Cord Milking Impacts Neurodevelopmental Outcomes in Very Low Birth Weight Infants
| Status: | Terminated |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/17/2018 |
| Start Date: | May 2016 |
| End Date: | May 15, 2018 |
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.
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.
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.
Primary Aims
To Measure:
1. Cerebral oxygenation and function (aEEG abnormalities) in first 24 hours of life
2. 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
To Measure:
1. Cerebral oxygenation and function (aEEG abnormalities) in first 24 hours of life
2. 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
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
We found this trial at
1
site
Click here to add this to my saved trials
