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| Name | Class |
|---|---|
| Sharp Mary Birch Hospital for Women & Newborns | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical Cord Milking | Active Comparator | 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. |
|
| Early Cord Clamping | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Output | Left ventricular output measurements taken by cardiac ultrasound. | 12 ± 6 hours of life |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Right Ventricular Output | Obtained from the modified short axis view of the neonatal echocardiogram performed at 12 hours of life ± 6 hours. | 12 ± 6 hours of life |
| Neonatal Superior Vena Cava Flow |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 ± 6 hours of life |
| Number of Neonates With a Patent Ductus Arteriosus |
Inclusion Criteria:
• Non-vigorous newborns born between 35-42 weeks gestation.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anup Katheria, MD | Sharp Mary Birch Hospital for Women & Newborns | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Mary Birch Hospital for Women and Newborns | San Diego | California | 92123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36914049 | Derived | Katheria A, Mercer J, Poeltler D, Morales A, Torres N, Lakshminrusimha S, Singh Y. Hemodynamic Changes with Umbilical Cord Milking in Nonvigorous Newborns: A Randomized Cluster Cross-over Trial. J Pediatr. 2023 Jun;257:113383. doi: 10.1016/j.jpeds.2023.03.001. Epub 2023 Mar 11. |
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The two hospitals who participated in the echocardiography sub-study and were both randomized to implement umbilical cord milking in the initial period (Period 1) and randomized to implement early cord clamping in the cross over period (Period 2).
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Umbilical Cord Milking Then Early Cord Clamping Site Randomization - Neonate | In the first study period infants assessed as non-vigorous at delivery had the umbilical cord is grasped by the obstetric provider, and blood was pushed toward the infant 4 times before the cord is clamped. In the second study period infants assessed as non-vigorous at delivery had the umbilical cord clamped by 60 seconds of life. |
| FG001 | Early Cord Clamping Then Umbilical Cord Milking - Neonate | In the first study period infants assessed as non-vigorous at delivery had the umbilical cord clamped as soon as possible and within 60 seconds of delivery. In the second study period umbilical cord was grasped by the obstetric provider, and blood was pushed toward the infant 4 times before the cord is clamped. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Initial Randomized Intervention |
| |||||||||||||
| Crossover Randomized Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Umbilical Cord Milking - Neonate | At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. Both participating hospitals were randomized to perform umbilical cord milking as the first intervention in the primary trial. Maternal data is presented for all participating mothers. Only unique participants are presented. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Left Ventricular Output | Left ventricular output measurements taken by cardiac ultrasound. | Posted | Mean | Standard Deviation | mL/kg/min | 12 ± 6 hours of life |
|
Assessed from neonate's birth to discharge home up to 180 days of life
Adverse events were assessed for all neonate participants enrolled in the study and were collected from delivery to discharge home or up to 180 days of life.
All known adverse events are reported in the All-Cause Mortality, serious adverse events, and other adverse events tables.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Umbilical Cord Milking - Neonate | At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. Both participating hospitals were randomized to perform umbilical cord milking as the first intervention in the primary trial. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anup Katheria | Sharp Healthcare | 8589394170 | Anup.Katheria@sharp.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2022 | Feb 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001238 | Asphyxia Neonatorum |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D000087526 | Umbilical Cord Clamping |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Cluster Randomized Crossover
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Cardiac research sonographers that obtained study measurements were blinded to the study intervention
| Early Cord Clamping | Procedure | The umbilical cord is clamped within 60 seconds of delivery. |
|
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.
