Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

Neonatal Sepsis Clinical Trial

Official title:

Systematic Randomized , Single Blinded, Placebo-Controlled Trial of Early Versus Late Lactoferrin in Prevention of Neonatal Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02959229
• Other study ID #: FMASU M.S 23/2016
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2016
• Last updated: November 5, 2016
• Start date: August 2014
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and PopulationEgypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

The present study was designed to evaluate the effectiveness of oral lactoferrin in prevention of neonatal sepsis with comparison early (1st day) versus late (48-72 hours) Lactoferrin administration, Secondary aim was to study effect of Lactoferrin administration on serum Ferritin and follow up long term outcome (Bronchopulmonary dysplasia, retinopathy of prematurity and necrotizing enterocolitis.

Description:

This study was carried out on 180 preterm neonates(< 37 weeks of gestation counting from the first day of the Last Menstrual Period and confirmed by Ballard score) admitted to the Neonatal Intensive Care Units of Ain Shams University Hospitals in the period from August 2014 to December 2015.

Enrolled subjects were further randomly subdivided into three groups according to the dose regimen of Lactoferrin supplementation.

• Group A: (60 preterm neonates) who received oral Lactoferrin supplementation in a dose of 100 mg/day starting on day 1 and continue for 4-6 weeks.

• Group B: (60 preterm neonates) who received oral Lactoferrin supplementation in a dose of 100 mg/day starting on day 3 (48hrs-72hrs) of life and continue for 4-6 weeks.

• Group C: (60 preterm neonates) who match the subjected neonates, received placebo in form of distilled water.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

Inclusion Criteria:

1. Neonates with a < 37 weeks of gestation counting from the first day of the Last Menstrual Period.

2. Preterm neonates are breast fed, artificially fed or on total parenteral nutrition.

3. Preterm neonates born in, or referred to our Neonatal Intensive Care Unit in the first day of life free from infection and not fed.

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 with early onset sepsis.

6. Neonates whose parents decline to participate.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neonatal Sepsis
• Sepsis
• Toxemia

Intervention

Drug:
• Lactoferrin

• Placebo (for Lactoferrin)
placebo in form of distilled water

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

References & Publications (2)

Kaur G, Gathwala G. Efficacy of Bovine Lactoferrin Supplementation in Preventing Late-onset Sepsis in low Birth Weight Neonates: A Randomized Placebo-Controlled Clinical Trial. J Trop Pediatr. 2015 Oct;61(5):370-6. doi: 10.1093/tropej/fmv044. — View Citation

Manzoni P, Meyer M, Stolfi I, Rinaldi M, Cattani S, Pugni L, Romeo MG, Messner H, Decembrino L, Laforgia N, Vagnarelli F, Memo L, Bordignon L, Maule M, Gallo E, Mostert M, Quercia M, Bollani L, Pedicino R, Renzullo L, Betta P, Ferrari F, Alexander T, Magaldi R, Farina D, Mosca F, Stronati M. Bovine lactoferrin supplementation for prevention of necrotizing enterocolitis in very-low-birth-weight neonates: a randomized clinical trial. Early Hum Dev. 2014 Mar;90 Suppl 1:S60-5. doi: 10.1016/S0378-3782(14)70020-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effectiveness of oral Lactoferrin in prevention of neonatal sepsis according to Tollner score, hematological scoring system (HSS) and positive blood culture.		4-6 weeks of life	No
Primary	Compare early (1st day) versus late (48-72 hours) Lactoferrin administration on neonatal sepsis according to Tollner score, hematological scoring system (HSS) and positive blood culture		4-6 weeks of life	No
Secondary	Effect of Lactoferrin supplementation on long term complications	Long term complications as: Broncho-Pulmonary Dysplasia using clinical symptoms and signs and chest X ray findings.; Retinopathy of Prematurity using the International Classification of Retinopathy of Prematurity (ICROP).; Necrotizing Enterocolitis using Modified Bell's criteria for staging Necrotizing Enterocolitis.	4-6 weeks of life	No
Secondary	any reported side effects for Bovine Lactoferrin		4-6 weeks of life	Yes