Very Low Birth Weight InfantCordmilkingNCT02987764
Cord Milking Impacts Neurodevelopmental Outcomes in Very Low Birth Weight Infants
A study testing cord milking in people with Very Low Birth Weight Infant, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Premature birth is a major risk factor for perinatal brain damage and cerebral palsy (CP) with 47% of all CP cases occurring in infants with birth weight less than 2500 g. CP has life-long neurological consequences that affect quality of life for the patient. Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Very Low Birth Weight Infant
- What is being tested?
- cord milking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 15 May 2018
- 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 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Expected delivery at <32 week GA.
Who cannot join
- 1. Prenatal diagnosis of chromosomal or severe congenital malformations such as cyanotic congenital heart disease 2. Cord accidents such as ruptured Vasa Previa results in fetal blood loss, need for urgent delivery, placental abruption and cord prolapse 3. considered non-viable by attending neonatologist or obstetrician 4. Consent not granted
Trial locations and contacts
1 site in 1 country.
United States1 site
Mattel Children's Hospital UCLA
Los Angeles, California, 90095
About this study
Official title: Neurodevelopmental Outcomes of Cord Milking in Preterm Infants: Randomized Controlled Trial
Premature birth is a major risk factor for perinatal brain damage and cerebral palsy (CP) with 47% of all CP cases occurring in infants with birth weight less than 2500 g. CP has life-long neurological consequences that affect quality of life for the patient. In the last 2 decades, improvements in neonatal intensive care have improved survival of VLBW infants significantly. This increased survival of VLBW infants poses new challenges towards developing novel treatments and interventions to decrease neurodevelopmental impairment and CP. While it is common for extremely preterm infant to survive at 23 weeks of gestation, the neurologic consequences range from learning difficulties and cognitive defects to severe disability and cerebral palsy. Currently prenatal neuroprotective agents such as corticosteroids are utilized whenever a preterm birth is anticipated. However, there are no proven postnatal interventions to prevent brain damage and cerebral palsy in VLBW infants.
Many recent studies show that delaying umbilical cord clamping (DCC) may improve hemodynamic stability and decrease intraventricular hemorrhage (IVH) in preterm infants. A decrease in incidence of IVH has a conceivable prospective benefit of decreasing brain injury and improving long-term outcomes. Based on these findings, the American College of Obstetricians and Gynecologist and American Academy of Pediatrics endorse that DCC may benefit the preterm infants. However, these recommendations have not been adopted by most obstetricians in USA. The main concern regarding the practice of DCC is the care delay in initiating resuscitation and providing the needed care to this vulnerable population.
Read more
Therefore, as an alternative to DCC, method of cord milking (CM) has been developed to provide cord blood transfusion to premature infants. CM offers a more practical alternative to delayed cord clamping that may provide the same benefits without the need to delay resuscitation. However, there are very few studies of CM in VLBW infants and there is no evidence demonstrating long-term neurological outcomes and CP after CM.
The investigators hypothesize that cord milking in VLBW infants will result in improving cerebral oxygenation, function and result in improved long-term neurodevelopmental outcomes at 2 years of post-menstrual age. Premature infants born at less than or equal to 32 weeks gestation age will receive cord milking after cutting versus standard care of immediate cord clamping.
Read the detailed description
Primary Aims
To Measure:
- Cerebral oxygenation and function (aEEG abnormalities) in first 24 hours of life
- Neurodevelopmental outcomes at 18 - 24 months PMA Secondary Aims
- Assessment of Improved transition: Delivery room resuscitation, Apgar scores, acidosis from cord gas or first hour blood gas 2. Neurological injury assessment: IVH/PVIH/PVL on head ultrasound on day #3-5 and day #7-14, and at 36 wk PMA, MRI at 36 wk CGA 3. CVS response: Blood pressure and ionotropic support in first 3-5 days 4. Hematological assessment: Hemoglobin, Hematocrit of admission, and first 72 hours of life, need for phototherapy and highest bilirubin level in first 7 days, blood transfusions needed till 36 wk PMA 5. Gastrointestinal protection: Necrotizing enterocolitis till 36 wk PMA In this pilot study, we plan to enroll 15 VLBW infants in each group (n=30) from Mattel Children's Hospital and Santa Monica Hospital labor and delivery. Data pertaining to primary and secondary aims will be obtained from EMR. Follow up utilizing Bayley's scores of infant development (BSID III) will be scheduled at 18-22 months PMA
- Conditions
- Very Low Birth Weight Infant
- Being tested
- cord milking
- Keywords
- Premature, Birth weight
- Medical subject headings
- Premature Birth, Birth Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cord milkingOther
For infants in the cord milking group, the cord will be clamped at the longest distance possible and neonatal team will bring the infant to the resuscitation table for further care. The clinical care will be provided by the clinicians taking care of the infant. The research team will be trained and be responsible for requesting the obstetrician in advance to provide the maximum length of umbilical cord.
