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The overall objective of the present study is to examine the effects of delayed umbilical cord clamping in preterm infants on neonatal outcomes using a prospective randomized controlled trial comparing immediate cord clamping (standard at present) with delayed cord clamping.
Our specific aim is to determine if a 30 to 45 second delay in umbilical cord clamping improves neonatal outcome as assessed by a composite of intraventricular hemorrhage and late onset sepsis in preterm infants born between 24 and 32 weeks gestation. Secondary outcomes to be examined include improvements in the following: 1) lung function as assessed by oxygen dependency at 36 weeks corrected gestational age (CGA), 2) cardiovascular function as assessed by the need for volume expansion, inotropes, or clinically suspected PDA requiring intervention prior to discharge home, and 3) anemia as assessed by initial hemoglobin, need for transfusion during stay in the NICU, and number of transfusions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A 1 | Experimental | Delayed umbilical cord clamping 30-45 seconds. |
|
| A 2 | No Intervention | Immediate umbilibcal cord clamping |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical cord clamping | Procedure | Delay of umbilical cord clamping 30 to 45 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Composite outcome of Intraventricular Hemorrhage and/or Late Onset Sepsis | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcomes include: 1) lung function 2) cardiovascular function and 3) anemia. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kellie E. Murphy, MD MSc | Contact | 416 586-8570 | kmurphy@mtsinai.on.ca | |
| Kelly Chu, MD | Contact | kelly.chu@utoronto.ca |
| Name | Affiliation | Role |
|---|---|---|
| Kellie E Murphy, MD MSc | Mount Sinai Hospital, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31875737 | Derived | Chu KS, Shah PS, Whittle WL, Windrim R, Murphy KE. The "DUC" trial: a pilot randomized controlled trial of immediate versus delayed cord clamping in preterm infants born between 24 and 32 weeks gestation. J Matern Fetal Neonatal Med. 2021 Dec;34(24):4049-4052. doi: 10.1080/14767058.2019.1702959. Epub 2019 Dec 25. |
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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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| D000091642 | Urogenital Diseases |