Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy

Thomas Jefferson University

Status: Completed

Conditions: Umbilical Cord Milking; Hypoxic Ischemic Encephalopathy

Treatments: Procedure: Umbilical Cord Milking

Study type: Interventional

Funder types: Other

Identifiers

NCT02287077

14D.522

Details and patient eligibility

About

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

Full 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.

Enrollment: 101 patients

Sex: All

Ages: Under 1 minute old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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101 participants in 2 patient groups

Immediate cord clamping

No Intervention group

Description:

At birth, neonate will be held at the level of placenta and umbilical cord will be clamped immediately (standard of care for depressed neonates).

Umbilical cord milking

Experimental group

Description:

At birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord.

Treatment:

Procedure: Umbilical Cord Milking