| Study group | Role | What they receive |
|---|---|---|
| Cord Milking | Experimental | The research team member will untwist the cord, and hold it in a vertical position. The cord will then be milked twice towards the abdominal insertion of the cord. The cord will be cut 1 inch above the abdominal wall. After milking for exact measurement of the cord will be obtained. Receives: Other: cord milking |
| Observational | No intervention | Observational infants will receive usual care with immediate cord clamping by the delivering obstetrician. The time of cord clamping will be recorded for both groups using a timer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Cerebral oxygenation and function
Measured: First 24 hours of life
Secondary outcomes (6)
Apgar Scores
Basic score to measure the newborn status. From 0 to 10.
Measured: 1 and 5 minutes
Neurological injury assessment
Head ultrasound on day #3-5
Measured: Days 3-5 and at 36 weeks postmenstrual age
Neurological injury assessment
MRI at 36 wk CGA
Measured: weeks postmenstrual age
Hematological assessment
Hematocrit of admission
Measured: First 72 hours of life
Gastrointestinal protection
Necrotizing enterocolitis till 36 wk PMA
Measured: 36 weeks postmenstrual age
Measure Neurodevelopmental impairment
Outcome assessments will be conducted by physicians or nurse practitioners or occupation therapist specializing in neonatal follow-up examination using Bayley Scales of Infant Development III
Measured: 18-24 months postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startMay 2016
- Primary completion15 May 2018
- Study completion15 May 2018
Why it stopped: Subject recruitment and enrollment was low throughout the three years the study was active.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Low Birth Weight InfantStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meena Garg, MD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987764
- Sponsor's protocol ID
- 15-001134
- Acronym
- Cordmilking
- Status last verified
- Oct 2018
- First submitted
- 1 Dec 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental Outcomes of Cord Milking in Preterm Infants: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02987764
- Acronym / sponsor ID
- Cordmilking / 15-001134
- Conditions
- Very Low Birth Weight Infant
- Keywords
- Premature, Birth weight
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Subject recruitment and enrollment was low throughout the three years the study was active.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 9 Dec 2016 (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 birth is a major risk factor for perinatal brain damage and cerebral palsy (CP) with 47% of all CP cases occurring in infants with birth weight less than 2500 g. CP has life-long neurological consequences that affect quality of life for the patient. In the last 2 decades, improvements in neonatal intensive care have improved survival of VLBW infants significantly. This increased survival of VLBW infants poses new challenges towards developing novel treatments and interventions to decrease neurodevelopmental impairment and CP. While it is common for extremely preterm infant to survive at 23 weeks of gestation, the neurologic consequences range from learning difficulties and cognitive defects to severe disability and cerebral palsy. Currently prenatal neuroprotective agents such as corticosteroids are utilized whenever a preterm birth is anticipated. However, there are no proven postnatal interventions to prevent brain damage and cerebral palsy in VLBW infants.
Many recent studies show that delaying umbilical cord clamping (DCC) may improve hemodynamic stability and decrease intraventricular hemorrhage (IVH) in preterm infants. A decrease in incidence of IVH has a conceivable prospective benefit of decreasing brain injury and improving long-term outcomes. Based on these findings, the American College of Obstetricians and Gynecologist and American Academy of Pediatrics endorse that DCC may benefit the preterm infants. However, these recommendations have not been adopted by most obstetricians in USA. The main concern regarding the practice of DCC is the care delay in initiating resuscitation and providing the needed care to this vulnerable population.
