Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy

Not Applicable

Completed

• Conditions: Umbilical Cord Milking; Hypoxic Ischemic Encephalopathy
• Interventions: Procedure: Umbilical Cord Milking

• Registration Number: NCT02287077
• Lead Sponsor: Thomas Jefferson University

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.

Study Timeline

• Study First Submitted: 2014-10-31
• Study First Submitted QC: 2014-11-07
• Study First Posted: 2014-11-10
• Study Start: 2014-12
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2017-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Umbilical cord milking	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.

Primary Outcome Measures

Name	Time	Method
The number of depressed neonates in whom umbilical cord milking was performed.	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 Outcome Measures

Name	Time	Method
The effect of umbilical cord milking on stem and progenitor cells in peripheral blood of neonates.	24 hours	Evaluate stem and progenitor cell count in peripheral blood of neonates with UCM and compare them with the control group (no UCM).
The effect of umbilical cord milking on neurotrophic factors in peripheral blood of neonates.	24 hours	Compare levels of neurotrophic factors in peripheral blood of neonates with and without UCM.
The effect of umbilical cord milking on monocytes and lymphocytes in peripheral blood of neonates.	24 hours	Evaluate absolute monocyte and lymphocyte count in peripheral blood of neonates with UCM and compare them with the control group (no UCM).
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	In infants with moderate or severe HIE, compare survival, neurological examination at discharge, and neuro-imaging studies in infants with and without UCM.

Trial Locations

Locations (1)

Lata Mangeshkar Hospital and NKP Salve Institute of Medical Sciences; 🇮🇳 Nagpur, MS, India