Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-26
SponsorNemours Children's Clinic
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Enrolled in CORDMILK trial
Non-vigorous at birth
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Umbilical Cord Milking
Other interventionAt 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.
Treatment groups
3,442 Participants
are divided into 2 treatment groupsGroup A: Umbilical Cord MilkingActive comparator 1 intervention
Group B: Early Cord ClampingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
22-26 monthsSecondary outcomes
1
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nemours Children's Clinic
Lead sponsor
Sharp HealthCare
Collaborator
Thomas Jefferson University
Collaborator
University of California, San Diego
Collaborator
St. Louis University
Collaborator
KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India
Collaborator
Government Medical College, Nagpur
Collaborator
Daga Memorial Maternity and Children's Hospital, Nagpur, India
Collaborator
Mahatma Gandhi Institute of Medical Sciences
Collaborator
Karnataka Institute of Medical Sciences, Hubbali, India
Collaborator
All India Institute of Medical Sciences
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Indira Gandhi Government Medical College & Hospital, Nagpur, India
Collaborator
Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India
Collaborator
Source ClinicalTrials.gov