Therefore, as an alternative to DCC, method of cord milking (CM) has been developed to provide cord blood transfusion to premature infants. CM offers a more practical alternative to delayed cord clamping that may provide the same benefits without the need to delay resuscitation. However, there are very few studies of CM in VLBW infants and there is no evidence demonstrating long-term neurological outcomes and CP after CM.
The investigators hypothesize that cord milking in VLBW infants will result in improving cerebral oxygenation, function and result in improved long-term neurodevelopmental outcomes at 2 years of post-menstrual age. Premature infants born at less than or equal to 32 weeks gestation age will receive cord milking after cutting versus standard care of immediate cord clamping.
Detailed description
Primary Aims
To Measure:
- Cerebral oxygenation and function (aEEG abnormalities) in first 24 hours of life
- Neurodevelopmental outcomes at 18 - 24 months PMA Secondary Aims
- Assessment of Improved transition: Delivery room resuscitation, Apgar scores, acidosis from cord gas or first hour blood gas 2. Neurological injury assessment: IVH/PVIH/PVL on head ultrasound on day #3-5 and day #7-14, and at 36 wk PMA, MRI at 36 wk CGA 3. CVS response: Blood pressure and ionotropic support in first 3-5 days 4. Hematological assessment: Hemoglobin, Hematocrit of admission, and first 72 hours of life, need for phototherapy and highest bilirubin level in first 7 days, blood transfusions needed till 36 wk PMA 5. Gastrointestinal protection: Necrotizing enterocolitis till 36 wk PMA In this pilot study, we plan to enroll 15 VLBW infants in each group (n=30) from Mattel Children's Hospital and Santa Monica Hospital labor and delivery. Data pertaining to primary and secondary aims will be obtained from EMR. Follow up utilizing Bayley's scores of infant development (BSID III) will be scheduled at 18-22 months PMA
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cord Milking | Experimental | Other: cord milkingThe research team member will untwist the cord, and hold it in a vertical position. The cord will then be milked twice towards the abdominal insertion of the cord. The cord will be cut 1 inch above the abdominal wall. After milking for exact measurement of the cord will be obtained. |
| Observational | No intervention | –Observational infants will receive usual care with immediate cord clamping by the delivering obstetrician. The time of cord clamping will be recorded for both groups using a timer. |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Expected delivery at <32 week GA.
Key exclusion criteria (1 listed)
- 1. Prenatal diagnosis of chromosomal or severe congenital malformations such as cyanotic congenital heart disease 2. Cord accidents such as ruptured Vasa Previa results in fetal blood loss, need for urgent delivery, placental abruption and cord prolapse 3. considered non-viable by attending neonatologist or obstetrician 4. Consent not granted
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 |
|---|---|---|
| cord milkingFor infants in the cord milking group, the cord will be clamped at the longest distance possible and neonatal team will bring the infant to the resuscitation table for further care. The clinical care will be provided by the clinicians taking care of the infant. The research team will be trained and be responsible for requesting the obstetrician in advance to provide the maximum length of umbilical cord. | Other | Cord Milking |
Primary outcome
Measure Cerebral oxygenation and function
Time frame: First 24 hours of life
6 secondary outcomes
Apgar Scores
Time frame: 1 and 5 minutes
Neurological injury assessment
Time frame: Days 3-5 and at 36 weeks postmenstrual age
Neurological injury assessment
Time frame: weeks postmenstrual age
Hematological assessment
Time frame: First 72 hours of life
Gastrointestinal protection
Time frame: 36 weeks postmenstrual age
Measure Neurodevelopmental impairment
Time frame: 18-24 months postmenstrual age
Results and safety
The study was stopped early (reason given: Subject recruitment and enrollment was low throughout the three years the study was active.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- 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.
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 cord milking in people with Very Low Birth Weight Infant, run by University of California, Los Angeles 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 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: stopped early, as of the sponsor's last update on 15 Oct 2018. 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 was stopped early (reason given: Subject recruitment and enrollment was low throughout the three years the study was active.). Results are not available in the source record.
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?
Measure Cerebral oxygenation and function (time frame: First 24 hours of life). 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 15 Oct 2018.