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Completed

NCT Number: NCT00182390

Premature Infants in Need of Transfusion (PINT)

Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined as one or more of retinopathy of prematurity, bronchopulmonary dysplasia, or periventricular leukomalacia/ventriculomegaly).

Primary Objective: To determine whether either a liberal or more restrictive threshold of hemoglobin level for red cell transfusion in ELBW infants is safer, by randomizing to either a high transfusion hemoglobin threshold or a low transfusion hemoglobin threshold.

Follow-up at a corrected age of 18 months represents a conventional age at which to first assess neurodevelopmental outcomes, and to predict long-term outcomes.

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Key information

Conditions

Anemia of Prematurity Anemia Brain Diseases Bronchopulmonary Dysplasia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Encephalomalacia Eye Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hydrocephalus Infant, Newborn, Diseases Infant, Premature, Diseases Leukomalacia, Periventricular Lung Diseases Lung Injury Nervous System Diseases Respiratory Tract Diseases Retinal Diseases Retinopathy of Prematurity Vascular Diseases Ventilator-Induced Lung Injury

Age range

Up to 48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mercy Hospital for Women, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • birth weight <1000g
  • postnatal age <48 hours
  • no transfusion beyond first 6 hours of life
  • estimated gestational age of 30 completed weeks or less

Exclusion criteria

  • infant considered non-viable by attending physician
  • infant has cyanotic congenital heart disease
  • infant's parents known to be opposed to blood transfusion
  • either parent has hemoglobinopathies or congenital anemias
  • infant has hemolytic disease
  • infant has severe acute hemorrhage, severe shock, severe sepsis with coagulopathy or requires peri-operative transfusion
  • prior treatment with or intention to treat with erythropoietin

Treatment and study plan

Red blood cell transfusion

Procedure

Primary outcomes

  1. Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury)

    Time frame: neonatal phase

  2. Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay)

    Time frame: follow-up phase 18 months corrected age

Secondary outcomes

  1. growth in weight and head circumference

    Time frame: neonatal phase

  2. time to extubation

    Time frame: neonatal phase

  3. time on oxygen

    Time frame: neonatal phase

  4. length of hospital stay until discharge home

    Time frame: neonatal phase

  5. confirmed necrotizing enterocolitis

    Time frame: neonatal phase

  6. apnea requiring treatment

    Time frame: neonatal phase

  7. culture-proven infections

    Time frame: neonatal phase

  8. use of post-natal steroids

    Time frame: neonatal phase

  9. mean levels of hemoglobin

    Time frame: neonatal phase

  10. number of transfusions

    Time frame: neonatal phase

  11. number of donor exposures

    Time frame: neonatal phase

  12. serum ferritin levels

    Time frame: neonatal phase

  13. milder forms of cerebral palsy

    Time frame: follow-up phase 18 months corrected age

  14. milder neurologic disorder

    Time frame: follow-up phase 18 months corrected age

  15. personal and social functional capabilities

    Time frame: follow-up phase 18 months corrected age

  16. hydrocephalus requiring a shunt

    Time frame: follow-up phase 18 months corrected age

  17. seizure disorder

    Time frame: follow-up phase 18 months corrected age

  18. respiratory disease

    Time frame: follow-up phase 18 months corrected age

  19. iron nutritional status

    Time frame: follow-up phase 18 months corrected age

  20. physical growth including head size

    Time frame: follow-up phase 18 months corrected age

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

A Randomized Controlled Trial of Two Hemoglobin Thresholds for Transfusion in Newborns <1000g Birth Weight

Important dates

Study start
2001
Primary completion
2003
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Sep 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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