Clinical trial NCT02987764: Cord Milking Impacts Neurodevelopmental Outcomes in Very Low Birth Weight Infants
Official title: Neurodevelopmental Outcomes of Cord Milking in Preterm Infants: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Very Low Birth Weight Infant
Keywords: Premature
Birth weight
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 5
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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:

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

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

Primary outcomes:
measure: Measure Cerebral oxygenation and function
timeFrame: First 24 hours of life
Secondary outcomes:
measure: Apgar Scores
timeFrame: 1 and 5 minutes
measure: Neurological injury assessment
timeFrame: Days 3-5 and at 36 weeks postmenstrual age
measure: Neurological injury assessment
timeFrame: weeks postmenstrual age
measure: Hematological assessment
timeFrame: First 72 hours of life
measure: Gastrointestinal protection
timeFrame: 36 weeks postmenstrual age
measure: Measure Neurodevelopmental impairment
timeFrame: 18-24 months postmenstrual age
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Mattel Children's Hospital UCLA
state: California
Study officials:
References: