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| ID | Type | Description | Link |
|---|---|---|---|
| U10HD021364 | U.S. NIH Grant/Contract | View source | |
| U01HD021438 | U.S. NIH Grant/Contract | View source | |
| U10HD027853 | U.S. NIH Grant/Contract | View source | |
| U10HD027904 | U.S. NIH Grant/Contract | View source | |
| M01RR000080 | U.S. NIH Grant/Contract | View source | |
| M01RR008084 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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This study tested the feasibility of conducting a randomized controlled trial to vary the timing that doctors clamp the umbilical cord after birth in extremely low birthweight infants. The study also tested whether delaying cord clamping by 30-35 seconds and holding the newborn approximately 10 inches below the birth canal would result in increased hematocrit at 4 hours of age.
This study tested the hypothesis that delaying clamping of the umbilical cord in extremely low birthweight (ELBW) infants would result in additional blood transfusion from the placenta to the baby, increasing the infant's blood volume and blood pressure. Higher blood pressure may improve blood flow to the brain that may reduce potential the risk of hypoxic ischemic encephalopathy (HIE) and/or intraventricular hemorrhage (IVH). The additional placental flow may also increase the amount of stem cells and cytokines flowing to the baby, improving immune status and reducing the risk of infection, while at the same time reducing the need for blood transfusions in the neonatal period.
This was a pilot study to test the feasibility of having obstetricians delay cord clamping for 30-45 seconds, and to confirm whether the procedure significantly increases the baby's hematocrit during the first 4 hours of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Cord Clamping | Active Comparator |
| |
| Delayed Cord Clamping | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Cord Clamping | Procedure | Immediate clamping (<5 seconds) of the umbilical cord after delivery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infants enrolled | Number of infants enrolled in the pilot within 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intention to treat | Identify obstetricians willing to participate in randomizing subjects. | 6 months |
| Hematocrit level | 4 hours of age | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Oh, MD | Brown University, Women & Infants Hospital of Rhode Island | Principal Investigator |
| Avroy A. Fanaroff, MD | Case Western Reserve University, Rainbow Babies and Children's Hospital | Principal Investigator |
| Edward F. Donovan, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Waldemar A. Carlo, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35249-7335 | United States | ||
| Cincinnati Children's Medical Center |
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| Label | URL |
|---|---|
| NICHD Neonatal Research Network | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 12, 2000 | Jun 15, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2000 | Jun 15, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| 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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| Delayed Cord Clamping | Procedure | Clamping of the umbilical cord at 30-45 seconds after birth. |
|
| Arterial blood pressure |
| 12 hours of age |
| Use of volume expansion or pressor therapy | 24 hours of age |
| Blood transfusions | Until hospital discharge or 120 days of life |
| Cincinnati |
| Ohio |
| 45267 |
| United States |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | United States |
| Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | United States |
| D000091642 | Urogenital Diseases |