Role of Umbilical Cord Milking in the Management of Hypoxic-ischemic Encephalopathy in Neonates
Role of Umbilical Cord Milking in the Management of Hypoxic-ischemic Encephalopathy in Neonates
The purpose of this study is to investigate the efficacy and safety of umbilical cord milking
 in depressed neonates at birth for prevention of hypoxic ischemic encephalopathy.
Hypoxic-ischemic encephalopathy (HIE) is a brain injury caused by inadequate supply of oxygen
 and blood to the brain of a newborn baby. Therapeutic hypothermia is the only proven therapy
 for these infants. Even after receiving therapeutic hypothermia, 50% of all infants with
 moderate and severe HIE die or develop neurological and functional impairment. There is a
 need for a new intervention for neonatal HIE, which is readily available in developing
 countries and can complement hypothermia.

 The American College of Obstetricians and Gynecologists and American Academy of Pediatrics
 recommend a delay in umbilical cord clamping in vigorous term and preterm infants for at
 least 30-60 seconds after birth. Immediate umbilical cord clamping is contraindicated in
 maternal hemodynamic instability, need for immediate resuscitation of the newborn and in
 conditions where placental circulation is not intact. Umbilical cord milking (UCM) is a
 simple method of delivering volume and possibly stem cells to those neonates, where
 resuscitation cannot be postponed for obtaining the benefits of delayed cord clamping.

 We hypothesize that depressed neonates who receive umbilical cord milking will have lower
 incidence and severity of hypoxic ischemic encephalopathy compared to depressed neonates who
 receive immediate cord clamping.We propose to investigate the safety and effectiveness of UCM
 in term and late preterm (≥35 week's gestation) infants who are depressed at birth, in
 preventing the development and/or progression of hypoxic ischemic encephalopathy. The need
 for immediate resuscitation measures, abnormal parameters (clinical, hematological and
 biochemical) and neuroimaging will be compared in depressed neonates with and without UCM. If
 UCM is found to be safe and beneficial, it can be a useful substitute for delayed cord
 clamping in depressed neonates worldwide.

 Conditions: Depressed neonate, Hypoxic-ischemic encephalopathy Intervention: Umbilical cord
 milking

 Study Design Study Type: Interventional Study Design: Allocation: Randomized Endpoint
 Classification: Efficacy/Safety Study Intervention Model: Parallel Assignment Number of Arms:
 2 Masking: Single Blind (Subject) Primary Purpose: Prevention Enrollment: 400 [Anticipated]

 Arms and Interventions:

 Arms:2, Assigned Interventions: 1. Experimental: Umbilical Cord Milking and 2. No
 Intervention: Immediate Umbilical Cord Clamping

 1. Experimental: Umbilical Cord Milking,Other Name: Umbilical cord stripping Umbilical Cord
 Milking involves milking a 30 cm long segment of umbilical cord at birth, after
 initiation of ventilation Procedure: Umbilical Cord Milking (UCM) At birth the umbilical
 cord of a depressed newborn is clamped immediately and cut 30 cm from the umbilicus and
 the neonate placed on the resuscitation table. After completion of initial steps, if the
 baby does not have adequate spontaneous respirations and a heart rate of 100 bpm or
 higher, positive pressure ventilation (PPV) is given for 30 seconds, along with UCM. The
 cord is untwisted and held in a vertical position. It is milked 3 times towards the baby
 at a speed of 10 cm/s and then clamped 3 cm from the umbilicus. The time of cord
 clamping will be recorded using a timer. After completion of PPV along with UCM, if the
 baby requires further resuscitation, the NRP 2015 guidelines will be followed. Depressed
 newborns who respond to initial steps of resuscitation with normal breathing and heart
 rate of 100 bpm or higher, will receive UCM after this.

 2. No Intervention: Immediate Umbilical Cord Clamping, Other Name: routine clamping of the
 umbilical cord Procedure: Immediate Cord Clamping, At birth the umbilical cord of a
 depressed newborn is clamped immediately (current recommendation) and cut 3 cm from the
 umbilicus and the neonate placed on the resuscitation table. The time of cord clamping
 will be recorded using a timer. After completion of initial steps, if the baby requires
 further resuscitation, the NRP 2015 guidelines will be followed.
Inclusion Criteria:

 • Neonates of ≥35 week's gestation and born depressed (defined by NRP 2015 criteria: as
 those neonates who doesn't cry or breathe at birth and whose tone is poor) in the hospital

 Exclusion Criteria:

 -  MCDA Twin pregnancy (DCDA twins are included)

 -  Triplet or quadruplet pregnancy

 -  Presence of IUGR in antenatal scans (< 10th Centile)

 -  Short umbilical cord length (<30 cm)

 -  Rh-negative or retrovirus positive mothers

 -  Major chromosomal or congenital anomalies

 -  Hydrops fetalis

 -  Severe placental abruption

 -  Cord prolapse and cord abnormalities such as true knots

 -  Culture positive early onset neonatal sepsis