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ThrombocytopeniaNeoPlaTTNCT06676904

Neonatal Platelet Transfusion Threshold Trial

A study testing Higher Platelet Transfusion Threshold and Lower Platelet Transfusion Threshold in people with Thrombocytopenia and Neonatal, run by NICHD Neonatal Research Network at 20 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 1 hour to 48 hoursHealthy volunteers can take part
Conditions the study is for
Thrombocytopenia, Neonatal, Platelet Transfusion
What is being tested?
Higher Platelet Transfusion Threshold and Lower Platelet Transfusion Threshold
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,433 participants
Where
20 sitesUnited States
Study dates
13 Jun 2025to 30 Apr 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 hour to 48 hours
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ravi M Patel, MD contact

404-727-5905

rmpatel@emory.edu

Abhik Das, PhD contact

301-230-4640

adas@rti.org

20 sites in 1 country

United States20 sites, 20 recruiting

  • University of New Mexico

    Albuquerque, New Mexico, 87131

    Janell Fuller, MD

    Janell Fuller, MD

    Recruiting

  • Emory University

    Atlanta, Georgia, 30303

    Ravi Patel, MD

    Brenda Poindexter, MD

    Recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Sunah Hwang, MD

    Sunah Hwang, MD

    Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Waldemar A Carlo, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Helen Healy, MD

    Helen Healy, MD

    Recruiting

  • Northwestern Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

    Aaron Hamvas, MD

    Aaron Hamvas, MD

    Recruiting

  • Cincinnati Children's Medical Center

    Cincinnati, Ohio, 45267

    Stephanie Merhar, MD MS

    Vivek Narendran, MD, MBA

    Recruiting

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

    Cleveland, Ohio, 44106

    Anna Maria Hibbs, MD

    Anna Maria Hibbs, MD

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Pablo Sanchez, MD

    Pablo Sanchez, MD

    Recruiting

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75235

    Myra Myckoff, MD

    Myra Wyckoff, MD

    Recruiting

  • Duke University

    Durham, North Carolina, 27710

    Michael Cotten, MD

    Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Jon Tyson

    Jon Tyson, MD, MPH

    Recruiting

  • University of Iowa

    Iowa City, Iowa, 52242

    Tarah Colaizy, MD, MPH, 319-356-3508

    Edward F. Bell, MD

    Recruiting

  • Vanderbilt University

    Nashville, Tennessee, 37232

    Hendrick Weitkamp, MD

    Hendrick Weitkamp, MD

    Recruiting

  • Stanford University

    Palo Alto, California, 94304

    Valerie Chock, MD

    Valerie Chock, MD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Sara DeMauro, MD

    Sara DeMauro, MD

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Carl T D'Angio, MD

    Carl T D'Angio, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84108

    Robin Ohls, MD

    Robin Ohls, MD

    Recruiting

  • Pediatrix Medical Group

    San Antonio, Texas, 78229

    Kaashif Ahmad, MD

    Kaashif Ahmad, MD

    Recruiting

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California, 92123

    Anup Katheria, MD

    Anup Katheria, MD

    Recruiting

Other trials in United States

About this study

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).

Read the detailed description

Thrombocytopenia, defined as a platelet count <150 x 10^9/L, is a common neonatal problem that affects 22% to 35% of infants admitted to the neonatal intensive care unit. Platelets are important for primary hemostasis to prevent blood extravasation after vascular injury. Based on the role of platelets in hemostasis, prophylactic platelet transfusions are routinely administered to preterm infants with thrombocytopenia to prevent bleeding. The incidence of thrombocytopenia and administration of platelet transfusion are both inversely related to the gestational age at birth. Currently, there is uncertainty regarding the optimal platelet transfusion threshold, particularly among the most immature infants in the first week of life, which represents the period of highest bleeding risk.

The NeoPlaTT trial was designed to address this pressing uncertainty in the highest risk population (<27 weeks GA). It will test whether a threshold of 20x10^9/L could be safely used after the first week of life, when the risk of serious bleeding is significantly lower, and reduce the need for platelet transfusion altogether. The results of this study have a potential to change clinical practice and improve outcomes in this vulnerable population, while also decreasing costs and resource utilization.

This is a randomized trial with 1:1 allocation to parallel arms. Infants, inborn or outborn, who are admitted to participating NICUs, and who meet the inclusion and exclusion criteria, will be invited to enroll into the trial for platelet count monitoring. Only consented and enrolled infants meeting the additional platelet count trigger of < 50 x 10^9/L (postnatal days 1-7) or <35 x 10^9/L (8 or more postnatal days) will be randomized. Postnatal day 1 starts at birth. Randomization will be allowed to occur up to 36 6/7 weeks' PMA; subjects will be monitored through 40 0/7 weeks PMA. Approximately 30% of consented and enrolled infants are expected to meet the platelet count threshold for randomization.

Being tested
Higher Platelet Transfusion Threshold, Lower Platelet Transfusion Threshold
Keywords
platelet transfusion, neonatal, thrombosis
Medical subject headings
Thrombocytopenia, Infant, Newborn, Diseases, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Higher Platelet Transfusion ThresholdProcedure or surgery

    Also called Liberal Transfusion Threshold

    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.

  • Lower Platelet Transfusion ThresholdProcedure or surgery

    Also called Restrictive Transfusion Threshold

    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.

Study groups in NCT06676904
Study groupRoleWhat they receive
Higher Platelet Transfusion ThresholdActive comparatorInfants 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.
Receives: Procedure: Higher Platelet Transfusion Threshold
Lower Platelet Transfusion ThresholdOtherInfants 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.
Receives: Procedure: Lower Platelet Transfusion Threshold

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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)

  1. Death

    Measured: 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.

  2. Major or severe bleeding

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

    Measured: 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)

  3. Number of platelet transfusions

    Measured: 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)

  4. At least one platelet transfusion

    Measured: 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)

  5. Bronchopulmonary dysplasia among survivors to 36 weeks postmenstrual age

    Measured: At 36 weeks postmenstrual age

  6. Retinopathy of Prematurity (ROP)

    Stage 3 ROP, or stage 1 or 2 in Zone 1, or plus disease

    Measured: 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.

  7. Periventricular leukomalacia

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2024
  2. Study start13 Jun 2025
  3. Primary completion31 Jan 2031 (estimated)
  4. Study completion30 Apr 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
2,433 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06676904
Sponsor's protocol ID
NICHD-NRN-0065
Other IDs
1U24HL173304-01, UG3HL173303
Acronym
NeoPlaTT
Status last verified
Mar 2026
First submitted
3 Oct 2024
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • 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.

    PubMed 23144007

Questions about this trial

What is this clinical trial studying?

A study testing Higher Platelet Transfusion Threshold and Lower Platelet Transfusion Threshold in people with Thrombocytopenia and Neonatal, run by NICHD Neonatal Research Network at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ravi M Patel, MD (404-727-5905, rmpatel@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival without major or severe bleeding (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06676904, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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