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Umbilical Cord Milking in Non-Vigorous Infants - NIRS Sub-study (MINVI_NIRS) (MINVINIRS)

Primary Purpose

Birth Asphyxia With Neurologic Involvement

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Umbilical Cord Milking
Early Cord Clamping
Sponsored by
Sharp HealthCare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Birth Asphyxia With Neurologic Involvement focused on measuring Near-Infrared Spectroscopy

Eligibility Criteria

35 Weeks - 42 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sharp Grossmont Hospial
  • Sharp Mary Birch Hospital for Women and Newborns
  • Governors of University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Umbilical Cord Milking

Early Cord Clamping

Arm Description

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 30 seconds of delivery.

Outcomes

Primary Outcome Measures

St02 in the first 10 minutes of life
As part of the Near Infrared Spectroscopy (NIRS) sub-study, 3 sites will collect physiological and resuscitation data from birth (mean airway pressure, fractional oxygen) in addition to cerebral oxygenation. Once the newborn is delivered, receives the intervention (UCM or ECC), and is stabilized during resuscitation, a NIRS sensor (Fore-Sight, CAS Medical, Branford, CT) will be placed on the right forehead within 10 minutes of the newborn being placed on the warmer

Secondary Outcome Measures

Heart Rate at 10 Minutes
As part of the NIRS sub-study, 3 sites will collect heart rate from the electrocardiogram in addition to cerebral oxygenation.

Full Information

First Posted
August 6, 2018
Last Updated
September 12, 2023
Sponsor
Sharp HealthCare
Collaborators
Sharp Mary Birch Hospital for Women & Newborns
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1. Study Identification

Unique Protocol Identification Number
NCT03621956
Brief Title
Umbilical Cord Milking in Non-Vigorous Infants - NIRS Sub-study (MINVI_NIRS)
Acronym
MINVINIRS
Official Title
Umbilical Cord Milking in Non-Vigorous Infants - NIRS Sub-study (MINVI_NIRS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sharp HealthCare
Collaborators
Sharp Mary Birch Hospital for Women & Newborns

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
3 clinical sites enrolling in the primary MINVI trial (NCT# ) 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.
Detailed Description
Rationale: Caregivers and researchers raised theoretical concerns that the UCM technique may deliver blood rapidly toward a non-vigorous newborn predisposing them to higher rates of brain injury or dislodging cellular debris into the brain. However, of the 13 studies on term infants comparing UCM to ECC, none have reported adverse outcomes. Even in more fragile preterm infants, no harm has been reported. All demonstrated improvements similar to DCC with increased red cell mass (measured by hematocrit or hemoglobin) improved blood pressure, increased pulmonary blood flow and improved ferritin at 6 weeks to 6 months of age with UCM. Nevertheless, careful assessment of safety is essential. Immediate physiological measurements on a subset (n=200) of infants of the two sub-study sites where the use of NIRS is standard of care, University of Alberta and SMBHWN, to establish the safety and efficacy of UCM. This aim will further test our hypotheses that infants in the UCM group will have improved early cardiac and cerebral hemodynamics within the first 10 minutes. The Near-infrared spectroscopy (NIRS) is a technology that allows non-invasive continuous real-time measurement of the regional tissue oxygen saturation (StO2) of organs such as the brain. There are well-established reference cerebral StO2 values for uncomplicated term and preterm deliveries; however, there are no completed RCTs using NIRS in the delivery room. Our group is currently leading the first multicenter trial (1R01HD088646-01A1) comparing DCC and UCM measuring NIRS at birth in premature infants. If cerebral oxygenation is improved, it will provide one plausible explanation for the long-term benefits expected with UCM. While published data exists on cerebral oxygenation directly comparing UCM with DCC, some studies demonstrated increases in cerebral oxygenation at 4 hours of age with DCC, and a decrease in cerebral oxygenation at birth with DCC compared to immediate cord clamping. To our knowledge, no studies using cerebral oxygenation in non-vigorous term/near-term infants have ever been performed. This sub-study (n=200) will yield the largest available sample of specific measurements of cerebral oximetry in non-vigorous term newborns. Substudy Sites: Three sites experienced with NIRS (University of Alberta, Sharp Grossmont Hospital and SMBHWN) will obtain and report the physiological changes with UCM and ECC at 10 minutes of life. Data from the non-invasive monitoring devices are recorded using a continuous real-time data acquisition system that provides a second-by-second record of the resuscitation that is also time-linked to the video recordings. Both sites have 24/7 research team coverage that attend all high-risk deliveries. The research team will ensure accurate sensor placement and data collection. These two exceptional settings will allow us to collect significant data regarding resuscitation outcomes linked to cerebral oxygenation. Protocol for NIRS Sub-Study: At the two sub-study sites, the use of NIRS is standard of care. As part of the NIRS sub-study, sites will collect physiological and resuscitation data from birth (mean airway pressure, fractional oxygen) in addition to cerebral oxygenation. Once the newborn is delivered, receives the intervention (UCM or ECC), and is stabilized during resuscitation, a NIRS sensor (Fore-Sight, CAS Medical, Branford, CT) will be placed on the right forehead within 10 minutes of the newborn being placed on the warmer. While arterial saturation and heart rate data will be available to the clinical team, data from NIRS will be blinded. Data on all study infants will be recorded for the first 10 minutes in the delivery room at the two sites. Heart rate, oxygen saturations, and cerebral oxygenation will be downloaded as per both site's practice for neonatal resuscitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Asphyxia With Neurologic Involvement
Keywords
Near-Infrared Spectroscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Umbilical Cord Milking
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Early Cord Clamping
Arm Type
Active Comparator
Arm Description
The umbilical cord is clamped within 30 seconds of delivery.
Intervention Type
Procedure
Intervention Name(s)
Umbilical Cord Milking
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Early Cord Clamping
Intervention Description
The umbilical cord is clamped within 30 seconds of delivery.
Primary Outcome Measure Information:
Title
St02 in the first 10 minutes of life
Description
As part of the Near Infrared Spectroscopy (NIRS) sub-study, 3 sites will collect physiological and resuscitation data from birth (mean airway pressure, fractional oxygen) in addition to cerebral oxygenation. Once the newborn is delivered, receives the intervention (UCM or ECC), and is stabilized during resuscitation, a NIRS sensor (Fore-Sight, CAS Medical, Branford, CT) will be placed on the right forehead within 10 minutes of the newborn being placed on the warmer
Time Frame
1st 10 minutes of life
Secondary Outcome Measure Information:
Title
Heart Rate at 10 Minutes
Description
As part of the NIRS sub-study, 3 sites will collect heart rate from the electrocardiogram in addition to cerebral oxygenation.
Time Frame
1st 10 minutes of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anup Katheria, MD
Organizational Affiliation
Sharp Mary Birch Hospital for Women & Newborns
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sharp Grossmont Hospial
City
San Diego
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Sharp Mary Birch Hospital for Women and Newborns
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Governors of University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R3
Country
Canada

12. IPD Sharing Statement

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Umbilical Cord Milking in Non-Vigorous Infants - NIRS Sub-study (MINVI_NIRS)

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