- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03476980
Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping) (PREMOD2FU)
November 22, 2022 updated by: Sharp HealthCare
Two Year Developmental Follow-up for Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2
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.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Anticipated)
1200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Anup Katheria, MD
- Phone Number: 858 939-4170
- Email: anup.katheria@sharp.com
Study Contact Backup
- Name: Jane Steen, RN
- Phone Number: 858 939-4114
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 2R3
- Recruiting
- Governors of University of Alberta
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Contact:
- Matthew Hicks, MD
- Email: matt.hicks@ahs.ca
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Baden-Wurttemberg
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Ulm, Baden-Wurttemberg, Germany, 89075
- Recruiting
- University of Ulm
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Contact:
- Jochen Essers, MD
- Email: Jochen.Essers@uniklinik-ulm.de
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Cork, Ireland
- Recruiting
- Cork University Maternity Hospital
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Contact:
- Eugene Dempsey, MD
- Email: G.Dempsey@ucc.ie
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Alabama
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Birmingham, Alabama, United States, 35294-0004
- Recruiting
- University of Alabama
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Contact:
- Wally Carlo, MD
- Email: wcarlo@peds.uab.edu
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California
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Loma Linda, California, United States, 92350
- Recruiting
- Loma Linda Medical Center
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Contact:
- Farha Vora, MD
- Email: FVora@llu.edu
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Los Angeles, California, United States, 90033
- Recruiting
- LAC+USC Medical Center
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Contact:
- Fiona Wertheimer, DO
- Phone Number: 323-409-3322
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Los Angeles, California, United States, 90033
- Recruiting
- PIH Health Good Samaritan Hospital
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Contact:
- Manoj Biniwale, MD
- Phone Number: 323-409-3406
- Email: Biniwale@usc.edu
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Orange, California, United States, 92868
- Recruiting
- University of California, Irvine Medical Center
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Contact:
- Fayez Bany-Mohammed, MD
- Phone Number: 714-456-6933
- Email: fbanymoh@hs.uci.edu
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San Diego, California, United States, 92123
- Recruiting
- Sharp Mary Birch Hospital for Women and Newborns
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Contact:
- Yvonne Vaucher, MD
- Email: yvaucher@ucsd.edu
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San Diego, California, United States, 91942
- Recruiting
- Sharp Grossmont Hospital
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Contact:
- Kevin Fulford, MD
- Email: kevin.fulford@sharp.com
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Delaware
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Newark, Delaware, United States, 19718
- Recruiting
- Christiana Care
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Contact:
- Shazia Bhat, MD
- Email: SBhat@ChristianaCare.org
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Illinois
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Chicago, Illinois, United States, 60612
- Recruiting
- John H. Stroger, Jr. Hospital of Cook County
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Contact:
- Janardhan Mydam, MD
- Email: jmydam@cookcountyhhs.org
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Mississippi
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Jackson, Mississippi, United States, 39216
- Recruiting
- University of Mississippi Medical Center
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Contact:
- Simon Karam, MD
- Email: skaram@umc.edu
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Contact:
- Rachael Morris, MD
- Email: rmorris@umc.edu
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Missouri
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Saint Louis, Missouri, United States, 63104
- Recruiting
- St. Louis University
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Contact:
- Nitin Chouthai, MD
- Email: nitin.chouthai@health.slu.edu
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Ohio
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Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati CHildren's Hospital
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Contact:
- Vivek Narendran, MD
- Email: vivek.narendran@cchmc.org
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Oregon
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Portland, Oregon, United States, 97225-6603
- Recruiting
- Providence St. Vincent Medical Center
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Contact:
- Michele Raddish, MD
- Email: Michele.Raddish@providence.org
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- Magee-Womens Hospital
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Contact:
- Sue Beers, PhD
- Email: beerssr@upmc.edu
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Utah
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Salt Lake City, Utah, United States, 84112
- Recruiting
- University of Utah
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Contact:
- Erin Clark, MD
- Email: erin.clark@hsc.utah.edu
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Contact:
- Tara DuPont, MD
- Email: tara.dupont@hsc.utah.edu
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 3 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Randomized to Umbilical Cord Milking at birth
Milking the umbilical cord towards the infant at a speed of 20cm/2seconds at birth.
