Intestinal Blood FlowNCT01628133
Packed Red Blood Cell Transfusion and Intestinal Blood Flow in Preterm Neonates
An observational study of Intestinal Blood Flow, run by St. Louis University at 1 site in United States.
Trial summary
The purpose of the study is to determine whether packed red blood cell (PRBC) transfusion affects intestinal blood flow of premature infants during feedings and if so, whether return of normal intestinal blood flow pattern occurs within 48 hours of blood transfusion. Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Intestinal Blood Flow
- What is being tested?
- ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jan 2014
- Phase
- Observational
- 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 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Preterm neonates (≤1500 grams of birth weight) of singleton and multiple births who are admitted to the NICU at Cardinal Glennon Children's Hospital and who are tolerating ≥ 20 ml/kg/day of feeding volume run over 30 minutes or less; both males and females of all ethnic groups. Very Low Birth Weight (VLBW) neonates will be studied since morbidities such as transfusion related acute gastrointestinal injury and/or necrotizing enterocolitis, PDA and feeding intolerance most frequently occur in this group. Because the need to ensure parental comprehension prior to consent documentation, parents who, in the judgement of the attending physician and/or research team members, do not have an adequate command of the English language will not be invited to participate in the study.
Who may be able to join
- birth weight ≤ 1500 gm
- singleton and multiple gestation
- small and appropriate birth weight for gestational age
- tolerance of ≥ 20 ml/kg/day of feeding volumes over 30 minutes or less
- at least 14 days of age and ≤ 35 6/7 weeks corrected gestational age at time of transfusion.
- Expected age range of 0-3 months is based on expected age of extremely low birth weight infants at limit (35 6/7 weeks) of corrected gestational age.
- Only those infants who receive transfusion at < or equal to 35 weeks will undergo the PDA/SMA and BFV procedures and have data included in analysis.
Who cannot join
- major congenital or chromosomal anomalies
- presence of congenital heart disease (minus patent ductus arteriosus
- presence of shock
- presence of vasopressor use
- presence of severe lung disease
- concurrent treatment with antibiotics for sepsis
- history of NEC Bell stage 2 or greater
- Infants experiencing changes in vital signs or oxygen level drop needing intervention (such as oxygen increase or stimulation) will have studies discontinued and will be excluded from further analysis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardinal Glennon Children's Hospital / Saint Louis University
St Louis, Missouri, 63104
About this study
Official title: Packed Red Blood Cell Transfusion and Intestinal Blood Flow in Preterm Infants
The purpose of the study is to determine whether packed red blood cell (PRBC) transfusion affects intestinal blood flow of premature infants during feedings and if so, whether return of normal intestinal blood flow pattern occurs within 48 hours of blood transfusion.
Abnormal intestinal responses to the feedings (insufficient postprandial blood flow increase in order to digest given feeding volume or overall decrease of intestinal blood flow) may predispose infants to feeding intolerance and to serious intestinal disease called necrotizing enterocolitis (NEC).
Read more
Patent ductus arteriosus (PDA) is a relatively common heart condition found in young preterm infants that can lead to decreased blood flow in different organs, including intestines. Thus, the determination of the presence or absence of PDA is an important part of the study, since it can be a relevant confounding variable.
In this study, the investigators will assess intestinal blood flow by using sonogram to measure velocity through the superior mesenteric artery (SMA), the artery supplying most of the intestine, both pre- and 45 minutes post feeding. The investigators will also use echocardiogram to determine the presence or absence of PDA. Each set of measurements will be done immediately before and after the transfusion, and again 24 and 48 hours after the transfusion.
Specific Hypothesis: The investigators hypothesize that infants will have attenuated postprandial blood flow velocities in immediate posttransfusion state when compared to the pretransfusion values. The investigators further hypothesize that normal, pretransfusion postprandial blood flow velocities will be achieved 48 hrs after the blood transfusion.
Read the detailed description
Necrotizing enterocolitis (NEC) is the death of intestinal tissue. It most often affects premature or sick babies. NEC occurs when the lining of the intestinal wall dies and the tissue falls off. NEC is a known complication of prematurity with high morbidity and mortality. About 7 to 13% of all very low birth weight infants admitted to Neonatal Intensive Care Units (NICU) develop NEC, with mortality ranging from 10 to 44% (1,2,3).
NEC is considered a multifactorial disorder converging on a common final clinical presentation associated with several etiologic mechanisms, including ischemia (eg reperfusion), infection (eg, gut colonization), mechanical injury (eg, viscosity, embolic), iatrogenic factors (eg catheters, excessive enteral feeding), and immunological barrier dysfunction (1,13,4,5) To date, there is no single, unifying consensus on causation (6).
Newly, the association between NEC and Packed Red Blood Cell (PRBC)transfusion has been a subject of recent debate. Several retrospective studies report increased incidence of NEC 22 hrs (7) or 48-72 hrs after PRBC transfusion (8) and increased odds of NEC development within 48 hrs posttransfusion (9). Singh, measuring the strength of association between the NEC and PRBC transfusion describes the association as strong < 24hrs, less strong < 48 hrs and absent at 96 hrs (10). Importantly, the majority of the infants in these studies were stable premature neonates on full enteral feeds, who decompensated and developed NEC after being transfused.
Based on poor or no evidence, many NICUs are implementing policy not to feed premature infants during the blood transfusion (11). A small recent prospective trial (8) reported decreased incidence of NEC (from 5.3 to 1.3%) when feeds are withheld during the transfusion. Similarly, the limited investigation of the superior mesenteric artery (blood vessel that supplies the greatest volume of blood to the intestinal tract) blood flow velocities (SMA BFV) revealed that the expected post-prandial increase in SMA BFV disappeared following the PRBC, placing the fed neonates receiving blood transfusion at higher risk for NEC (12).
This initial study had several major limitations, such as enrolling larger and more mature preterm neonates at lesser risk for PRBC transfusion related NEC, excluding infants with patent ductus arteriosus (PDA), common clinical condition in preterm neonates, losing 11 out of 22 patients for follow up studies (hence "normalization" of post-prandial blood flow velocities and finding potentially safe time point for feeds reintroduction could not be suggested by the study results) and using relatively less commonly transfused PRBC volumes over longer period of time.
In this study, the investigators intend to further their understanding of the hemodynamic consequences of PRBC transfusion in very low birth weight (VLBW) neonates by evaluating pre-and post-prandial SMA BFV in neonates who are not fed during the transfusion at different time points and correlate those with relevant clinical outcome measures. The investigators anticipate that the results from this study will be used by clinicians to help guide them in making decisions regarding the safety of administering PRBC transfusion in VLBW neonates.
- Conditions
- Intestinal Blood Flow
- Being tested
- ultrasound
- Keywords
- Transfusion, Neonate, Infant, Very Low Birth Weight, Patent Ductus Arteriosus, Packed Red Blood Cell
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundProcedure or surgery
sonographic evaluation of intestinal blood flow
| Study group | Role | What they receive |
|---|---|---|
| blood transfusion group | Not described Receives: Procedure: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing intestinal blood flow by comparing superior mesenteric artery velocities in preterm neonates before and after packed red blood cell transfusion using sonogram.
Prospective investigation of pre- and post-prandial (45 minutes after feeding completion) SMA BVF in preterm neonates before and after blood transfusion. The pretransfusion SMA BFV measurements (pre- and post-prandial) are done during the last feeding before the transfusion; the postransfusion SMA BFV (pre- and post-prandial) measurements are done during the first feeding immediately following the blood transfusion and again during the feedings 24 and 48 hrs after the transfusion (Total of 8 SMA BFV assessments).
Measured: Measurements are obtained both before and 45 minutes after feeding prior to transfusion; again before and after feeding after transfusion and again at 24 and 48 hours after the transfusion.
Secondary outcomes (1)
To determine whether packed red blood cell transfusion affects patent ductus arteriosus status of the subjects using Echocardiogram to determine the presence or absence of PDA.
Before each SMA BFV measurement prior to feeding, the investigators will determine the presence or absence of PDA, since the presence of PDA can affect SMA BFV (total of 4 PDA studies for each enrolled subject).
Measured: Each set of measurements will be done immediately before and after the transfusion, and again 24 and 48 hours 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 posted26 Jun 2012 (estimated)
- Study startDec 2011
- Primary completionAug 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Intestinal Blood FlowStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Pitzele, MD, St. Louis University
- Investigators
- Thomas Havranek, MD, Study director, Saint Louis University, Cardinal Glennon Children's HospitalAaron Pitzele, MD, Principal investigator, Saint Louis University, Cardinal Glennon Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628133
- Sponsor's protocol ID
- '20969
- Status last verified
- Jun 2014
- First submitted
- 1 Jun 2012
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stoll BJ. Epidemiology of necrotizing enterocolitis. Clin Perinatol. 1994 Jun;21(2):205-18. doi: 10.1016/S0095-5108(18)30341-5.
PubMed 8070222Luig M, Lui K; NSW & ACT NICUS Group. Epidemiology of necrotizing enterocolitis--Part II: Risks and susceptibility of premature infants during the surfactant era: a regional study. J Paediatr Child Health. 2005 Apr;41(4):174-9. doi: 10.1111/j.1440-1754.2005.00583.x.
PubMed 15813870Holman RC, Stoll BJ, Clarke MJ, Glass RI. The epidemiology of necrotizing enterocolitis infant mortality in the United States. Am J Public Health. 1997 Dec;87(12):2026-31. doi: 10.2105/ajph.87.12.2026.
PubMed 9431297La Gamma EF, Browne LE. Feeding practices for infants weighing less than 1500 G at birth and the pathogenesis of necrotizing enterocolitis. Clin Perinatol. 1994 Jun;21(2):271-306.
PubMed 8070227Uauy RD, Fanaroff AA, Korones SB, Phillips EA, Phillips JB, Wright LL. Necrotizing enterocolitis in very low birth weight infants: biodemographic and clinical correlates. National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1991 Oct;119(4):630-8. doi: 10.1016/s0022-3476(05)82418-7.
PubMed 1919897Obladen M. Necrotizing enterocolitis--150 years of fruitless search for the cause. Neonatology. 2009;96(4):203-10. doi: 10.1159/000215590. Epub 2009 Apr 29.
PubMed 19407465Mally P, Golombek SG, Mishra R, Nigam S, Mohandas K, Depalhma H, LaGamma EF. Association of necrotizing enterocolitis with elective packed red blood cell transfusions in stable, growing, premature neonates. Am J Perinatol. 2006 Nov;23(8):451-8. doi: 10.1055/s-2006-951300. Epub 2006 Sep 28.
PubMed 17009195El-Dib M, Narang S, Lee E, Massaro AN, Aly H. Red blood cell transfusion, feeding and necrotizing enterocolitis in preterm infants. J Perinatol. 2011 Mar;31(3):183-7. doi: 10.1038/jp.2010.157. Epub 2011 Jan 20.
PubMed 21252964Paul DA, Mackley A, Novitsky A, Zhao Y, Brooks A, Locke RG. Increased odds of necrotizing enterocolitis after transfusion of red blood cells in premature infants. Pediatrics. 2011 Apr;127(4):635-41. doi: 10.1542/peds.2010-3178. Epub 2011 Mar 14.
PubMed 21402638Singh R, Visintainer PF, Frantz ID 3rd, Shah BL, Meyer KM, Favila SA, Thomas MS, Kent DM. Association of necrotizing enterocolitis with anemia and packed red blood cell transfusions in preterm infants. J Perinatol. 2011 Mar;31(3):176-82. doi: 10.1038/jp.2010.145. Epub 2011 Jan 27.
PubMed 21273983Agwu JC, Narchi H. In a preterm infant, does blood transfusion increase the risk of necrotizing enterocolitis? Arch Dis Child. 2005 Jan;90(1):102-3. doi: 10.1136/adc.2004.051532. No abstract available.
