Birth AsphyxiaMINVINCT03631940
Umbilical Cord Milking in Non-Vigorous Infants
A study testing Umbilical Cord Milking and Early Cord Clamping in people with Birth Asphyxia, run by Sharp HealthCare at 10 sites in 3 countries.
Trial summary
The investigators will conduct a study of non-vigorous term infants to determine if umbilical cord milking (UCM) results in a lower rate of NICU admissions than early clamping and cutting of the umbilical cord at birth for infants who need resuscitation. Read more about this study
- Who is it for?
- Ages 35 to 42 weeks
- Conditions the study is for
- Birth Asphyxia
- What is being tested?
- Umbilical Cord Milking and Early Cord Clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,730 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 5 Jan 2019to 26 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Non-vigorous newborns born between 35-42 weeks gestation
Who cannot join
- 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 anomaly (i.e. cord avulsion, true knot)
- Presence of non-reducible nuchal cord
Show all 9Show fewer
- Perinatal providers unaware of the protocol
- Incomplete delivery data
- Infants born in extremis, for whom additional treatment will not be offered
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States7 sites
University of California, Davis
Davis, California, 95616
Loma Linda Medical Center
Loma Linda, California, 92350
Providence St. Vincent Medical Center
Portland, Oregon, 97225-6603
University of Utah/IMH
Salt Lake City, Utah, 84113
Sharp Grossmont Hospital
San Diego, California, 91942
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123
George Washington University
Washington D.C., District of Columbia, 20052
Canada2 sites
Dalhousie University
Dalhousie, New Brunswick, E8C 2R6
University of Alberta
Edmonton, Alberta, T6G 2R3
About this study
The investigators will conduct a study of non-vigorous term infants to determine if umbilical cord milking (UCM) results in a lower rate of NICU admissions than early clamping and cutting of the umbilical cord at birth for infants who need resuscitation.
Read the detailed description
At birth, it is critical that an infant begins breathing quickly. The infant has to switch from relying on the placenta for oxygen to using its lungs for the first time. The currently recommended practice for infants who need resuscitation is to immediately clamp the umbilical cord. Animal studies show that clamping the cord before the baby breathes can cause the heart beat to slow and can decrease the amount of blood being pumped out of the heart each minute. This study will test whether infants will benefit from UCM. The cord will be quickly milked four times before cutting and will not delay the resuscitation procedures. This study is important because when there is need for resuscitation, neither UCM or delayed cord clamping, are recommended by national and international organizations due to lack of evidence. Yet, several large studies from around the world have identified that infants needing resuscitation are more likely to develop conditions such as cerebral palsy, autism and other developmental problems.
The trial is a cluster crossover design in which each hospital will be randomly assigned to use either early cord clamping or UCM for any infant needing resuscitation over a period of 12 months. Then sites will change to the other method for an additional 12 months.
- Conditions
- Birth Asphyxia
- Being tested
- Umbilical Cord Milking, Early Cord Clamping
- Keywords
- Umbilical Cord Milking, Immediate Cord Clamping, Resuscitation
- Medical subject headings
- Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord MilkingProcedure or surgery
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 ClampingProcedure or surgery
The umbilical cord is clamped within 60 seconds of delivery.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Milking | Experimental | 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 ECC as we have demonstrated in our previous trials. Receives: Procedure: Umbilical Cord Milking |
| Early Cord Clamping | Active comparator | This will occur by clamping the umbilical cord as soon as possible. Since both ECC and UCM 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. Receives: Procedure: Early Cord Clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Neonatal Participants Admitted to the NICU for Predefined Criteria
Number of neonatal participants admitted to the neonatal intensive care unit for study-specific predefined criteria including respiratory distress, oxygen desaturation, hypoglycemia, hypotonia, apnea, lethargy or difficulty arousing, hypertonia or irritability, temperature instability, bradycardia or tachycardia, seizures or seizure-like activity, poor feeding or emesis, hyperbilirubinemia, death before NICU admission.
Measured: Birth to first 48 hours of life.
Secondary outcomes (6)
Median Neonatal Hemoglobin Between 12 to 48 Hours of Life
Single hemoglobin measurement for the neonate which was obtained between 12 to 48 hours of life collected with written consent or as part of standard care.
Measured: 12-48 hours of life
Number of Neonates Treated With Therapeutic Hypothermia ("Cooling")
Number of neonates that were treated with therapeutic hypothermia (Cooling to 33.5 degrees Celsius) for 72 hours and initiated within the first 6 hours of life.
Measured: Birth to 78 hours of life.
Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life
Number of neonates treated with normal saline bolus in the first 24 hours of life to support blood pressure.
Measured: Birth through 24 hours of life
Median Peak Total Serum Bilirubin in Neonates
Highest single measurement of total serum bilirubin obtained as part of standard care to assess hyperbilirubinemia in neonate.
Measured: First week of life
Median Transcutaneous Bilirubin in Neonates
Highest single measurement of transcutaneous bilirubin obtained as part of standard care to assess hyperbilirubinemia in each neonate.
