Clinical trial NCT03682042: Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up
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
Overall status: RECRUITING
Phase: NA
Conditions: Hypoxic-Ischemic Encephalopathy
Birth Asphyxia
Keywords: Placental transfusion
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: Sharp HealthCare
name: Thomas Jefferson University
name: University of California, San Diego
name: St. Louis University
name: KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India
name: Government Medical College, Nagpur
name: Daga Memorial Maternity and Children's Hospital, Nagpur, India
name: Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital, Wardha, India
name: Karnataka Institute of Medical Sciences, Hubbali, India
name: All India Institute of Medical Sciences
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Indira Gandhi Government Medical College & Hospital, Nagpur, India
name: Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India
First posted: 2018-09-24
Enrollment: 3442
Sex: ALL
Minimum age (years): 22
Maximum age (years): 26
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Enrolled in CORDMILK trial
* Non-vigorous at birth

Exclusion Criteria:

* None

Primary outcomes:
measure: Neurodevelopmental Outcome at 2 Years of Age
timeFrame: 22-26 months
Secondary outcomes:
measure: Neurodevelopmental Outcome at 1 Year of Age
timeFrame: 10-14 months
Other outcomes:
Locations:
city: Belgaum
country: India
facility: KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
state: Karnataka
city: Nagpur
country: India
facility: Indira Gandhi Government Medical College & Hospital
state: Maharashtra
city: Pune
country: India
facility: Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital
state: Maharashtra
city: Chandrapur
country: India
facility: Government Medical College
state: MS
city: Nagpur
country: India
facility: Daga Memorial Woman and Children Hospital
state: MS
city: Nagpur
country: India
facility: Government Medical College and Hospital
state: MS
city: Nagpur
country: India
facility: All India Institute of Medical Science
state: MS
city: Wardha
country: India
facility: Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
state: MS
city: Jaipur
country: India
facility: Sawai Man Singh (SMS) Medical College
state: Rajasthan
Study officials:
affiliation: Nemours Children's Clinic
name: Zubair Aghai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sharp Mary Birch Hospital for Women & Newborns
name: Anup Katheria, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: KLE Academy of Higher Education and Research
name: Sangappa Dhaded
role: PRINCIPAL_INVESTIGATOR
References: