Safety and Efficacy of Oral Bovine Lactoferrin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-03-02

Brief Summary

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Oral lactoferrin versus Placebo will be given to preterm neonates

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Detailed Description

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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.

Conditions

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Neonatal SEPSIS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

placebo group 100 patient will receive 2 ml saline for one month in comparison with oral lactoferrin for the same period to another 100 patient

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Follow up of the patients with CRP and different cultures.

Study Groups

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placebo

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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

placebp is given in 2 ml saline

lacoferrin

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

Group Type ACTIVE_COMPARATOR

Lactoferrin

Intervention Type DRUG

lactoferrin is given orally in comparsion to placebp

Interventions

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Lactoferrin

lactoferrin is given orally in comparsion to placebp

Intervention Type DRUG

Placebos

placebp is given in 2 ml saline

Intervention Type DRUG

Other Intervention Names

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Pravotin sachets saline

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes