N/A
N=1,824
Transfusion of Prematures Trial
Infant, Newborn, Diseases · Infant, Extremely Low Birth Weight · Infant, Small for Gestational Age · Bronchopulmonary Dysplasia (BPD) · Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01702805 ↗Enrolled (actual)
1,824
Serious AEs
22.2%
Results posted
Feb 2022
Primary outcome: Primary: Death or Neurodevelopmental Impairment — 423; 422; 422; 425 Participants — p=0.93
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Liberal Cell Transfusion (Procedure); Restricted red cell transfusion (Procedure)
- Age
- Pediatric
- Sex
- All
- Sponsor
- NICHD Neonatal Research Network
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Death or Neurodevelopmental Impairment |
423; 422; 422; 425 | 0.93 |
| PRIMARY Death |
146; 135; 757; 766 | — |
| PRIMARY Neurodevelopmental Impairment |
277; 287; 422; 425 | — |
| PRIMARY Cognitive Delay |
269; 270; 426; 442 | — |
| PRIMARY Moderate or Severe Cerebral Palsy |
48; 55; 663; 665 | — |
| PRIMARY Severe Vision Impairment |
708; 714; 5; 6 | — |
| PRIMARY Severe Hearing Impairment |
696; 690; 14; 25 | — |
| SECONDARY Survival to Discharge Without Severe Complications |
644; 614; 257; 274 | — |
| SECONDARY Bronchopulmonary Dysplasia, Diagnosed on the Basis of the Need for Supplemental Oxygen After a Standardized Oxygen Reduction Test at 36 Weeks of Postmenstrual Age |
469; 453; 326; 352 | — |
| SECONDARY Retinopathy of Prematurity Stage >=3 or Treatment for That Condition Received |
640; 660; 157; 137 | — |
| SECONDARY Grade 3 or 4 Intraventricular Hemorrhage, Cystic Periventricular Leukomalacia, or Ventriculomegaly Diagnosed on Ultrasonographic Examination |
146; 154; 709; 705 | — |
| SECONDARY Necrotizing Enterocolitis, Bell's Stage >=2 |
91; 95; 816; 811 | — |
| SECONDARY Number of Transfusions Per Infant |
6.2; 4.4 | — |
| SECONDARY Weight-for-age: Z-score |
-1.2; -1.3 | — |
| SECONDARY Length-for-age: Z-score |
-1.9; -1.9 | — |
| SECONDARY Head Circumference-for-age: Z-score |
-1.4; -1.4 | — |
| SECONDARY Postmenstrual Age at Final Trachael Extubation |
30; 30.2 | — |
| SECONDARY Postmenstrual Age at Final Caffeine Dose in Infants Who Received Caffeine Treatment |
33.8; 34.0 | — |
| SECONDARY Length of Stay |
96; 97 | — |
| SECONDARY Time to Full Enteral Feeding |
19.5; 19.0 | — |
| SECONDARY Severe Cerebral Palsy |
690; 709; 20; 11 | — |
| SECONDARY Hydrocephalus Shunt |
20; 22; 697; 706 | — |
| SECONDARY Microcephaly |
61; 52; 639; 658 | — |
| SECONDARY Seizure Disorder |
672; 685; 42; 41 | — |
| SECONDARY Respiratory Disease Necessitating Readmission Before Follow-up |
467; 496; 248; 230 | — |
| SECONDARY Composite Language Score Less Than 85 |
316; 323; 355; 368 | — |
| SECONDARY Composite Motor Score Less Than 85 |
423; 415; 255; 280 | — |
| SECONDARY Composite Cognitive Score Less Than 70 |
607; 616; 88; 96 | — |
| SECONDARY Composite Language Score Less Than 70 |
507; 528; 164; 163 | — |
| SECONDARY Composite Motor Score Less Than 70 |
591; 596; 87; 99 | — |
Summary
The objective of the TOP trial is to determine whether higher hemoglobin thresholds for transfusing ELBW infants resulting in higher hemoglobin levels lead to improvement in the primary outcome of survival and rates of neurodevelopmental impairment (NDI) at 22-26 months of age, using standardized assessments by Bayley.
Eligibility Criteria
Inclusion Criteria
- Birth weight less than or equal to 1000 grams.
- Gestational age at least 22 weeks but less than 29 weeks
- Admitted to the NICU within 48 hours of life
Exclusion Criteria
- Considered nonviable by the attending neonatologist
- Cyanotic congenital heart disease
- Parents opposed to the transfusion of blood
- Parents with hemoglobinopathy or congenital anemia
- In-utero fetal transfusion
- Twin-to-twin transfusion syndrome
- Isoimmune hemolytic disease
- Lack of parental consent
- Severe acute hemorrhage, acute shock, sepsis with coagulopathy, or need for perioperative transfusion.
- Prior blood transfusion on clinical grounds beyond the first 6 hours of life
- Infant has received erythropoietin prior to randomization, or is intended to receive erythropoietin through the neonatal course
- Congenital condition, other than premature birth, that adversely affects life expectancy or neurodevelopment.
- High probability that the family is socially disorganized to the point of being unable to attend follow-up at 22-26 months.
Data sourced from ClinicalTrials.gov (NCT01702805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.