Feeding During Transfusion, Necrotising Enterocolitis, Transfusion, Transfusion Related Acute Gut Injury
Conditions
Keywords
transfusion, feeding, TRAGI, NEC
Brief 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. 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.
Interventions
OTHERWithholding feeds
At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded
OTHERfeeding during transfusion
The feeding process will be continued during the transfusion
Sponsors
Zekai Tahir Burak Women's Health Research and Education Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Days to 3 Months
Healthy volunteers
No
Inclusion criteria
* \<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.
Exclusion criteria
* Babies with severe sepsis signs. * Babies with severe hypoxia and asphyxia. * Babies with congenital anomaly or complex cardiac anomaly.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| increase in the abdominal circumference | 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) |
Secondary
| Measure | Time frame |
|---|---|
| increase in the amounts of gastric residual aspirates | Within 3 days after the transfusion |
Other
| Measure | Time frame |
|---|---|
| occult or obvious blood in stool | within 1 day after transfusion |
Countries
Turkey (Türkiye)
Contacts
Primary ContactSuzan Sahin, MD
Outcome results
None listed