Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 19, 2018
First Posted Date  ICMJE March 26, 2018
Last Update Posted Date December 26, 2019
Actual Study Start Date  ICMJE July 6, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2019)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: March 19, 2018)
NeuroDevelopmental Outcome [ Time Frame: 22-26 months corrected gestational age ]
Bayley 3 Composite Score (motor, cognitive, language)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2019)
  • 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.
  • 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.
  • 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.
  • 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
  • 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)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2018)
  • 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.
  • 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.
  • Cerebral Palsy [ Time Frame: 22-26 months corrected gestational age ]
    Classified as None, Mild, Moderate or Severe based on GMFCS score
  • Neurological Function [ Time Frame: 22-26 months corrected gestational age ]
    Classified as Normal, Suspect or Abnormal
  • Gross Motor Function Classification Scale (GMFCS) [ Time Frame: 22-26 months corrected gestational age ]
    The GMFCS is a validated system used to describe the severity of motor dysfunction in children and can be used for children between 22 and 26 months corrected age.
Current Other Pre-specified Outcome Measures
 (submitted: December 18, 2019)
  • 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)
  • Exploratory, hypothesis-generating [ Time Frame: 4 hours of life +/- 2 hours ]
    Hemoglobin or Hematocrit at 4 hours of age
  • 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
  • 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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping)
Official Title  ICMJE Two Year Developmental Follow-up for Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Neurodevelopmental Abnormality
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Randomized to Umbilical Cord Milking at birth
    Milking the umbilical cord towards the infant at a speed of 20cm/2seconds at birth.
    Intervention: Procedure: Randomized to Umbilical Cord Milking at birth
  • Active Comparator: Randomized to Delayed Cord Clamping at birth
    Delayed clamping of the umbilical cord at birth.
    Intervention: Procedure: Randomized to Delayed Cord Clamping at birth
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 27, 2018)
1200
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2018)
1350
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Months to 26 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anup Katheria, MD 858 939-4170 anup.katheria@sharp.com
Contact: Jane Steen, RN 858 939-4114
Listed Location Countries  ICMJE Canada,   Germany,   Ireland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03476980
Other Study ID Numbers  ICMJE PREMOD2 Follow-Up
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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
Responsible Party Sharp HealthCare
Study Sponsor  ICMJE Sharp HealthCare
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Anup Katheria, MD Sharp Mary Birch Hospital for Women & Newborns
PRS Account Sharp HealthCare
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP