Cord Milking Impacts Neurodevelopmental Outcomes in Very Low Birth Weight Infants

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.

Conditions

• Very Low Birth Weight Infant

Interventions

OTHER

cord milking

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.

Sponsors & Collaborators

• University of California, Los Angeles

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

32 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-31

Primary Completion

2018-05-15

Completion

2018-05-15

Countries

• United States

Study Locations