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This study was not funded. The same study with few modifications in the trial was later funded by the NICHD. Now study started enrolling babies using new registration and identification IDs ( NCT03682042 and NCT03657394).
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| Name | Class |
|---|---|
| NPKSIMS, Nagpur, India | UNKNOWN |
| Sharp HealthCare | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical Cord Milking | Active Comparator | 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. |
|
| Immediate Cord Clamping | No Intervention | The umbilical cord is clamped immediately after the delivery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord Milking | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Neurodevelopmental Outcome at 2 Years of Age | Overall and Domain Scores - Ages and Stages, 3rd ed. Questionnaire | 22-26 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fidgety Movements at 3 months of age | Assessment of Fidgety Movements by Prechtl's method | 3-5 months |
| Neurodevelopmental Outcome at 1 Year of Age | Developmental Activities Screening Inventory - Second Edition (DASI-II) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zubair Aghai, MD | Nemours Children's Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daga Memorial Woman and Children Hospital | Nagpur | MS | 440002 | India | ||
| Government Medical College and Hospital |
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| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| D001238 | Asphyxia Neonatorum |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000087526 | Umbilical Cord Clamping |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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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.
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Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
| 10-14 months |
| Autism Outcome | Modified Checklist for Autism in Toddlers (M-CHAT-R) | 22-26 months |
| Nagpur |
| MS |
| 440009 |
| India |
| NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital | Nagpur | MS | 440019 | India |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |