Clinical trial NCT03476980: Two Year Developmental Follow-up for PREMOD2 Trial (Premature Infants Receiving Milking or Delayed Cord Clamping)
Official title: Two Year Developmental Follow-up for Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurodevelopmental Abnormality
Keywords: Neurodevelopmental impairment, prematurity
Disability
Umbilical cord milking
Delayed cord clamping
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: Sharp Mary Birch Hospital for Women & Newborns
name: Loma Linda University
name: University of Pittsburgh
name: Providence Hospital
name: University of Alabama at Birmingham
name: University of Alberta
name: University College Cork
name: University of Ulm
name: Christiana Care Health Services
name: Thrasher Research Fund
name: Sharp Grossmont Hospital
name: University of Utah
name: University of Mississippi Medical Center
name: PIH Health Good Samaritan Hospital
name: University of California, Irvine
name: Children's Hospital Medical Center, Cincinnati
name: Cook County Health
name: St. Louis University
name: LAC+USC Medical Center
First posted: 2018-03-26
Enrollment: 1200
Sex: ALL
Minimum age (years): 22
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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. This prospective multi-national randomized controlled trial (RCT) is a two-arm parallel non-inferiority design of two alternative approaches of treatment.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Developmental Outcome
timeFrame: 22-26 months corrected gestational age (CGA). All assessments may be extended to 42 months CGA due to Covid-19 pandemic.
Secondary outcomes:
measure: Moderate/Severe Neurodevelopmental Impairment
timeFrame: 22-26 months corrected gestational age
measure: Mild Neurodevelopmental Impairment
timeFrame: 22-26 months corrected gestational age
measure: Gross Motor Function Classification System Scale (GMFCS)
timeFrame: 22-26 months corrected gestational age
measure: Cerebral Palsy (CP)
timeFrame: 22-26 months corrected gestational age
measure: 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.
timeFrame: 22-26 months corrected gestational age
measure: Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC
timeFrame: 22-26 months corrected gestational age
measure: Developmental Outcomes in infants born at 23 -27 and 28-32 weeks GA who received UCM or DCC
timeFrame: 22-26 months corrected gestational age
measure: Compare levels of developmental impairment as assessed by BSID-3 or 4 versus the ASQ-3 screening tool.
timeFrame: 22-26 months corrected gestational age
measure: 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)
timeFrame: From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
measure: Death in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery)
timeFrame: From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
measure: 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.
timeFrame: 22-26 months corrected gestational age
measure: 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.
timeFrame: 22-26 months corrected gestational age
Other outcomes:
measure: Exploratory, hypothesis-generating
timeFrame: From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
measure: Exploratory, hypothesis-generating
timeFrame: 4 hours of life +/- 2 hours
measure: Exploratory, hypothesis-generating
timeFrame: In the first 10 minutes of life
measure: Exploratory, hypothesis-generating
timeFrame: In the first 24 hours of life
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Loma Linda
country: United States
facility: Loma Linda Medical Center
state: California
city: Los Angeles
country: United States
facility: LAC+USC Medical Center
state: California
city: Los Angeles
country: United States
facility: PIH Health Good Samaritan Hospital
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: San Diego
country: United States
facility: Sharp Grossmont Hospital
state: California
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Chicago
country: United States
facility: John H. Stroger, Jr. Hospital of Cook County
state: Illinois
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Edmonton
country: Canada
facility: Governors of University of Alberta
state: Alberta
city: Ulm
country: Germany
facility: University of ULM
state: Baden-Wurttemberg
city: Cork
country: Ireland
facility: Cork University Maternity Hospital
Study officials:
affiliation: Sharp Mary Birch Hospital for Women & Newborns
name: Anup Katheria, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.