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Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries (CORDMILK)

Primary Purpose

Hypoxic-Ischemic Encephalopathy, Birth Asphyxia

Status

Recruiting

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Umbilical cord milking

About this trial

This is an interventional prevention trial for Hypoxic-Ischemic Encephalopathy focused on measuring Placental transfusion

Eligibility Criteria

35 Weeks - 42 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Non-vigorous neonates born between 35-42 weeks

Exclusion Criteria:

Congenital malformation of CNS.
Chromosomal abnormalities.
Major congenital malformations.
Abruption/cutting through the placenta at delivery.
Umbilical cord knots or inadequate cord length.
Mono-chorionic twins or twins with no information on amnion/chorion.
Multiple gestation >2 .

Sites / Locations

KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
Karnataka Institute of Medical Sciences
Indira Gandhi Government Medical College & HospitalRecruiting
Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial HospitalRecruiting
Daga Memorial Woman and Children HospitalRecruiting
Government Medical College and HospitalRecruiting
All India Institute of Medical Science
Mahatma Gandhi Institute of Medical Sciences/ Kasturba HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Umbilical Cord Milking

Early Cord Clamping

Arm Description

The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk 20-30 centimeters length of the umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for ECC.

Umbilical cord will be clamped immediately after birth (within 60 seconds)

Outcomes

Primary Outcome Measures

Moderate to severe HIE or death

Number of infants with moderate to severe HIE or death

Secondary Outcome Measures

NICU Admission

Number of non-vigorous infants admitted to the NICU

Neurological examination at discharge

Number of infants with moderate to severe HIE who have abnormal neurological examination at discharge

MRI of the brain

Number of infants with moderate to severe HIE who have abnormal brain MRI

Full Information

NCT ID

NCT03657394

First Posted

August 30, 2018

Last Updated

February 9, 2023

Sponsor

Nemours Children's Clinic

Collaborators

Sharp HealthCare, Thomas Jefferson University, University of San Diego, St. Louis University, Jawaharlal Nehru Medical College, Daga Memorial Maternity and Children's Hospital, Nagpur, India, Mahatma Gandhi Institue of Medical Sciences, Wardha, India, Karnataka Institue of Medical Sciences, Hubbali, India, Jawaharlal Institute of Postgraduate Medical Education & Research, All India Institute of Medical Sciences, Nagpur, India, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Indira Gandhi Government Medical College & Hospital, Nagpur, India, Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India, Government Medical College, Nagpur

1. Study Identification

Unique Protocol Identification Number

NCT03657394

Brief Title

Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries

Acronym

CORDMILK

Official Title

A Cluster Randomized Clinical Trial of Umbilical Cord Milking Versus Early Cord Clamping on Short and Long-term Outcomes in Neonates Who Are Non-Vigorous at Birth

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 17, 2022 (Actual)

Primary Completion Date

June 16, 2024 (Anticipated)

Study Completion Date

June 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nemours Children's Clinic

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The investigators will conduct a study on non-vigorous infants at birth to determine if umbilical cord milking (UCM) results in lower rate of moderate to severe hypoxic ischemic encephalopathy (HIE) or death than early clamping and for infants who are non-vigorous at birth and need immediate resuscitation.

Detailed Description

Hypoxic-ischemic encephalopathy (HIE) is a brain injury caused by inadequate blood flow and oxygen delivery to the neonatal brain. Almost all infants with severe HIE and 30-50% infants with moderate HIE either die or develop significant developmental delay, cerebral palsy or other disabilities.The incidence of HIE is 1-3 per 1,000 term births in developed countries and 15-20 times higher in developing countries (Worldwide, 0.5 to 1 million infants develop HIE each year). Therapeutic hypothermia is the only proven therapy for infants with HIE. Even after receiving therapeutic hypothermia, one-half of all infants with moderate and severe HIE die or develop neurological and functional impairment. Therapeutic hypothermia is not widely available and ineffective in developing nations.There is an urgent need for a new therapy for neonates with HIE, which can complement hypothermia and be readily available in developing nations. Stem cell transplantation is a potential therapy for infants with HIE. Umbilical cord blood is a rich source of stem cells. Umbilical cord milking (UCM) may have similar effect as autologous umbilical cord blood cell transplantation. Preliminary evidence suggests a placental transfusion in term infants may be a neuroprotective mechanism that can also facilitate cardiovascular transition for neonates depressed at birth and result in decreased mortality and improved neurodevelopmental outcomes. Infants with HIE, due to varied complications during the birth process, have poor perfusion due to fetal blood volume loss to the placenta. However, the most common method of providing placental blood, delayed cord clamping (DCC) cannot be performed since infants with HIE are non-vigorous and providers often need to perform resuscitation immediately after birth. The World Health Organization and the American College of Obstetrics and Gynecology (ACOG) also does not recommended DCC in neonates who are non-vigorous (limp, pale, and not breathing) at birth and require immediate resuscitation. Umbilical cord milking (UCM) or gently squeezing cord blood toward the baby, is an alternative to DCC, which can achieve significant placental transfusion without delaying resuscitation. Further, UCM can be completed as quickly as immediate cord clamping (ICC) and UCM requires minimal training and no additional staff. The investigators hypothesized that UCM will reduce the number of infants developing moderate to severe HIE or death in neonates who are non-vigorous at birth compared to early cord clamping (ECC). This will be a cluster crossover randomized controlled trial. Each hospital will be randomly assigned to use either ECC or UCM for any infant who is non-vigorous at birth and needing resuscitation over a period of 6 months. Then the site will change to the other method for an additional 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxic-Ischemic Encephalopathy, Birth Asphyxia

Keywords

Placental transfusion

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Cluster Randomized Crossover

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

3442 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Umbilical Cord Milking

Arm Type

Active Comparator

Arm Description

Arm Title

Early Cord Clamping

Arm Type

No Intervention

Arm Description

Umbilical cord will be clamped immediately after birth (within 60 seconds)

Intervention Type

Other

Intervention Name(s)

Umbilical cord milking

Intervention Description

At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 1--15 seconds.

