Umbilical Cord Milking for Neonates With Hypoxic Ischemic Encephalopathy

NCT02287077 | Completed

• 1 other identifier: 14D.522
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxic Ischemic Encephalopathy; Umbilical Cord Milking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 monocytes and lymphocytes in peripheral blood of neonates.

  24 hours

• The effect of umbilical cord milking on neurotrophic factors 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

Study Arms (2)

Immediate cord clamping

NO INTERVENTION

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

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

Interventions

Umbilical Cord Milking PROCEDURE

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

Also known as: Umbilical cord stripping

Umbilical cord milking

Eligibility Criteria

• Age: Up to 1 Minute
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Term and near term neonates (35 weeks and more)
• Depressed at birth

You may not qualify if:

• Congenital malformation of central nervous system
• Chromosomal abnormalities
• Major congenital malformations

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Lata Mangeshkar Hospital, NKP Salve Institute of Medical Sciences, Nagpur, India: collaborator

Study Sites (1)

Lata Mangeshkar Hospital and NKP Salve Institute of Medical Sciences

Nagpur, MS, 440019, India

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 10, 2014
• Study Start: December 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 18, 2017

Record last verified: 2017-12

Locations

IN (1)