Neurodevelopmental Abnormality
Conditions
Keywords
Neurodevelopmental impairment, prematurity, Disability, Umbilical cord milking, Delayed cord clamping
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.
Interventions
PROCEDURERandomized 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.
PROCEDURERandomized 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.
Sponsors
Sharp Mary Birch Hospital for Women & Newborns
Loma Linda University
University of Pittsburgh
Providence Hospital
University of Alabama at Birmingham
University of Alberta
University College Cork
University of Ulm
Christiana Care Health Services
Thrasher Research Fund
Sharp Grossmont Hospital
University of Utah
University of Mississippi Medical Center
PIH Health Good Samaritan Hospital
University of California, Irvine
Children's Hospital Medical Center, Cincinnati
Cook County Health
St. Louis University
LAC+USC Medical Center
Sharp HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
22 Months to 42 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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 |
| 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 in infants born at 23 -27 and 28-32 weeks GA who received 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) in infants 23-27 weeks GA and 28-32+6 weeks GA. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory, hypothesis-generating | From birth through hospital discharge, up to 6 months corrected gestational age (CGA) | Any grade IVH, from 1 to 4 (higher is worse) |
Countries
Canada, Germany, Ireland, United States
Contacts
Primary ContactAnup Katheria, MD
Backup ContactJane Steen, RN
Outcome results
None listed