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).
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
3,442
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.
KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College
Belagavi, Karnataka, India
NOT_YET_RECRUITINGIndira Gandhi Government Medical College & Hospital
Nagpur, Maharashtra, India
RECRUITINGNeurodevelopmental 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.
Time frame: 22-26 months
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.
Time frame: 10-14 months
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Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital
Pune, Maharashtra, India
RECRUITINGGovernment Medical College
Chandrapur, MS, India
RECRUITINGDaga Memorial Woman and Children Hospital
Nagpur, MS, India
RECRUITINGGovernment Medical College and Hospital
Nagpur, MS, India
RECRUITINGAll India Institute of Medical Science
Nagpur, MS, India
NOT_YET_RECRUITINGMahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital
Wardha, MS, India
RECRUITINGSawai Man Singh (SMS) Medical College
Jaipur, Rajasthan, India
RECRUITING