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

ISRCTN	ISRCTN72553588
DOI	https://doi.org/10.1186/ISRCTN72553588
ClinicalTrials.gov (NCT)	NCT00182390
Protocol serial number	MCT-41549 (follow-up trial PINTOS [started in 2002]: MCT-58455)
Sponsor	McMaster University (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr.irsc.gc.ca (ref: PINT: MCT-41549/PINTOS: MCT-58455)

Submission date: 26/07/2007
Registration date: 26/07/2007
Last edited: 08/06/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Haresh M. Kirpalani
Scientific

Room 3N11F
McMaster University Medical Center
1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada

Phone	+1 905 521 2100 ext. 73024
Email	kirpalan@mcmaster.ca

Study information

Primary study design	Interventional
Study design	Multicentre, international, therapeutic management strategy randomised parallel, two arm trial, with outcome assessor and data analyst blinded.
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled trial: two haemoglobin thresholds for transfusion in newborns less than 1000 g birth weight
Study acronym	PINT (Preterms In Need of Transfusion)
Study objectives	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.
Ethics approval(s)	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).
Health condition(s) or problem(s) studied	Anaemia of prematurity
Intervention	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 Childrens 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
Intervention type	Other
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.
Key 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.
Completion date	15/09/2005

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	451
Key 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
Key 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
Date of first enrolment	04/02/2001
Date of final enrolment	15/09/2005

Locations

Countries of recruitment

Australia
Canada
United States of America

Study participating centre

Room 3N11F

Hamilton, Ontario
L8N 3Z5
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/09/2006		Yes	No
Other publications	follow up study	01/01/2009	08/06/2022	Yes	No

Editorial Notes

08/06/2022: Publication reference added.