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Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping)

Not Applicable
Recruiting
Conditions
Neurodevelopmental Abnormality
Interventions
Procedure: Randomized to Delayed Cord Clamping at birth
Procedure: 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
Inclusion Criteria
  • Children enrolled in the PREMOD2 non-inferiority trial at birth who survive to 2 years corrected age.
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Exclusion Criteria
  • Children enrolled in the PREMOD2 non-inferiority trial at birth who did not survive or are lost to follow-up.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Randomized to Delayed Cord Clamping at birthRandomized to Delayed Cord Clamping at birthDelayed clamping of the umbilical cord at birth.
Randomized to Umbilical Cord Milking at birthRandomized to Umbilical Cord Milking at birthMilking the umbilical cord towards the infant at a speed of 20cm/2seconds at birth.
Primary Outcome Measures
NameTimeMethod
Developmental Outcome22-26 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
NameTimeMethod
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 Impairment22-26 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 Impairment22-26 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 DCC22-26 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

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