Cord Milking Impacts Neurodevelopmental Outcomes in Very Low Birth Weight Infants

NCT02987764 | Terminated

• 1 other identifier: 15-001134
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Very Low Birth Weight Infant

Keywords

Premature; Birth weight

Outcome Measures

Primary Outcomes (1)

• Measure Cerebral oxygenation and function

  First 24 hours of life

Secondary Outcomes (6)

• Apgar Scores

  1 and 5 minutes

• Neurological injury assessment

  Days 3-5 and at 36 weeks postmenstrual age

• Neurological injury assessment

  weeks postmenstrual age

• Hematological assessment

  First 72 hours of life

• Gastrointestinal protection

  36 weeks postmenstrual age

Study Arms (2)

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.

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.

Interventions

cord milking OTHER

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.

Cord Milking

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Expected delivery at \<32 week GA.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Mattel Children's Hospital UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Premature Birth; Birth Weight

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 9, 2016
• Study Start: May 1, 2016
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)