Anemia of PrematurityPhase 3NCT00182390
Premature Infants in Need of Transfusion (PINT)
A Phase 3 study testing Red blood cell transfusion in people with Anemia of Prematurity, run by McMaster University at 10 sites in 3 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Anemia of Prematurity
- What is being tested?
- Red blood cell transfusion
- Type of treatment
- Surgery or procedure
- How many people
- 424 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Feb 2001to Nov 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- birth weight <1000g
- postnatal age <48 hours
- no transfusion beyond first 6 hours of life
- estimated gestational age of 30 completed weeks or less
Who cannot join
- 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
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Canada6 sites
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3T9
IWK Health Centre
Halifax, Nova Scotia, B3P 1R8
McMaster University
Hamilton, Ontario, L8S 4J9
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Sunnybrook & Women's College Health Science Centre
Toronto, Ontario, M5S 1B2
United States2 sites
Albany Medical Center
Albany, New York, 12208
Brooklyn Hospital Center
Brooklyn, New York, 11201
Australia2 sites
Royal Women's Hospital
Melbourne, Victoria, 3053
Mercy Hospital for Women
Melbourne, Victoria, 3084
About this study
Official title: A Randomized Controlled Trial of Two Hemoglobin Thresholds for Transfusion in Newborns <1000g Birth Weight
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.
- Conditions
- Anemia of Prematurity
- Being tested
- Red blood cell transfusion
- Keywords
- ELBW premature infants, neonatal transfusion, bronchopulmonary dysplasia, periventricular leukomalacia, ventriculomegaly, retinopathy of prematurity
- Medical subject headings
- Anemia, Bronchopulmonary Dysplasia, Leukomalacia, Periventricular, Hydrocephalus, Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red blood cell transfusionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury)
Measured: neonatal phase
Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay)
Measured: follow-up phase 18 months corrected age
Secondary outcomes (20)
growth in weight and head circumference
Measured: neonatal phase
time to extubation
Measured: neonatal phase
time on oxygen
Measured: neonatal phase
length of hospital stay until discharge home
Measured: neonatal phase
confirmed necrotizing enterocolitis
Measured: neonatal phase
apnea requiring treatment
Measured: neonatal phase
culture-proven infections
Measured: neonatal phase
use of post-natal steroids
Measured: neonatal phase
mean levels of hemoglobin
Measured: neonatal phase
number of transfusions
Measured: neonatal phase
number of donor exposures
Measured: neonatal phase
serum ferritin levels
Measured: neonatal phase
milder forms of cerebral palsy
Measured: follow-up phase 18 months corrected age
milder neurologic disorder
Measured: follow-up phase 18 months corrected age
personal and social functional capabilities
Measured: follow-up phase 18 months corrected age
hydrocephalus requiring a shunt
Measured: follow-up phase 18 months corrected age
seizure disorder
Measured: follow-up phase 18 months corrected age
respiratory disease
Measured: follow-up phase 18 months corrected age
iron nutritional status
Measured: follow-up phase 18 months corrected age
physical growth including head size
Measured: follow-up phase 18 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startFeb 2001
- Primary completionFeb 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anemia of PrematurityStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 424 participants
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Haresh Kirpalani, MD, MSc, Principal investigator, McMaster UniversityRobin K Whyte, MD, Principal investigator, Dalhousie UniversityRobin S Roberts, MTech, Study director, McMaster UniversityElizabeth Asztalos, MD, MSc, Study director, Sunnybrook & Women's College Health Sciences CentreChad Andersen, MD, Study director, Mercy Hospital for WomenMorris Blajchman, PhD, Study director, McMaster UniversityNancy Heddle, MSc, Study director, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182390
- Sponsor's protocol ID
- CTMG-2001-PINT
- Other IDs
- CIHR MCT-41549, CIHR MCT-58455
- Status last verified
- Sep 2015
- First submitted
- 13 Sep 2005
- Last updated
- 24 Sep 2015
- Results posted
- No
Publications
Kirpalani H, Whyte RK, Andersen C, Asztalos EV, Heddle N, Blajchman MA, Peliowski A, Rios A, LaCorte M, Connelly R, Barrington K, Roberts RS. The Premature Infants in Need of Transfusion (PINT) study: a randomized, controlled trial of a restrictive (low) versus liberal (high) transfusion threshold for extremely low birth weight infants. J Pediatr. 2006 Sep;149(3):301-307. doi: 10.1016/j.jpeds.2006.05.011.
