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

Hypoxic-Ischemic Encephalopathy Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03682042
• Other study ID #: CORDMILK FU
• Secondary ID: R01HD102967
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: June 2023
• Source: Nemours Children's Clinic
• Contact: Zubair H Aghai, MD
• Phone: 215 955 6523
• Email: zaghai[@]nemours.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3442
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Months to 26 Months

Eligibility

Inclusion Criteria:

• Enrolled in CORDMILK trial
• Non-vigorous at birth

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Asphyxia
• Brain Diseases
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy

Intervention

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.

Locations

Country	Name	City	State
India	KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College	Belgaum	Karnataka
India	Karnataka Institute of Medical Sciences	Hubli	Karnataka
India	All India Institute of Medical Science	Nagpur	MS
India	Daga Memorial Woman and Children Hospital	Nagpur	MS
India	Government Medical College and Hospital	Nagpur	MS
India	Indira Gandhi Government Medical College & Hospital	Nagpur	Maharashtra
India	Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital	Pune	Maharashtra
India	Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital	Wardha	MS

Sponsors (14)

Lead Sponsor

Collaborator

Nemours Children's Clinic

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

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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