Birth Asphyxia, Hypoxic-Ischemic Encephalopathy
Conditions
Keywords
Placental transfusion
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.
Interventions
OTHERUmbilical 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.
Sponsors
Nemours Children's Clinic
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
Karnataka Institute of Medical Sciences, Hubbali, India
All India Institute of Medical Sciences
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
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
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.
Eligibility
Sex/Gender
ALL
Age
22 Months to 26 Months
Healthy volunteers
No
Inclusion criteria
* Enrolled in CORDMILK trial * Non-vigorous at birth
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurodevelopmental Outcome at 2 Years of Age | 22-26 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Neurodevelopmental Outcome at 1 Year of Age | 10-14 months | 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. |
Countries
India
Contacts
PRINCIPAL_INVESTIGATORZubair Aghai, MD
Nemours Children's Clinic
PRINCIPAL_INVESTIGATORAnup Katheria, MD
Sharp Mary Birch Hospital for Women & Newborns
PRINCIPAL_INVESTIGATORSangappa Dhaded
KLE Academy of Higher Education and Research
Outcome results
None listed