Neurodevelopmental AbnormalityMINVIFUNCT03621943
Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
A study testing Umbilical Cord Milking and Early Cord Clamping in people with Neurodevelopmental Abnormality, run by Sharp HealthCare at 10 sites in 3 countries.
Trial summary
A sub-study to evaluate longer-term developmental outcomes in non-vigorous term and near-term newborns who receive umbilical cord milking in comparison to those who undergo early cord clamping at delivery. Read more about this study
- Who is it for?
- Ages 22 to 26 months
- Conditions the study is for
- Neurodevelopmental Abnormality
- 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
- 1,207 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 7 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 22 to 26 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Enrolled in the primary trial NCT:03631940 and parental written consent to participate in developmental follow-up through 2 years of age was obtained.
- Enrolled in the primary trial NCT:03631940 and did not survive to 2 years.
Who cannot join
- Enrolled in the primary trial NCT:03631940 but parent/guardian declined consent to developmental follow-up participation.
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
A sub-study to evaluate longer-term developmental outcomes in non-vigorous term and near-term newborns who receive umbilical cord milking in comparison to those who undergo early cord clamping at delivery.
Read the detailed description
This sub-study investigates the potential difference in neurodevelopmental outcomes during early childhood between newborns who undergo umbilical cord milking and those who experience early cord clamping at birth. The developmental progress of participants is evaluated using the Ages and Stages Questionnaire-3 which measures five developmental areas: communication, problem-solving, fine motor skills, gross motor skills, and personal-social behavior. Additionally, the Modified Checklist for Autism in Toddlers is employed as a secondary assessment. The recruitment of participants is conducted through the primary study Umbilical Cord Milking in Nonvigorous Infants trial (NCT03631940) with the method of umbilical cord management for each newborn being dictated by the randomized treatment allocation of the primary study.
- Conditions
- Neurodevelopmental Abnormality
- Being tested
- Umbilical Cord Milking, Early Cord Clamping
- Keywords
- Neurodevelopmental outcomes, Disability, Umbilical cord milking, Early cord clamping, Non-vigorous infants, Term infants, Near-Term infants, Developmental screening, Early childhood
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.
Early Cord ClampingProcedure or surgery
The umbilical cord is clamped as soon as possible and within 60 seconds of delivery.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Milking | Active comparator | At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. Receives: Procedure: Umbilical Cord Milking |
| Early Cord Clamping | Active comparator | The umbilical cord is clamped as soon as possible and within 60 seconds of delivery. Receives: Procedure: Early Cord Clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total and Domain Scores on the Ages and Stages Questionnaire, Third Edition.
Neurodevelopmental Outcome at 2 Years of Age defined as overall and domain scores on the Ages and Stages, third edition. Questionnaire. Minimum score of 0 and maximum score of 60 per domain. Scores from 5 subscales are summed to obtain a total score. 5 domains assessed include communication, gross motor, fine motor, problem solving, personal social with a total minimum score of 0 and maximum score of 300. Higher scores indicate a lower risk of developmental delays or conditions
Measured: 22 to 26 months
Secondary outcomes (1)
Score Ranges on the Modified Checklist for Autism in Toddlers Questionnaire
Modified Checklist for Autism in Toddlers. Minimum score of 0 and maximum score of 20. Higher scores indicate higher risk for autism spectrum disorder. Total scores of 0 to 2 indicates a low risk of autism spectrum disorder. Total scores of 3 to 7 indicates a moderate risk of autism spectrum disorder. Total scores of 8 to 20 indicate high risk of autism spectrum disorder.
Measured: 22-26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start7 Jan 2019
- Primary completion2 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.
- Other trials for Neurodevelopmental AbnormalityStudies 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
- Parallel groups
- Model description
- Randomization assignment was determined at time of enrollment in the primary study (Umbilical Cord Milking in Nonvigorous Infants Study NCT:03631940). The primary study model was a cluster randomized crossover trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anup Katheria, M.D., Sharp HealthCare
- Investigators
- Anup Katheria, MD, Principal investigator, Neonatologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621943
- Sponsor's protocol ID
- MINVIFU
- Acronym
- MINVIFU
- Status last verified
- Mar 2025
- First submitted
- 6 Aug 2018
- Last updated
- 27 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Milking in Non-Vigorous Infants Developmental Followup (MINVIFU)
- ClinicalTrials.gov ID
- NCT03621943
- Acronym / sponsor ID
- MINVIFU / MINVIFU
- Conditions
- Neurodevelopmental Abnormality
- Keywords
- Neurodevelopmental outcomes, Disability, Umbilical cord milking, Early cord clamping, Non-vigorous infants, Term infants, Near-Term infants, Developmental screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,207 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Posted 27 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A sub-study to evaluate longer-term developmental outcomes in non-vigorous term and near-term newborns who receive umbilical cord milking in comparison to those who undergo early cord clamping at delivery.
Detailed description
This sub-study investigates the potential difference in neurodevelopmental outcomes during early childhood between newborns who undergo umbilical cord milking and those who experience early cord clamping at birth. The developmental progress of participants is evaluated using the Ages and Stages Questionnaire-3 which measures five developmental areas: communication, problem-solving, fine motor skills, gross motor skills, and personal-social behavior. Additionally, the Modified Checklist for Autism in Toddlers is employed as a secondary assessment. The recruitment of participants is conducted through the primary study Umbilical Cord Milking in Nonvigorous Infants trial (NCT03631940) with the method of umbilical cord management for each newborn being dictated by the randomized treatment allocation of the primary study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization assignment was determined at time of enrollment in the primary study (Umbilical Cord Milking in Nonvigorous Infants Study NCT:03631940). The primary study model was a cluster randomized crossover trial.
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Milking | Active comparator | Procedure: Umbilical Cord MilkingAt delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. |
| Early Cord Clamping | Active comparator | Procedure: Early Cord ClampingThe umbilical cord is clamped as soon as possible and within 60 seconds of delivery. |
Who may qualify
- Ages
- 22 to 26 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Enrolled in the primary trial NCT:03631940 and parental written consent to participate in developmental follow-up through 2 years of age was obtained.
- Enrolled in the primary trial NCT:03631940 and did not survive to 2 years.
Key exclusion criteria (1 listed)
- Enrolled in the primary trial NCT:03631940 but parent/guardian declined consent to developmental follow-up participation.
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. | Procedure or surgery | Umbilical Cord Milking |
| Early Cord ClampingThe umbilical cord is clamped as soon as possible and within 60 seconds of delivery. | Procedure or surgery | Early Cord Clamping |
Primary outcome
Total and Domain Scores on the Ages and Stages Questionnaire, Third Edition.
Time frame: 22 to 26 months
Neurodevelopmental Outcome at 2 Years of Age defined as overall and domain scores on the Ages and Stages, third edition. Questionnaire. Minimum score of 0 and maximum score of 60 per domain. Scores from 5 subscales are summed to obtain a total score. 5 domains assessed include communication, gross motor, fine motor, problem solving, personal social with a total minimum score of 0 and maximum score of 300. Higher scores indicate a lower risk of developmental delays or conditions
1 secondary outcome
Score Ranges on the Modified Checklist for Autism in Toddlers Questionnaire
Time frame: 22-26 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
Neonatologist
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 Neurodevelopmental Abnormality, 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 2 inclusion and 1 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 27 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 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 27 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?
Total and Domain Scores on the Ages and Stages Questionnaire, Third Edition. (time frame: 22 to 26 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2025.