Trial record 9 of 35 for:    infant health | Open Studies | nichd [Lead] | NIH

Transfusion of Prematures Trial (TOP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 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: March 19, 2014
Last verified: February 2014
  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:


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 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.

  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

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: Brenda B. Poindexter, MD MS    317-274-4768      
Principal Investigator: Brenda B. Poindexter, MD MS         
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: Ron N Goldberg, MD Duke University
Principal Investigator: Barbara J Stoll, MD Emory University
Principal Investigator: Brenda B Poindexter, MD, MS 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: Pablo J Sanchez, 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: Leif Nelin, 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: March 19, 2014
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:
Infant, Newborn, Diseases
Infant, Premature, Diseases
Anemia
Birth Weight
Bronchopulmonary Dysplasia
Hematologic Diseases
Body Weight
Signs and Symptoms
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014