Abnormal Vascular FlowNCT01434732
Effects of Milking the Umbilical Cord on Systemic Blood Flow
A study testing Umbilical Cord Milking and Immediate Cord Clamping in people with Abnormal Vascular Flow, run by Sharp HealthCare at 1 site in United States.
Trial summary
Premature babies are at risk for bleeding in their brains, which can result in developmental delays or other neurological problems such as cerebral palsy. Clamping the baby's umbilical cord immediately after birth is standard, but delaying this procedure allows more of the baby's blood to move from the placenta into… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abnormal Vascular Flow
- What is being tested?
- Umbilical Cord Milking and Immediate Cord Clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- infants < 32 weeks gestation
Who cannot join
- obstetrician's refusal to participate
- multiple gestations (if Di-Mo placentation) surrogate delivery
- parental desire for cord blood banking
- major congenital anomalies
- severe maternal illness
- placental abruption or previa
- ruptured uterus at delivery, or hemoperitoneum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Umbilical Cord Milking Versus Immediate Cord Clamping on Systemic Blood Flow in Premature Infants
Premature babies are at risk for bleeding in their brains, which can result in developmental delays or other neurological problems such as cerebral palsy. Clamping the baby's umbilical cord immediately after birth is standard, but delaying this procedure allows more of the baby's blood to move from the placenta into the baby and prevents head bleeds. However, a delay in clamping the umbilical cord is not usually done in very premature babies, because it would delay their treatment and they could get cold. Milking the umbilical cord is another way to give premature babies more of their own blood while avoiding a delay in treatment. Umbilical cord milking has been shown to improve blood pressure, decrease the need for blood transfusions, and increase the amount of urine made in the first few days of life.
Read the detailed description
The aim of this study is to determine whether umbilical cord milking improves blood flow in premature babies, and thereby reduce the occurrence of neurological problems. The investigators predict that the blood flow measured by ultrasounds of the heart will be higher in babies who receive umbilical cord milking compared to those whose cords are clamped immediately. Secondly, the investigators predict that cord milking will improve blood volume, blood pressure, and urine output, and delay the need for blood transfusions.
This will be the first study to look at the effect that umbilical cord milking has on important measures of blood flow, which can predict bleeding in the head and subsequent developmental problems in very premature babies.
- Conditions
- Abnormal Vascular Flow
- Being tested
- Umbilical Cord Milking, Immediate Cord Clamping
- Keywords
- Superior vena cava flow, umbilical cord milking, hemodynamics, systemic blood flow
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 stripping the umbilical cord
UCM will be performed by the obstetric team by having the delivering obstetrician hold the infant below the mother's introitus at vaginal delivery or below the level of the incision at cesarean section and having the assistant (the second obstetrician) milk about 20 cm of umbilical cord over 2 seconds and repeating two additional times.
Immediate Cord ClampingProcedure or surgery
Also called routine clamping of the umbilical cord
The umbilical cord will be clamped soon after birth without any milking of the umbilical cord.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Milking | Experimental | Umbilical Cord Milking involved milking the umbilical cord at birth. Receives: Procedure: Umbilical Cord Milking |
| Immediate Cord Clamping | Active comparator | Umbilical cord is clamped soon after birth without any milking of the cord. Receives: Procedure: Immediate Cord Clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superior Vena Cava Flow
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher SVC flow at 6 hours.
Measured: 6 hours
Secondary outcomes (7)
Blood Pressure
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher blood pressures at 6 hours of life.
Measured: 6 hours of life
Neurodevelopmental Outcomes
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have improved neurodevelopmental outcomes. Neurodevelopmental follow-up data including cognitive, language, motor, social-emotional, and adaptive behavior composite scores from the Bayley Scales of Infant and Toddler Development (BSID-III) will be recorded when available. The presence of cerebral palsy, hearing and visual impairment will also be recorded when available.
Measured: between 18 and 36 months of life
number of blood transfusions
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have fewer blood transfusions at 36 weeks corrected gestational age.
Measured: 36 weeks corrected gestational age
Superior Vena Cava Flow
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher SVC flow at 18 hours.
Measured: 18 hours of life
Superior Vena Cava Flow
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher SVC flow at 30 hours.
Measured: 30 hours of life
Blood Pressure
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher blood pressures at 18 hours of life.
Measured: at 18 hours of life
Blood Pressure
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher blood pressures at 30 hours of life.
Measured: 30 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 posted15 Sep 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abnormal Vascular FlowStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 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 C Katheria, M.D., Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434732
- Sponsor's protocol ID
- CORDMILK
- Status last verified
- Oct 2017
- First submitted
- 3 Jun 2011
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Katheria A, Garey D, Truong G, Akshoomoff N, Steen J, Maldonado M, Poeltler D, Harbert MJ, Vaucher YE, Finer N. A Randomized Clinical Trial of Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants: Neurodevelopmental Outcomes at 22-26 Months of Corrected Age. J Pediatr. 2018 Mar;194:76-80. doi: 10.1016/j.jpeds.2017.10.037. Epub 2017 Dec 12.
PubMed 29246467Katheria A, Blank D, Rich W, Finer N. Umbilical cord milking improves transition in premature infants at birth. PLoS One. 2014 Apr 7;9(4):e94085. doi: 10.1371/journal.pone.0094085. eCollection 2014.
