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Transfusion of Prematures Trial (TOP)
This study is ongoing, but not recruiting participants.
Sponsor:
NICHD Neonatal Research Network
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network
ClinicalTrials.gov Identifier:
NCT01702805
First received: August 30, 2012
Last updated: June 19, 2017
Last verified: June 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Infant, Newborn, Diseases Infant, Extremely Low Birth Weight Infant, Small for Gestational Age Bronchopulmonary Dysplasia (BPD) Anemia | Procedure: Liberal Cell Transfusion Procedure: Restricted red cell transfusion | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Transfusion of Prematures (TOP) Trial: Does a Liberal Red Blood Cell Transfusion Strategy Improve Neurologically-Intact Survival of Extremely-Low-Birth-Weight Infants as Compared to a Restrictive Strategy? |
Resource links provided by NLM:
Further study details as provided by NICHD Neonatal Research Network:
Primary Outcome Measures:
- Death or significant neurodevelopmental impairment [ Time Frame: Birth to 22-26 months corrected gestational age ]Number of children surviving without significant neurodevelopmental impairment at 22-26 months of corrected age.
Secondary Outcome Measures:
- Grade 3 or 4 IVH, cystic PVL, or ventriculomegaly [ Time Frame: Birth to 36 weeks PMA ]
- Moderate or severe cerebral palsy [ Time Frame: Birth to 26 months corrected age ]
- Episodes of necrotizing enterocolitis [ Time Frame: Birth to 36 weeks PMA ]Episodes of NEC Bell stage II or higher.
- Time to full feeds [ Time Frame: Birth to 36 weeks PMA ]The amount of time it takes for infant to achieve full feeds.
- Length of hospital stay [ Time Frame: Birth to 36 weeks PMA ]
- Number of transfusions [ Time Frame: Birth to 36 weeks PMA ]Number of transfusions, numbers of donor exposures by RBC donors or other blood product
- Age at final tracheal extubation [ Time Frame: Birth to 36 weeks PMA ]
- Age at final caffeine dose [ Time Frame: Birth to 36 weeks PMA ]
- Growth [ Time Frame: Birth to 36 weeks PMA ]Weight, length, and head circumference at 36 weeks postmenstrual age
- Survival to discharge without severe morbidity [ Time Frame: Birth to 36 weeks PMA ]Survival to discharge without severe morbidity, defined as any of the following: bronchopulmonary dysplasia, retinopathy of prematurity (stage >3 or requiring treatment), or serious brain abnormality (grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia, or ventriculomegaly).
- Respiratory disease [ Time Frame: Birth to 26 months corrected age ]The presence of respiratory disease necessitating readmission before 22-26 months follow-up.
- Hydrocephalus shunt, microcephaly, or seizure disorder [ Time Frame: Birth to 26 months corrected age ]
- Economic cost-benefit analysis [ Time Frame: Birth to 26 months corrected age ]
| Enrollment: | 1824 |
| Actual Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2019 |
| Estimated Primary Completion Date: | October 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Low Threshold Transfusion
Transfusions will be administered using a lower threshold hemoglobin value. The low threshold values reflect more common practice, so this is considered the 'usual treatment' group
|
Procedure: Restricted red cell transfusion |
|
Active Comparator: High Threshold Transfusion
Transfusions will be administered using a higher threshold hemoglobin value.
|
Procedure: Liberal Cell Transfusion |
Detailed Description:
Long-term outcomes of extremely low birth weight (ELBW) preterm infants, those weighing less than or equal to 1000 g at birth, are poor and pose a major health care burden. Virtually all of these infants are transfused, but at inconsistent hemoglobin (Hgb) thresholds.
The investigators propose in TOP to randomize infants less than or equal to 1000 g BW and < 29 weeks GA to receive red blood cell (RBC) transfusions according to one of two strategies of Hgb thresholds, either a high Hgb (liberal transfusion) or a low Hgb (restrictive transfusion) algorithm. It is currently unknown which transfusion strategy is superior. TOP is powered to demonstrate which strategy reduces the primary outcome of death or neurodisability in survivors at 22-26 months.
