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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD102967 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Sharp HealthCare | OTHER |
| Thomas Jefferson University | OTHER |
| University of California, San Diego | OTHER |
| St. Louis University |
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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.
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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. |
|
| Early Cord Clamping | No Intervention | The umbilical cord is clamped immediately after the delivery (within 60 seconds). |
| 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 | 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. | 22-26 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zubair H Aghai, MD | Contact | 215 955 6523 | zaghai@nemours.org | |
| Anup Katheria, MD | Contact | 858 839 4170 | anup.katheria@sharp.com |
| Name | Affiliation | Role |
|---|---|---|
| Zubair Aghai, MD | Nemours Children's Clinic | Principal Investigator |
| Anup Katheria, MD | Sharp Mary Birch Hospital for Women & Newborns | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KLE Academy of Higher Education and Research (Deemed-to-be-University) Jawaharlal Nehru Medical College | Not yet recruiting | Belagavi | Karnataka | 590010 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41250198 | Derived | Yogeshkumar S, Vernekar SS, Dhaded SM, Talekar K, Leiby BE, Hartman R, Vaucher Y, Chouthai N, Girish M, Jain M, Jain S, Parvekar S, Jain V, Patankar A, Suryawanshi M, Tiwari M, Waikar M, Nashine N, Ambike D, Asalkar M, Kulkarni R, Haribhaktha S, Narkhede H, Chaudhari S, Kamble M, Shrirame D, Falke B, Mehta S, Verma A, Gothwal S, Goudar SS, Derman R, Katheria A, Aghai ZH. CORDMILK: Umbilical Cord Milking versus Early Cord Clamping on short-and long-term outcomes in neonates who are non-vigorous at birth-study protocol of a multi-center, cluster-randomized, crossover-controlled trial. Trials. 2025 Nov 17;26(1):509. doi: 10.1186/s13063-025-09197-8. |
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| OTHER |
| KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India | UNKNOWN |
| Government Medical College, Nagpur | INDUSTRY |
| Daga Memorial Maternity and Children's Hospital, Nagpur, India | UNKNOWN |
| Mahatma Gandhi Institute of Medical Sciences | OTHER |
| Karnataka Institute of Medical Sciences, Hubbali, India | UNKNOWN |
| All India Institute of Medical Sciences | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Indira Gandhi Government Medical College & Hospital, Nagpur, India | UNKNOWN |
| Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India | UNKNOWN |
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.
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Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
| 10-14 months |
| Sangappa Dhaded |
| KLE Academy of Higher Education and Research |
| Principal Investigator |
| Indira Gandhi Government Medical College & Hospital | Recruiting | Nagpur | Maharashtra | 440018 | India |
|
| Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital | Recruiting | Pune | Maharashtra | 411018 | India |
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| Government Medical College | Recruiting | Chandrapur | MS | 442401 | India |
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| Daga Memorial Woman and Children Hospital | Recruiting | Nagpur | MS | 440002 | India |
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| Government Medical College and Hospital | Recruiting | Nagpur | MS | 440009 | India |
|
| All India Institute of Medical Science | Not yet recruiting | Nagpur | MS | 441108 | India |
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| Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital | Recruiting | Wardha | MS | 442102 | India |
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| Sawai Man Singh (SMS) Medical College | Recruiting | Jaipur | Rajasthan | 302004 | India |
|
| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| D001238 | Asphyxia Neonatorum |
| D005330 | Fetofetal Transfusion |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| 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 |
| D000751 | Anemia, Neonatal |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic 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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