Clinical trial NCT04886674: Bovine Colostrum in Prevention of Necrotizing Enterocolitis and Sepsis in Very Low Birth Weight Neonates
Official title: Bovine Colostrum in Prevention of Necrotizing Enterocolitis and Sepsis in Very Low Birth Weight Neonates: a Prospective Study at Neonatology Unit of Children's Hospital Assiut University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NEC
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 65
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The neonates will receive the colostrum in a dose of 2 g/dose for the 1000-1500 g stratum and 1.2 g/dose for \< 1000 g stratum, four times a day until discharge or death or day 21 of life, whichever is earlier.

Brief summary: Primary Aim: The aim of this study is to investigate the efficacy of bovine colostrum in prevention of necrotizing enterocolitis (NEC) and sepsis in very low birth weight (VLBW) infants.

Secondary Aim: To improve outcomes of neonatal sepsis and NEC in the pe-terrms and to decrease their hospital stay.

Detailed description: Necrotizing enterocolitis (NEC) primarily occurs in premature and very low birth weight (VLBW) babies, the incidence varying from 5 to 10% in various neonatal intensive care unit (NICUs) .

Many researchers believe that an exaggerated inflammatory response mounted by immature intestinal epithelial cells in response to abnormal intestinal colonization plays a vital role in the pathogenesis of NEC and bacteria belonging to Enterobacteriaceae have often been linked to NEC .

Colonization with commensal bacteria soon after birth is essential for the development of normal intestinal function however, this process is often altered in premature babies in NICUs, leading to colonization with pathogenic bacteria .

Commercially available bovine colostrum has high concentrations of anti-infective factors such as immunoglobulins, lactoferrin, organism-specific antibodies, lactoperoxidase, insulin-like growth factors and transforming growth factors.

These components have substantial homology to their human counterparts . Bovine colostrums has been tried in the treatment of Escherichia coli and Shigella and Rotavirus diarrhea in children, Helicobacter pylori infection in children and E. coli intestinal infection in term and preterm neonates.

No major adverse effects were reported in any of the studies using bovine colostrum in infants and preterm babies .

In an in vitro study, the authors showed that bovine colostrum significantly reduces the adherence of various Enterobacteriaceae species known to be associated with NEC to human intestinal epithelial cells .

A randomized controlled trial has shown that the use of bovine lactoferrin reduced the incidence of neonatal sepsis .

Till date, there are no studies in neonates on the use of bovine colostrum for the prevention of NEC.

Eligibility criteria: Inclusion Criteria:

* Babies with birth weight ≤ 1500 g

Exclusion Criteria:

* Babies who have any contraindication for initiating milk feeds; who will fail to achieve adequate feed volume to be able to administer the study drug.
* Those with suspected/ proven gastrointestinal malformations.
* Preexisting sepsis (definite or suspect) or NEC at the time of enrollment.
* Those with a family history of an inborn error metabolism (that precludes exposure to proteins/lactose).

Primary outcomes:
measure: The primary outcome will be definite NEC
timeFrame: baseline
Secondary outcomes:
measure: Descriptive statistics will be used for describing baseline variables.Dichotomous outcomes will be compared by Chi square test with continuity correction or Fisher's Exact as applicable.
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
citation: Thompson AM, Bizzarro MJ. Necrotizing enterocolitis in newborns: pathogenesis, prevention and management. Drugs. 2008;68(9):1227-38. doi: 10.2165/00003495-200868090-00004.
citation: Grave GD, Nelson SA, Walker WA, Moss RL, Dvorak B, Hamilton FA, Higgins R, Raju TN. New therapies and preventive approaches for necrotizing enterocolitis: report of a research planning workshop. Pediatr Res. 2007 Oct;62(4):510-4. doi: 10.1203/PDR.0b013e318142580a.
citation: Hoy CM, Wood CM, Hawkey PM, Puntis JW. Duodenal microflora in very-low-birth-weight neonates and relation to necrotizing enterocolitis. J Clin Microbiol. 2000 Dec;38(12):4539-47. doi: 10.1128/JCM.38.12.4539-4547.2000.
citation: Peter CS, Feuerhahn M, Bohnhorst B, Schlaud M, Ziesing S, von der Hardt H, Poets CF. Necrotising enterocolitis: is there a relationship to specific pathogens? Eur J Pediatr. 1999 Jan;158(1):67-70. doi: 10.1007/s004310051012.
citation: Hoy C, Millar MR, MacKay P, Godwin PG, Langdale V, Levene MI. Quantitative changes in faecal microflora preceding necrotising enterocolitis in premature neonates. Arch Dis Child. 1990 Oct;65(10 Spec No):1057-9. doi: 10.1136/adc.65.10_spec_no.1057.