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

NCT03476980 | Unknown DMC

• 1 other identifier: PREMOD2 Follow-Up
• Study Type: interventional
• Target: 1,200
• Locations: 4 countries
• Sites: 18

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.

Conditions

Neurodevelopmental Abnormality

Keywords

Neurodevelopmental impairment, prematurity; Disability; Umbilical cord milking; Delayed cord clamping

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Moderate/Severe Neurodevelopmental Impairment

  22-26 months corrected gestational age

• Mild Neurodevelopmental Impairment

  22-26 months corrected gestational age

• Gross Motor Function Classification System Scale (GMFCS)

  22-26 months corrected gestational age

• Cerebral Palsy (CP)

  22-26 months corrected gestational age

• 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.

  22-26 months corrected gestational age

Other Outcomes (4)

• Exploratory, hypothesis-generating

  From birth through hospital discharge, up to 6 months corrected gestational age (CGA)

• Exploratory, hypothesis-generating

  4 hours of life +/- 2 hours

• Exploratory, hypothesis-generating

  In the first 10 minutes of life

Study Arms (2)

Randomized to Umbilical Cord Milking at birth

ACTIVE COMPARATOR

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

Procedure: Randomized to Umbilical Cord Milking at birth

Randomized to Delayed Cord Clamping at birth

ACTIVE COMPARATOR

Delayed clamping of the umbilical cord at birth.

Procedure: Randomized to Delayed Cord Clamping at birth

Interventions

Randomized to Umbilical Cord Milking at birth PROCEDURE

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.

Also known as: UCM

Randomized to Umbilical Cord Milking at birth

Randomized to Delayed Cord Clamping at birth PROCEDURE

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.

Also known as: DCC

Randomized to Delayed Cord Clamping at birth

Eligibility Criteria

• Age: 22 Months - 42 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children enrolled in the PREMOD2 non-inferiority trial at birth who survive to 2 years corrected age.

You may not qualify if:

• Children enrolled in the PREMOD2 non-inferiority trial at birth who did not survive or are lost to follow-up.

Sponsors & Collaborators

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

Study Sites (18)

University of Alabama

Birmingham, Alabama, 35294-0004, United States

RECRUITING

Loma Linda Medical Center

Loma Linda, California, 92350, United States

RECRUITING

LAC+USC Medical Center

Los Angeles, California, 90033, United States

RECRUITING

PIH Health Good Samaritan Hospital

Los Angeles, California, 90033, United States

RECRUITING

University of California, Irvine Medical Center

Orange, California, 92868, United States

RECRUITING

Sharp Grossmont Hospital

San Diego, California, 91942, United States

RECRUITING

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

RECRUITING

Christiana Care

Newark, Delaware, 19718, United States

RECRUITING

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, 60612, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

St. Louis University

St Louis, Missouri, 63104, United States

RECRUITING

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

RECRUITING

Providence St. Vincent Medical Center

Portland, Oregon, 97225-6603, United States

RECRUITING

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Governors of University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

RECRUITING

University of ULM

Ulm, Baden-Wurttemberg, 89075, Germany

RECRUITING

Cork University Maternity Hospital

Cork, Ireland

RECRUITING

Related 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.

  PMID: 29246467 BACKGROUND

• 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.

  PMID: 26122803 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Anup Katheria, MD

  Sharp Mary Birch Hospital for Women & Newborns

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anup Katheria, MD

CONTACT

858 939-4170; anup.katheria@sharp.com

Jane Steen, RN

CONTACT

858 939-4114

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neurodevelopmental providers will be blinded to the randomization of the toddler during the examination.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 26, 2018
• Study Start: July 6, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

DE (1); IE (1); US (15); CA (1)