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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
1,200
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.
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.
University of Alabama
Birmingham, Alabama, United States
RECRUITINGDevelopmental 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)
Time frame: 22-26 months corrected gestational age (CGA). All assessments may be extended to 42 months CGA due to Covid-19 pandemic.
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.
Time frame: 22-26 months corrected gestational age
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
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Loma Linda Medical Center
Loma Linda, California, United States
RECRUITINGLAC+USC Medical Center
Los Angeles, California, United States
RECRUITINGPIH Health Good Samaritan Hospital
Los Angeles, California, United States
RECRUITINGUniversity of California, Irvine Medical Center
Orange, California, United States
RECRUITINGSharp Grossmont Hospital
San Diego, California, United States
RECRUITINGSharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States
RECRUITINGChristiana Care
Newark, Delaware, United States
RECRUITINGJohn H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States
RECRUITINGUniversity of Mississippi Medical Center
Jackson, Mississippi, United States
RECRUITING...and 8 more locations
Each domain is scored from 0 to 60, the higher score is better.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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).
Time frame: 22-26 months corrected gestational age