Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01628133 · ClinicalTrials.gov registry record
Packed Red Blood Cell Transfusion and Intestinal Blood Flow in Preterm Neonates
A clinical trial, sponsored by St. Louis University.
- Completed
- Registry status
- 25
- Enrollment target
NCT01628133: Completed study, sponsored by St. Louis University.
NCT01628133 is a clinical trial that has completed, run by St. Louis University. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01628133 has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- 25 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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
Interventions
- PROCEDURE ultrasound
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-01 |
What the finished NCT01628133 record still lists
NCT01628133 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which ultrasound is the first listed.
NCT01628133 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01628133 about?
NCT01628133 is a clinical study titled "Packed Red Blood Cell Transfusion and Intestinal Blood Flow in Preterm Neonates". 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 t...
What is the current status of trial NCT01628133?
This trial is currently completed. The enrollment target is 25 participants. The study started on 2011-12. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01628133?
The interventions under investigation include: ultrasound (PROCEDURE).
Who is sponsoring clinical trial NCT01628133?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01166854 · 25 participants
Characterization of Familial Myopathy and Paget Disease of Bone
- NCT01913106 · 25 participants · Phase 1
HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer
- NCT02138669 · 25 participants · NA
Intacs Prescription Inserts for Keratoconus Patients
- NCT02174549 · 25 participants · Phase 1
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia