Late Onset Neonatal Sepsis, Necrotising Enterocolitis, Very Low Birth Weight Infants
Conditions
Keywords
VLBW, NEC, Late onset sepsis
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLactoferrin (bovine origin)
Bovine lactoferrin 200 mg/daily, given with either human milk or preterm formula
Sponsors
Ankara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
15 Minutes to 1 Days
Healthy volunteers
No
Inclusion criteria
* Inborn infants * Gestational age \< 32 weeks * Birth weight \< 1500 g * Parental consent
Exclusion criteria
* Congenital abnormalities * Severe perinatal asphyxia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| late onset sepsis | from birth to discharge from NICU | 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. |
| Necrotising enterocolitis | from birth to discharge from NICU | 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. |
| Effect on T regulatory cells | at discharge | FOXP3 expression on CD4+CD25+ T cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of lactoferrin in VLBW infants | during the oral use of lactoferrin | the effect oral lactoferrin use on feeding tolerance, abdominal distension, vomiting and gastric residuals |
| duration of hospitalization | from birth to discharge from neonatal intensive care unit | the effect of oral lactoferrin on the duration of hospitalization |
Countries
Turkey (Türkiye)
Outcome results
None listed