Prophylaxis with lactoferrin and lactobacillusGG in Very Low Birth Weight (VLBW) neonates in Neonatal Intensive Care Unit (NICU): a double-blind, multicentre, placebo-controlled, randomised trial

Conditions

Bacterial and fungal colonization and infection, and Necrotising EnteroColitis (NEC) in Very Low Birth Weight (VLBW) neonates Neonatal Diseases

Manzoni P, García Sánchez R, Meyer M, Stolfi I, Pugni L, Messner H, Cattani S, Betta PM, Memo L, Decembrino L, Bollani L, Rinaldi M, Fioretti M, Quercia M, Maule M, Tavella E, Mussa A, Tzialla C, Laforgia N, Mosca F, Magaldi R, Mostert M, Farina D, Italian Task Force for the Study, and Prevention of Neonatal Fungal Infections and the Italian Society of Neonatology.

2017-12-0128 citations

10.1016/j.jpeds.2017.09.080

Bovine lactoferrin supplementation for prevention of necrotizing enterocolitis in very-low-birth-weight neonates: a randomized clinical trial.

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.

2014-03-01134 citations

10.1016/s0378-3782(14)70020-9

Bovine lactoferrin supplementation for prevention of late-onset sepsis in very low-birth-weight neonates: a randomized trial.

Manzoni P, Rinaldi M, Cattani S, Pugni L, Romeo MG, Messner H, Stolfi I, Decembrino L, Laforgia N, Vagnarelli F, Memo L, Bordignon L, Saia OS, Maule M, Gallo E, Mostert M, Magnani C, Quercia M, Bollani L, Pedicino R, Renzullo L, Betta P, Mosca F, Ferrari F, Magaldi R, Stronati M, Farina D, Italian Task Force for the Study and Prevention of Neonatal Fungal Infections, Italian Society of Neonatology.

2009-10-01358 citations

10.1001/jama.2009.1403

Interventions

The regimens in the two intervention groups will be: Group A: LactobacillusGG, 6 x 109 Colony-Forming Units (CFU)/day (Dicoflor 60®, Dicofarm spa, Italy) plus Lactoferrin 100 mg (LF100®, Dicofarm spa,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All neonates with birth weight <1500 g (i.e. VLBW) born within the study period, whether at one of the eighteen participating institutions or elsewhere, were eligible for the study.

Exclusion criteria

Exclusion criteria: 1. Parental refusal 2. Admission after 12 hours of life 3. Death prior to 72 hours of life 4. Ongoing systemic antifungal management 5. Ongoing antifungal prophylaxis

Design outcomes

Primary

Measure	Time frame
Evaluation of the effectiveness of LF (alone, or in combination with the probiotic LGG) compared to placebo in the prevention of Bacterial and fungal colonization and infection, and of necrotizing enterocolitis (NEC), in the preterm very low birth weight neonates admitted to the participant NICUs. This will be based on the following outcome measures: 1. Assessment of the incidence of Gram-positive , Gram-negative and Candida sepsis prior to discharge 2. Mortality (overall, bacterial sepsis- and Candida-attributable) prior to discharge 3. Rate of progression from fungal colonization to fungal infection prior to discharge 4. Ligation of patent ductus arteriosus prior to discharge 5. Threshold retinopathy of prematurity requiring surgery at discharge 6. Severe (grade 3-4) intraventricular haemorrhage at discharge 7. Bronchopulmonary dysplasia at discharge 8. Incidence of organ locations (major complications) in infected patients prior to discharge 9. Absence of changes in the relative frequencies of the various Candida sub-species isolated at discharge	—

Measure

Time frame

Evaluation of the effectiveness of LF (alone, or in combination with the probiotic LGG) compared to placebo in the prevention of Bacterial and fungal colonization and infection, and of necrotizing enterocolitis (NEC), in the preterm very low birth weight neonates admitted to the participant NICUs. This will be based on the following outcome measures: 1. Assessment of the incidence of Gram-positive , Gram-negative and Candida sepsis prior to discharge 2. Mortality (overall, bacterial sepsis- and Candida-attributable) prior to discharge 3. Rate of progression from fungal colonization to fungal infection prior to discharge 4. Ligation of patent ductus arteriosus prior to discharge 5. Threshold retinopathy of prematurity requiring surgery at discharge 6. Severe (grade 3-4) intraventricular haemorrhage at discharge 7. Bronchopulmonary dysplasia at discharge 8. Incidence of organ locations (major complications) in infected patients prior to discharge 9. Absence of changes in the relative frequencies of the various Candida sub-species isolated at discharge

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

Italy

Outcome results

None listed