Working…
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 : July 23, 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
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 July 23, 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: March 19, 2018)
NeuroDevelopmental Outcome [ Time Frame: 22-26 months corrected gestational age ]
Bayley 3 Composite Score (motor, cognitive, language)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03476980 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 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 ]
    A clinical practitioner will perform a Physical Exam. The neurologic assessment includes assessment of vision, hearing, muscle tone, movements, reflexes, hand function. These will be 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. 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.
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 Not Provided
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 impairment 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 2023
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 No
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
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