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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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An extension of the PREMOD2 trial, the PREMOD2 Follow-Up trial will evaluate the neurodevelopmental outcomes at 22-26 months corrected age of preterm children who received UCM or DCC. This prospective multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.
The PREMOD2 Follow-up trial will examine the difference in early childhood neurodevelopmental outcomes of subjects enrolled in the PREMOD2 umbilical cord milking (UCM) vs. delayed cord clamping (DCC) trial, using standardized neurologic and developmental assessments at 22-26 months corrected age (CA). The corrected age may be extended out to 42 months CA due to Covid-19 pandemic for undetermined period of time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized to Umbilical Cord Milking at birth | Active Comparator | Milking the umbilical cord towards the infant at a speed of 20cm/2seconds at birth. |
|
| Randomized to Delayed Cord Clamping at birth | Active Comparator | Delayed clamping of the umbilical cord at birth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Randomized to Umbilical Cord Milking at birth | Procedure | The subjects in this group were randomized to UCM X4 at birth. This procedure infuses a placental transfusion of blood by milking the umbilical cord towards the infant at birth. |
| Measure | Description | Time Frame |
|---|---|---|
| Developmental Outcome | Bayley Scales of Infant Development (BSID), 3rd or 4th Ed. Composite Score (cognitive 55-145, language 45-155, motor 45-155; higher scores are better) | 22-26 months corrected gestational age (CGA). All assessments may be extended to 42 months CGA due to Covid-19 pandemic. |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate/Severe Neurodevelopmental Impairment | Defined having at least one of the following: a cognitive score <70, GMFCS greater or equal 2, blindness (vision <20/200), or hearing impairment interfering with the ability to communicate with amplification. | 22-26 months corrected gestational age |
| Mild Neurodevelopmental Impairment |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory, hypothesis-generating | Any grade IVH, from 1 to 4 (higher is worse) | From birth through hospital discharge, up to 6 months corrected gestational age (CGA) |
| Exploratory, hypothesis-generating |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anup Katheria, MD | Contact | 858 939-4170 | anup.katheria@sharp.com | |
| Jane Steen, RN | Contact | 858 939-4114 |
| Name | Affiliation | Role |
|---|---|---|
| Anup Katheria, MD | Sharp Mary Birch Hospital for Women & Newborns | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Recruiting | Birmingham | Alabama | 35294-0004 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29246467 | Background | Katheria A, Garey D, Truong G, Akshoomoff N, Steen J, Maldonado M, Poeltler D, Harbert MJ, Vaucher YE, Finer N. A Randomized Clinical Trial of Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants: Neurodevelopmental Outcomes at 22-26 Months of Corrected Age. J Pediatr. 2018 Mar;194:76-80. doi: 10.1016/j.jpeds.2017.10.037. Epub 2017 Dec 12. | |
| 26122803 |
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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.
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| OTHER |
| University of Alabama at Birmingham | OTHER |
| University of Alberta | OTHER |
| University College Cork | OTHER |
| University of Ulm | OTHER |
| Christiana Care Health Services | OTHER |
| Thrasher Research Fund | 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 |
Neurodevelopmental assessments will be done at 2 years of corrected age (22-26 months) for subjects who were randomized at birth to receive either delayed cord clamping or umbilical cord milking as part of the PREMOD2 trial. This prospective multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.
