Cord Milking Impacts Neurodevelopmental Outcomes in Very Low Birth Weight Infants

Very Low Birth Weight Infant Clinical Trial

— Cordmilking  

Official title:

Neurodevelopmental Outcomes of Cord Milking in Preterm Infants: Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02987764
• Other study ID #: 15-001134
• Status: Terminated
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 15, 2018

Study information

• Verified date: October 2018
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Very Low Birth Weight Infant

Intervention

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.

Locations

Country	Name	City	State
United States	Mattel Children's Hospital UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure Cerebral oxygenation and function		First 24 hours of life
Secondary	Apgar Scores	Basic score to measure the newborn status. From 0 to 10.	1 and 5 minutes
Secondary	Neurological injury assessment	Head ultrasound on day #3-5	Days 3-5 and at 36 weeks postmenstrual age
Secondary	Neurological injury assessment	MRI at 36 wk CGA	weeks postmenstrual age
Secondary	Hematological assessment	Hematocrit of admission	First 72 hours of life
Secondary	Gastrointestinal protection	Necrotizing enterocolitis till 36 wk PMA	36 weeks postmenstrual age
Secondary	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	18-24 months postmenstrual age