| 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. | 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. | 12 ± 6 hours of life |
Diagnosis of patent ductus arteriosus in neonate by echocardiogram with diameter measurement and direction of flow. |
| 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. | 12 ± 6 hours of life |
| NOT COMPLETED |
|
| BG001 | Early Cord Clamping - Neonate | The umbilical cord is clamped as early as possible and within 60 seconds of delivery. Both participating hospitals were randomized to perform early cord clamping as the second intervention in the primary trial. Maternal data is presented for all participating mothers. Only unique participants are presented. |
| BG002 | Total | Total of all reporting groups |
| weeks |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Maternal Diabetes | Number of neonates delivered by a mother with diabetes during pregnancy. | Count of Participants | Participants |
|
| Maternal Hypertension or Pre-eclampsia | Number of neonates delivered by a mother who experienced hypertension or pre-eclampsia during pregnancy. | Count of Participants | Participants |
|
| Maternal Intrauterine Inflammation/Infection | Number of neonates delivered by a mother diagnosed with intrauterine inflammation or intrauterine infection. | Count of Participants | Participants |
|
| Maternal Group B Streptococcus Positive | Number on infants born to a mother with positive group B streptococcus culture prior to delivery | Count of Participants | Participants |
|
| Maternal General Anesthesia | Number of neonates delivered by a mother who was administered general anesthesia at the time of delivery. | Count of Participants | Participants |
|
| Multiple Gestation | Number of neonates delivered by a mother with a multiple gestation pregnancy | Count of Participants | Participants |
|
| Delivery of the Neonate via Cesarean Section | Count of Participants | Participants |
|
| Number of hours Membranes were Ruptured Before Delivery | Median | Inter-Quartile Range | hours |
|
| Neonatal Weight at Birth | Mean | Standard Deviation | grams |
|
| Neonates with Poor Color at Birth | In the first 15 seconds of life the infant's skin color was assessed by the obstetric provider and assessment of poor color (pale, dusky, cyanotic) was reported on the study specific case report form. | Count of Participants | Participants |
|
| Neonates with Poor Tone at Birth | In the first 15 seconds of life the infant's tone was assessed by the obstetric provider and assessment of poor infant tone was reported on the study specific case report form. | Count of Participants | Participants |
|
| Neonates with Poor Respiratory Effort at Birth | In the first 15 seconds of life the infant is assessed for respiratory effort by the obstetric provider and assessment of poor respiratory effort it reported on the study specific case report form. | Count of Participants | Participants |
|
| Neonates Treated with Therapeutic Hypothermia | Number of neonates treated with therapeutic hypothermia (cooling to 33.5 degrees Celsius) for 72 hours and initiated in the first 6 hours of life. | Count of Participants | Participants |
|
| Neonates Treated with Cardiac Inotropes | Count of Participants | Participants |
|
| Neonates Treated with Volume Expanders | Count of Participants | Participants |
|
| Time of Echocardiogram Exam from Neonate's Time of Birth | Median | Inter-Quartile Range | hours |
|
| Venous Cord Blood Gas pH | Venous cord gas values reported for all neonates with results available for venous cord blood pH results. | Mean | Standard Deviation | no units |
|
| Venous Cord Blood Gas Base Excess | Venous cord gas values reported for all neonates with results available for venous cord blood base excess results. | Mean | Standard Deviation | mEq/L |
|
| Arterial Cord Blood Gas pH | Arterial cord gas values reported for all neonates with results available arterial cord blood pH results. | Mean | Standard Deviation | no units |
|
| Arterial Cord Blood Gas Base Excess | Venous cord gas values reported for all neonates with results available for arterial cord blood base excess results. | Mean | Standard Deviation | mEq/L |
|
|
|
|
| Secondary | Neonatal Right Ventricular Output | Obtained from the modified short axis view of the neonatal echocardiogram performed at 12 hours of life ± 6 hours. | Posted | Mean | Standard Deviation | mL/kg/min | 12 ± 6 hours of life |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mL/kg/min | 12 ± 6 hours of life |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percent | 12 ± 6 hours of life |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | meters/second | 12 ± 6 hours of life |
|
|
|
| Other Pre-specified | 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 | Posted | Mean | Standard Deviation | mm | 12 ± 6 hours of life |
|
|
|
| Other Pre-specified | Number of Neonates With a Patent Ductus Arteriosus | Diagnosis of patent ductus arteriosus in neonate by echocardiogram with diameter measurement and direction of flow. | Posted | Count of Participants | Participants | 12 ± 6 hours of life |
|
|
|
| Other Pre-specified | Neonatal Direction of Ductal Shunt | Direction of ductal shunt in neonate assessed by echocardiogram which was performed at 12 hours of life ± 6 hours. | Direction of shunt assessed only for neonates with a patent ductus arteriosus present. | Posted | Count of Participants | Participants | 12 ± 6 hours of life |
|
|
|
| Post-Hoc | Diameter of Neonatal Ductus Arteriosus | Diameter of neonatal ductus arteriosus assessed by echocardiogram which was performed at 12 hours of life ± 6 hours | Posted | Mean | Standard Deviation | cm | 12 ± 6 hours of life |
|
|
|
| Post-Hoc | Neonatal Peak Pulmonary Artery Pressure | Neonatal peak pulmonary artery pressure as measured by echocardiogram at 12 hours of life ± 6 hours. | Posted | Mean | Standard Deviation | mm Hg | 12 ± 6 hours of life |
|
|
|
| Post-Hoc | Mean Neonatal Blood Pressure at Time of Echocardiogram | blood pressure measurement obtained at the time of cardiac ultrasound examination | Posted | Mean | Standard Deviation | g/dL | 12 ± 6 hours of life |
|
|
|
| Post-Hoc | Median Neonatal Hemoglobin | Single neonatal hemoglobin measurement obtained between 12 and 48 hours of life either as part of standard care or obtained with parental written consent | Posted | Mean | Standard Deviation | g/dL | 12 to 48 hours of life |
|
|
|
| 0 |
| 106 |
| 0 |
| 106 |
| 0 |
| 106 |
| EG001 | Early Cord Clamping - Neonate | The umbilical cord is clamped as early as possible and within 60 seconds of delivery. Both participating hospitals were randomized to perform early cord clamping as the second intervention in the primary trial. | 0 | 121 | 0 | 121 | 0 | 121 |
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| Unknown or Not Reported |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Bidirectional |
|