A secondary study entitled "Effect of Blood Transfusion Practices on Cerebral and Somatic Oximetry", also known as the NIRS study, will determine differences in cerebral oxygenation and fractional tissue oxygen extraction with NIRS between high and low hemoglobin threshold groups during red blood cell transfusions. The investigators also propose to determine whether abnormal cerebral NIRS measures are a better predictor of NDI than hemoglobin alone and whether abnormal mesenteric NIRS measures are associated with the development of NEC within the 48 hours following a transfusion.
Eligibility| Ages Eligible for Study: | up to 48 Hours (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Birth weight less than 1000 grams.
- Gestational age at least 22 weeks but less than 29 completed 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
- High probability that the family is socially disorganized to the point of being unable to attend follow-up at 22-26 months.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702805
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702805
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| University of California - Los Angeles | |
| Los Angeles, California, United States, 90025 | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| RTI International | |
| Durham, North Carolina, United States, 27705 | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cincinnati Children's Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| Research Institute at Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205 | |
| United States, Pennsylvania | |
| Univeristy of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75235 | |
| University of Texas Health Science Center at Houston | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84108 | |
Sponsors and Collaborators
NICHD Neonatal Research Network
National Heart, Lung, and Blood Institute (NHLBI)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Principal Investigator: | Michele C Walsh, MD | Case Western Reserve University, Rainbow Babies and Children's Hospital |
| Principal Investigator: | Abhik Das, PhD | RTI International |
| Principal Investigator: | Beena Sood, MD | Wayne State University |
| Principal Investigator: | Abbot R Laptook, MD | Brown University, Women & Infants Hospital of Rhode Island |
| Principal Investigator: | Michael Cotten, MD | Duke University |
| Principal Investigator: | Ravi Patel, MD | Emory University |
| Principal Investigator: | Greg Sokol, MD | Indiana University |
| Principal Investigator: | Krisa P Van Meurs, MD | Stanford University |
| Principal Investigator: | Brenda Poindexter, MD | Children's Hospital Medical Center, Cincinnati |
| Principal Investigator: | Waldemar A Carlo, MD | University of Alabama at Birmingham |
| Principal Investigator: | Kristi L Watterberg, MD | University of New Mexico |
| Principal Investigator: | Myra Wyckoff, MD | University of Texas, Southwestern Medical Center at Dallas |
| Principal Investigator: | Kathleen A Kennedy, MD, MPH | The University of Texas Health Science Center, Houston |
| Principal Investigator: | Carl T D'Angio, MD | University of Rochester |
| Principal Investigator: | Pablo Sanchez, MD | Research Institute at Nationwide Children's Hospital |
| Principal Investigator: | William Truog, MD | Children's Mercy Hospital Kansas City |
| Principal Investigator: | Uday Devaskar, MD | University of California, Los Angeles |
| Study Director: | Haresh M Kirpalani, MD | University of Pennsylvania |
| Principal Investigator: | Bradley Yoder, MD | University of Utah |
More Information
Additional Information:
| Responsible Party: | NICHD Neonatal Research Network |
| ClinicalTrials.gov Identifier: | NCT01702805 History of Changes |
| Other Study ID Numbers: |
NICHD-NRN-0050 U01HL112776 ( U.S. NIH Grant/Contract ) U01HL112748 ( U.S. NIH Grant/Contract ) |
| Study First Received: | August 30, 2012 |
| Last Updated: | June 19, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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) |
Keywords provided by NICHD Neonatal Research Network:
|
NICHD Neonatal Research Network Very Low Birth Weight (VLBW) Extremely Low Birth Weight (ELBW) Transfusions |
Additional relevant MeSH terms:
|
Birth Weight Bronchopulmonary Dysplasia Infant, Newborn, Diseases Body Weight Signs and Symptoms |
Ventilator-Induced Lung Injury Lung Injury Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases |
ClinicalTrials.gov processed this record on August 17, 2017