Liberal Versus Restrictive Transfusion Guidelines for Preterm Infants

NCT00369005 | Completed

• 3 other identifiers: IowaBell001P01HL046925M01RR000059
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to determine whether restrictive guidelines for red blood cell (RBC) transfusions for preterm infants can reduce the number of transfusions without adverse consequences.

Conditions

Infant, Premature; Anemia; Intracranial Hemorrhages; Leukomalacia, Periventricular; Apnea

Keywords

Transfusions; Erythrocyte; Anemia; Brain; Infant, Premature

Outcome Measures

Primary Outcomes (2)

• number of red blood cell transfusions

• number of transfusion donors

Secondary Outcomes (23)

• survival to discharge

• patent ductus arteriosus

• germinal matrix or intraventricular hemorrhage

• periventricular leukomalacia

• retinopathy of prematurity

Interventions

Red blood cell transfusion guidelines PROCEDURE

Eligibility Criteria

• Age: 0 Years - 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infant
• Birth weight 500-1300 grams

You may not qualify if:

• Alloimmune hemolytic disease
• Congenital heart disease
• Other major birth defect requiring surgery
• Chromosomal abnormality
• Thought to be facing imminent death
• Parental philosophical or religious objections to transfusion
• More than 2 transfusions before enrollment
• Participation in other research study with potential impact on this study

Sponsors & Collaborators

• University of Iowa: lead
• National Institutes of Health (NIH): collaborator

Related Publications (2)

• Bell EF, Strauss RG, Widness JA, Mahoney LT, Mock DM, Seward VJ, Cress GA, Johnson KJ, Kromer IJ, Zimmerman MB. Randomized trial of liberal versus restrictive guidelines for red blood cell transfusion in preterm infants. Pediatrics. 2005 Jun;115(6):1685-91. doi: 10.1542/peds.2004-1884.

  PMID: 15930233 RESULT

• Nopoulos PC, Conrad AL, Bell EF, Strauss RG, Widness JA, Magnotta VA, Zimmerman MB, Georgieff MK, Lindgren SD, Richman LC. Long-term outcome of brain structure in premature infants: effects of liberal vs restricted red blood cell transfusions. Arch Pediatr Adolesc Med. 2011 May;165(5):443-50. doi: 10.1001/archpediatrics.2010.269. Epub 2011 Jan 3.

  PMID: 21199970 DERIVED

MeSH Terms

Conditions

Premature Birth; Anemia; Intracranial Hemorrhages; Leukomalacia, Periventricular; Apnea

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Encephalomalacia; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Edward F. Bell, M.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 28, 2006
• First Posted: August 29, 2006
• Study Start: December 1, 1992
• Study Completion: June 1, 1999
• Last Updated: August 29, 2006

Record last verified: 2006-08