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

Birth Asphyxia With Neurologic Involvement Clinical Trial

— MINVINIRS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03621956
• Other study ID #: MINVI_NIRS Sub-study
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 7, 2019
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Weeks to 42 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Asphyxia With Neurologic Involvement

Intervention

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.
• Early Cord Clamping
The umbilical cord is clamped within 30 seconds of delivery.

Locations

Country	Name	City	State
Canada	Governors of University of Alberta	Edmonton	Alberta
United States	Sharp Grossmont Hospial	San Diego	California
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Sharp HealthCare	Sharp Mary Birch Hospital for Women & Newborns

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1st 10 minutes of life
Secondary	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.	1st 10 minutes of life