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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD088646-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Ulm | OTHER |
| University College Cork | OTHER |
| University of Alberta | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Early hemodynamic effects (within 3 hours of life) of Delayed Cord Clamping compared to Umbilical Cord Milking are still unknown. Four sites experienced in the use of NIRS and who have appropriate data collection equipment in the delivery room (Alberta, Ulm, Cork and San Diego) will obtain and report the physiological changes with UCM and DCC from birth until 24 hours of life. This data will yield the largest available sample of continuously recorded heart rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and administered FiO2 to delineate the short term responses to two methods of placental transfusion. In our initial trial we demonstrated increased blood pressure from 3-15 HOL with UCM compared to DCC in premature newborns <32 weeks, but did not show any differences in cerebral oxygenation.
This substudy will include 400 infants <28 weeks GA enrolled in the PREMOD2 trial. Once the newborn has been delivered, received the intervention (UCM or DCC), and been placed on the resuscitation bed a NIRS sensor and a pulse oximeter will be placed within 60 seconds. While arterial saturation and heart rate data will be available to the clinical team, data from NIRS will be blinded. Data on all study infants will be recorded for at least the first 10 minutes in the delivery room, and then for 24 hours in the NICU. Heart rate, oxygen saturations, and cerebral oxygenation, will be downloaded as per each site's practice for neonatal resuscitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical Cord Milking | Active Comparator | Milking the umbilical cord 4 times towards the infant at a speed of 20cm over 2 seconds. |
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| Delayed Cord Clamping | Active Comparator | Delayed clamping of the umbilical cord for at least 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 it is clamped. The procedure infuses a placental transfusion of blood into the preterm infant and can be done in 15-20 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| StO2 - 10M | Cerebral Tissue Oxygen Saturation in the Delivery Room | 1st 10 minutes of life |
| Measure | Description | Time Frame |
|---|---|---|
| StO2 - 24H | Cerebral Tissue Oxygen Saturation in the NICU | 1st 24 hours of life |
| HR - 10M | Heart Rate in the Delivery Room | 1st 10 minutes of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anup C Katheria, MD | Sharp Mary Birch Hospital for Women & Newborns | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Mary Birch Hospital for Women and Newborns | San Diego | California | 92123 | United States | ||
| Governors of University of Alberta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32482392 | Derived | Katheria AC, Szychowski JM, Essers J, Mendler MR, Dempsey EM, Schmolzer GM, Arnell K, Rich WD, Hassen K, Allman P, Varner M, Cutter GR, Finer N. Early Cardiac and Cerebral Hemodynamics with Umbilical Cord Milking Compared with Delayed Cord Clamping in Infants Born Preterm. J Pediatr. 2020 Aug;223:51-56.e1. doi: 10.1016/j.jpeds.2020.04.010. Epub 2020 May 29. |
| Label | URL |
|---|---|
| PREMOD2 main trial | View source |
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| ID | Term |
|---|---|
| D002534 | Hypoxia, Brain |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000860 | Hypoxia |
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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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| NIH |
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| Delayed Cord Clamping | Procedure | At delivery, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 60 seconds. |
|
| HR 24H | Heart rate in the NICU | 1st 24 hours of life |
| Blood Pressure NICU | Mean Blood Pressure in the 1st 24 hours | 2st 24 hours of life |
| Edmonton |
| Alberta |
| T6G 2R3 |
| Canada |
| University of ULM | Ulm | Baden-Wurttemberg | 89075 | Germany |
| Cork University Maternity Hospital | Cork | Ireland |
| D012818 |
| Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |