TransfusionPhase 4Tx-TRAGINCT02132819
Withholding Feeds During Red Blood Cell Transfusion and TRAGI
A Phase 4 study testing Withholding feeds and feeding during transfusion in people with Transfusion and Feeding During Transfusion, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Necrotising enterocolitis (NEC) is a devastating picture that all the neonatologists are afraid of facing during the follow up of newborns. During the last years, investigators ran retrospective observational studies abut NEC developing within the 48 hours after red blood cell transfusion. Read more about this study
- Who is it for?
- Ages 7 days to 3 months
- Conditions the study is for
- Transfusion, Feeding During Transfusion, Transfusion Related Acute Gut Injury
- What is being tested?
- Withholding feeds and feeding during transfusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2014to Apr 2015
- Phase
- Phase 4
- 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 7 days to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- <32 weeks of gestational age or <1500 gr, >7 days old premature babies.
- Babies which are fed enterally well at the time of tha planning of transfusion.
Who cannot join
- Babies with severe sepsis signs.
- Babies with severe hypoxia and asphyxia.
- Babies with congenital anomaly or complex cardiac anomaly.
Trial locations and contacts
1 site in 1 country.
Suzan Sahin, MD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Suzan Sahin
Ankara, Altındag, 06230
Suzan Sahin, MD, suzan_balkan@yahoo.com
Ugur Dilmen, Prof
About this study
Official title: The Effect of Withholding Feeds During Red Blood Cell Transfusion on Development of TRAGI in Very Low Birth Weight Infants
Necrotising enterocolitis (NEC) is a devastating picture that all the neonatologists are afraid of facing during the follow up of newborns. During the last years, investigators ran retrospective observational studies abut NEC developing within the 48 hours after red blood cell transfusion. In the previous studies, the incidence of transfusion associated NEC (TANEC) was found to be 20-35%.Multiple transfusions potentially cause an increased risk for retinopathy of prematurity (ROP) and NEC. Investigators have also proposed a hypothesis about transfusion related acute gut injury (TRAGI), an adverse reaction of transfusion, similar to transfusion related acute lung injury (TRALI) seen in adults.In most of the neonatology clinics, withholding feeds during transfusion is not preferred. But several recent studies show an increase in the incidence of TANEC if the newborn goes on feeding before, during and after the transfusion process, especially if it is fed with a formula. The main aim of this study is to investigate the effect of withholding feeds during transfusion, on the development of TRAGI.
- Conditions
- Transfusion, Feeding During Transfusion, Transfusion Related Acute Gut Injury, Necrotising Enterocolitis
- Being tested
- Withholding feeds, feeding during transfusion
- Keywords
- transfusion, feeding, TRAGI, NEC
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withholding feedsOther
At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded
feeding during transfusionOther
The feeding process will be continued during the transfusion
| Study group | Role | What they receive |
|---|---|---|
| Feeding During Transfusion | Placebo comparator | The feeding process will be continued during the transfusion Receives: Other: feeding during transfusion |
| witholding feeds | Active comparator | At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded Receives: Other: Withholding feeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase in the abdominal circumference
Bell's stage 1/Suspected disease:
Mild systemic disease (apnoea, bradycardia, temperature instability) Mild intestinal signs (abdominal distention, gastric residuals, bloody stools) Non-specific or normal radiological signs
Bell's stage 2/Definite disease:
Mild to moderate systemic signs Additional intestinal signs (absent bowel sounds, abdominal tenderness) Specific radiologic signs (pneumatosis intestinalis or portal venous air) Laboratory changes (metabolic acidosis, thrombocytopaenia)
Bell's stage 3/Advanced disease:
Severe systemic illness (hypotension) Additional intestinal signs (striking abdominal distention, peritonitis) Severe radiologic signs (pneumoperitoneum) Additional laboratory changes (metabolic and respiratory acidosis, disseminated intravascular coagulation)
Measured: within 3 days after transfusion but participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary outcomes (1)
increase in the amounts of gastric residual aspirates
Measured: Within 3 days after the transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransfusionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzan Sahin, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- Suzan Sahin, MD, Principal investigator, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132819
- Sponsor's protocol ID
- Sahin1
- Acronym
- Tx-TRAGI
- Status last verified
- May 2014
- First submitted
- 17 Apr 2014
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Withholding Feeds During Red Blood Cell Transfusion on Development of TRAGI in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT02132819
- Acronym / sponsor ID
- Tx-TRAGI / Sahin1
- Conditions
- Transfusion, Feeding During Transfusion, Transfusion Related Acute Gut Injury, Necrotising Enterocolitis
- Keywords
- transfusion, feeding, TRAGI, NEC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 7 May 2014 (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.
Necrotising enterocolitis (NEC) is a devastating picture that all the neonatologists are afraid of facing during the follow up of newborns. During the last years, investigators ran retrospective observational studies abut NEC developing within the 48 hours after red blood cell transfusion. In the previous studies, the incidence of transfusion associated NEC (TANEC) was found to be 20-35%.Multiple transfusions potentially cause an increased risk for retinopathy of prematurity (ROP) and NEC. Investigators have also proposed a hypothesis about transfusion related acute gut injury (TRAGI), an adverse reaction of transfusion, similar to transfusion related acute lung injury (TRALI) seen in adults.In most of the neonatology clinics, withholding feeds during transfusion is not preferred. But several recent studies show an increase in the incidence of TANEC if the newborn goes on feeding before, during and after the transfusion process, especially if it is fed with a formula. The main aim of this study is to investigate the effect of withholding feeds during transfusion, on the development of TRAGI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feeding During Transfusion | Placebo comparator | Other: feeding during transfusionThe feeding process will be continued during the transfusion |
| witholding feeds | Active comparator | Other: Withholding feedsAt least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded |
Who may qualify
- Ages
- 7 days to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- <32 weeks of gestational age or <1500 gr, >7 days old premature babies.
- Babies which are fed enterally well at the time of tha planning of transfusion.
Key exclusion criteria (3 listed)
- Babies with severe sepsis signs.
- Babies with severe hypoxia and asphyxia.
- Babies with congenital anomaly or complex cardiac anomaly.
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 |
|---|---|---|
| Withholding feedsAt least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded | Other | witholding feeds |
| feeding during transfusionThe feeding process will be continued during the transfusion | Other | Feeding During Transfusion |
Primary outcome
increase in the abdominal circumference
Time frame: within 3 days after transfusion but participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Bell's stage 1/Suspected disease: Mild systemic disease (apnoea, bradycardia, temperature instability) Mild intestinal signs (abdominal distention, gastric residuals, bloody stools) Non-specific or normal radiological signs Bell's stage 2/Definite disease: Mild to moderate systemic signs Additional intestinal signs (absent bowel sounds, abdominal tenderness) Specific radiologic signs (pneumatosis intestinalis or portal venous air) Laboratory changes (metabolic acidosis, thrombocytopaenia) Bell's stage 3/Advanced disease: Severe systemic illness (hypotension) Additional intestinal signs (striking abdominal distention, peritonitis) Severe radiologic signs (pneumoperitoneum) Additional laboratory changes (metabolic and respiratory acidosis, disseminated intravascular coagulation)
1 secondary outcome
increase in the amounts of gastric residual aspirates
Time frame: Within 3 days after the transfusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
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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.
Suzan Sahin, MD contact
Suzan Sahin, MD principal investigator
Zekai Tahir Burak Women's Health Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Withholding feeds and feeding during transfusion in people with Transfusion and Feeding During Transfusion, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suzan Sahin, MD (suzan_balkan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
increase in the abdominal circumference (time frame: within 3 days after transfusion but participants will be followed for the duration of hospital stay, an expected average of 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2014.