A randomised controlled trial: two haemoglobin thresholds for transfusion in newborns less than 1000 g birth weight

Not Applicable

Completed

• Conditions: Anaemia of prematurity; Pregnancy and Childbirth; Haemorrhagic and haematological disorders of foetus and newborn

• Registration Number: ISRCTN72553588
• Lead Sponsor: McMaster University (Canada)

Brief Summary

2006 Results article in http://www.ncbi.nlm.nih.gov/pubmed/16939737 2009 Other publications in https://pubmed.ncbi.nlm.nih.gov/19117884/ follow up study (added 08/06/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-09-15
• Study Start: 2007-07-26
• Last Update Posted: 20 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 451

Inclusion Criteria

1. Infants of birth weight less than 1000 g, either sex
2. Postnatal age less than 48 hours
3. No transfusion beyond first six hours of life
4. Estimated gestational age of 30 completed weeks or less

Exclusion Criteria

1. Infant considered non-viable by attending physician
2. Infant has cyanotic congenital heart disease
3. Infant's parents known to be opposed to blood transfusion
4. Either parent has haemoglobinopathies or congenital anaemias
5. Infant has haemolytic disease
6. Infant has severe acute haemorrhage, severe shock, severe sepsis with coagulopathy or requires peri-operative transfusion
7. Prior treatment with or intention to treat with erythropoietin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Survival to tertiary hospital discharge without severe morbidity (one or all of bronchopulmonary dysplasia, retinopathy of prematurity Grade 3 - 4, periventricular leukomalacia/ventriculomegaly present on ultra-sound scans) at corrected age 40 weeks.<br><br> PINTOS:<br> Composite outcome of death or the presence of cerebral palsy, cognitive delay, blindness or deafness measured at or during 24 months.<br>