Clinical trial NCT03798093: Echocardiography Sub-Study of the Umbilical Cord Milking in Non-Vigorous Infants Trial (MINVI)
Official title: Hemodynamic Changes With Umbilical Cord Milking in Nonvigorous Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth Asphyxia
Keywords: Umbilical Cord Milking
Immediate Cord Clamping
Resuscitation
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: Sharp Mary Birch Hospital for Women & Newborns
First posted: 2019-01-09
Enrollment: 227
Sex: ALL
Minimum age (years): 35
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Cluster Randomized Crossover
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Left Ventricular Output
timeFrame: 12 ± 6 hours of life
Secondary outcomes:
measure: Neonatal Right Ventricular Output
timeFrame: 12 ± 6 hours of life
measure: Neonatal Superior Vena Cava Flow
timeFrame: 12 ± 6 hours of life
measure: Neonatal Peak Systolic Strain
timeFrame: 12 ± 6 hours of life
measure: Neonatal Peak Systolic Velocity
timeFrame: 12 ± 6 hours of life
Other outcomes:
measure: Tricuspid Annular Plane Systolic Excursion Measurement in Neonate
timeFrame: 12 ± 6 hours of life
measure: Number of Neonates With a Patent Ductus Arteriosus
timeFrame: 12 ± 6 hours of life
measure: Neonatal Direction of Ductal Shunt
timeFrame: 12 ± 6 hours of life
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
Study officials:
affiliation: Sharp Mary Birch Hospital for Women & Newborns
name: Anup Katheria, MD
role: PRINCIPAL_INVESTIGATOR
References: