Birth AsphyxiaNCT03798093
Echocardiography Sub-Study of the Umbilical Cord Milking in Non-Vigorous Infants Trial (MINVI)
A study testing Umbilical Cord Milking and Early Cord Clamping in people with Birth Asphyxia, run by Sharp HealthCare at 1 site in United States.
Trial 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. 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
- 227 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2019to 4 Nov 2022
- 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 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
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
1 site in 1 country.
United States1 site
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123
About this study
Official title: Hemodynamic Changes With Umbilical Cord Milking in Nonvigorous Newborns
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.
Read the 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
- 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 | Active comparator | 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 Early Cord Clamping 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 Early Cord Clamping and Umbilical Cord Milking 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.
Left Ventricular Output
Left ventricular output measurements taken by cardiac ultrasound.
Measured: 12 ± 6 hours of life
Secondary outcomes (4)
Neonatal Right Ventricular Output
Obtained from the modified short axis view of the neonatal echocardiogram performed at 12 hours of life ± 6 hours.
Measured: 12 ± 6 hours of life
Neonatal Superior Vena Cava Flow
superior vena cava (SVC) flow (Diameter obtained from the infraclavicular view (hybrid view) and doppler assessment from the subcostal view of the neonatal echocardiogram exam performed at 12 hours of life ± 6 hours.
Measured: 12 ± 6 hours of life
Neonatal Peak Systolic Strain
This measurement reflects the deformation (strain) of the heart muscle during systole (the phase of the heartbeat when the heart contracts) relative to its original length. More negative values indicate better myocardial function while values closer to 0 suggest impaired myocardial function.
Measured: 12 ± 6 hours of life
Neonatal Peak Systolic Velocity
Measure of left and right ventricular peak systolic tissue doppler velocity on neonatal echocardiogram performed at 12 hours of life ± 6 hours.
Measured: 12 ± 6 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start7 Jan 2019
- Primary completion1 Jun 2021
- Study completion4 Nov 2022
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster Randomized Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Collaborators
- Sharp Mary Birch Hospital for Women & Newborns
- Responsible party
- Principal investigator, Anup Katheria, M.D., Sharp HealthCare
- Investigators
- Anup Katheria, MD, Principal investigator, Sharp Mary Birch Hospital for Women & Newborns
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798093
- Sponsor's protocol ID
- MINVI Echo Study
- Status last verified
- Mar 2025
- First submitted
- 7 Jan 2019
- Last updated
- 25 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katheria A, Mercer J, Poeltler D, Morales A, Torres N, Lakshminrusimha S, Singh Y. Hemodynamic Changes with Umbilical Cord Milking in Nonvigorous Newborns: A Randomized Cluster Cross-over Trial. J Pediatr. 2023 Jun;257:113383. doi: 10.1016/j.jpeds.2023.03.001. Epub 2023 Mar 11.
PubMed 36914049
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Changes With Umbilical Cord Milking in Nonvigorous Newborns
- ClinicalTrials.gov ID
- NCT03798093
- Acronym / sponsor ID
- MINVI Echo Study
- Conditions
- Birth Asphyxia
- Keywords
- Umbilical Cord Milking, Immediate Cord Clamping, Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Collaborators
- Sharp Mary Birch Hospital for Women & Newborns
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 9 Jan 2019 (actual)
- Results
- Posted 25 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster Randomized Crossover
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Milking | Active comparator | 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 Early Cord Clamping 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 Early Cord Clamping and Umbilical Cord Milking 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 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)
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
Left Ventricular Output
Time frame: 12 ± 6 hours of life
Left ventricular output measurements taken by cardiac ultrasound.
4 secondary outcomes
Neonatal Right Ventricular Output
Time frame: 12 ± 6 hours of life
Neonatal Superior Vena Cava Flow
Time frame: 12 ± 6 hours of life
Neonatal Peak Systolic Strain
Time frame: 12 ± 6 hours of life
Neonatal Peak Systolic Velocity
Time frame: 12 ± 6 hours of life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36914049Katheria A, Mercer J, Poeltler D, Morales A, Torres N, Lakshminrusimha S, Singh Y. Hemodynamic Changes with Umbilical Cord Milking in Nonvigorous Newborns: A Randomized Cluster Cross-over Trial. J Pediatr. 2023 Jun;257:113383. doi: 10.1016/j.jpeds.2023.03.001. Epub 2023 Mar 11.
- Individual participant dataSharing planned: No
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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 Mary Birch Hospital for Women & Newborns
1 site in 1 country: 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 1 site in United States.
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 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 25 Mar 2025). 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?
Left Ventricular Output (time frame: 12 ± 6 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 NCT03798093, 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 25 Mar 2025.