A novel approach to standardised recording of bleeding in a high risk neonatal population.
Vidheya Venkatesh, Anna Curley, Rizwan Khan...
https://pubmed.ncbi.nlm.nih.gov/23144007Actively Recruiting
Phase Not Applicable
Age: 1Hour - 48Hours
All Genders
Healthy Volunteers
ID06676904
Neonatal Platelet Transfusion Threshold Trial for Extremely Preterm Infants with Thrombocytopenia
Led by NICHD Neonatal Research Network · Updated on 2026-03-25
2433
Participants Needed
20
Research Sites
12 weeks
Total Duration
On this page
Sponsors
N
NICHD Neonatal Research Network
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether using a lower platelet transfusion threshold compared to a higher threshold improves survival without major or severe bleeding in extremely preterm infants born between 23 0/7 and 26 6/7 weeks' gestation. This study focuses on infants in neonatal intensive care who often experience thrombocytopenia, a condition where platelet counts are low. The goal is to find the best platelet transfusion practice to reduce bleeding risks and improve outcomes in this vulnerable group. The study randomly assigns infants to one of two groups. One group follows a higher platelet transfusion threshold during the first week of life and then a moderate threshold afterward, while the other group follows lower thresholds during these periods. Platelet transfusions are given at a dose of 10 ml/kg over 60 to 120 minutes. The treatment protocol continues until infants reach 40 0/7 weeks postmenstrual age. Participants are monitored from randomization until 40 0/7 weeks postmenstrual age or earlier if discharged or transferred. Researchers will collect data on survival without major bleeding, number of platelet transfusions, and other health outcomes like bronchopulmonary dysplasia and retinopathy of prematurity. The total participation duration averages about 98 days postnatal age, with safety and health closely observed throughout the study.
CONDITIONS
Brief Title
Neonatal Platelet Transfusion Threshold Trial
Who Can Participate
Age: 1Hour - 48Hours
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Gestational age of 23 0/7 to 26 6/7 weeks
- Postnatal age less than 48 hours
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - From randomization up to 40 0/7 weeks postmenstrual age (approximately 98 days postnatal age)
Participants are randomized to receive platelet transfusion monitoring at either a higher or lower platelet transfusion threshold through 40 0/7 weeks postmenstrual age.
Ongoing monitoring visits during the treatment period
Trial Site Locations
Total: 20 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
3
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States, 92123
Actively Recruiting
4
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Emory University
Atlanta, Georgia, United States, 30303
Actively Recruiting
6
Northwestern Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
7
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Actively Recruiting
10
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
11
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
12
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45267
Actively Recruiting
13
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
14
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
15
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
16
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
17
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
Actively Recruiting
18
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
19
Pediatrix Medical Group
San Antonio, Texas, United States, 78229
Actively Recruiting
20
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
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Research Team
R
Ravi M Patel, MD
A
Abhik Das, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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