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Neonatal Platelet Transfusion Threshold Trial

ConditionsThrombocytopeniaNeonatalPlatelet TransfusionInfant, Newborn, DiseasesInfant, Extremely Low Birth WeightInfant, Small for Gestational AgeThrombosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-48
SponsorNICHD Neonatal Research Network

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Gestational age of 23 0/7 to 26 6/7 weeks

Postnatal age of < 48 hours

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Higher Platelet Transfusion Threshold

    Procedure/Surgery

    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 Threshold

    Procedure/Surgery

    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.

Treatment groups

2,433 Participants
are divided into 2 treatment groups
Group A: Higher Platelet Transfusion ThresholdActive comparator 1 intervention
Group B: Lower Platelet Transfusion ThresholdOther 1 intervention

Trial outcomes

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)

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)

Secondary outcomes

1

Death

Time frame
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)

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)
3

Number of platelet transfusions

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)
4

At least one platelet transfusion

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)

Other outcomes

1

Late-onset sepsis

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)
2

Necrotizing enterocolitis

Modified Bells Stage IIA or greater

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)
3

Thrombosis requiring therapy

Thrombosis requiring therapy such as heparin, enoxaparin, or aspirin

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)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NICHD Neonatal Research Network

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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