Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping)
- Conditions
- Neurodevelopmental Abnormality
- Interventions
- Procedure: Randomized to Delayed Cord Clamping at birthProcedure: Randomized to Umbilical Cord Milking at birth
- Registration Number
- NCT03476980
- Lead Sponsor
- Sharp HealthCare
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1200
- Children enrolled in the PREMOD2 non-inferiority trial at birth who survive to 2 years corrected age.
- Children enrolled in the PREMOD2 non-inferiority trial at birth who did not survive or are lost to follow-up.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Randomized to Delayed Cord Clamping at birth Randomized to Delayed Cord Clamping at birth Delayed clamping of the umbilical cord at birth. Randomized to Umbilical Cord Milking at birth Randomized to Umbilical Cord Milking at birth Milking the umbilical cord towards the infant at a speed of 20cm/2seconds at birth.
- Primary Outcome Measures
Name Time Method Developmental Outcome 22-26 months corrected gestational age (CGA). All assessments may be extended to 42 months CGA due to Covid-19 pandemic. 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)
- Secondary Outcome Measures
Name Time Method Gross Motor Function Classification System Scale (GMFCS) 22-26 months corrected gestational age 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.
Moderate/Severe Neurodevelopmental Impairment 22-26 months corrected gestational age 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.
Mild Neurodevelopmental Impairment 22-26 months corrected gestational age 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.
Cerebral Palsy (CP) 22-26 months corrected gestational age 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
Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC 22-26 months corrected gestational age ASQ-3 scores (0 to 60, the higher score is better) in infants 23-27 weeks GA and 28-32+6 weeks GA.
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) From birth through hospital discharge, up to 6 months corrected gestational age (CGA) Any IVH grade from 1 to grade 4, higher grade is worse
Death in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery) From birth through hospital discharge, up to 6 months corrected gestational age (CGA) Death
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. 22-26 months corrected gestational age BSID Cognitive, Language \& Motor composite scores (cognitive 55-145, language 45-155, motor 45-155; higher scores are better)
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. 22-26 months corrected gestational age ASQ-3 scores (0 to 60, the higher score is better).
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. 22-26 months corrected gestational age Each domain is scored from 0 to 60, the higher score is better.
Compare levels of developmental impairment as assessed by BSID-3 or 4 versus the ASQ-3 screening tool. 22-26 months corrected gestational age Mild, moderate or severe impairment
Trial Locations
- Locations (18)
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
John H. Stroger, Jr. Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Governors of University of Alberta
🇨🇦Edmonton, Alberta, Canada
Cork University Maternity Hospital
🇮🇪Cork, Ireland
University of ULM
🇩🇪Ulm, Baden-Wurttemberg, Germany
University of Alabama
🇺🇸Birmingham, Alabama, United States
Sharp Grossmont Hospital
🇺🇸San Diego, California, United States
Sharp Mary Birch Hospital for Women and Newborns
🇺🇸San Diego, California, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of California, Irvine Medical Center
🇺🇸Orange, California, United States
St. Louis University
🇺🇸Saint Louis, Missouri, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Christiana Care
🇺🇸Newark, Delaware, United States