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

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ClinicalTrials.gov Identifier: NCT03621956
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : November 11, 2019
Sponsor:
Collaborator:
Sharp Mary Birch Hospital for Women & Newborns
Information provided by (Responsible Party):
Anup Katheria, M.D., Sharp HealthCare

Brief Summary:
2 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.

Condition or disease Intervention/treatment Phase
Birth Asphyxia With Neurologic Involvement Procedure: Umbilical Cord Milking Procedure: Early Cord Clamping Not Applicable

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: Two sites experienced with NIRS (University of Alberta 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Umbilical Cord Milking in Non-Vigorous Infants - NIRS Sub-study (MINVI_NIRS)
Actual Study Start Date : January 7, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Umbilical Cord Milking
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.
Procedure: Umbilical Cord Milking
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.

Active Comparator: Early Cord Clamping
The umbilical cord is clamped within 30 seconds of delivery.
Procedure: Early Cord Clamping
The umbilical cord is clamped within 30 seconds of delivery.




Primary Outcome Measures :
  1. St02 in the first 10 minutes of life [ Time Frame: 1st 10 minutes of life ]
    As part of the Near Infrared Spectroscopy (NIRS) sub-study, 2 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 :
  1. Heart Rate at 10 Minutes [ Time Frame: 1st 10 minutes of life ]
    As part of the NIRS sub-study, 2 sites will collect heart rate from the electrocardiogram in addition to cerebral oxygenation.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621956


Contacts
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Contact: Anup Katheria, MD 8589394170 anup.katheria@sharp.com
Contact: Katherine Baker, RN 8589394113 katherine.baker@sharp.com

Locations
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United States, California
Sharp Mary Birch Hospital for Women and Newborns Recruiting
San Diego, California, United States, 92123
Contact: Anup Katheria, MD    858-939-4198    anup.katheria@sharp.com   
Contact: Kathy Arnell, RN    858 939 4966    kathy.arnell@sharp.com   
Principal Investigator: Anup Katheria, MD         
Canada, Alberta
Governors of University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2R3
Contact: Georg Schmoelzer, MD       georg.schmoelzer@me.com   
Contact: Radha Chari, MD       radha.chari@albertahealthservices.ca   
Sponsors and Collaborators
Sharp HealthCare
Sharp Mary Birch Hospital for Women & Newborns
Investigators
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Principal Investigator: Anup Katheria, MD Sharp Mary Birch Hospital for Women & Newborns

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Responsible Party: Anup Katheria, M.D., Director, Neonatal Research Institute, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT03621956     History of Changes
Other Study ID Numbers: MINVI_NIRS Sub-study
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: November 11, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anup Katheria, M.D., Sharp HealthCare:
Near-Infrared Spectroscopy
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Asphyxia
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases