search
Back to results

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

Primary Purpose

Neurodevelopmental Abnormality

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Randomized to Umbilical Cord Milking at birth
Randomized to Delayed Cord Clamping at birth
Sponsored by
Sharp HealthCare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neurodevelopmental Abnormality focused on measuring Neurodevelopmental impairment, prematurity, Disability, Umbilical cord milking, Delayed cord clamping

Eligibility Criteria

22 Months - 42 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of AlabamaRecruiting
  • Loma Linda Medical CenterRecruiting
  • LAC+USC Medical CenterRecruiting
  • PIH Health Good Samaritan HospitalRecruiting
  • University of California, Irvine Medical CenterRecruiting
  • Sharp Grossmont HospitalRecruiting
  • Sharp Mary Birch Hospital for Women and NewbornsRecruiting
  • Christiana CareRecruiting
  • John H. Stroger, Jr. Hospital of Cook CountyRecruiting
  • University of Mississippi Medical CenterRecruiting
  • St. Louis UniversityRecruiting
  • Cincinnati Children's HospitalRecruiting
  • Providence St. Vincent Medical CenterRecruiting
  • Magee-Womens HospitalRecruiting
  • University of UtahRecruiting
  • Governors of University of AlbertaRecruiting
  • University of ULMRecruiting
  • Cork University Maternity HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Randomized to Umbilical Cord Milking at birth

Randomized to Delayed Cord Clamping at birth

Arm Description

Milking the umbilical cord towards the infant at a speed of 20cm/2seconds at birth.

Delayed clamping of the umbilical cord at birth.

Outcomes

Primary Outcome Measures

Developmental Outcome
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

Moderate/Severe Neurodevelopmental Impairment
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
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)
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 (CP)
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 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.
Each domain is scored from 0 to 60, the higher score is better.
Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC
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.
Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC
ASQ-3 scores (0 to 60, the higher score is better) in infants 23-27 weeks GA and 28-32+6 weeks GA.
Compare levels of developmental impairment as assessed by BSID-3 or 4 versus the ASQ-3 screening tool.
Mild, moderate or severe impairment
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)
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)
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.
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.
ASQ-3 scores (0 to 60, the higher score is better).

Full Information

First Posted
March 19, 2018
Last Updated
November 22, 2022
Sponsor
Sharp HealthCare
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, PIH Health Good Samaritan Hospital, University of California, Irvine, Children's Hospital Medical Center, Cincinnati, Cook County Health, St. Louis University, LAC+USC Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03476980
Brief Title
Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping)
Acronym
PREMOD2FU
Official Title
Two Year Developmental Follow-up for Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sharp HealthCare
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, PIH Health Good Samaritan Hospital, University of California, Irvine, Children's Hospital Medical Center, Cincinnati, Cook County Health, St. Louis University, LAC+USC Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodevelopmental Abnormality
Keywords
Neurodevelopmental impairment, prematurity, Disability, Umbilical cord milking, Delayed cord clamping

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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. This prospective multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Randomized to Umbilical Cord Milking at birth
Arm Type
Active Comparator
Arm Description
Milking the umbilical cord towards the infant at a speed of 20cm/2seconds at birth.
Arm Title
Randomized to Delayed Cord Clamping at birth
Arm Type
Active Comparator
Arm Description
Delayed clamping of the umbilical cord at birth.
Intervention Type
Procedure
Intervention Name(s)
Randomized to Umbilical Cord Milking at birth
Other Intervention Name(s)
UCM
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Randomized to Delayed Cord Clamping at birth
Other Intervention Name(s)
DCC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Developmental Outcome
Description
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)
Time Frame
22-26 months corrected gestational age (CGA). All assessments may be extended to 42 months CGA due to Covid-19 pandemic.
Secondary Outcome Measure Information:
Title
Moderate/Severe Neurodevelopmental Impairment
Description
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.
Time Frame
22-26 months corrected gestational age
Title
Mild Neurodevelopmental Impairment
Description
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.
Time Frame
22-26 months corrected gestational age
Title
Gross Motor Function Classification System Scale (GMFCS)
Description
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.
Time Frame
22-26 months corrected gestational age
Title
Cerebral Palsy (CP)
Description
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
Time Frame
22-26 months corrected gestational age
Title
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.
Description
Each domain is scored from 0 to 60, the higher score is better.
Time Frame
22-26 months corrected gestational age
Title
Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC
Description
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.
Time Frame
22-26 months corrected gestational age
Title
Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC
Description
ASQ-3 scores (0 to 60, the higher score is better) in infants 23-27 weeks GA and 28-32+6 weeks GA.
Time Frame
22-26 months corrected gestational age
Title
Compare levels of developmental impairment as assessed by BSID-3 or 4 versus the ASQ-3 screening tool.
Description
Mild, moderate or severe impairment
Time Frame
22-26 months corrected gestational age
Title
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)
Description
Any IVH grade from 1 to grade 4, higher grade is worse
Time Frame
From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
Title
Death in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery)
Description
Death
Time Frame
From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
Title
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.
Description
BSID Cognitive, Language & Motor composite scores (cognitive 55-145, language 45-155, motor 45-155; higher scores are better)
Time Frame
22-26 months corrected gestational age
Title
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.
Description
ASQ-3 scores (0 to 60, the higher score is better).
Time Frame
22-26 months corrected gestational age
Other Pre-specified Outcome Measures:
Title
Exploratory, hypothesis-generating
Description
Any grade IVH, from 1 to 4 (higher is worse)
Time Frame
From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
Title
Exploratory, hypothesis-generating
Description
Hemoglobin or Hematocrit at 4 hours of age
Time Frame
4 hours of life +/- 2 hours
Title
Exploratory, hypothesis-generating
Description
Delivery room interventions received: positive pressure ventilation, continuous positive airway pressure, intubation, chest compressions and medications
Time Frame
In the first 10 minutes of life
Title
Exploratory, hypothesis-generating
Description
Blood pressures in the first 24 hours of life: on admission, 6, 12, 18 and 24 hours of life
Time Frame
In the first 24 hours of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Months
Maximum Age & Unit of Time
42 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anup Katheria, MD
Phone
858 939-4170
Email
anup.katheria@sharp.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jane Steen, RN
Phone
858 939-4114
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anup Katheria, MD
Organizational Affiliation
Sharp Mary Birch Hospital for Women & Newborns
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wally Carlo, MD
Email
wcarlo@peds.uab.edu
Facility Name
Loma Linda Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farha Vora, MD
Email
FVora@llu.edu
Facility Name
LAC+USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiona Wertheimer, DO
Phone
323-409-3322
Facility Name
PIH Health Good Samaritan Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manoj Biniwale, MD
Phone
323-409-3406
Email
Biniwale@usc.edu
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fayez Bany-Mohammed, MD
Phone
714-456-6933
Email
fbanymoh@hs.uci.edu
Facility Name
Sharp Grossmont Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Fulford, MD
Email
kevin.fulford@sharp.com
Facility Name
Sharp Mary Birch Hospital for Women and Newborns
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne Vaucher, MD
Email
yvaucher@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Anup Katheria, MD
Email
anup.katheria@sharp.com
First Name & Middle Initial & Last Name & Degree
Anup Katheria, MD
Facility Name
Christiana Care
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shazia Bhat, MD
Email
SBhat@ChristianaCare.org
Facility Name
John H. Stroger, Jr. Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janardhan Mydam, MD
Email
jmydam@cookcountyhhs.org
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon Karam, MD
Email
skaram@umc.edu
First Name & Middle Initial & Last Name & Degree
Rachael Morris, MD
Email
rmorris@umc.edu
Facility Name
St. Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nitin Chouthai, MD
Email
nitin.chouthai@health.slu.edu
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivek Narendran, MD
Email
vivek.narendran@cchmc.org
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225-6603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Raddish, MD
Email
Michele.Raddish@providence.org
Facility Name
Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue Beers, PhD
Email
beerssr@upmc.edu
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Clark, MD
Email
erin.clark@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Tara DuPont, MD
Email
tara.dupont@hsc.utah.edu
Facility Name
Governors of University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2R3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Hicks, MD
Email
matt.hicks@ahs.ca
Facility Name
University of ULM
City
Ulm
State/Province
Baden-Wurttemberg
ZIP/Postal Code
89075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jochen Essers, MD
Email
Jochen.Essers@uniklinik-ulm.de
Facility Name
Cork University Maternity Hospital
City
Cork
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugene Dempsey, MD
Email
G.Dempsey@ucc.ie

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://clinicaltrials.gov
Citations:
PubMed Identifier
29246467
Citation
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.
Results Reference
background
PubMed Identifier
26122803
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs