NCT06676904

Brief Summary

The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without major or severe bleeding up to 40 0/7 weeks' postmenstrual age (PMA).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,433

participants targeted

Target at P75+ for not_applicable

Timeline
61mo left

Started Jun 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jun 2025Apr 2031

First Submitted

Initial submission to the registry

October 3, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

June 13, 2025

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2031

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2031

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

5.6 years

First QC Date

October 3, 2024

Last Update Submit

March 24, 2026

Conditions

Infant, Extremely Low Birth WeightInfant, Small for Gestational AgeThrombocytopeniaNeonatalPlatelet TransfusionInfant, Newborn, DiseasesThrombosis

Keywords

platelet transfusionneonatalthrombosis

Outcome Measures

Primary Outcomes (1)

  • Survival without major or severe bleeding

    Bleeding will be assessed using the neonatal Bleeding Assessment Tool (NeoBAT), a validated bleeding assessment tool (Venkatesh V, 2013)

    Randomization to 40 0/7 weeks postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 98 days postnatal age)

Secondary Outcomes (7)

  • Death

    Randomization to 52 0/7 weeks' postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first, per Neonatal Research Network Generic Research Database Registry protocol.

  • Major or severe bleeding

    Randomization to 40 0/7 weeks postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 98 days postnatal age)

  • Number of platelet transfusions

    Randomization to 40 0/7 weeks postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 98 days postnatal age)

  • At least one platelet transfusion

    Randomization to 40 0/7 weeks postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 98 days postnatal age)

  • Bronchopulmonary dysplasia among survivors to 36 weeks postmenstrual age

    At 36 weeks postmenstrual age

  • +2 more secondary outcomes

Other Outcomes (3)

  • Late-onset sepsis

    Randomization to 40 0/7 weeks postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 98 days postnatal age)

  • Necrotizing enterocolitis

    Randomization to 40 0/7 weeks postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 98 days postnatal age)

  • Thrombosis requiring therapy

    Randomization to 40 0/7 weeks postmenstrual age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 98 days postnatal age)

Study Arms (2)

Higher Platelet Transfusion Threshold

ACTIVE COMPARATOR

Infants randomized to this arm will be monitored for a platelet transfusion threshold of 50 x 10\^9/L during postnatal days 1-7, and then for a platelet transfusion threshold of 35 x 10\^9/L at 8 or more postnatal days of life. Infants will remain on this protocol-driven threshold through 40 0/7 weeks postmenstrual age. The platelet dose will be 10 ml/kg administered over 60-120 minutes.

Procedure: Higher Platelet Transfusion Threshold

Lower Platelet Transfusion Threshold

OTHER

Infants randomized to this arm will be monitored for a platelet transfusion threshold of 25 x 10\^9/L during postnatal days 1-7, and then for a platelet transfusion threshold of 20 x 10\^9/L at 8 or more postnatal days of life. Infants will remain on this protocol-driven threshold through 40 0/7 weeks postmenstrual age. The platelet dose will be 10 ml/kg administered over 60-120 minutes.

Procedure: Lower Platelet Transfusion Threshold

Interventions

Higher Platelet Transfusion ThresholdPROCEDURE

Infants randomized to this arm will be monitored for a platelet transfusion threshold of 50 x 10\^9/L during postnatal days 1-7, and then for a platelet transfusion threshold of 35 x 10\^9/L at 8 or more postnatal days of life. Infants will remain on this protocol-driven threshold through 40 0/7 weeks postmenstrual age. The platelet dose will be 10 ml/kg administered over 60-120 minutes.

Also known as: Liberal Transfusion Threshold
Higher Platelet Transfusion Threshold
Lower Platelet Transfusion ThresholdPROCEDURE

Infants randomized to this arm will be monitored for a platelet transfusion threshold of 25 x 10\^9/L during postnatal days 1-7, and then for a platelet transfusion threshold of 20 x 10\^9/L at 8 or more postnatal days of life. Infants will remain on this protocol-driven threshold through 40 0/7 weeks postmenstrual age. The platelet dose will be 10 ml/kg administered over 60-120 minutes.

Also known as: Restrictive Transfusion Threshold
Lower Platelet Transfusion Threshold

Eligibility Criteria

Age1 Hour - 48 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age of 23 0/7 to 26 6/7 weeks
  • Postnatal age of \< 48 hours

You may not qualify if:

  • Comfort care or withdrawal of care planned
  • Neonatal alloimmune thrombocytopenia or suspected/confirmed congenital platelet or bleeding disorder
  • Receipt of platelet transfusion
  • No receipt of Vitamin K
  • Parents/guardian decline consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, 92123, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Emory University

Atlanta, Georgia, 30303, United States

RECRUITING

Northwestern Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

University of New Mexico

Albuquerque, New Mexico, 87131, United States

RECRUITING

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

RECRUITING

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37232, United States

RECRUITING

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

RECRUITING

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Pediatrix Medical Group

San Antonio, Texas, 78229, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

Related Publications (1)

  • Venkatesh V, Curley A, Khan R, Clarke P, Watts T, Josephson C, Muthukumar P, New H, Seeney F, Morris S, Stanworth S. A novel approach to standardised recording of bleeding in a high risk neonatal population. Arch Dis Child Fetal Neonatal Ed. 2013 May;98(3):F260-3. doi: 10.1136/archdischild-2012-302443. Epub 2012 Nov 9.

    PMID: 23144007BACKGROUND

MeSH Terms

Conditions

ThrombocytopeniaInfant, Newborn, DiseasesThrombosis

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Ravi M Patel, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ravi M Patel, MD

CONTACT

404-727-5905rmpatel@emory.edu

Abhik Das, PhD

CONTACT

301-230-4640adas@rti.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
There will be no blinding/masking of the treatment group allocation to providers or parents to ensure providers are aware of treatment allocation to guide platelet transfusions. This is necessary to ensure adherence to the treatment arms. However, a standard tool will be used to assess bleeding as described below and grading of the severity of bleeding will be performed centrally. In addition, radiologists interpreting cranial ultrasound findings will be blinded to treatment arm allocation.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized trial with 1:1 allocation to parallel arms within strata of Study Center and gestational age (23-24 weeks and 25-26 weeks PMA). Multiples will be randomized independently. Approximately 30% of enrolled participants are expected to meet the platelet count threshold for randomization. The target sample size for randomization is 730, or 365 per arm.
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2024

First Posted

November 6, 2024

Study Start

June 13, 2025

Primary Completion (Estimated)

January 31, 2031

Study Completion (Estimated)

April 30, 2031

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. The NRN plans to share de-identified data after final publication in an NIH supported data repository such as the NICHD Data and Specimen Hub (https://dash.nichd.nih.gov).

Locations

US(20)