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

Primary Purpose

Hypoxic-Ischemic Encephalopathy, Birth Asphyxia

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Umbilical Cord Milking
Sponsored by
Nemours Children's Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

22 Months - 26 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Enrolled in CORDMILK trial
  • Non-vigorous at birth

Exclusion Criteria:

  • None

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

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 10-15 seconds.

The umbilical cord is clamped immediately after the delivery (within 60 seconds).

Outcomes

Primary Outcome Measures

Neurodevelopmental Outcome at 2 Years of Age
Neurodevelopmental assessment will be performed by the trained and experienced examiner who will be blinded to the interventions. Severe neurodevelopmental impairment will be defined having at least one of the following: BSID (IV) composite cognitive score <70, GMFCS level 3-5, blindness (vision <20/200), or hearing impairment requiring hearing aids/cochlear implant. Moderate neurodevelopmental impairment will be defined as having a cognitive composite score 70-84, GMFCS level 2, unilateral blindness (vision/20/200 in only one eye), or hearing impairment with no amplification/cochlear implant.

Secondary Outcome Measures

Neurodevelopmental Outcome at 1 Year of Age
Neurodevelopmental assessment will be performed by the trained and experienced examiner who will be blinded to the intervention using the Developmental Assessment Scales for Indian Infants (DASII). DAASI provides developmental motor quotient (DMoQ), developmental mental quotient (DMeQ), and composite developmental quotient (DQ). With a mean DQ of 100 and standard deviation (SD) of 15, 1SD and 2SD below mean correspond to DQ of 85 and 70, respectively. A DMoQ, DMeQ or DQ score of <70 (2SD) is considered as neurodevelopmental impairment.

Full Information

First Posted
September 20, 2018
Last Updated
June 14, 2023
Sponsor
Nemours Children's Clinic
Collaborators
Sharp HealthCare, Thomas Jefferson University, University of California, San Diego, St. Louis University, KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India, Government Medical College, Nagpur, Daga Memorial Maternity and Children's Hospital, Nagpur, India, Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital, Wardha, India, Karnataka Institute of Medical Sciences, Hubbali, India, All India Institute of Medical Science, 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
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1. Study Identification

Unique Protocol Identification Number
NCT03682042
Brief Title
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up
Acronym
CORDMILK-FU
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
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Clinic
Collaborators
Sharp HealthCare, Thomas Jefferson University, University of California, San Diego, St. Louis University, KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India, Government Medical College, Nagpur, Daga Memorial Maternity and Children's Hospital, Nagpur, India, Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital, Wardha, India, Karnataka Institute of Medical Sciences, Hubbali, India, All India Institute of Medical Science, 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
An extension of the CORDMILK trial, the CORDMILK follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were non-vigorous at birth and received umbilical cord milking (UCM) or early cord clamping (ECC).
Detailed Description
The CORDMILK Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were non-vigorous at birth and enrolled in the CORDMILK trial. The difference in survival and neurodevelopmental impairment in infants who received UCM and ECC will be assessed using standardized neurological and developmental assessment tools at 22-26 months of age.

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
Neurodevelopmental assessments will be done at 2 years of age (22-26 months) for subjects who were randomized to receive either early cord clamping or umbilical cord milking as part of the CORDMILK trial.
Masking
Outcomes Assessor
Masking Description
Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
Allocation
Randomized
Enrollment
3442 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Umbilical Cord Milking
Arm Type
Active Comparator
Arm 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 10-15 seconds.
Arm Title
Early Cord Clamping
Arm Type
No Intervention
Arm Description
The umbilical cord is clamped immediately after the delivery (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 10-15 seconds.
Primary Outcome Measure Information:
Title
Neurodevelopmental Outcome at 2 Years of Age
Description
Neurodevelopmental assessment will be performed by the trained and experienced examiner who will be blinded to the interventions. Severe neurodevelopmental impairment will be defined having at least one of the following: BSID (IV) composite cognitive score <70, GMFCS level 3-5, blindness (vision <20/200), or hearing impairment requiring hearing aids/cochlear implant. Moderate neurodevelopmental impairment will be defined as having a cognitive composite score 70-84, GMFCS level 2, unilateral blindness (vision/20/200 in only one eye), or hearing impairment with no amplification/cochlear implant.
Time Frame
22-26 months
Secondary Outcome Measure Information:
Title
Neurodevelopmental Outcome at 1 Year of Age
Description
Neurodevelopmental assessment will be performed by the trained and experienced examiner who will be blinded to the intervention using the Developmental Assessment Scales for Indian Infants (DASII). DAASI provides developmental motor quotient (DMoQ), developmental mental quotient (DMeQ), and composite developmental quotient (DQ). With a mean DQ of 100 and standard deviation (SD) of 15, 1SD and 2SD below mean correspond to DQ of 85 and 70, respectively. A DMoQ, DMeQ or DQ score of <70 (2SD) is considered as neurodevelopmental impairment.
Time Frame
10-14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Months
Maximum Age & Unit of Time
26 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Enrolled in CORDMILK trial Non-vigorous at birth Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zubair H Aghai, MD
Phone
215 955 6523
Email
zaghai@nemours.org
First Name & Middle Initial & Last Name or Official Title & Degree
Anup Katheria, MD
Phone
858 839 4170
Email
anup.katheria@sharp.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zubair 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
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
Email
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
Deepa 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
Email
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
Email
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
Email
ambikedeepa@gmail.com
First Name & Middle Initial & Last Name & Degree
Deepali Ambike, MD
First Name & Middle Initial & Last Name & Degree
Mahesh Asalkar, MD
Facility Name
Daga Memorial Woman and Children Hospital
City
Nagpur
State/Province
MS
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
Email
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
MS
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
Email
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
MS
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
Email
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
MS
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
Email
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

Learn more about this trial

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

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