Transfusion of Prematures Trial (TOP)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2014 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01702805
First received: August 30, 2012
Last updated: February 9, 2015
Last verified: September 2014
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label 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:
MedlinePlus related topics:
Birth Weight
Blood Transfusion and Donation
Body Weight
Common Infant and Newborn Problems
Uncommon Infant and Newborn Problems
U.S. FDA Resources
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- Death or significant neurodevelopmental impairment [ Time Frame: Birth to 22-26 months corrected gestational age ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- Moderate or severe cerebral palsy [ Time Frame: Birth to 26 months corrected age ] [ Designated as safety issue: Yes ]
- Episodes of necrotizing enterocolitis [ Time Frame: Birth to 36 weeks PMA ] [ Designated as safety issue: Yes ]Episodes of NEC Bell stage II or higher.
- Time to full feeds [ Time Frame: Birth to 36 weeks PMA ] [ Designated as safety issue: Yes ]The amount of time it takes for infant to achieve full feeds.
- Length of hospital stay [ Time Frame: Birth to 36 weeks PMA ] [ Designated as safety issue: Yes ]
- Number of transfusions [ Time Frame: Birth to 36 weeks PMA ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- Age at final caffeine dose [ Time Frame: Birth to 36 weeks PMA ] [ Designated as safety issue: Yes ]
- Growth [ Time Frame: Birth to 36 weeks PMA ] [ Designated as safety issue: Yes ]Weight, length, and head circumference at 36 weeks postmenstrual age
- Survival to discharge without severe morbidity [ Time Frame: Birth to 36 weeks PMA ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- Economic cost-benefit analysis [ Time Frame: Birth to 26 months corrected age ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1824 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | August 2017 |
| Estimated Primary Completion Date: | August 2015 (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 |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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
Contacts
| Contact: Haresh M Kirpalani, MD | 215-590-1653 | ||
| Contact: Rosemary Higgins, MD | (301) 435-5575 |
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Waldemar A. Carlo, MD 205-934-4680 | |
| Principal Investigator: Waldemar A. Carlo, MD | |
| United States, California | |
| University of California - Los Angeles | Recruiting |
| Los Angeles, California, United States, 90025 | |
| Contact: Uday Devaskar, MD 310-825-9314 | |
| Principal Investigator: Uday Devaskar, MD | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Krisa P. Van Meurs, MD 650-723-5711 | |
| Principal Investigator: Krisa P. Van Meurs, MD | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: Ravi Patel, MD 404-727-5905 | |
| Principal Investigator: Barbara J. Stoll, MD | |
| United States, Indiana | |
| Indiana University | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Greg Sokol, MD 317-274-4715 | |
| United States, Iowa | |
| University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Edward F. Bell, MD 319-356-4006 | |
| Principal Investigator: Edward F. Bell, MD | |
| United States, Michigan | |
| Wayne State University | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Seetha Shankaran, MD 313-745-1436 | |
| Principal Investigator: Seetha Shankaran, MD | |
| United States, Missouri | |
| Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: William Truog, MD 816-234-3592 | |
| Principal Investigator: William Truog, MD | |
| United States, New Mexico | |
| University of New Mexico | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Robin Ohls, MD 505-272-0180 | |
| Principal Investigator: Kristi L. Watterberg, MD | |
| United States, New York | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Ronnie Guillet, MD 585-275-6209 | |
| Principal Investigator: Carl T D'Angio, MD | |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Ronald N. Goldberg, MD 919-681-6024 | |
| Principal Investigator: Ronald N. Goldberg, MD | |
| Sub-Investigator: C. Michael Cotten, MD MHS | |
| RTI International | Active, not recruiting |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Cincinnati Children's Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Kurt Schibler, MD 513-636-3972 | |
| Principal Investigator: Kurt Schibler, MD | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Michele C. Walsh, MD MS 216-844-3387 | |
| Principal Investigator: Michele C. Walsh, MD MS | |
| Research Institute at Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Leif Nelin, MD 614-355-6724 | |
| Principal Investigator: Leif Nelin, MD | |
| United States, Pennsylvania | |
| Univeristy of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Haresh Kirpalani, MD 215-590-1653 | |
| Principal Investigator: Barbara Schmidt, MD | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | Recruiting |
| Providence, Rhode Island, United States, 02905 | |
| Contact: Abbot R. Laptook, MD 401-274-1122 ext 43200 | |
| Principal Investigator: Abbot R. Laptook, MD | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Myra Wyckoff, MD 214-648-3923 | |
| Principal Investigator: Myra Wyckoff, MD | |
| University of Texas Health Science Center at Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Kathleen A. Kennedy, MD MPH 713-500-6708 | |
| Principal Investigator: Kathleen A. Kennedy, MD MPH | |
| Sub-Investigator: Jon E. Tyson, MD MPH | |
Sponsors and Collaborators
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: | Kurt Schibler, MD | Cincinnati Children's Medical Center | |
| 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, MO | |
| Principal Investigator: | Uday Devaskar, MD | University of California, Los Angeles | |
| Study Director: | Haresh M Kirpalani, MD | University of Pennsylvania |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT01702805 History of Changes |
| Other Study ID Numbers: | NICHD-NRN-0050, U01HL112776, U01HL112748 |
| Study First Received: | August 30, 2012 |
| Last Updated: | February 9, 2015 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
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 Infant, Premature, Diseases |
Lung Diseases Lung Injury Respiratory Tract Diseases Signs and Symptoms Ventilator-Induced Lung Injury |
ClinicalTrials.gov processed this record on March 03, 2015