Necrotizing Enterocolitis Clinical Trial
Official title:
Splanchnic Oxygenation in Response to Enteral Feeds Before and After Red Blood Cell Transfusion in Preterm Infants
Since 1987, red blood cell (RBC) transfusions have been proposed as a potential risk factor
for necrotizing enterocolitis (NEC), which is one of the most severe gastrointestinal
complications of prematurity.
Evidence from Doppler studies have shown a post-transfusion impairment of mesenteric blood
flow in response to feeds, whereas NIRS studies have reported transient changes of splanchnic
oxygenation after RBC transfusion; a possible role for these findings in increasing the risk
for TANEC development has been hypothesized.
The aim of this study is to evaluate SrSO2 patterns in response to enteral feeding before and
after transfusion.
Premature neonates are among the most transfused population, but the risks and benefits of
this procedure remain unclear. Since 1987, red blood cell (RBC) transfusions have been
proposed as a potential risk factor for necrotizing enterocolitis (NEC), which is one of the
most common and feared gastrointestinal complications of prematurity. Several observational
studies have tried to demonstrate this causal correlation, defining the so-called
transfusion-associated NEC (TANEC), which occurs within 48 hours after RBC transfusion.
Evidence from Doppler studies have shown a post-transfusion impairment of mesenteric blood
flow in response to feeds, whereas NIRS studies have reported transient changes of splanchnic
oxygenation after RBC transfusion. This evidence, which has been hypothesized to play a role
on the risk of TANEC development, has significantly raised the attention over the feeding
plans during and after RBC transfusion.
To date, splanchnic oxygenation response to feeds before and after transfusion has not been
investigated, but could bring useful information to understand the splanchnic hemodynamic
changes associated to RBC transfusion.
Therefore, the aim of this study is to evaluate SrSO2 patterns in response to enteral feeding
before and after transfusion.
Enrolled infants will undergo a 12-h monitoring of cerebral (CrSO2) and splanchnic (SrSO2)
oxygenation, performed using an INVOS 5100 oxymeter (Medtronic, Boulder, CO), whose neonatal
sensors will be placed in the central region of the forehead and the below the umbilicus,
respectively.
The study monitoring includes the following phases:
- Phase 1 (0-3 hours): pre-transfusion feed and related post-prandial period
- Phase 2 (4-9 hours): RBC transfusion (10 ml/kg),administered over 3 hours, following
which feeds are hold for 3 hours.
- Phase 3 (10-12 hours): post-transfusion feed and related post-prandial period.
CrSO2 and SrSO2 patterns before and after transfusion and the related changes from baseline
values will be analyzed. SCOR (CrSO2/SrSO2 ratio) patterns will be also calculated and
analyzed. IBM SPSS Statistics (Statistical Package for the Social Sciences, SPSS Inc., IBM,
Armonk, NY) will be used for statistical analysis. If any infant develops TANEC after
transfusion, the related patterns will be evaluated and analyzed separately.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05544097 -
Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis
|
N/A | |
| Recruiting |
NCT03210831 -
Early Predictors of Necrotizing Enterocolitis in Neonates
|
||
| Not yet recruiting |
NCT06045130 -
PUFAs in Preterm Infants
|
||
| Recruiting |
NCT02552706 -
The Efficacy and Mechanisms of Oral Probiotics in Preventing Necrotizing Enterocolitis
|
N/A | |
| Completed |
NCT02400697 -
Placental Transfusion Project for Preterm Infants
|
N/A | |
| Completed |
NCT01751477 -
Infloran® for Prevention of Necrotizing Enterocolitis
|
N/A | |
| Terminated |
NCT01156480 -
Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants
|
N/A | |
| Completed |
NCT00787124 -
Transfusions and Nitric Oxide Level in Preterm Infants
|
||
| Unknown status |
NCT00254176 -
Cysteine Supplementation in Critically Ill Neonates
|
Phase 2/Phase 3 | |
| Recruiting |
NCT01441739 -
Intestinal Failure in Necrotising Enterocolitis
|
N/A | |
| Recruiting |
NCT03869827 -
Necrotizing Enterocolitis in Fetuses With Intrauterine Growth Restriction
|
||
| Recruiting |
NCT04074824 -
A Genome-Wide Association Study for Neonatal Diseases
|
||
| Terminated |
NCT03320785 -
Circulating Markers in Preterm Infants With Perinatal and Neonatal Inflammation
|
||
| Active, not recruiting |
NCT03554278 -
Alteration of Stool Microbiota in Preterm Infants With Anemia
|
||
| Not yet recruiting |
NCT04541771 -
The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants
|
Phase 2 | |
| Not yet recruiting |
NCT03700957 -
The Impact of Docosahexaenoic Acid on the Prevention of Necrotizing Enterocolitis in Preterm Neonates
|
N/A | |
| Completed |
NCT03551600 -
Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
|
||
| Unknown status |
NCT01807858 -
The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants
|
N/A | |
| Completed |
NCT01745510 -
Enteral Administration of Docosahexaenoic Acid to Prevent Necrotizing Enterocolitis in Preterm Neonates
|
Phase 1/Phase 2 | |
| Completed |
NCT01735578 -
Splanchnic Tissue Oxygenation During Enteral Feedings in Anemic Premature Infants at Risk for Necrotizing Enterocolitis
|
N/A |