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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.
Other Names:
|
ACTIVE_COMPARATOR: Randomized to Delayed Cord Clamping at birth
Delayed clamping of the umbilical cord at birth.
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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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Developmental Outcome
Time Frame: 22-26 months corrected gestational age (CGA). All assessments may be extended to 42 months CGA due to Covid-19 pandemic.
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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)
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22-26 months corrected gestational age (CGA). All assessments may be extended to 42 months CGA due to Covid-19 pandemic.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moderate/Severe Neurodevelopmental Impairment
Time Frame: 22-26 months corrected gestational age
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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.
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22-26 months corrected gestational age
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Mild Neurodevelopmental Impairment
Time Frame: 22-26 months corrected gestational age
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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.
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22-26 months corrected gestational age
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Gross Motor Function Classification System Scale (GMFCS)
Time Frame: 22-26 months corrected gestational age
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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.
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22-26 months corrected gestational age
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Cerebral Palsy (CP)
Time Frame: 22-26 months corrected gestational age
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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
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22-26 months corrected gestational age
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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.
Time Frame: 22-26 months corrected gestational age
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Each domain is scored from 0 to 60, the higher score is better.
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22-26 months corrected gestational age
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Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC
Time Frame: 22-26 months corrected gestational age
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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.
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22-26 months corrected gestational age
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Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC
Time Frame: 22-26 months corrected gestational age
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ASQ-3 scores (0 to 60, the higher score is better) in infants 23-27 weeks GA and 28-32+6 weeks GA.
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22-26 months corrected gestational age
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Compare levels of developmental impairment as assessed by BSID-3 or 4 versus the ASQ-3 screening tool.
Time Frame: 22-26 months corrected gestational age
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Mild, moderate or severe impairment
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22-26 months corrected gestational age
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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)
Time Frame: From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
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Any IVH grade from 1 to grade 4, higher grade is worse
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From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
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Death in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery)
Time Frame: From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
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Death
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From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
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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.
Time Frame: 22-26 months corrected gestational age
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BSID Cognitive, Language & Motor composite scores (cognitive 55-145, language 45-155, motor 45-155; higher scores are better)
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22-26 months corrected gestational age
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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.
Time Frame: 22-26 months corrected gestational age
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ASQ-3 scores (0 to 60, the higher score is better).
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22-26 months corrected gestational age
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory, hypothesis-generating
Time Frame: From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
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Any grade IVH, from 1 to 4 (higher is worse)
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From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
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Exploratory, hypothesis-generating
Time Frame: 4 hours of life +/- 2 hours
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Hemoglobin or Hematocrit at 4 hours of age
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4 hours of life +/- 2 hours
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Exploratory, hypothesis-generating
Time Frame: In the first 10 minutes of life
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Delivery room interventions received: positive pressure ventilation, continuous positive airway pressure, intubation, chest compressions and medications
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In the first 10 minutes of life
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Exploratory, hypothesis-generating
Time Frame: In the first 24 hours of life
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Blood pressures in the first 24 hours of life: on admission, 6, 12, 18 and 24 hours of life
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In the first 24 hours of life
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 6, 2019
Primary Completion (ANTICIPATED)
December 1, 2024
Study Completion (ANTICIPATED)
December 1, 2024
Study Registration Dates
First Submitted
March 19, 2018
First Submitted That Met QC Criteria
March 19, 2018
First Posted (ACTUAL)
March 26, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 25, 2022
Last Update Submitted That Met QC Criteria
November 22, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PREMOD2 Follow-Up
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be made available per NICHD requirements (National Institute of Child Health and Human Development).
IPD Sharing Time Frame
2 years after primary publication
IPD Sharing Access Criteria
An archived dataset with documentation will be made available for additional uses by outside investigators, in collaboration with the study investigators.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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