Anemia of PrematurityPhase 1NCT00167388
The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants
A Phase 1 study testing feed during blood transfusion in people with Anemia of Prematurity, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of the study is to see if a blood transfusion changes how fast blood flows to the intestines of a premature baby. Blood flow is measured by an ultrasound test. The investigators also look to see if the blood flow to the intestines depends on whether the baby feeds or doesn't feed during the blood… Read more about this study
- Who is it for?
- Ages 25 to 38 weeks
- Conditions the study is for
- Anemia of Prematurity
- What is being tested?
- feed during blood transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Nov 2006
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 38 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Singleton infants born at 25-32 weeks gestation who are < 38 weeks post-conceptual age at enrollment
- First infant of twin gestation born at 25-32 weeks gestation who requires a blood transfusion; if both infants require transfusion on the same day the larger infant will be enrolled.
- Receiving bolus enteral feeds [PO (bottle) and/or PE (feeding tube)] of at least 60 cc/kg/day
- A planned packed red blood cell transfusion, as per the clinical team, for anemia
- Infant is very likely to require a blood transfusion according to the attending neonatologist.
Who cannot join
- Known congenital anomalies of the heart, brain, kidneys or intestine
- Chromosomal abnormality
- Intrauterine growth restriction at < 3% for weight at birth since this has been shown to alter mesenteric BFV and the post-prandial hyperemia
- Twin to twin transfusion sequence
- Higher order multiples
- Patent ductus arteriosus known to be present or currently being treated
Show all 11Show fewer
- History of definite necrotizing enterocolitis Bell Stage 2 or greater
- Concurrent treatments with antibiotics or steroids
- Feeding intolerance, defined as gastric aspirate > 30% of feed volume on 3 sequential feeds
- Concurrent enrollment in another randomized trial
- Infants discharged or transferred to another facility without having received a PRBC transfusion will be excluded post-hoc.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: The Effect of Packed Red Blood Cell Transfusion on Superior Mesenteric Artery Blood Flow Velocity in Premature Infants After Feeding
The purpose of the study is to see if a blood transfusion changes how fast blood flows to the intestines of a premature baby. Blood flow is measured by an ultrasound test. The investigators also look to see if the blood flow to the intestines depends on whether the baby feeds or doesn't feed during the blood transfusion.
Read the detailed description
Currently a disparity exists among the NICU staff at Magee-Womens Hospital regarding whether premature infants should be fed during a blood transfusion. The effects of a blood transfusion on superior mesenteric artery blood flow velocity and the post-prandial hyperemia are not known.
We hypothesize that the post-prandial change in mesenteric blood flow velocity (BFV) will be the same before as after a packed red blood cell (PRBC) transfusion among anemic premature infants.
Sixty anemic infants (25-32 weeks GA, feeding >= 60 cc/kg/day) will undergo pre- and post-feed superior mesenteric artery Doppler studies both before and after a blood transfusion. Infants will be stratified by current weight into two groups (< 1250 grams and > 1250 grams). In each weight stratum the infants will be randomized to feeding or NPO during the PRBC transfusion. Randomization will be by block design, with block sizes ranging from two to six infants. The investigator performing the Doppler studies will remain masked to the feeding assignment of the infant.
The primary outcome for the study is the superior mesenteric artery blood flow velocity response to feeding between anemic and non-anemic states among premature infants. Our secondary outcome is the effect of feeding on BFV between anemic and non-anemic states in these infants. Statistical analysis will include paired and unpaired Student t-tests and regression analysis.
