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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Hypoxic-Ischemic Encephalopathy; Birth Asphyxia
• Intervention / Treatment: Other: Umbilical Cord Milking

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.

• Study Type: Interventional
• Enrollment (Estimated): 3442
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anup Katheria, MD; Phone Number: 858 839 4170; Email: anup.katheria@sharp.com
• Study Contact Backup: Name: Zubair H Aghai, MD; Phone Number: 215 955 6523; Email: zaghai@nemours.org

Study Locations

• India
  • Karnataka
    • Belgaum, Karnataka, India, 590010
      • Not yet recruiting
      • KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
      • Contact: Sangappa Dhaded, MD; Phone Number: +91 98442 32586; Email: drdhadedsm@gmail.com
      • Principal Investigator: Yeshita Pujar, MD
      • Principal Investigator: Bahvana Koppad, MD
      • Sub-Investigator: Santosh Patil, MD
      • Sub-Investigator: Shivaprasad Goudar, MD
      • Sub-Investigator: Deepa Metgud, MD
    • Hubli, Karnataka, India, 580022
      • Not yet recruiting
      • Karnataka Institute of Medical Sciences
      • Contact: Kasturi Donimath; Phone Number: +91-94483 75802; Email: dkasturiv@rediffmail.com
      • Principal Investigator: Kasturi Donimath, MD
      • Principal Investigator: Prakash Wari, MD
      • Sub-Investigator: GC Patil, MD
      • Sub-Investigator: BR Sahithya, MD
  • MS
    • Nagpur, MS, India, 440002
      • Recruiting
      • Daga Memorial Woman and Children Hospital
      • Contact: Seema Parvekar, MD; Phone Number: +91-98909 87153; Email: seemaparvekar@gmail.com
      • Principal Investigator: Vineeta Jain, MD
      • Sub-Investigator: Mustafa Biviji, MD
      • Principal Investigator: Seema Parvekar, MD
    • Nagpur, MS, India, 440009
      • Recruiting
      • Government Medical College and Hospital
      • Contact: Manoj Bhatanagar, MD; Phone Number: +91-98812 37232; Email: manojbhatnagar76@gmail.com
      • Principal Investigator: Manoj Bhatnagar, MD
      • Principal Investigator: Manjushri Waikar, MD
    • Nagpur, MS, India, 441108
      • Not yet recruiting
      • All India Institute of Medical Science
      • Contact: Meenakshi Girish, MD; Phone Number: +91-94221 09733; Email: meenakshimgirish@gmail.com
      • Sub-Investigator: Akash Bang, MD
      • Sub-Investigator: Urmila Chauhan, MD
      • Principal Investigator: Meenakshi Girish, MD
    • Wardha, MS, India, 442102
      • Recruiting
      • Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
      • Contact: Manish Jain, MD; Phone Number: +91-98226 95195; Email: manish@mgims.ac.in
      • Principal Investigator: Shuchi Jain, MD
      • Sub-Investigator: Sushil Kale, MD
      • Sub-Investigator: Anurag Chandel, MD
      • Principal Investigator: Manish Jain, MD
  • Maharashtra
    • Nagpur, Maharashtra, India, 440018
      • Recruiting
      • Indira Gandhi Government Medical College & Hospital
      • Contact: Milind Suryavanshi, MD; Email: dr.milind.suryawanshi@gmail.com
      • Principal Investigator: Milind Suryavanshi, MD
      • Principal Investigator: Alka Patankar, MD
    • Pune, Maharashtra, India, 411018
      • Recruiting
      • Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital
      • Contact: Deepali Ambike, MD; Email: ambikedeepa@gmail.com
      • Principal Investigator: Deepali Ambike, MD
      • Principal Investigator: Mahesh Asalkar, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Enrolled in CORDMILK trial
• Non-vigorous at birth

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Umbilical Cord Milking; 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.	Other: Umbilical Cord Milking; 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.
No Intervention: Early Cord Clamping; The umbilical cord is clamped immediately after the delivery (within 60 seconds).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	22-26 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10-14 months

Collaborators and Investigators

• Sponsor: Nemours Children's Clinic
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of California, San Diego; Thomas Jefferson University; St. Louis University; Sharp HealthCare; Daga Memorial Maternity and Children's Hospital, Nagpur, India; 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; KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, 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
• Investigators: Principal Investigator: Sangappa Dhaded, KLE Academy of Higher Education and Research; Principal Investigator: Zubair Aghai, MD, Nemours Children's Clinic; Principal Investigator: Anup Katheria, MD, Sharp Mary Birch Hospital for Women & Newborns

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Placental transfusion
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Signs and Symptoms, Respiratory; Death; Hypoxia; Hypoxia, Brain; Brain Ischemia; Brain Diseases; Hypoxia-Ischemia, Brain; Asphyxia; Asphyxia Neonatorum
• Other Study ID Numbers: CORDMILK FU; R01HD102967 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No