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A randomised controlled trial: two haemoglobin thresholds for transfusion in newborns less than 1000 g birth weight
ISRCTN ISRCTN72553588
DOI 10.1186/ISRCTN72553588
ClinicalTrials.gov identifier NCT00182390
EudraCT number
Public title A randomised controlled trial: two haemoglobin thresholds for transfusion in newborns less than 1000 g birth weight
Scientific title
Acronym PINT (Preterms In Need of Transfusion)
Serial number at source MCT-41549 (follow-up trial PINTOS [started in 2002]: MCT-58455)
Study hypothesis A high haemoglobin 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).

PINTOS: Neurodevelopmental outcome of extremely low birth weight infants randomised to high or low haemoglobin triggers for blood transfusion -
A follow up study was added to this trial in 2002 by Dr Whyte (all details pertaining to the follow up will be headed with the title 'PINTOS'). The hypothesis for this follow-up was that a low haemoglobin threshold as compared to a high haemoglobin threshold for transfusion in ELBW infants is associated with a lower rate of the combined outcome of death or, in survivors, the presence of cerebral palsy, cognitive delay, blindness or deafness at 18 - 21 months follow-up.

Please note that this trial was intially submitted for an ISRCTN in September 2005.
Lay summary
Ethics approval Ethics approval was gained from the Research Ethics Boards:
For PINT: of McMaster University (Canada) on the 20th November 2002 (ref: #00-255).
For PINTOS: of IWK Health Centre, Halifax, NS, Canada, 14 July 2004 (ref: #2052).
Study design Multicentre, international, therapeutic management strategy randomised parallel, two arm trial, with outcome assessor and data analyst blinded.
Countries of recruitment Australia, Canada, United States of America
Disease/condition/study domain Anaemia of prematurity
Participants - 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
Participants - 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
Anticipated start date 04/02/2001
Anticipated end date 15/09/2005
Status of trial Completed
Patient information material
Target number of participants 424 (451 were recruited in total by the time of the PINTOS study in 2002)
Interventions Transfusion at low haemoglobin threshold; blood transfusion with 15 ml/kg packed erythrocytes when the haemoglobin level, taken from capillary or central sites, falls to or below the following levels:

Group 1: Haemoglobin Threshold for Transfusion -
1. Week 1 (postnatal age):
1.1. Capillary sampling site: respiratory support: 115 g/l; not requiring respiratory support: 100 g/l
1.2. Central sampling site: respiratory support: 104 g/l; not requiring respiratory support: 90 g/l
2. Week 2 (postnatal age):
2.1. Capillary sampling site: respiratory support: 100 g/l; not requiring respiratory support: 85 g/l
2.2. Central sampling site: respiratory support: 90 g/l; not requiring respiratory support: 77 g/l
3. Greater than or equal to week 3 (postnatal age):
3.1. Capillary sampling site: respiratory support: 85 g/l; not requiring respiratory support: 75 g/l
3.2. Central sampling site: respiratory support: 77 g/l; not requiring respiratory support: 68 g/l

Group 2: Haemoglobin Threshold for Transfusion -
1. Week 1 (postnatal age):
1.1. Capillary sampling site: respiratory support: 135 g/l; not requiring respiratory support: 120 g/l
1.2. Central sampling site: respiratory support: 122 g/l; not requiring respiratory support: 109 g/l
2. Week 2 (postnatal age):
2.1. Capillary sampling site: respiratory support: 120 g/l; not requiring respiratory support: 100 g/l
2.2. Central sampling site: respiratory support: 109 g/l; not requiring respiratory support: 90 g/l
3. Greater than or equal to week 3 (postnatal age):
3.1. Capillary sampling site: respiratory support: 100 g/l; not requiring respiratory support: 85 g/l
3.2. Central sampling site: respiratory support: 90 g/l; not requiring respiratory support: 77 g/l

Alternative address for contact for PINT trial:
Dr. Haresh Kirpalani
University Pennsylvania, at Children’s Hospital of Philadelphia
Division Neonatology
34th Street & Civic Center
Philadelphia PA 19104
USA
Phone: +1 215 590 2455
Fax: +1 215 590 3051
Email: kirpalanih@email.chop.edu

Sponsor for PINTOS trial:
Dalhousie University (Canada)
c/o Carl Breckenridge, PhD
Vice President, Research
6299 South Street
Halifax, Nova Scotia
B3H 4H6
Canada
Tel: +1 902 494 2211
Fax: +1 902 494 2319

Contact for PINTOS trial:
Dr Robin K Whyte
IWK Health Centre
5980 University Avenue
Halifax, Nova Scotia
B3J 6R8
Canada
Tel: +1 902 470 7426
Fax: +1 902 470 6469
Email: robin.whyte@dal.ca
Primary outcome measure(s) 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.

PINTOS:
Composite outcome of death or the presence of cerebral palsy, cognitive delay, blindness or deafness measured at or during 24 months.
Secondary outcome measure(s) 1. Growth in weight and head circumference
2. Time to extubation, by discharge from hospital
3. Time on oxygen, by discharge from hospital
4. Length of hospital stay until discharge home
5. Incidences of necrotising enterocolitis
6. Apnoea requiring treatment
7. Number of infections
8. Use of post-natal steroids
9. Intraventricular haemorrhage Grade 4 or with hydrocephalus
10. Mean levels of haemoglobin
11. Number of transfusions
12. Number of donor exposures

Time point of measurement: at discharge from hospital or at corrected age of 40 weeks.

PINTOS:
1. Vineland Communication score
2. Vineland Daily Living score
3. Vineland Socialisation score
4. Vineland Motor Skills score
5. Gross Motor Function Classification System Levels
6. Weight
7. Length
8. Head Circumference
9. Haemoglobin
10. Haematocrit
11. Mean Corpuscular Haemoglobin
12. Mean Cell Volume
13. Ferritin

Time point of measurement: 18 - 21 months corrected gestational age.
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr.irsc.gc.ca (ref: PINT: MCT-41549/PINTOS: MCT-58455)
Trial website
Publications Results from PINT study:
http://www.ncbi.nlm.nih.gov/pubmed/16939737
Contact name Dr  Haresh M.  Kirpalani
  Address Room 3N11F
McMaster University Medical Center
1200 Main Street West
  City/town Hamilton, Ontario
  Zip/Postcode L8N 3Z5
  Country Canada
  Tel +1 905 521 2100 ext. 73024
  Fax +1 905 521 7914
  Email kirpalan@mcmaster.ca
Sponsor McMaster University (Canada)
  Address 1200 Main Street West
c/o Debbie Billings, Finance Manager
Department Clinical Epidemiology and Biostatistics
Room HSC-2C4
  City/town Hamilton, Ontario
  Zip/Postcode L8N 3Z5
  Country Canada
  Tel +1 905 525 9140 ext: 22665
  Fax +1 905 570 0742 (RESEARCH)
  Email billings@mcmaster.ca
  Sponsor website: http://www.mcmaster.ca/
Date applied 26/07/2007
Last edited 08/09/2008
Date ISRCTN assigned 26/07/2007
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