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

Neurodevelopmental Abnormality Clinical Trial

— PREMOD2FU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03476980
• Other study ID #: PREMOD2 Follow-Up
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2019
• Est. completion date: December 2024

Study information

• Verified date: November 2022
• Source: Sharp HealthCare
• Contact: Anup Katheria, MD
• Phone: 858 939-4170
• Email: anup.katheria[@]sharp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Months to 42 Months

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Neurodevelopmental Abnormality
• Premature Birth

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Governors of University of Alberta	Edmonton	Alberta
Germany	University of ULM	Ulm	Baden-Wurttemberg
Ireland	Cork University Maternity Hospital	Cork
United States	University of Alabama	Birmingham	Alabama
United States	John H. Stroger, Jr. Hospital of Cook County	Chicago	Illinois
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Loma Linda Medical Center	Loma Linda	California
United States	LAC+USC Medical Center	Los Angeles	California
United States	PIH Health Good Samaritan Hospital	Los Angeles	California
United States	Christiana Care	Newark	Delaware
United States	University of California, Irvine Medical Center	Orange	California
United States	Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	St. Louis University	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	Sharp Grossmont Hospital	San Diego	California
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California

Sponsors (20)

Lead Sponsor

Collaborator

Sharp HealthCare

Children's Hospital Medical Center, Cincinnati, Christiana Care Health Services, John H. Stroger Hospital, LAC+USC Medical Center, Loma Linda University, PIH Health Good Samaritan Hospital, Providence Hospital, Sharp Grossmont Hospital, Sharp Mary Birch Hospital for Women & Newborns, St. Louis University, Thrasher Research Fund, University College Cork, University of Alabama at Birmingham, University of Alberta, University of California, Irvine, University of Mississippi Medical Center, University of Pittsburgh, University of Ulm, University of Utah

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Ireland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory, hypothesis-generating	Any grade IVH, from 1 to 4 (higher is worse)	From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
Other	Exploratory, hypothesis-generating	Hemoglobin or Hematocrit at 4 hours of age	4 hours of life +/- 2 hours
Other	Exploratory, hypothesis-generating	Delivery room interventions received: positive pressure ventilation, continuous positive airway pressure, intubation, chest compressions and medications	In the first 10 minutes of life
Other	Exploratory, hypothesis-generating	Blood pressures in the first 24 hours of life: on admission, 6, 12, 18 and 24 hours of life	In the first 24 hours of life
Primary	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)	22-26 months corrected gestational age (CGA). All assessments may be extended to 42 months CGA due to Covid-19 pandemic.
Secondary	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.	22-26 months corrected gestational age
Secondary	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.	22-26 months corrected gestational age
Secondary	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.	22-26 months corrected gestational age
Secondary	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	22-26 months corrected gestational age
Secondary	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.	22-26 months corrected gestational age
Secondary	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.	22-26 months corrected gestational age
Secondary	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.	22-26 months corrected gestational age
Secondary	Compare levels of developmental impairment as assessed by BSID-3 or 4 versus the ASQ-3 screening tool.	Mild, moderate or severe impairment	22-26 months corrected gestational age
Secondary	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	From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
Secondary	Death in premature newborns 23 - 32+6 weeks GA who received UCM or DCC by mode of delivery (C-Section vs vaginal delivery)	Death	From birth through hospital discharge, up to 6 months corrected gestational age (CGA)
Secondary	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)	22-26 months corrected gestational age
Secondary	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).	22-26 months corrected gestational age