PubMed 24709780Katheria AC, Leone TA, Woelkers D, Garey DM, Rich W, Finer NN. The effects of umbilical cord milking on hemodynamics and neonatal outcomes in premature neonates. J Pediatr. 2014 May;164(5):1045-1050.e1. doi: 10.1016/j.jpeds.2014.01.024. Epub 2014 Feb 20.
PubMed 24560179
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Umbilical Cord Milking Versus Immediate Cord Clamping on Systemic Blood Flow in Premature Infants
- ClinicalTrials.gov ID
- NCT01434732
- Acronym / sponsor ID
- CORDMILK
- Conditions
- Abnormal Vascular Flow
- Keywords
- Superior vena cava flow, umbilical cord milking, hemodynamics, systemic blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Sep 2011 (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.
Premature babies are at risk for bleeding in their brains, which can result in developmental delays or other neurological problems such as cerebral palsy. Clamping the baby's umbilical cord immediately after birth is standard, but delaying this procedure allows more of the baby's blood to move from the placenta into the baby and prevents head bleeds. However, a delay in clamping the umbilical cord is not usually done in very premature babies, because it would delay their treatment and they could get cold. Milking the umbilical cord is another way to give premature babies more of their own blood while avoiding a delay in treatment. Umbilical cord milking has been shown to improve blood pressure, decrease the need for blood transfusions, and increase the amount of urine made in the first few days of life.
Detailed description
The aim of this study is to determine whether umbilical cord milking improves blood flow in premature babies, and thereby reduce the occurrence of neurological problems. The investigators predict that the blood flow measured by ultrasounds of the heart will be higher in babies who receive umbilical cord milking compared to those whose cords are clamped immediately. Secondly, the investigators predict that cord milking will improve blood volume, blood pressure, and urine output, and delay the need for blood transfusions.
This will be the first study to look at the effect that umbilical cord milking has on important measures of blood flow, which can predict bleeding in the head and subsequent developmental problems in very premature babies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Milking | Experimental | Procedure: Umbilical Cord MilkingUmbilical Cord Milking involved milking the umbilical cord at birth. |
| Immediate Cord Clamping | Active comparator | Procedure: Immediate Cord ClampingUmbilical cord is clamped soon after birth without any milking of the cord. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- infants < 32 weeks gestation
Key exclusion criteria (7 listed)
- obstetrician's refusal to participate
- multiple gestations (if Di-Mo placentation) surrogate delivery
- parental desire for cord blood banking
- major congenital anomalies
- severe maternal illness
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: stripping the umbilical cordUCM will be performed by the obstetric team by having the delivering obstetrician hold the infant below the mother's introitus at vaginal delivery or below the level of the incision at cesarean section and having the assistant (the second obstetrician) milk about 20 cm of umbilical cord over 2 seconds and repeating two additional times. | Procedure or surgery | Umbilical Cord Milking |
| Immediate Cord ClampingAlso: routine clamping of the umbilical cordThe umbilical cord will be clamped soon after birth without any milking of the umbilical cord. | Procedure or surgery | Immediate Cord Clamping |
Primary outcome
Superior Vena Cava Flow
Time frame: 6 hours
Researchers hypothesize that infants who receive umbilical cord milking (UCM) compared to infants who receive immediate cord clamping (ICC) will have higher SVC flow at 6 hours.
7 secondary outcomes
Blood Pressure
Time frame: 6 hours of life
Neurodevelopmental Outcomes
Time frame: between 18 and 36 months of life
number of blood transfusions
Time frame: 36 weeks corrected gestational age
Superior Vena Cava Flow
Time frame: 18 hours of life
Superior Vena Cava Flow
Time frame: 30 hours of life
Blood Pressure
Time frame: at 18 hours of life
Blood Pressure
Time frame: 30 hours of life
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 9 Oct 2017.
- Derived from this study: PubMed 29246467Katheria A, Garey D, Truong G, Akshoomoff N, Steen J, Maldonado M, Poeltler D, Harbert MJ, Vaucher YE, Finer N. A Randomized Clinical Trial of Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants: Neurodevelopmental Outcomes at 22-26 Months of Corrected Age. J Pediatr. 2018 Mar;194:76-80. doi: 10.1016/j.jpeds.2017.10.037. Epub 2017 Dec 12.
- Derived from this study: PubMed 24709780Katheria A, Blank D, Rich W, Finer N. Umbilical cord milking improves transition in premature infants at birth. PLoS One. 2014 Apr 7;9(4):e94085. doi: 10.1371/journal.pone.0094085. eCollection 2014.
- Derived from this study: PubMed 24560179Katheria AC, Leone TA, Woelkers D, Garey DM, Rich W, Finer NN. The effects of umbilical cord milking on hemodynamics and neonatal outcomes in premature neonates. J Pediatr. 2014 May;164(5):1045-1050.e1. doi: 10.1016/j.jpeds.2014.01.024. Epub 2014 Feb 20.
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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 C Katheria, M.D. principal investigator
UCSD
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 Immediate Cord Clamping in people with Abnormal Vascular Flow, 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 7 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 9 Oct 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 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?
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?
Superior Vena Cava Flow (time frame: 6 hours). 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 NCT01434732, which also lists 3 linked publications.
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 9 Oct 2017.