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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
| Thomas Jefferson University | OTHER |
| Sharp HealthCare | OTHER |
| Jawaharlal Nehru Medical College |
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The goal of this multicenter, cluster-randomized, crossover trial is to determine if umbilical cord milking compared to early cord clamping will reduce in-hospital mortality in non-vigorous preterm infants born between 30 weeks and 34 weeks of gestation.
Background: Prematurity is the leading cause of death in children younger than 5 years of age. Worldwide, 15 million infants are born premature, and India alone contributes to quarter of them. Approximately 1 million children die each year due to complications of prematurity.
Delayed cord clamping (DCC), one of the methods of transfer of placental blood to neonates (placental transfusion) immediately after birth reduce mortality by 30% in premature infants. But DCC is not recommended in neonates who require immediate resuscitation. Umbilical cord milking (UCM) is an option for placental transfusion in preterm infants who require immediate resuscitation but not currently recommended due to lack of randomized clinical trials.
HYPOTHESIS: UCM will reduce the in-hospital mortality in non-vigorous preterm infants born between 30 weeks to 34 weeks of gestation compared to early cord clamping.
METHODS: This multicenter cluster crossover randomized trial will enroll approximately 800 preterm infants to early cord clamping or milking the intact cord 4 times prior to clamping.
IMPACT: If investigators find that UCM is beneficial, this simple, low-tech, no cost intervention can be used in preventing deaths in preterm infants. This trial will potentially provide evidence to support a change in guidelines making UCM part of standard practice worldwide for preterm infants who require immediate resuscitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical Cord Milking | Active Comparator | The delivering practitioner will place the newborn below the level of the incision (at the edge of the table) at C/S and a second team member will milk the cord four times. For vaginal delivery, the delivering obstetrician, midwife or perinatal provider will hold the infant against their body or place the infant on the mother's abdomen and the cord will be milked either four times by the obstetrical provider or by a second team member. For the cord milking procedure, the obstetrical provider will milk 20-30 centimeters length of the umbilical cord over two seconds, repeating three additional times as described previously. This time is not significantly different from the time for early cord clamping (ECC). |
|
| Early Cord Clamping | No Intervention | Umbilical cord will be clamped immediately after birth (within 60 seconds) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical cord milking | Procedure | 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 1--15 seconds. |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital mortality | Death of a baby during birth hospitalization | From date of birth until the date of discharge from the hospital or date of death from any cause, whichever come first, assessed up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin at or after 24 hours | Hb levels | Days 1-7 |
| Early and late onset culture positive sepsis | Number of infants with early onset or late onset sepsis |
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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 |
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| 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 |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D066088 | Infant Death |
| D005330 | Fetofetal Transfusion |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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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| OTHER |
| Daga Memorial Maternity and Children's Hospital, Nagpur, India | UNKNOWN |
| Mahatma Gandhi Institute of Medical Sciences | OTHER |
| Indira Gandhi Government Medical College & Hospital, Nagpur, India | UNKNOWN |
| Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India | UNKNOWN |
| Government Medical College, Nagpur | INDUSTRY |
| Government Medical College, Chandrapur, India | UNKNOWN |
| Osmania Medical College, Niloufer Hospital, Hyderabad, India | UNKNOWN |
Cluster Randomized Crossover
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|
| From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. |
| Any intraventricular hemorrhage (IVH) and severe IVH (grade 3 or 4) | Number of infants with any IVH or severe IVH | From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. |
| Need for blood transfusion | Number of infants received blood transfusion | From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. |
| Moderate to severe hypoxemic ischemic encephalopathy | Number of infants with moderate to severe hypoxemic ischemic encephalopathy | From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. |
| Necrotizing enterocolitis (Bell's stage 2 or higher) | Number of infants with necrotizing enterocolitis (Bell's stage 2 or higher) | From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. |
| Need for medications for hypotension | Number of infants needed medications for hypotension | From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. |
| Need for phototherapy for jaundice | Number of infants needed phototherapy for jaundice | From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. |
| Retinopathy of prematurity (ROP) requiring intervention | Number of infants with ROP that required intervention | From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. |
| Length of hospitalization | Number of days infants stayed in hospital | From date of birth until the date of discharge from the hospital, assessed up to 12 weeks. |
| Government Medical College | Not yet recruiting | Chandrapur | Maharashtra | 442401 | India |
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| Indira Gandhi Government Medical College & Hospital | Not yet recruiting | Nagpur | Maharashtra | 440018 | India |
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| Yashwantrao Chavan Memorial Hospital | Not yet recruiting | Pune | Maharashtra | 411018 | 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 | Not yet recruiting | Nagpur | MS | 440009 | India |
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| Mahatma Gandhi Institute of Medical Sciences/ Kasturba Hospital | Not yet recruiting | Wardha | MS | 442102 | India |
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| Sawai Man Singh Medical College | Recruiting | Jaipur | Rajasthan | 302004 | India |
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| Osmania Medical College, Niloufer Hospital | Recruiting | Hyderabad | Telangana | 500004 | India |
|
| D000091642 | Urogenital Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000751 | Anemia, Neonatal |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |