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extremely poor recruitment & since the study was approved, medical practice has evolved to where cord milking is now common practice.
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Anemia in preterm neonates is a significant problem encountered frequently in the neonatal intensive care unit. Most preterm neonates born at less than 33 weeks gestation will require at least one blood transfusion during their hospital course and many will require repeated transfusions. Blood transfusions, albeit necessary, carry increased risk of viral infections and transfusion reactions as well as increase the cost of healthcare. The umbilical cord and placenta harbor up to 40% of blood available during fetal life. The current standard of care is immediate umbilical cord clamping. The investigators are performing a randomized controlled trial comparing immediate cord clamping to milking the umbilical cord prior to clamping in neonate born preterm less than 33 weeks gestation. The investigators hypothesize that milking the umbilical cord will demonstrate the same benefits as delayed cord clamping, without delaying neonatal resuscitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate umbilical cord clamping | Active Comparator | The umbilical cord will be clamped immediately after delivery. |
|
| Cord milking group | Experimental | The umbilical cord will be "milked" in direction towards neonate 4 times over the course of 10 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milking group | Procedure | The umbilical cord will be "milked" toward the neonate four times prior to clamping the umbilical cord. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin during NICU course | within 24 hours of birth and through NICU stay |
| Measure | Description | Time Frame |
|---|---|---|
| 1-min Apgar | at 1 minute of life | |
| 5 min Apgar | at 5 minutes of life | |
| Blood Sugar upon admission to NICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Bienstock, MD MPH | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | 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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| ID | Term |
|---|---|
| D000087526 | Umbilical Cord Clamping |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Immediate cord clamping | Procedure | The umbilical cord will be clamped and cut immediately after delivery of the neonate. |
|
| within 1 hour of birth |
| Temperature on admission to NICU | within 1 hour of birth |
| Cord blood pH | within 1 hour of birth |
| Blood pressure upon admission to NICU | within 1 hour of birth |
| Number of volume challenges in first 24 hours of life | at 24 hours of birth |
| Days requiring ventilation | 2 months |
| Neonatal death | 6 months |
| Length of hospital stay | 6 months |
| Intraventricular hemorrhage | 6 months |
| Number and volume of blood transfusions | 10 units |
| duration of phototherapy | 1 month |
| Maximum serum bilirubin | 1 month |
| D000091642 | Urogenital Diseases |