Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy

Study Overview
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Brief Summary
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The objective of this pilot study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth.

Detailed Description
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Hypoxic-ischemic encephalopathy (HIE) is a brain injury in neonates due to inadequate blood flow and oxygen delivery to the neonatal brain. Umbilical cord milking can potentially improve brain injury in neonates with HIE. The objective of this study is to investigate the feasibility of performing umbilical cord milking in neonates who are depressed at birth. The investigators hypothesized that umbilical cord milking is feasible and safe in neonates who are depressed at birth. The investigators also hypothesized that umbilical cord milking will increase stem cells in neonatal blood circulation and improve short term outcomes in neonates with moderate and severe HIE.

Official Title
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A Randomized Controlled Trial of Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy

Conditions
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Hypoxic Ischemic Encephalopathy, Umbilical Cord Milking

Intervention / Treatment
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* Procedure: Umbilical Cord Milking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term and near term neonates (35 weeks and more) Depressed at birth Exclusion Criteria: Congenital malformation of central nervous system Chromosomal abnormalities Major congenital malformations

Ages Eligible for Study
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Maximum Age: 1 Minute

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Immediate cord clamping<br>At birth, neonate will be held at the level of placenta and umbilical cord will be clamped immediately (standard of care for depressed neonates). | |
| Experimental: Umbilical cord milking<br>At birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord. | Procedure: Umbilical Cord Milking<br>* At birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord.<br>* Other names: Umbilical cord stripping;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of depressed neonates in whom umbilical cord milking was performed. | The number of neonates who are depressed at birth will be determined and the percentage of depressed neonates in whom UCM performed will be calculated. The investigators expect that more than 80% of neonates who qualify will receive UCM. The investigators will aslo compare resuscitation efforts (use of positive pressure ventilation, intubation, chest compression, medication and fluid boluses) and short term outcomes of resuscitation (5 minutes apgar, severity of HIE, blood gas at 1 hour) in neonates with and without UCM. | Participants will be followed for the duration of hospital stay, an expected average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of umbilical cord milking on stem and progenitor cells in peripheral blood of neonates. | Evaluate stem and progenitor cell count in peripheral blood of neonates with UCM and compare them with the control group (no UCM). | 24 hours | 
| The effect of umbilical cord milking on monocytes and lymphocytes in peripheral blood of neonates. | Evaluate absolute monocyte and lymphocyte count in peripheral blood of neonates with UCM and compare them with the control group (no UCM). | 24 hours | 
| The effect of umbilical cord milking on neurotrophic factors in peripheral blood of neonates. | Compare levels of neurotrophic factors in peripheral blood of neonates with and without UCM. | 24 hours | 
| Survival and short term outcomes in neonates with moderate and severe HIE | In infants with moderate or severe HIE, compare survival, neurological examination at discharge, and neuro-imaging studies in infants with and without UCM. | Participants will be followed for the duration of hospital stay, an expected average of 5 days |