- Conditions
- Anemia of Prematurity
- Being tested
- feed during blood transfusion
- Keywords
- anemia, prematurity, blood flow velocity, superior mesenteric artery, intestinal blood flow in premature infants
- Medical subject headings
- Anemia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
feed during blood transfusionOther
babies receiving the intervention are fed during the PRBC transfusion
| Study group | Role | What they receive |
|---|---|---|
| group 1 | No intervention | All babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be NPO during the PRBC transfusion |
| group 2 | Active comparator | Babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion Receives: Other: feed during blood transfusion |
| group 3 | No intervention | All babies >1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion |
| group 4 | Experimental | All babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion Receives: Other: feed during blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States
Time-averaged mean and Peak systolic Doppler blood flow velocity in the mesenteric artery was measured before and after a feed when the baby was anemic (pre-PRBC transfusion) and then again when the baby was immediately post-transfusion
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anemia of PrematurityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Irene McLeneham Young Investigator Award through Magee Womens Research Institute
- Responsible party
- Principal investigator, Toby Yanowitz, University of Pittsburgh
- Investigators
- Gretchen Krimmel, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167388
- Sponsor's protocol ID
- 0404184
- Status last verified
- Apr 2017
- First submitted
- 9 Sep 2005
- Last updated
- 21 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Packed Red Blood Cell Transfusion on Superior Mesenteric Artery Blood Flow Velocity in Premature Infants After Feeding
- ClinicalTrials.gov ID
- NCT00167388
- Acronym / sponsor ID
- 0404184
- Conditions
- Anemia of Prematurity
- Keywords
- anemia, prematurity, blood flow velocity, superior mesenteric artery, intestinal blood flow in premature infants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Irene McLeneham Young Investigator Award through Magee Womens Research Institute
- Study start
- Sep 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Posted 21 Jul 2017
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 see if a blood transfusion changes how fast blood flows to the intestines of a premature baby. Blood flow is measured by an ultrasound test. The investigators also look to see if the blood flow to the intestines depends on whether the baby feeds or doesn't feed during the blood transfusion.
Detailed description
Currently a disparity exists among the NICU staff at Magee-Womens Hospital regarding whether premature infants should be fed during a blood transfusion. The effects of a blood transfusion on superior mesenteric artery blood flow velocity and the post-prandial hyperemia are not known.
We hypothesize that the post-prandial change in mesenteric blood flow velocity (BFV) will be the same before as after a packed red blood cell (PRBC) transfusion among anemic premature infants.
Sixty anemic infants (25-32 weeks GA, feeding >= 60 cc/kg/day) will undergo pre- and post-feed superior mesenteric artery Doppler studies both before and after a blood transfusion. Infants will be stratified by current weight into two groups (< 1250 grams and > 1250 grams). In each weight stratum the infants will be randomized to feeding or NPO during the PRBC transfusion. Randomization will be by block design, with block sizes ranging from two to six infants. The investigator performing the Doppler studies will remain masked to the feeding assignment of the infant.
The primary outcome for the study is the superior mesenteric artery blood flow velocity response to feeding between anemic and non-anemic states among premature infants. Our secondary outcome is the effect of feeding on BFV between anemic and non-anemic states in these infants. Statistical analysis will include paired and unpaired Student t-tests and regression analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 | No intervention | –All babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be NPO during the PRBC transfusion |
| group 2 | Active comparator | Other: feed during blood transfusionBabies <1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion |
| group 3 | No intervention | –All babies >1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion |
| group 4 | Experimental | Other: feed during blood transfusionAll babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion |
Who may qualify
- Ages
- 25 to 38 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Singleton infants born at 25-32 weeks gestation who are < 38 weeks post-conceptual age at enrollment
- First infant of twin gestation born at 25-32 weeks gestation who requires a blood transfusion; if both infants require transfusion on the same day the larger infant will be enrolled.
- Receiving bolus enteral feeds [PO (bottle) and/or PE (feeding tube)] of at least 60 cc/kg/day
- A planned packed red blood cell transfusion, as per the clinical team, for anemia
- Infant is very likely to require a blood transfusion according to the attending neonatologist.
Key exclusion criteria (11 listed)
- Known congenital anomalies of the heart, brain, kidneys or intestine
- Chromosomal abnormality
- Intrauterine growth restriction at < 3% for weight at birth since this has been shown to alter mesenteric BFV and the post-prandial hyperemia
- Twin to twin transfusion sequence
- Higher order multiples
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 |
|---|---|---|
| feed during blood transfusionbabies receiving the intervention are fed during the PRBC transfusion | Other | group 2, group 4 |
Primary outcome
Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States
Time frame: 1 hour
Time-averaged mean and Peak systolic Doppler blood flow velocity in the mesenteric artery was measured before and after a feed when the baby was anemic (pre-PRBC transfusion) and then again when the baby was immediately post-transfusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Gretchen Krimmel, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing feed during blood transfusion in people with Anemia of Prematurity, run by University of Pittsburgh 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 5 inclusion and 11 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 21 Jul 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States (time frame: 1 hour). 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 21 Jul 2017.