Hypoxic Ischemic EncephalopathyNCT02287077
Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy
A study testing Umbilical Cord Milking in people with Hypoxic Ischemic Encephalopathy and Umbilical Cord Milking, run by Thomas Jefferson University at 1 site in India.
Trial summary
The objective of this pilot study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth. Read more about this study
- Who is it for?
- Ages Up to 1 minute
- Conditions the study is for
- Hypoxic Ischemic Encephalopathy, Umbilical Cord Milking
- What is being tested?
- Umbilical Cord Milking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2014to Oct 2016
- 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 Up to 1 minute
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term and near term neonates (35 weeks and more)
- Depressed at birth
Who cannot join
- Congenital malformation of central nervous system
- Chromosomal abnormalities
- Major congenital malformations
Trial locations and contacts
1 site in 1 country.
India1 site
Lata Mangeshkar Hospital and NKP Salve Institute of Medical Sciences
Nagpur, MS, 440019
About this study
Official title: A Randomized Controlled Trial of Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy
The objective of this pilot study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth.
Read the detailed description
Hypoxic-ischemic encephalopathy (HIE) is a brain injury in neonates due to inadequate blood flow and oxygen delivery to the neonatal brain. Umbilical cord milking can potentially improve brain injury in neonates with HIE. The objective of this study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth. The investigators hypothesized that umbilical cord milking is feasible and safe in neonates who are depressed at birth. The investigators also hypothesized that umbilical cord milking will increase stem cells in neonatal blood circulation and improve short term outcomes in neonates with moderate and severe HIE.
- Being tested
- Umbilical Cord Milking
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord MilkingProcedure or surgery
Also called Umbilical cord stripping
At birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord.
| Study group | Role | What they receive |
|---|---|---|
| Immediate cord clamping | No intervention | At birth, neonate will be held at the level of placenta and umbilical cord will be clamped immediately (standard of care for depressed neonates). |
| Umbilical cord milking | Experimental | At birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord. Receives: Procedure: Umbilical Cord Milking |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of depressed neonates in whom umbilical cord milking was performed.
The number of neonates who are depressed at birth will be determined and the percentage of depressed neonates in whom UCM performed will be calculated. The investigators expect that more than 80% of neonates who qualify will receive UCM. The investigators will aslo compare resuscitation efforts (use of positive pressure ventilation, intubation, chest compression, medication and fluid boluses) and short term outcomes of resuscitation (5 minutes apgar, severity of HIE, blood gas at 1 hour) in neonates with and without UCM.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes (4)
The effect of umbilical cord milking on stem and progenitor cells in peripheral blood of neonates.
Evaluate stem and progenitor cell count in peripheral blood of neonates with UCM and compare them with the control group (no UCM).
Measured: 24 hours
The effect of umbilical cord milking on monocytes and lymphocytes in peripheral blood of neonates.
Evaluate absolute monocyte and lymphocyte count in peripheral blood of neonates with UCM and compare them with the control group (no UCM).
Measured: 24 hours
The effect of umbilical cord milking on neurotrophic factors in peripheral blood of neonates.
Compare levels of neurotrophic factors in peripheral blood of neonates with and without UCM.
Measured: 24 hours
Survival and short term outcomes in neonates with moderate and severe HIE
In infants with moderate or severe HIE, compare survival, neurological examination at discharge, and neuro-imaging studies in infants with and without UCM.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2016
- Study completionOct 2016
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.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Lata Mangeshkar Hospital, NKP Salve Institute of Medical Sciences, Nagpur, India
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287077
- Sponsor's protocol ID
- 14D.522
- Status last verified
- Dec 2017
- First submitted
- 31 Oct 2014
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy
- ClinicalTrials.gov ID
- NCT02287077
- Acronym / sponsor ID
- 14D.522
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Lata Mangeshkar Hospital, NKP Salve Institute of Medical Sciences, Nagpur, India
- Study start
- Dec 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 10 Nov 2014 (estimated)
- 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.
The objective of this pilot study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth.
Detailed description
Hypoxic-ischemic encephalopathy (HIE) is a brain injury in neonates due to inadequate blood flow and oxygen delivery to the neonatal brain. Umbilical cord milking can potentially improve brain injury in neonates with HIE. The objective of this study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth. The investigators hypothesized that umbilical cord milking is feasible and safe in neonates who are depressed at birth. The investigators also hypothesized that umbilical cord milking will increase stem cells in neonatal blood circulation and improve short term outcomes in neonates with moderate and severe HIE.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate cord clamping | No intervention | –At birth, neonate will be held at the level of placenta and umbilical cord will be clamped immediately (standard of care for depressed neonates). |
| Umbilical cord milking | Experimental | Procedure: Umbilical Cord MilkingAt birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord. |
Who may qualify
- Ages
- Up to 1 minute
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Term and near term neonates (35 weeks and more)
- Depressed at birth
Key exclusion criteria (3 listed)
- Congenital malformation of central nervous system
- Chromosomal abnormalities
- Major congenital malformations
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 MilkingAlso: Umbilical cord strippingAt birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord. | Procedure or surgery | Umbilical cord milking |
Primary outcome
The number of depressed neonates in whom umbilical cord milking was performed.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
The number of neonates who are depressed at birth will be determined and the percentage of depressed neonates in whom UCM performed will be calculated. The investigators expect that more than 80% of neonates who qualify will receive UCM. The investigators will aslo compare resuscitation efforts (use of positive pressure ventilation, intubation, chest compression, medication and fluid boluses) and short term outcomes of resuscitation (5 minutes apgar, severity of HIE, blood gas at 1 hour) in neonates with and without UCM.
4 secondary outcomes
The effect of umbilical cord milking on stem and progenitor cells in peripheral blood of neonates.
Time frame: 24 hours
The effect of umbilical cord milking on monocytes and lymphocytes in peripheral blood of neonates.
Time frame: 24 hours
The effect of umbilical cord milking on neurotrophic factors in peripheral blood of neonates.
Time frame: 24 hours
Survival and short term outcomes in neonates with moderate and severe HIE
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
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Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
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Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Hypoxic Ischemic Encephalopathy and Umbilical Cord Milking, run by Thomas Jefferson University at 1 site 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 2 inclusion and 3 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 18 Dec 2017. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of depressed neonates in whom umbilical cord milking was performed. (time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days). 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 18 Dec 2017.