PubMed 16939737Whyte RK, Kirpalani H, Asztalos EV, Andersen C, Blajchman M, Heddle N, LaCorte M, Robertson CM, Clarke MC, Vincer MJ, Doyle LW, Roberts RS; PINTOS Study Group. Neurodevelopmental outcome of extremely low birth weight infants randomly assigned to restrictive or liberal hemoglobin thresholds for blood transfusion. Pediatrics. 2009 Jan;123(1):207-13. doi: 10.1542/peds.2008-0338.
PubMed 19117884
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Two Hemoglobin Thresholds for Transfusion in Newborns <1000g Birth Weight
- ClinicalTrials.gov ID
- NCT00182390
- Acronym / sponsor ID
- CTMG-2001-PINT
- Conditions
- Anemia of Prematurity
- Keywords
- ELBW premature infants, neonatal transfusion, bronchopulmonary dysplasia, periventricular leukomalacia, ventriculomegaly, retinopathy of prematurity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Feb 2001
- Primary completion
- Feb 2003 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- birth weight <1000g
- postnatal age <48 hours
- no transfusion beyond first 6 hours of life
- estimated gestational age of 30 completed weeks or less
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red blood cell transfusion | Procedure or surgery | – |
Primary outcome
Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury)
Time frame: neonatal phase
Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay)
Time frame: follow-up phase 18 months corrected age
20 secondary outcomes
growth in weight and head circumference
Time frame: neonatal phase
time to extubation
Time frame: neonatal phase
time on oxygen
Time frame: neonatal phase
length of hospital stay until discharge home
Time frame: neonatal phase
confirmed necrotizing enterocolitis
Time frame: neonatal phase
apnea requiring treatment
Time frame: neonatal phase
culture-proven infections
Time frame: neonatal phase
use of post-natal steroids
Time frame: neonatal phase
mean levels of hemoglobin
Time frame: neonatal phase
number of transfusions
Time frame: neonatal phase
number of donor exposures
Time frame: neonatal phase
serum ferritin levels
Time frame: neonatal phase
milder forms of cerebral palsy
Time frame: follow-up phase 18 months corrected age
milder neurologic disorder
Time frame: follow-up phase 18 months corrected age
personal and social functional capabilities
Time frame: follow-up phase 18 months corrected age
hydrocephalus requiring a shunt
Time frame: follow-up phase 18 months corrected age
seizure disorder
Time frame: follow-up phase 18 months corrected age
respiratory disease
Time frame: follow-up phase 18 months corrected age
iron nutritional status
Time frame: follow-up phase 18 months corrected age
physical growth including head size
Time frame: follow-up phase 18 months corrected age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
- Results publication: PubMed 16939737Kirpalani H, Whyte RK, Andersen C, Asztalos EV, Heddle N, Blajchman MA, Peliowski A, Rios A, LaCorte M, Connelly R, Barrington K, Roberts RS. The Premature Infants in Need of Transfusion (PINT) study: a randomized, controlled trial of a restrictive (low) versus liberal (high) transfusion threshold for extremely low birth weight infants. J Pediatr. 2006 Sep;149(3):301-307. doi: 10.1016/j.jpeds.2006.05.011.
- Results publication: PubMed 19117884Whyte RK, Kirpalani H, Asztalos EV, Andersen C, Blajchman M, Heddle N, LaCorte M, Robertson CM, Clarke MC, Vincer MJ, Doyle LW, Roberts RS; PINTOS Study Group. Neurodevelopmental outcome of extremely low birth weight infants randomly assigned to restrictive or liberal hemoglobin thresholds for blood transfusion. Pediatrics. 2009 Jan;123(1):207-13. doi: 10.1542/peds.2008-0338.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haresh Kirpalani, MD, MSc principal investigator
McMaster University
Robin K Whyte, MD principal investigator
Dalhousie University
Robin S Roberts, MTech study director
McMaster University
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Red blood cell transfusion in people with Anemia of Prematurity, run by McMaster University at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada, United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury) (time frame: neonatal phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182390, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015.