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/23144007/Actively Recruiting
Led by NICHD Neonatal Research Network · Updated on 2026-03-25
2433
Participants Needed
20
Research Sites
12 weeks
Total Duration
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 07 and 26 67 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 mlkg over 60 to 120 minutes. The treatment protocol continues until infants reach 40 07 weeks postmenstrual age. Participants are monitored from randomization until 40 07 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
Neonatal Platelet Transfusion Threshold Trial
R
Ravi M Patel, MD
A
Abhik Das, PhD
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NICHD Neonatal Research Network
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Higher‑threshold strategy | Lower‑threshold strategy |
|---|---|---|
| What it is | A prophylactic platelet transfusion strategy using a threshold of 50×10⁹/L in first postnatal week, then 35×10⁹/L thereafter until 40 0/7 weeks postmenstrual age | A prophylactic platelet transfusion strategy using a threshold of 25×10⁹/L in first postnatal week, then 20×10⁹/L thereafter until 40 0/7 weeks postmenstrual age |
| Role in trial | One of two randomized transfusion threshold protocols tested in the trial | Comparator randomized transfusion threshold protocol in the same trial |
| Primary use | To prevent major or severe bleeding and improve survival without such bleeding in extremely preterm infants | To prevent major or severe bleeding and support survival without such bleeding in extremely preterm infants |
| How it is performed | Platelets given at 10 ml/kg over 60–120 minutes when count falls below the threshold | Platelets given at 10 ml/kg over 60–120 minutes when count falls below the threshold |
| Evidence status | Randomized data (PlaNeT‑2) in similar preterm neonate population showed higher threshold associated with increased death or major bleeding compared with lower threshold | Randomized data from PlaNeT‑2 trial demonstrated lower threshold was associated with lower rates of death or major bleeding |
| Important risks | Associated with higher risk of death or major bleeding compared with lower threshold in preterm infants | Lower risk of death or major bleeding compared with higher threshold; overall safety outcomes similar |
| Important limitations | Existing evidence comes from slightly older gestational cohorts (<34 weeks) and may not fully generalize to extremely preterm infants (23–26 weeks) | Long‑term outcomes such as neurodevelopment beyond survival without bleeding remain under study |
| Patient impact | Higher threshold strategy was linked to worse short‑term clinical outcomes (higher death or major bleeding rates) | Lower threshold strategy was linked to better short‑term outcomes with lower rates of death or major bleeding |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Vidheya Venkatesh, Anna Curley, Rizwan Khan...
https://pubmed.ncbi.nlm.nih.gov/23144007/NICHD Neonatal Research Network
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor