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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03476980
Other study ID # PREMOD2 Follow-Up
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 6, 2019
Est. completion date December 2024

Study information

Verified date November 2022
Source Sharp HealthCare
Contact Anup Katheria, MD
Phone 858 939-4170
Email anup.katheria@sharp.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 22 Months to 42 Months
Eligibility Inclusion Criteria: - Children enrolled in the PREMOD2 non-inferiority trial at birth who survive to 2 years corrected age. Exclusion Criteria: - Children enrolled in the PREMOD2 non-inferiority trial at birth who did not survive or are lost to follow-up.

Study Design


Intervention

Procedure:
Randomized to Umbilical Cord Milking at birth
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.
Randomized to Delayed Cord Clamping at birth
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.

Locations

Country Name City State
Canada Governors of University of Alberta Edmonton Alberta
Germany University of ULM Ulm Baden-Wurttemberg
Ireland Cork University Maternity Hospital Cork
United States University of Alabama Birmingham Alabama
United States John H. Stroger, Jr. Hospital of Cook County Chicago Illinois
United States Cincinnati Children's Hospital Cincinnati Ohio
United States University of Mississippi Medical Center Jackson Mississippi
United States Loma Linda Medical Center Loma Linda California
United States LAC+USC Medical Center Los Angeles California
United States PIH Health Good Samaritan Hospital Los Angeles California
United States Christiana Care Newark Delaware
United States University of California, Irvine Medical Center Orange California
United States Magee-Womens Hospital Pittsburgh Pennsylvania
United States Providence St. Vincent Medical Center Portland Oregon
United States St. Louis University Saint Louis Missouri
United States University of Utah Salt Lake City Utah
United States Sharp Grossmont Hospital San Diego California
United States Sharp Mary Birch Hospital for Women and Newborns San Diego California

Sponsors (20)

Lead Sponsor Collaborator
Sharp HealthCare Children's Hospital Medical Center, Cincinnati, Christiana Care Health Services, John H. Stroger Hospital, LAC+USC Medical Center, Loma Linda University, PIH Health Good Samaritan Hospital, Providence Hospital, Sharp Grossmont Hospital, Sharp Mary Birch Hospital for Women & Newborns, St. Louis University, Thrasher Research Fund, University College Cork, University of Alabama at Birmingham, University of Alberta, University of California, Irvine, University of Mississippi Medical Center, University of Pittsburgh, University of Ulm, University of Utah

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Ireland, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other 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)
Other Exploratory, hypothesis-generating Hemoglobin or Hematocrit at 4 hours of age 4 hours of life +/- 2 hours
Other 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
Other 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
Primary 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.
Secondary 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
Secondary Mild Neurodevelopmental Impairment 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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)
Secondary 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)
Secondary 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
Secondary 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
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