Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy

Hypoxic Ischemic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287077
• Other study ID #: 14D.522
• Status: Completed
• Phase: N/A
• First received: October 31, 2014
• Last updated: December 14, 2017
• Start date: December 2014
• Est. completion date: October 2016

Study information

• Verified date: December 2017
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Minute

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypoxia
• Hypoxia-Ischemia, Brain
• Hypoxic Ischemic Encephalopathy
• Ischemia
• Umbilical Cord Milking

Intervention

Procedure:
• Umbilical Cord Milking
At birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord.

Locations

Country	Name	City	State
India	Lata Mangeshkar Hospital and NKP Salve Institute of Medical Sciences	Nagpur	MS

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Lata Mangeshkar Hospital, NKP Salve Institute of Medical Sciences, Nagpur, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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