Safety and Efficacy of Oral Bovine Lactoferrin

Cairo University (CU)

Status and phase: Completed; Early Phase 1

Conditions: Neonatal SEPSIS

Treatments: Drug: Lactoferrin; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT04094597

01525316 (Registry Identifier)

Abu Elrich children hospital

Details and patient eligibility

About

Oral lactoferrin versus Placebo will be given to preterm neonates

Full description

200 patient were included in the study , one hundred received oral placebo in the form of 2 ml saline , the other 100 preterm neonates received oral lactoferrin with monitoring of C-reactive protein , different cultures, complete blood count on day 7 and after one month.

Enrollment: 200 patients

Sex: All

Ages: 1 to 7 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

All neonates born at Cairo university hospital NICU

Exclusion criteria

• Neonatal deaths before 3 days postnatal .
• Neonates with underlying gastrointestinal problems that prevent oral intake.
• Neonates with major congenital anomalies .
• Neonates with severe hypoxic ischemic encephaloapathy .
• Neonates whose parents refuse to participate.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

saline is given orally in dose of 2 ml per day for one month

Treatment:

Drug: Placebos

lacoferrin

Active Comparator group

Description:

Pravotin is given orally 100 mg per sachet dissolved in 5 ml water given for one month

Treatment:

Drug: Lactoferrin