PubMed 15613530Krimmel GA, Baker R, Yanowitz TD. Blood transfusion alters the superior mesenteric artery blood flow velocity response to feeding in premature infants. Am J Perinatol. 2009 Feb;26(2):99-105. doi: 10.1055/s-0028-1090595. Epub 2008 Nov 19.
PubMed 19021097Simmonds A, LaGamma EF. Addressing the
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Packed Red Blood Cell Transfusion and Intestinal Blood Flow in Preterm Infants
- ClinicalTrials.gov ID
- NCT01628133
- Acronym / sponsor ID
- '20969
- Conditions
- Intestinal Blood Flow
- Keywords
- Transfusion, Neonate, Infant, Very Low Birth Weight, Patent Ductus Arteriosus, Packed Red Blood Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Jun 2012 (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.
The purpose of the study is to determine whether packed red blood cell (PRBC) transfusion affects intestinal blood flow of premature infants during feedings and if so, whether return of normal intestinal blood flow pattern occurs within 48 hours of blood transfusion.
Abnormal intestinal responses to the feedings (insufficient postprandial blood flow increase in order to digest given feeding volume or overall decrease of intestinal blood flow) may predispose infants to feeding intolerance and to serious intestinal disease called necrotizing enterocolitis (NEC).
Patent ductus arteriosus (PDA) is a relatively common heart condition found in young preterm infants that can lead to decreased blood flow in different organs, including intestines. Thus, the determination of the presence or absence of PDA is an important part of the study, since it can be a relevant confounding variable.
In this study, the investigators will assess intestinal blood flow by using sonogram to measure velocity through the superior mesenteric artery (SMA), the artery supplying most of the intestine, both pre- and 45 minutes post feeding. The investigators will also use echocardiogram to determine the presence or absence of PDA. Each set of measurements will be done immediately before and after the transfusion, and again 24 and 48 hours after the transfusion.
Specific Hypothesis: The investigators hypothesize that infants will have attenuated postprandial blood flow velocities in immediate posttransfusion state when compared to the pretransfusion values. The investigators further hypothesize that normal, pretransfusion postprandial blood flow velocities will be achieved 48 hrs after the blood transfusion.
Detailed description
Necrotizing enterocolitis (NEC) is the death of intestinal tissue. It most often affects premature or sick babies. NEC occurs when the lining of the intestinal wall dies and the tissue falls off. NEC is a known complication of prematurity with high morbidity and mortality. About 7 to 13% of all very low birth weight infants admitted to Neonatal Intensive Care Units (NICU) develop NEC, with mortality ranging from 10 to 44% (1,2,3).
NEC is considered a multifactorial disorder converging on a common final clinical presentation associated with several etiologic mechanisms, including ischemia (eg reperfusion), infection (eg, gut colonization), mechanical injury (eg, viscosity, embolic), iatrogenic factors (eg catheters, excessive enteral feeding), and immunological barrier dysfunction (1,13,4,5) To date, there is no single, unifying consensus on causation (6).
Newly, the association between NEC and Packed Red Blood Cell (PRBC)transfusion has been a subject of recent debate. Several retrospective studies report increased incidence of NEC 22 hrs (7) or 48-72 hrs after PRBC transfusion (8) and increased odds of NEC development within 48 hrs posttransfusion (9). Singh, measuring the strength of association between the NEC and PRBC transfusion describes the association as strong < 24hrs, less strong < 48 hrs and absent at 96 hrs (10). Importantly, the majority of the infants in these studies were stable premature neonates on full enteral feeds, who decompensated and developed NEC after being transfused.
Based on poor or no evidence, many NICUs are implementing policy not to feed premature infants during the blood transfusion (11). A small recent prospective trial (8) reported decreased incidence of NEC (from 5.3 to 1.3%) when feeds are withheld during the transfusion. Similarly, the limited investigation of the superior mesenteric artery (blood vessel that supplies the greatest volume of blood to the intestinal tract) blood flow velocities (SMA BFV) revealed that the expected post-prandial increase in SMA BFV disappeared following the PRBC, placing the fed neonates receiving blood transfusion at higher risk for NEC (12).
This initial study had several major limitations, such as enrolling larger and more mature preterm neonates at lesser risk for PRBC transfusion related NEC, excluding infants with patent ductus arteriosus (PDA), common clinical condition in preterm neonates, losing 11 out of 22 patients for follow up studies (hence "normalization" of post-prandial blood flow velocities and finding potentially safe time point for feeds reintroduction could not be suggested by the study results) and using relatively less commonly transfused PRBC volumes over longer period of time.
In this study, the investigators intend to further their understanding of the hemodynamic consequences of PRBC transfusion in very low birth weight (VLBW) neonates by evaluating pre-and post-prandial SMA BFV in neonates who are not fed during the transfusion at different time points and correlate those with relevant clinical outcome measures. The investigators anticipate that the results from this study will be used by clinicians to help guide them in making decisions regarding the safety of administering PRBC transfusion in VLBW neonates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood transfusion group | – | Procedure: ultrasound |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm neonates (≤1500 grams of birth weight) of singleton and multiple births who are admitted to the NICU at Cardinal Glennon Children's Hospital and who are tolerating ≥ 20 ml/kg/day of feeding volume run over 30 minutes or less; both males and females of all ethnic groups. Very Low Birth Weight (VLBW) neonates will be studied since morbidities such as transfusion related acute gastrointestinal injury and/or necrotizing enterocolitis, PDA and feeding intolerance most frequently occur in this group. Because the need to ensure parental comprehension prior to consent documentation, parents who, in the judgement of the attending physician and/or research team members, do not have an adequate command of the English language will not be invited to participate in the study.
Key inclusion criteria (7 listed)
- birth weight ≤ 1500 gm
- singleton and multiple gestation
- small and appropriate birth weight for gestational age
- tolerance of ≥ 20 ml/kg/day of feeding volumes over 30 minutes or less
- at least 14 days of age and ≤ 35 6/7 weeks corrected gestational age at time of transfusion.
Key exclusion criteria (8 listed)
- major congenital or chromosomal anomalies
- presence of congenital heart disease (minus patent ductus arteriosus
- presence of shock
- presence of vasopressor use
- presence of severe lung 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 |
|---|---|---|
| ultrasoundsonographic evaluation of intestinal blood flow | Procedure or surgery | blood transfusion group |
Primary outcome
Assessing intestinal blood flow by comparing superior mesenteric artery velocities in preterm neonates before and after packed red blood cell transfusion using sonogram.
Time frame: Measurements are obtained both before and 45 minutes after feeding prior to transfusion; again before and after feeding after transfusion and again at 24 and 48 hours after the transfusion.
Prospective investigation of pre- and post-prandial (45 minutes after feeding completion) SMA BVF in preterm neonates before and after blood transfusion. The pretransfusion SMA BFV measurements (pre- and post-prandial) are done during the last feeding before the transfusion; the postransfusion SMA BFV (pre- and post-prandial) measurements are done during the first feeding immediately following the blood transfusion and again during the feedings 24 and 48 hrs after the transfusion (Total of 8 SMA BFV assessments).
1 secondary outcome
To determine whether packed red blood cell transfusion affects patent ductus arteriosus status of the subjects using Echocardiogram to determine the presence or absence of PDA.
Time frame: Each set of measurements will be done immediately before and after the transfusion, and again 24 and 48 hours after the transfusion.
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 20 Jun 2014.
- Background: PubMed 8070222Stoll BJ. Epidemiology of necrotizing enterocolitis. Clin Perinatol. 1994 Jun;21(2):205-18. doi: 10.1016/S0095-5108(18)30341-5.
- Background: PubMed 15813870Luig M, Lui K; NSW & ACT NICUS Group. Epidemiology of necrotizing enterocolitis--Part II: Risks and susceptibility of premature infants during the surfactant era: a regional study. J Paediatr Child Health. 2005 Apr;41(4):174-9. doi: 10.1111/j.1440-1754.2005.00583.x.
- Background: PubMed 9431297Holman RC, Stoll BJ, Clarke MJ, Glass RI. The epidemiology of necrotizing enterocolitis infant mortality in the United States. Am J Public Health. 1997 Dec;87(12):2026-31. doi: 10.2105/ajph.87.12.2026.
- Background: PubMed 8070227La Gamma EF, Browne LE. Feeding practices for infants weighing less than 1500 G at birth and the pathogenesis of necrotizing enterocolitis. Clin Perinatol. 1994 Jun;21(2):271-306.
- Background: PubMed 1919897Uauy RD, Fanaroff AA, Korones SB, Phillips EA, Phillips JB, Wright LL. Necrotizing enterocolitis in very low birth weight infants: biodemographic and clinical correlates. National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1991 Oct;119(4):630-8. doi: 10.1016/s0022-3476(05)82418-7.
- Background: PubMed 19407465Obladen M. Necrotizing enterocolitis--150 years of fruitless search for the cause. Neonatology. 2009;96(4):203-10. doi: 10.1159/000215590. Epub 2009 Apr 29.
- Background: PubMed 17009195Mally P, Golombek SG, Mishra R, Nigam S, Mohandas K, Depalhma H, LaGamma EF. Association of necrotizing enterocolitis with elective packed red blood cell transfusions in stable, growing, premature neonates. Am J Perinatol. 2006 Nov;23(8):451-8. doi: 10.1055/s-2006-951300. Epub 2006 Sep 28.
- Background: PubMed 21252964El-Dib M, Narang S, Lee E, Massaro AN, Aly H. Red blood cell transfusion, feeding and necrotizing enterocolitis in preterm infants. J Perinatol. 2011 Mar;31(3):183-7. doi: 10.1038/jp.2010.157. Epub 2011 Jan 20.
- Background: PubMed 21402638Paul DA, Mackley A, Novitsky A, Zhao Y, Brooks A, Locke RG. Increased odds of necrotizing enterocolitis after transfusion of red blood cells in premature infants. Pediatrics. 2011 Apr;127(4):635-41. doi: 10.1542/peds.2010-3178. Epub 2011 Mar 14.
- Background: PubMed 21273983Singh R, Visintainer PF, Frantz ID 3rd, Shah BL, Meyer KM, Favila SA, Thomas MS, Kent DM. Association of necrotizing enterocolitis with anemia and packed red blood cell transfusions in preterm infants. J Perinatol. 2011 Mar;31(3):176-82. doi: 10.1038/jp.2010.145. Epub 2011 Jan 27.
- Background: PubMed 15613530Agwu JC, Narchi H. In a preterm infant, does blood transfusion increase the risk of necrotizing enterocolitis? Arch Dis Child. 2005 Jan;90(1):102-3. doi: 10.1136/adc.2004.051532. No abstract available.
- Background: PubMed 19021097Krimmel GA, Baker R, Yanowitz TD. Blood transfusion alters the superior mesenteric artery blood flow velocity response to feeding in premature infants. Am J Perinatol. 2009 Feb;26(2):99-105. doi: 10.1055/s-0028-1090595. Epub 2008 Nov 19.
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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.
Thomas Havranek, MD study director
Saint Louis University, Cardinal Glennon Children's Hospital
Aaron Pitzele, MD principal investigator
Saint Louis University, Cardinal Glennon Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Blood Flow, run by St. Louis University at 1 site in United States.
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 7 inclusion and 8 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 20 Jun 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 United States. 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.
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?
Assessing intestinal blood flow by comparing superior mesenteric artery velocities in preterm neonates before and after packed red blood cell transfusion using sonogram. (time frame: Measurements are obtained both before and 45 minutes after feeding prior to transfusion; again before and after feeding after transfusion and again at 24 and 48 hours after the transfusion.). 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 NCT01628133, which also lists 13 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 20 Jun 2014.