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Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
|
| Randomized to Delayed Cord Clamping at birth | Procedure | The subjects in this group were randomized to DCC at birth. At delivery, the obstetrician was instructed to delay clamping of the umbilical cord for 60 seconds. |
|
|
Defined having at least one of the following: a cognitive score 70-84, GMFCS =1, unilateral blindness (vision <20/200 in only one eye), or hearing impairment which does not interfere with the ability to communicate. |
| 22-26 months corrected gestational age |
| Gross Motor Function Classification System Scale (GMFCS) | The GMFCS is a validated system used to describe the severity of motor dysfunction. Scale measured from Level 0-5 with Level 0 being normal and Level 5 being the worst score. Measures ability to walk, sit, head control, voluntary movements and postures. | 22-26 months corrected gestational age |
| Cerebral Palsy (CP) | Classified as None, Mild, Moderate or Severe based on GMFCS score; No CP = GMFCS Level 0, Mild CP = GMFCS Level 1, Moderate CP = GMFCS Levels 2-3, Severe CP = GMFCS Levels 4-5 | 22-26 months corrected gestational age |
| Developmental Outcomes assessed by Ages & Stages Questionnaire, 3rd ed. (ASQ-3) five domains: Communication, Gross motor, Fine motor, Problem solving and Personal-social in infants born between 23-32+6 weeks GA who received UCM or DCC. | Each domain is scored from 0 to 60, the higher score is better. | 22-26 months corrected gestational age |
| Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC | BSID Cognitive, Language & Motor composite scores (cognitive 55-145, language 45-155, motor 45-155; higher scores are better) in infants 23-27 weeks GA and 28-32+6 weeks GA. | 22-26 months corrected gestational age |
| Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC | ASQ-3 scores (0 to 60, the higher score is better) in infants 23-27 weeks GA and 28-32+6 weeks GA. | 22-26 months corrected gestational age |
| Compare levels of developmental impairment as assessed by BSID-3 or 4 versus the ASQ-3 screening tool. | Mild, moderate or severe impairment | 22-26 months corrected gestational age |
| Any grade intraventricular hemorrhage (IVH) in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery) | Any IVH grade from 1 to grade 4, higher grade is worse | From birth through hospital discharge, up to 6 months corrected gestational age (CGA) |
| Death in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery) | Death | From birth through hospital discharge, up to 6 months corrected gestational age (CGA) |
| Compare neurodevelopmental outcomes from BSID assessments in newborns 23-32 weeks GA delivered by C-Section with those born by vaginal delivery receiving UCM or DCC. | BSID Cognitive, Language & Motor composite scores (cognitive 55-145, language 45-155, motor 45-155; higher scores are better) | 22-26 months corrected gestational age |
| Compare neurodevelopmental outcomes from ASQ assessments in newborns 23-32 weeks GA delivered by C-Section with those born by vaginal delivery receiving UCM or DCC. | ASQ-3 scores (0 to 60, the higher score is better). | 22-26 months corrected gestational age |
Hemoglobin or Hematocrit at 4 hours of age
| 4 hours of life +/- 2 hours |
| Exploratory, hypothesis-generating | Delivery room interventions received: positive pressure ventilation, continuous positive airway pressure, intubation, chest compressions and medications | In the first 10 minutes of life |
| Exploratory, hypothesis-generating | Blood pressures in the first 24 hours of life: on admission, 6, 12, 18 and 24 hours of life | In the first 24 hours of life |
| Loma Linda Medical Center | Recruiting | Loma Linda | California | 92350 | United States |
|
| LAC+USC Medical Center | Recruiting | Los Angeles | California | 90033 | United States |
|
| PIH Health Good Samaritan Hospital | Recruiting | Los Angeles | California | 90033 | United States |
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| University of California, Irvine Medical Center | Recruiting | Orange | California | 92868 | United States |
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| Sharp Grossmont Hospital | Recruiting | San Diego | California | 91942 | United States |
|
| Sharp Mary Birch Hospital for Women and Newborns | Recruiting | San Diego | California | 92123 | United States |
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| Christiana Care | Recruiting | Newark | Delaware | 19718 | United States |
|
| John H. Stroger, Jr. Hospital of Cook County | Recruiting | Chicago | Illinois | 60612 | United States |
|
| University of Mississippi Medical Center | Recruiting | Jackson | Mississippi | 39216 | United States |
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| St. Louis University | Recruiting | St Louis | Missouri | 63104 | United States |
|
| Cincinnati Children's Hospital | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| Providence St. Vincent Medical Center | Recruiting | Portland | Oregon | 97225-6603 | United States |
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| Magee-Womens Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| Governors of University of Alberta | Recruiting | Edmonton | Alberta | T6G 2R3 | Canada |
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| University of ULM | Recruiting | Ulm | Baden-Wurttemberg | 89075 | Germany |
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| Cork University Maternity Hospital | Recruiting | Cork | Ireland |
|
| Katheria AC, Truong G, Cousins L, Oshiro B, Finer NN. Umbilical Cord Milking Versus Delayed Cord Clamping in Preterm Infants. Pediatrics. 2015 Jul;136(1):61-9. doi: 10.1542/peds.2015-0368. |
| 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 |
| D000091642 | Urogenital Diseases |
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