Cord Milking Impacts Neurodevelopmental Outcomes in Very Low Birth Weight Infants (Cordmilking)
Primary Purpose
Very Low Birth Weight Infant
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cord milking
Sponsored by
About this trial
This is an interventional other trial for Very Low Birth Weight Infant focused on measuring Premature, Birth weight
Eligibility Criteria
Inclusion Criteria:
- 1. Expected delivery at <32 week GA.
Exclusion Criteria:
- 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
Sites / Locations
- Mattel Children's Hospital UCLA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cord Milking
Observational
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Measure Cerebral oxygenation and function
Secondary Outcome Measures
Apgar Scores
Basic score to measure the newborn status. From 0 to 10.
Neurological injury assessment
Head ultrasound on day #3-5
Neurological injury assessment
MRI at 36 wk CGA
Hematological assessment
Hematocrit of admission
Gastrointestinal protection
Necrotizing enterocolitis till 36 wk PMA
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
Full Information
NCT ID
NCT02987764
First Posted
December 1, 2016
Last Updated
October 10, 2018
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02987764
Brief Title
Cord Milking Impacts Neurodevelopmental Outcomes in Very Low Birth Weight Infants
Acronym
Cordmilking
Official Title
Neurodevelopmental Outcomes of Cord Milking in Preterm Infants: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Subject recruitment and enrollment was low throughout the three years the study was active.
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
May 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
1. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Very Low Birth Weight Infant
Keywords
Premature, Birth weight
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cord Milking
Arm Type
Experimental
Arm Description
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.
Arm Title
Observational
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
cord milking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure Cerebral oxygenation and function
Time Frame
First 24 hours of life
Secondary Outcome Measure Information:
Title
Apgar Scores
Description
Basic score to measure the newborn status. From 0 to 10.
Time Frame
1 and 5 minutes
Title
Neurological injury assessment
Description
Head ultrasound on day #3-5
Time Frame
Days 3-5 and at 36 weeks postmenstrual age
Title
Neurological injury assessment
Description
MRI at 36 wk CGA
Time Frame
weeks postmenstrual age
Title
Hematological assessment
Description
Hematocrit of admission
Time Frame
First 72 hours of life
Title
Gastrointestinal protection
Description
Necrotizing enterocolitis till 36 wk PMA
Time Frame
36 weeks postmenstrual age
Title
Measure Neurodevelopmental impairment
Description
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
Time Frame
18-24 months postmenstrual age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Expected delivery at <32 week GA.
Exclusion Criteria:
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
Facility Information:
Facility Name
Mattel Children's Hospital UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Cord Milking Impacts Neurodevelopmental Outcomes in Very Low Birth Weight Infants
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