Measured: birth to 7 days of life
Number of Neonatal Deaths
Number of neonatal deaths prior to discharge
Measured: Birth to discharge, assessed up to 180 days of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start5 Jan 2019
- Primary completion1 Jun 2021
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Birth AsphyxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster Randomized Crossover
- Masking
- None (open label)
- Enrolment
- 1,730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Collaborators
- Sharp Mary Birch Hospital for Women & Newborns, Sharp Grossmont Hospital, University of Utah, University of Alberta, Poznan University of Medical Sciences, IWK Health Centre, University of California, Davis, Loma Linda University, George Washington University, Providence Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Anup Katheria, M.D., Sharp HealthCare
- Investigators
- Anup Katheria, MD, Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631940
- Sponsor's protocol ID
- MINVI
- Other IDs
- 5R01HD096023-02
- Acronym
- MINVI
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2018
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Katheria AC, El Ghormli L, Clark E, Yoder B, Schmolzer GM, Law BHY, El-Naggar W, Rittenberg D, Sheth S, Martin C, Vora F, Lakshminrusimha S, Underwood M, Mazela J, Kaempf J, Tomlinson M, Gollin Y, Rich W, Morales A, Varner M, Poeltler D, Vaucher Y, Mercer J, Finer N, Rice MM. Two-Year Outcomes of Umbilical Cord Milking in Nonvigorous Infants: A Secondary Analysis of the MINVI Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2416870. doi: 10.1001/jamanetworkopen.2024.16870.
PubMed 38949814
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Milking in Non-Vigorous Infants
- ClinicalTrials.gov ID
- NCT03631940
- Acronym / sponsor ID
- MINVI / MINVI
- Conditions
- Birth Asphyxia
- Keywords
- Umbilical Cord Milking, Immediate Cord Clamping, Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,730 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Collaborators
- Sharp Mary Birch Hospital for Women & Newborns, Sharp Grossmont Hospital, University of Utah, University of Alberta, Poznan University of Medical Sciences, IWK Health Centre, University of California, Davis, Loma Linda University, George Washington University, Providence Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct a study of non-vigorous term infants to determine if umbilical cord milking (UCM) results in a lower rate of NICU admissions than early clamping and cutting of the umbilical cord at birth for infants who need resuscitation.
Detailed description
At birth, it is critical that an infant begins breathing quickly. The infant has to switch from relying on the placenta for oxygen to using its lungs for the first time. The currently recommended practice for infants who need resuscitation is to immediately clamp the umbilical cord. Animal studies show that clamping the cord before the baby breathes can cause the heart beat to slow and can decrease the amount of blood being pumped out of the heart each minute. This study will test whether infants will benefit from UCM. The cord will be quickly milked four times before cutting and will not delay the resuscitation procedures. This study is important because when there is need for resuscitation, neither UCM or delayed cord clamping, are recommended by national and international organizations due to lack of evidence. Yet, several large studies from around the world have identified that infants needing resuscitation are more likely to develop conditions such as cerebral palsy, autism and other developmental problems.
The trial is a cluster crossover design in which each hospital will be randomly assigned to use either early cord clamping or UCM for any infant needing resuscitation over a period of 12 months. Then sites will change to the other method for an additional 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster Randomized Crossover
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Milking | Experimental | Procedure: Umbilical Cord MilkingThe 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 ECC as we have demonstrated in our previous trials. |
| Early Cord Clamping | Active comparator | Procedure: Early Cord ClampingThis will occur by clamping the umbilical cord as soon as possible. Since both ECC and UCM 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. |
Who may qualify
- Ages
- 35 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Non-vigorous newborns born between 35-42 weeks gestation
Key exclusion criteria (9 listed)
- 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 anomaly (i.e. cord avulsion, true knot)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical Cord MilkingAt 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 or surgery | Umbilical Cord Milking |
| Early Cord ClampingThe umbilical cord is clamped within 60 seconds of delivery. | Procedure or surgery | Early Cord Clamping |
Primary outcome
Number of Neonatal Participants Admitted to the NICU for Predefined Criteria
Time frame: Birth to first 48 hours of life.
Number of neonatal participants admitted to the neonatal intensive care unit for study-specific predefined criteria including respiratory distress, oxygen desaturation, hypoglycemia, hypotonia, apnea, lethargy or difficulty arousing, hypertonia or irritability, temperature instability, bradycardia or tachycardia, seizures or seizure-like activity, poor feeding or emesis, hyperbilirubinemia, death before NICU admission.
6 secondary outcomes
Median Neonatal Hemoglobin Between 12 to 48 Hours of Life
Time frame: 12-48 hours of life
Number of Neonates Treated With Therapeutic Hypothermia ("Cooling")
Time frame: Birth to 78 hours of life.
Number of Neonates Treated With Normal Saline Bolus in the First 24 Hours of Life
Time frame: Birth through 24 hours of life
Median Peak Total Serum Bilirubin in Neonates
Time frame: First week of life
Median Transcutaneous Bilirubin in Neonates
Time frame: birth to 7 days of life
Number of Neonatal Deaths
Time frame: Birth to discharge, assessed up to 180 days of life.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38949814Katheria AC, El Ghormli L, Clark E, Yoder B, Schmolzer GM, Law BHY, El-Naggar W, Rittenberg D, Sheth S, Martin C, Vora F, Lakshminrusimha S, Underwood M, Mazela J, Kaempf J, Tomlinson M, Gollin Y, Rich W, Morales A, Varner M, Poeltler D, Vaucher Y, Mercer J, Finer N, Rice MM. Two-Year Outcomes of Umbilical Cord Milking in Nonvigorous Infants: A Secondary Analysis of the MINVI Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2416870. doi: 10.1001/jamanetworkopen.2024.16870.
- MINVI NIRS SubstudyLink provided by the sponsor.
- MINVI Follow-up studyLink provided by the sponsor.
- MINVI Echocardiogram SubstudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anup Katheria, MD principal investigator
Sharp HealthCare
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical Cord Milking and Early Cord Clamping in people with Birth Asphyxia, run by Sharp HealthCare at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Neonatal Participants Admitted to the NICU for Predefined Criteria (time frame: Birth to first 48 hours of life.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03631940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.