drugset / Trial / NCT00854633
Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
RandomizedParallel-groupTriple-blindPrevention
Summary
This study will evaluate the safety, toxicity and efficacy of talactoferrin in reducing the incidence of all nosocomial infections in prematurely-born infants.
Timeline
- Start
- 2009-06
- Primary completion
- 2012-03
- Completion
- 2012-12
Outcome
Met primary endpoint
paper The rate of hospital-acquired infections was 50% lower in the TLf group compared with the placebo group (P < .04), PMID 27260839 ↗
Publications
- Sherman MP, Adamkin DH, Niklas V, Radmacher P, Sherman J, Wertheimer F, Petrak K. Randomized Controlled Trial of Talactoferrin Oral Solution in Preterm Infants. J Pediatr. 2016 Aug;175:68-73.e3. doi: 10.1016/j.jpeds.2016.04.084. Epub 2016 May 31.
- Sherman MP, Sherman J, Arcinue R, Niklas V. Randomized Control Trial of Human Recombinant Lactoferrin: A Substudy Reveals Effects on the Fecal Microbiome of Very Low Birth Weight Infants. J Pediatr. 2016 Jun;173 Suppl:S37-42. doi: 10.1016/j.jpeds.2016.02.074.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Talactoferrin alfa | Protein / enzyme biologic | 150 mg/kg | Other |