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Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping) (PREMOD2FU)

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ClinicalTrials.gov Identifier: NCT03476980
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : December 26, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Neurodevelopmental Abnormality Procedure: Randomized to Umbilical Cord Milking at birth Procedure: Randomized to Delayed Cord Clamping at birth Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
Primary Purpose: Diagnostic
Official Title: Two Year Developmental Follow-up for Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2
Actual Study Start Date : July 6, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : June 2024

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.
Procedure: Randomized 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.
Other Name: UCM

Active Comparator: Randomized to Delayed Cord Clamping at birth
Delayed clamping of the umbilical cord at birth.
Procedure: Randomized 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.
Other Name: DCC




Primary Outcome Measures :
  1. Developmental Outcome [ Time Frame: 22-26 months corrected gestational age ]
    Bayley Scales of Infant Development, 3rd or 4th Ed. Composite Score (cognitive 55-145, language 45-155, motor 45-155; higher scores are better)


Secondary Outcome Measures :
  1. Moderate/Severe Neurodevelopmental Impairment [ Time Frame: 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.

  2. Mild Neurodevelopmental Impairment [ Time Frame: 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.

  3. Gross Motor Function Classification System Scale (GMFCS) [ Time Frame: 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.

  4. Cerebral Palsy [ Time Frame: 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

  5. Developmental Outcomes in infants born at 23 to 27 weeks GA who received UCM or DCC [ Time Frame: 22-26 months corrected gestational age ]
    BSID Cognitive, Language & Motor composite scores in infants 23-27 weeks GA. (cognitive 55-145, language 45-155, motor 45-155; higher scores are better)

  6. Any grade 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) ]
    Any IVH grade from 1 to grade 4, higher grade is worse

  7. 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) ]
    Death


Other Outcome Measures:
  1. Exploratory, hypothesis-generating [ Time Frame: From birth through hospital discharge, up to 6 months corrected gestational age (CGA) ]
    Any grade IVH, from 1 to 4 (higher is worse)

  2. Exploratory, hypothesis-generating [ Time Frame: 4 hours of life +/- 2 hours ]
    Hemoglobin or Hematocrit at 4 hours of age

  3. Exploratory, hypothesis-generating [ Time Frame: In the first 10 minutes of life ]
    Delivery room interventions received: positive pressure ventilation, continuous positive airway pressure, intubation, chest compressions and medications

  4. Exploratory, hypothesis-generating [ Time Frame: In the first 24 hours of life ]
    Blood pressures in the first 24 hours of life: on admission, 6, 12, 18 and 24 hours of life



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Months to 26 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476980


Contacts
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Contact: Anup Katheria, MD 858 939-4170 anup.katheria@sharp.com
Contact: Jane Steen, RN 858 939-4114

Locations
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United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35294-0004
Contact: Wally Carlo, MD       wcarlo@peds.uab.edu   
United States, California
Loma Linda Medical Center Recruiting
Loma Linda, California, United States, 92350
Contact: Farha Vora, MD       FVora@llu.edu   
Sharp Grossmont Hospital Recruiting
San Diego, California, United States, 91942
Contact: Kevin Fulford, MD       kevin.fulford@sharp.com   
Sharp Mary Birch Hospital for Women and Newborns Recruiting
San Diego, California, United States, 92123
Contact: Yvonne Vaucher, MD       yvaucher@ucsd.edu   
Contact: Anup Katheria, MD       anup.katheria@sharp.com   
Principal Investigator: Anup Katheria, MD         
United States, Delaware
Christiana Care Recruiting
Newark, Delaware, United States, 19718
Contact: Shazia Bhat, MD       SBhat@ChristianaCare.org   
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Simon Karam, MD       skaram@umc.edu   
Contact: Rachael Morris, MD       rmorris@umc.edu   
United States, Oregon
Providence St. Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225-6603
Contact: Michele Raddish, MD       Michele.Raddish@providence.org   
United States, Pennsylvania
Magee-Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sue Beers, PhD       beerssr@upmc.edu   
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Erin Clark, MD       erin.clark@hsc.utah.edu   
Contact: Tara DuPont, MD       tara.dupont@hsc.utah.edu   
Canada, Alberta
Governors of University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2R3
Contact: Matthew Hicks, MD       matt.hicks@ahs.ca   
Germany
University of ULM Recruiting
Ulm, Baden-Wurttemberg, Germany, 89075
Contact: Jochen Essers, MD       Jochen.Essers@uniklinik-ulm.de   
Ireland
Cork University Maternity Hospital Recruiting
Cork, Ireland
Contact: Eugene Dempsey, MD       G.Dempsey@ucc.ie   
Sponsors and Collaborators
Sharp HealthCare
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
Investigators
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Principal Investigator: Anup Katheria, MD Sharp Mary Birch Hospital for Women & Newborns

Publications:
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Responsible Party: Sharp HealthCare
ClinicalTrials.gov Identifier: NCT03476980    
Other Study ID Numbers: PREMOD2 Follow-Up
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available per NICHD requirements (National Institute of Child Health and Human Development).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 2 years after primary publication
Access Criteria: An archived dataset with documentation will be made available for additional uses by outside investigators, in collaboration with the study investigators.
URL: http://clinicaltrials.gov

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sharp HealthCare:
Neurodevelopmental impairment, prematurity
Disability
Umbilical cord milking
Delayed cord clamping
Additional relevant MeSH terms:
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Premature Birth
Congenital Abnormalities
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications