A Randomized Controlled Trial of Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypoxic Ischemic Encephalopathy
- Sponsor
- Thomas Jefferson University
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- The number of depressed neonates in whom umbilical cord milking was performed.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
The number of depressed neonates in whom umbilical cord milking was performed.
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days
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.
Secondary Outcomes
- The effect of umbilical cord milking on stem and progenitor cells in peripheral blood of neonates.(24 hours)
- The effect of umbilical cord milking on neurotrophic factors in peripheral blood of neonates.(24 hours)
- The effect of umbilical cord milking on monocytes and lymphocytes in peripheral blood of neonates.(24 hours)
- Survival and short term outcomes in neonates with moderate and severe HIE(Participants will be followed for the duration of hospital stay, an expected average of 5 days)