamping Then Umbilical Cord Milking - Neonate |
|---|---|---|
| Started | 121 | 0 |
| Completed | 121 | 0 |
| Not completed | 0 | 0 |
Left ventricular output measurements taken by cardiac ultrasound.
| mL/kg/min | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate |
|---|---|---|
| Left Ventricular Output | 225 ± 64 | 187 ± 52 |
Obtained from the modified short axis view of the neonatal echocardiogram performed at 12 hours of life ± 6 hours.
| mL/kg/min | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate |
|---|---|---|
| Neonatal Right Ventricular Output | 284 ± 88 | 222 ± 95 |
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.
| mL/kg/min | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate |
|---|---|---|
| Neonatal Superior Vena Cava Flow | 100 ± 36 | 86 ± 40 |
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.
| percent | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate |
|---|---|---|
| Neonatal Peak Systolic Strain | -17 ± 3 | -22 ± 3 |
Measure of left and right ventricular peak systolic tissue doppler velocity on neonatal echocardiogram performed at 12 hours of life ± 6 hours.
| meters/second | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate |
|---|---|---|
| Neonatal Peak Systolic Velocity | .06 ± .02 | .07 ± .02 |
Assessment of tricuspid annular plane systolic excursion in the neonate by echocardiogram performed at 12 hours of life ± 6 hours
| mm | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate |
|---|---|---|
| Tricuspid Annular Plane Systolic Excursion Measurement in Neonate | 9.04 ± 2.2 | 9.65 ± 1.7 |
Diagnosis of patent ductus arteriosus in neonate by echocardiogram with diameter measurement and direction of flow.
| Participants | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate |
|---|---|---|
| Number of Neonates With a Patent Ductus Arteriosus | 88 | 110 |
Direction of ductal shunt in neonate assessed by echocardiogram which was performed at 12 hours of life ± 6 hours.
| Participants | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate |
|---|---|---|
| All left to right | 59 | 80 |
| All right to left | 0 | 1 |
| Bidirectional | 28 | 27 |
Diameter of neonatal ductus arteriosus assessed by echocardiogram which was performed at 12 hours of life ± 6 hours
| cm | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate |
|---|---|---|
| Diameter of Neonatal Ductus Arteriosus | 0.19 ± 0.10 | 0.20 ± 0.10 |
Neonatal peak pulmonary artery pressure as measured by echocardiogram at 12 hours of life ± 6 hours.
| mm Hg | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate |
|---|---|---|
| Neonatal Peak Pulmonary Artery Pressure | 27 ± 15 | 27 ± 14 |
blood pressure measurement obtained at the time of cardiac ultrasound examination
| g/dL | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate |
|---|---|---|
| Mean Neonatal Blood Pressure at Time of Echocardiogram | 45 ± 7 | 46 ± 7 |
Single neonatal hemoglobin measurement obtained between 12 and 48 hours of life either as part of standard care or obtained with parental written consent
| g/dL | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate |
|---|---|---|
| Median Neonatal Hemoglobin | 17.6 ± 2.1 | 16.5 ± 2.4 |
Collected over Assessed from neonate's birth to discharge home up to 180 days of life. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Umbilical Cord Milking - Neonate | 0/106 (0%) | 0/106 (0%) | 0/106 (0%) |
| Early Cord Clamping - Neonate | 0/121 (0%) | 0/121 (0%) | 0/121 (0%) |
| Age, Continuous(weeks) | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate | Total |
|---|---|---|---|
| Neonatal Birth Gestational Age | 40 (39 to 40) | 39 (38 to 40) | 39 (38 to 40) |
| Age, Continuous(years) | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate | Total |
|---|---|---|---|
| Maternal Age | 31 (27 to 33) | 30 (25 to 36) | 31 (27 to 34) |
| Sex: Female, Male(Participants) | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate | Total |
|---|---|---|---|
| Neonatal Sex — Female | 45 | 50 | 95 |
| Neonatal Sex — Male | 61 | 71 | 132 |
| Ethnicity (NIH/OMB)(Participants) | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate | Total |
|---|---|---|---|
| Neonatal Ethnicity — Hispanic or Latino | 45 | 52 | 97 |
| Neonatal Ethnicity — Not Hispanic or Latino | 60 | 69 | 129 |
| Neonatal Ethnicity — Unknown or Not Reported | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate | Total |
|---|---|---|---|
| Maternal Ethnicity — Hispanic or Latino | 39 | 44 | 83 |
| Maternal Ethnicity — Not Hispanic or Latino | 66 | 77 | 143 |
| Maternal Ethnicity — Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate | Total |
|---|---|---|---|
| Neonatal Race — American Indian or Alaska Native | 0 | 0 | 0 |
| Neonatal Race — Asian | 5 | 7 | 12 |
| Neonatal Race — Native Hawaiian or Other Pacific Islander | 0 | 3 | 3 |
| Neonatal Race — Black or African American | 1 | 6 | 7 |
| Neonatal Race — White | 52 | 50 | 102 |
| Neonatal Race — More than one race | 28 | 34 | 62 |
| Neonatal Race — Unknown or Not Reported | 20 | 21 | 41 |
| Race (NIH/OMB)(Participants) | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate | Total |
|---|---|---|---|
| Maternal Race — American Indian or Alaska Native | 1 | 0 | 1 |
| Maternal Race — Asian | 5 | 11 | 16 |
| Maternal Race — Native Hawaiian or Other Pacific Islander | 0 | 4 | 4 |
| Maternal Race — Black or African American | 2 | 8 | 10 |
| Maternal Race — White | 64 | 58 | 122 |
| Maternal Race — More than one race | 13 | 16 | 29 |
| Maternal Race — Unknown or Not Reported | 21 | 24 | 45 |
| Maternal Diabetes(Participants) | Umbilical Cord Milking - Neonate | Early Cord Clamping - Neonate | Total |
|---|---|---|---|
| Count of participants | 14 | 16 | 30 |
19 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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