Birth Asphyxia, Hypoxic-Ischemic Encephalopathy
Conditions
Brief summary
An extension of the MIDAB trial, the MIDAB-Follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were depressed at birth and received umbilical cord milking (UCM) or immediate cord clamping (ICC).
Detailed description
The MIDAB-Follow-up trial will examine the difference in survival and neurodevelopmental impairment of infants who were depressed at birth and enrolled in MIDAB trial. The difference in survival and neurodevelopmental impairment in infants who received UCM and ICC 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
NPKSIMS, Nagpur, India
Sharp HealthCare
Nemours Children's Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
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 immediate cord clamping or umbilical cord milking as part of the MIDAB trial.
Eligibility
Sex/Gender
ALL
Age
3 Months to 26 Months
Healthy volunteers
No
Inclusion criteria
* Enrolled in MIDAB trial
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurodevelopmental Outcome at 2 Years of Age | 22-26 months | Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fidgety Movements at 3 months of age | 3-5 months | Assessment of Fidgety Movements by Prechtl's method |
| Neurodevelopmental Outcome at 1 Year of Age | 10-14 months | Developmental Activities Screening Inventory - Second Edition (DASI-II) |
| Autism Outcome | 22-26 months | Modified Checklist for Autism in Toddlers (M-CHAT-R) |
Countries
India
Outcome results
None listed