Primary Outcome Measure Information:

Title

Moderate to severe HIE or death

Description

Number of infants with moderate to severe HIE or death

Time Frame

From date of birth until the date of discharge from the hospital or date of death from any cause, whichever come first, asessed up to 10 weeks.

Secondary Outcome Measure Information:

Title

NICU Admission

Description

Number of non-vigorous infants admitted to the NICU

Time Frame

Delivery room death or admission to the NICU from the time of birth to 48 hours of age.

Title

Neurological examination at discharge

Description

Number of infants with moderate to severe HIE who have abnormal neurological examination at discharge

Time Frame

From date of birth until the date of discharge from the hospital, asessed up to 10 weeks.

Title

MRI of the brain

Description

Number of infants with moderate to severe HIE who have abnormal brain MRI

Time Frame

4 days to 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Weeks

Maximum Age & Unit of Time

42 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Non-vigorous neonates born between 35-42 weeks Exclusion Criteria: Congenital malformation of CNS. Chromosomal abnormalities. Major congenital malformations. Abruption/cutting through the placenta at delivery. Umbilical cord knots or inadequate cord length. Mono-chorionic twins or twins with no information on amnion/chorion. Multiple gestation >2 .

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zubair H Aghai, MD

Phone

215 955 6523

zaghai@nemours.org

First Name & Middle Initial & Last Name or Official Title & Degree

Anup Katheria, MD

Phone

858 939 4170

anup.katheria@sharp.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zubair H Aghai, MD

Organizational Affiliation

Nemours Children's Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anup Katheria, MD

Organizational Affiliation

Sharp Mary Birch Hospital for Women & Newborns

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sangappa Dhaded, MD

Organizational Affiliation

KLE Academy of Higher Education and Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College

City

Belgaum

State/Province

Karnataka

ZIP/Postal Code

590010

Country

India

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sangappa Dhaded, MD

Phone

+91 98442 32586

drdhadedsm@gmail.com

First Name & Middle Initial & Last Name & Degree

Yeshita Pujar, MD

First Name & Middle Initial & Last Name & Degree

Bahvana Koppad, MD

First Name & Middle Initial & Last Name & Degree

Santosh Patil, MD

First Name & Middle Initial & Last Name & Degree

Deppa Metgud, MD

First Name & Middle Initial & Last Name & Degree

Shivaprasad Goudar, MD

Facility Name

Karnataka Institute of Medical Sciences

City

Hubli

State/Province

Karnataka

ZIP/Postal Code

580022

Country

India

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kasturi Donimath

Phone

+91-94483 75802

dkasturiv@rediffmail.com

First Name & Middle Initial & Last Name & Degree

Kasturi Donimath, MD

First Name & Middle Initial & Last Name & Degree

Prakash Wari, MD

First Name & Middle Initial & Last Name & Degree

GC Patil, MD

First Name & Middle Initial & Last Name & Degree

BR Sahithya, MD

Facility Name

Indira Gandhi Government Medical College & Hospital

City

Nagpur

State/Province

Maharashtra

ZIP/Postal Code

440018

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Milind Suryavanshi, MD

dr.milind.suryawanshi@gmail.com

First Name & Middle Initial & Last Name & Degree

Milind Suryavanshi, MD

First Name & Middle Initial & Last Name & Degree

Alka Patankar, MD

Facility Name

Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411018

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Deepali Ambike, MD

ambikedeepa@gmail.com

First Name & Middle Initial & Last Name & Degree

Mahesh Asalkar, MD

First Name & Middle Initial & Last Name & Degree

Deepali Ambike, MD

Facility Name

Daga Memorial Woman and Children Hospital

City

Nagpur

State/Province

ZIP/Postal Code

440002

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Seema Parvekar, MD

Phone

+91-98909 87153

seemaparvekar@gmail.com

First Name & Middle Initial & Last Name & Degree

Vineeta Jain, MD

First Name & Middle Initial & Last Name & Degree

Seema Parvekar, MD

First Name & Middle Initial & Last Name & Degree

Mustafa Biviji, MD

Facility Name

Government Medical College and Hospital

City

Nagpur

State/Province

ZIP/Postal Code

440009

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Manoj Bhatanagar, MD

Phone

+91-98812 37232

manojbhatnagar76@gmail.com

First Name & Middle Initial & Last Name & Degree

Manoj Bhatnagar, MD

First Name & Middle Initial & Last Name & Degree

Manjushri Waikar, MD

Facility Name

All India Institute of Medical Science

City

Nagpur

State/Province

ZIP/Postal Code

441108

Country

India

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Meenakshi Girish, MD

Phone

+91-94221 09733

meenakshimgirish@gmail.com

First Name & Middle Initial & Last Name & Degree

Meenakshi Girish, MD

First Name & Middle Initial & Last Name & Degree

Akash Bang, MD

First Name & Middle Initial & Last Name & Degree

Urmila Chauhan, MD

Facility Name

Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital

City

Wardha

State/Province

ZIP/Postal Code

442102

Country

India

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Manish Jain, MD

Phone

+91-98226 95195

manish@mgims.ac.in

First Name & Middle Initial & Last Name & Degree

Manish Jain, MD

First Name & Middle Initial & Last Name & Degree

Shuchi Jain, MD

First Name & Middle Initial & Last Name & Degree

Sushil Kale, MD

First Name & Middle Initial & Last Name & Degree

Anurag Chandel, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries

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