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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD088646-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Sharp Mary Birch Hospital for Women & Newborns | OTHER |
| Loma Linda University | OTHER |
| University of Pittsburgh | OTHER |
| Providence Hospital |
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This study is being done to find out whether umbilical cord milking (UCM) is at least as good as or better than delayed cord clamping (DCC) to reduce bleeding in the brain or prevent death in premature newborns. The investigators will study short and long term outcomes of infants delivered before 32 weeks gestation that receive either UCM or DCC.
* The trial was stopped by the DSMB for safety in the small strata. They subsequently allowed for continuation of the trial in infants 29-32+6 wk GA.
Aim 1. Compare the incidence of severe intraventricular hemorrhage (IVH) and/or death in premature newborns <33 weeks gestational age (GA) delivered by C/S receiving UCM to those receiving DCC.
Hypothesis1: First demonstrate infants in the UCM group are not inferior to the DCC group (reject H10).
Hypothesis2: If H1 is true, demonstrate lower incidence of severe IVH and/or death in UCM infants compared to DCC.
Aim 2. Compare the safety and efficacy profiles of premature newborns <33 weeks GA delivered by C/S receiving UCM vs. DCC during their hospitalization.
Hypothesis3: UCM group will have a decreased need for resuscitation interventions with no differences in bilirubin or polycythemia compared to DCC.
Hypothesis4: UCM group will have improved blood pressures in the first 24 hours of life compared to DCC.
Aim 3 (exploratory). To compare the outcomes of premature newborns <33 weeks GA delivered by C/S (Cesarean section) (from Aims 1 and 2) with those born by V/D (vaginal delivery) receiving UCM or DCC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical cord milking UCM | Active Comparator | Milking the umbilical cord 4 times towards the infant at a speed of 20cm/2seconds. |
|
| Delayed cord clamping DCC | Active Comparator | Delayed clamping of the umbilical cord for at least 60 seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical cord milking UCM | Procedure | At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before it is clamped. This procedure infuses a placental transfusion of blood into the preterm neonate and can be done in 15-20 seconds. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of severe IVH or death | Severe intraventricular hemorrhage of grade 3 or 4 or death | Through study completion at death or discharge, up to 6 months corrected gestational age (CGA) |
| Measure | Description | Time Frame |
|---|---|---|
| All Grade IVH | Any intraventricular hemorrhage (grades 1-4) | Through study completion at discharge, up to 6 months corrected gestational age (CGA) |
| Severe IVH (Grade 3 or 4) | Severe intraventricular hemorrhage (bleeding in the brain parenchyma and/or ventricular dilation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anup C Katheria, MD | Sharp HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294-0004 | United States | ||
| Loma Linda Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33142340 | Derived | Katheria AC, Allman P, Szychowski JM, Essers J, Carlo WA, Schmolzer GM, Dempsey E, Yanowitz T, Kaempf J, Vora F, Bhat S, Arnell K, Rich W, Varner M. Perinatal Outcomes of Subjects Enrolled in a Multicenter Trial with a Waiver of Antenatal Consent. Am J Perinatol. 2022 Jun;39(8):904-908. doi: 10.1055/s-0040-1719184. Epub 2020 Nov 3. | |
| 31742630 | Derived | Katheria A, Reister F, Essers J, Mendler M, Hummler H, Subramaniam A, Carlo W, Tita A, Truong G, Davis-Nelson S, Schmolzer G, Chari R, Kaempf J, Tomlinson M, Yanowitz T, Beck S, Simhan H, Dempsey E, O'Donoghue K, Bhat S, Hoffman M, Faksh A, Arnell K, Rich W, Finer N, Vaucher Y, Khanna P, Meyers M, Varner M, Allman P, Szychowski J, Cutter G. Association of Umbilical Cord Milking vs Delayed Umbilical Cord Clamping With Death or Severe Intraventricular Hemorrhage Among Preterm Infants. JAMA. 2019 Nov 19;322(19):1877-1886. doi: 10.1001/jama.2019.16004. |
| Label | URL |
|---|---|
| NIRS Sub-study PREMOD2 | View source |
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Data will be made available per NICHD requirements (National Institute of Child Health and Human Development).
2 years after primary publication
An archived dataset with documentation will be made available for additional uses by outside investigators, in collaboration with the study investigators. We will work with NICHD program staff to develop a broad data sharing plan over time.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 15, 2026 | |
| Reset | Jan 30, 2026 |
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| OTHER |
| University of Alabama at Birmingham | OTHER |
| University of Alberta | OTHER |
| University College Cork | OTHER |
| University of Ulm | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Christiana Care Health Services | OTHER |
| Sharp Grossmont Hospital | OTHER |
| University of Utah | OTHER |
| University of Mississippi Medical Center | OTHER |
| PIH Health Good Samaritan Hospital | UNKNOWN |
| University of California, Irvine | OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| Cook County Health | OTHER_GOV |
| St. Louis University | OTHER |
| LAC+USC Medical Center | OTHER |
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It is not possible to blind the delivering obstetrician, however all other caregivers will be blinded. The procedure will be documented as "placental transfusion" in the delivery summary or admission-progress notes and all study assessments whether primary (head US) or secondary (neurodevelopmental exams) will be performed by blinded team members.
| Delayed cord clamping DCC | 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. |
|
| Through study completion at discharge, up to 6 months corrected gestational age (CGA) |
| Hemoglobin/Hematocrit at 4 hours | hemoglobin/hematocrit | 4 +/- 2 hours of life |
| Incidence of Severe IVH or death in infants <28 weeks gestation | Severe intraventricular hemorrhage (grade 3 or 4) in infants born under 28 weeks gestational age | Through study completion at discharge, up to 6 months corrected gestational age (CGA) |
| Delivery room interventions | Resuscitation interventions including positive pressure ventilation, continuous positive airway pressure, intubation, chest compressions and medications | In the first 10 minutes of life |
| Blood pressures in the first 24 hours of life | Blood pressure on admission, 6, 12, 18 and 24 hours of life | In the first 24 hours of life |
| Loma Linda |
| California |
| 92350 |
| United States |
| LAC+USC Medical Center | Los Angeles | California | 90033 | United States |
| PIH Health Good Samaritan Hospital | Los Angeles | California | 90033 | United States |
| University of California, Irvine Medical Center | Orange | California | 92868 | United States |
| Sharp Grossmont Hospital | San Diego | California | 91942 | United States |
| Sharp Mary Birch Hospital for Women and Newborns | San Diego | California | 92123 | United States |
| Christiana Care | Newark | Delaware | 19718 | United States |
| John H. Stroger, Jr. Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| St. Louis University | St Louis | Missouri | 63104 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225-6603 | United States |
| Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| Governors of University of Alberta | Edmonton | Alberta | T6G 2R3 | Canada |
| University of ULM | Ulm | Baden-Wurttemberg | 89075 | Germany |
| Cork University Maternity Hospital | Cork | Ireland |
| Followup Study-PREMOD2 | View source |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 15, 2026 | Jan 30, 2026 |
| ID | Term |
|---|---|
| D066087 | Perinatal Death |
| D047928 | Premature Birth |
| D003643 | Death |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor 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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