Hypoxic-Ischemic EncephalopathyMIDAB-FUNCT03681314
Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)
A study testing Umbilical Cord Milking in people with Hypoxic-Ischemic Encephalopathy and Birth Asphyxia, run by Nemours Children's Clinic at 3 sites in India.
Trial summary
An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or immediate cord clamping (ICC). Read more about this study
- Who is it for?
- Ages 3 to 26 months
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
- What is being tested?
- Umbilical Cord Milking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesIndia
- Study dates
- 17 Oct 2022to 16 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 26 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Enrolled in MIDAB trial
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
India3 sites
Daga Memorial Woman and Children Hospital
Nagpur, MS, 440002
Government Medical College and Hospital
Nagpur, MS, 440009
NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital
Nagpur, MS, 440019
About this study
Official title: Long-term Outcomes of Umbilical Cord Milking in Term and Late Preterm Neonates Who Are Depressed at Birth
An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or immediate cord clamping (ICC).
Read the detailed description
The MIDAB-Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were depressed at birth and enrolled in MIDAB trial. The difference in survival and neurodevelopmental impairment in infants who received UCM and ICC will be assessed using standardized neurological and developmental assessment tools at 22-26 months of age.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
- Being tested
- Umbilical Cord Milking
- Medical subject headings
- Hypoxia-Ischemia, Brain, Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord MilkingOther
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 10-15 seconds.
| 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. This procedure infuses a placental transfusion of blood into the infant and can be done in 10-15 seconds. Receives: Other: Umbilical Cord Milking |
| Immediate Cord Clamping | No intervention | The umbilical cord is clamped immediately after the delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopmental Outcome at 2 Years of Age
Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire
Measured: 22-26 months
Secondary outcomes (3)
Fidgety Movements at 3 months of age
Assessment of Fidgety Movements by Prechtl's method
Measured: 3-5 months
Neurodevelopmental Outcome at 1 Year of Age
Developmental Activities Screening Inventory - Second Edition (DASI-II)
Measured: 10-14 months
Autism Outcome
Modified Checklist for Autism in Toddlers (M-CHAT-R)
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 posted24 Sep 2018
- Study start17 Oct 2022
- Primary completion16 Jun 2024 (estimated)
- Study completion16 Aug 2026 (estimated)
Why it stopped: This study was not funded. The same study with few modifications in the trial was later funded by the NICHD. Now study started enrolling babies using new registration and identification IDs ( NCT03682042 and NCT03657394).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Neurodevelopmental assessments will be done at 2 years of age (22-26 months) for subjects who were randomized to receive either immediate cord clamping or umbilical cord milking as part of the MIDAB trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- NPKSIMS, Nagpur, India, Sharp HealthCare
- Responsible party
- Principal investigator, Zubair Aghai, Nemours Children's Clinic
- Investigators
- Zubair Aghai, MD, Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681314
- Sponsor's protocol ID
- UCM2018FU
- Acronym
- MIDAB-FU
- Status last verified
- Apr 2023
- First submitted
- 20 Sep 2018
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Umbilical Cord Milking in Term and Late Preterm Neonates Who Are Depressed at Birth
- ClinicalTrials.gov ID
- NCT03681314
- Acronym / sponsor ID
- MIDAB-FU / UCM2018FU
- Conditions
- Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was not funded. The same study with few modifications in the trial was later funded by the NICHD. Now study started enrolling babies using new registration and identification IDs ( NCT03682042 and NCT03657394).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- NPKSIMS, Nagpur, India, Sharp HealthCare
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 16 Jun 2024 (estimated)
- Study completion
- 16 Aug 2026 (estimated)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or immediate cord clamping (ICC).
Detailed description
The MIDAB-Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were depressed at birth and enrolled in MIDAB trial. The difference in survival and neurodevelopmental impairment in infants who received UCM and ICC will be assessed using standardized neurological and developmental assessment tools at 22-26 months of age.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Neurodevelopmental assessments will be done at 2 years of age (22-26 months) for subjects who were randomized to receive either immediate cord clamping or umbilical cord milking as part of the MIDAB trial.
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Milking | Active comparator | Other: 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 10-15 seconds. |
| Immediate Cord Clamping | No intervention | –The umbilical cord is clamped immediately after the delivery. |
Who may qualify
- Ages
- 3 to 26 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Enrolled in MIDAB trial
Key exclusion criteria (1 listed)
- None
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 10-15 seconds. | Other | Umbilical Cord Milking |
Primary outcome
Neurodevelopmental Outcome at 2 Years of Age
Time frame: 22-26 months
Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire
3 secondary outcomes
Fidgety Movements at 3 months of age
Time frame: 3-5 months
Neurodevelopmental Outcome at 1 Year of Age
Time frame: 10-14 months
Autism Outcome
Time frame: 22-26 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Neuro-MoD: Neuroplasticity With Motor Development
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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.
Zubair Aghai, MD principal investigator
Nemours Children's Clinic
3 sites 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 in people with Hypoxic-Ischemic Encephalopathy and Birth Asphyxia, run by Nemours Children's Clinic at 3 sites in India.
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 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: withdrawn, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Neurodevelopmental Outcome at 2 Years of Age (time frame: 22-26 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 25 Apr 2023.