Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate

Neonatal Sepsis Clinical Trial

Official title:

Oral Lactoferrin Supplementation for Prevention of Sepsis in Preterm Neonate.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01821989
• Other study ID #: moos80
• Status: Not yet recruiting
• Phase: Phase 0
• First received: March 27, 2013
• Last updated: May 8, 2014
• Start date: June 2013

Study information

• Verified date: May 2014
• Source: Mooselmokadem
• Contact: Mostafa AM Elmokadem, Master
• Phone: 01110857100
• Email: drmooselmokadem[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ain Shams university
• Study type: Interventional

Clinical Trial Summary

Hypothesis:

Orally ingested lactoferrin has effects on promotion of growth and differentiation of the immature gut; also it has immunomodulatory properties, so it will prevent serious infections in preterm infants.

The aim of the study is to:

• Evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis.

• Compare two dose regiment of lactoferrin supplementation.

• Study effect of lactoferrin supplementation on serum iron stores.

It is a prospective, randomized, double blind, placebo-controlled study, it will include 180 preterm neonates admitted to the Neonatal Intensive Care Units of of Ain Shams University Hospitals and Manshiet El Bakry Hospital.

•Group A: Who will receive oral lactoferrin supplementation in a dose of 100 mg/day.

•Group B: Who will receive oral lactoferrin supplementation in a dose of 150 mg/kg/ twice daily.

•Group C (Controls): Who match the subjected neonates, will receive placebo in form of distilled water.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

1. Neonates with a birth weight between 500g and 2500g.

2. Neonates with a = 36 weeks of gestation counting from the first day of the Last Menstrual Period.

3. Preterm neonates born in, or referred to the Neonatal Intensive Care Units of one of the participating hospitals in the first 48 hours of life.

Exclusion Criteria:

1. Neonates with underlying gastrointestinal problems that prevent oral intake.

2. Neonates with predisposing conditions that profoundly affect growth and development (chromosomal abnormalities, structural brain anomalies, severe congenital abnormalities).

3. Neonates with a family background of cow milk allergy.

4. Neonates who will not have the chance to complete the study time (who will be referred to another hospitals).

5. Neonates whose parents decline to participate.

6. Neonates with early onset sepsis.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neonatal Sepsis
• Sepsis

Intervention

Dietary Supplement:
• Lactoferrin
dose of 100 mg/day
• Lactoferrin
dose of 150 mg/kg/ twice daily
• Placebo
in form of distilled water

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo	Abassia

Sponsors (1)

Lead Sponsor	Collaborator
Mooselmokadem

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	C reactive protein quantitative assay		2 years	No
Primary	Blood culture		2 years	No
Secondary	Complete blood count with differential leucocytic count.		2 years	Yes