The aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin (LF) to very low birth weight infants reduces late onset sepsis and necrotising enterocolitis and the effect of LF on regulatory T cells.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
60
Bovine lactoferrin 200 mg/daily, given with either human milk or preterm formula
Ankara University School of Medicine Department of Pediatrics, NICU
Ankara, Turkey (Türkiye)
late onset sepsis
The effect of oral Lactoferrin prophylaxis on the number of culture proven sepsis attacks in very low birth weight infants during their hospitalization in neonatal intensive care unit. Sterile blood, urine and cerebrospinal fluid samples will be obtained in case of clinical symptoms of sepsis for culture.
Time frame: from birth to discharge from NICU
Necrotising enterocolitis
The effect of oral Lactoferrin prophylaxis on severe necrotising enterocolitis (NEC) (Bell's stage 2 and 3) in very low birth infants during the hospitalization period in Neonatal intensive care unit. In case of feeding intolerance, abdominal distention and findings of ileus with clinical deterioration, patient will be evaluated for thrombocytopenia, metabolic acidosis, hyponatremia, blood in stool and radiological findings of NEC. Staging will be performed with clinical, laboratory and radiological findings.
Time frame: from birth to discharge from NICU
Effect on T regulatory cells
FOXP3 expression on CD4+CD25+ T cells
Time frame: at discharge
Safety of lactoferrin in VLBW infants
the effect oral lactoferrin use on feeding tolerance, abdominal distension, vomiting and gastric residuals
Time frame: during the oral use of lactoferrin
duration of hospitalization
the effect of oral lactoferrin on the duration of hospitalization
Time frame: from birth to discharge from neonatal intensive care unit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.