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The purpose of this study is to determine if there is a difference in neonatal outcomes with delayed umbilical cord clamping at 30 versus 60 seconds. Our primary outcome will be intraventricular hemorrhage (IVH) (bleeding in the brain) in these infants.
Immediately following delivery, up to 40% of the total blood volume available to the infant is in the placenta. Over a period of 30 seconds to 3 minutes, a significant portion of this blood is transferred to the infant through the umbilical cord. Delayed cord clamping following delivery facilitates this transfer of blood.
Preterm infants are very susceptible to the effects of anemia and hypovolemia. A recent meta-analysis showed that a brief delay in umbilical cord clamping (30-60 seconds) decreases the risk of anemia, blood transfusion, intraventricular hemorrhage, necrotizing enterocolitis, and the need for blood pressure support after delivery. The same meta-analysis showed no impact on Apgar scores or hypothermia due to a brief delay in resuscitation efforts to allow delayed cord clamping.
Preterm infants are at significant risk for IVH and as high as 20% of very low birth weight infants will have it. IVH is an important cause of brain injury in these infants. In our study, we would like to determine the optimal timing of delayed cord clamping in order to prevent IVH in these infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 seconds | Active Comparator | For subjects in the 30 second arm, the umbilical cord will be clamped at 30 seconds after delivery. |
|
| 60 seconds | Experimental | For subjects in the 60 second arm, the umbilical cord will be clamped at 60 seconds after delivery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delayed cord clamping at 30 seconds | Procedure | For subjects enrolled in the 30 second arm, the umbilical cord will be clamped at exactly 30 seconds after delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraventricular hemorrhage | Neonates will be followed for up to 6-months during NICU admission to assess for the development of intraventricular hemorrhage. | During NICU admission up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin and hematocrit | Neonates will be followed for up to 6-months and initial H/H will be recorded. | During NICU admission up to 6 months |
| Need for blood transfusion | Neonates will be followed for up to 6-months and assessed for clinical or laboratory evidence of need for transfusion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
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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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| Delayed cord clamping at 60 seconds | Procedure | For subjects enrolled in the 60 second arm, the umbilical cord will be clamped at exactly 60 seconds after delivery |
|
| During NICU admission up to 6 months |
| Bilirubin levels | Neonates will be followed for up to 6-months and assessed for clinical jaundice. | During NICU admission up to 6 months |
| Delivery room temperature | Neonates will be assessed for hypothermia at the time of delivery. | Delivery |
| D000091642 | Urogenital Diseases |