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
Status: Active_not_recruiting
Location: See all (9) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 2
Healthy Volunteers: f
View:
• Enrolled in CORDMILK trial
• Non-vigorous at birth
Locations
Other Locations
India
KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
Belagavi
Government Medical College
Chandrapur
Sawai Man Singh (SMS) Medical College
Jaipur
All India Institute of Medical Science
Nagpur
Daga Memorial Woman and Children Hospital
Nagpur
Government Medical College and Hospital
Nagpur
Indira Gandhi Government Medical College & Hospital
Nagpur
Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital
Pune
Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
Wardha
Time Frame
Start Date: 2022-10-17
Completion Date: 2027-10-30
Participants
Target number of participants: 3442
Treatments
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.
No_intervention: Early Cord Clamping
The umbilical cord is clamped immediately after the delivery (within 60 seconds).
Authors
Alka Patankar, Manish Jain, Shuchi Jain, Dipty Jain, Prakash Wari, Meenakshi Girish, Akash Bang, Shivaprasad Goudar
Related Therapeutic Areas
Sponsors
Collaborators: University of California, San Diego, Daga Memorial Maternity and Children's Hospital, Nagpur, India, Sharp HealthCare, KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India, Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India, Government Medical College, Nagpur, Indira Gandhi Government Medical College & Hospital, Nagpur, India, St. Louis University, Karnataka Institute of Medical Sciences, Hubbali, India, All India Institute of Medical Sciences, Thomas Jefferson University, Mahatma Gandhi Institute of Medical Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Nemours Children's Clinic