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| [ Print-friendly version ] |
| 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 |
| ISRCTN | ISRCTN53107700 |
| ClinicalTrials.gov identifier | |
| Public title | 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 |
| Scientific title | |
| Acronym | LF+LGG/PRETERMS |
| Serial number at source | N/A |
| Study hypothesis |
To evaluate the efficacy of lactoferrin (LF) (alone, or in combination with lactobacillusGG [LGG]) in prevention of bacterial and fungal colonization and infection, and Necrotising EnteroColitis (NEC), in preterm very low birth weight (i.e., <1500 g at birth) infants in NICUs.
Disease/condition/study domain: 1. Colonization by Candida species 2. Invasive infection by Candida species 3. Colonization by bacterial (Gram+ and Gram-) species 4. Invasive infection by bacterial (Gram+ and Gram-) species 5. NEC (surgical stages) |
| Ethics approval | Ethical Committee of the Saint Anna Foundation (Fondazione Crescere Insieme al Santa Anna - ONLUS) on behalf of each participating institution. Approved on 18th 2007 June. |
| Study design | Multicentre prospective randomised double blind placebo controlled trial |
| Countries of recruitment | Italy |
| Disease/condition/study domain | Bacterial and fungal colonization and infection, and Necrotising EnteroColitis (NEC) in Very Low Birth Weight (VLBW) neonates. |
| Participants - 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. |
| Participants - 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 |
| Anticipated start date | 01/10/2007 |
| Anticipated end date | 31/07/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 219 |
| 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, Italy), to be started within the first 36 h of life: single administration (added to prepared milk or to 1 ml of a 5% glucose solution), daily for 4 or 6 weeks. Group B: Lactoferrin 100 mg (LF100®, Dicofarm spa, Italy), to be started within the first 36 h of life: single administration (added to prepared milk or to 1 ml of a 5% glucose solution), daily for 4 or 6 weeks. The regimen in the placebo group will be: Group C: Addition of 2 ml of 5% glucose solution to milk feeding, daily for 4 or 6 weeks. Six weeks (in infants with birth weight less than 1000 g, i.e. Extremely Low Birth Weight [ELBW]) and four weeks (in the infants with birth weight 1001 g to 1500 g) are chosen as the duration of therapy on the basis of the currently published data, unless earlier discharge. Neonates not feeding in the first 36 hours will receive the drug(s)/placebo by oral/naso-gastric tube and can be enrolled in the absence of gastric instability and/or repeated gastric residuals or vomit. If they repeatedly display gastric instability, gastric residuals or vomit, they may be enrolled at any point during the first week of life, depending on the first "efficacious" feedings. The day of life on which they first received the drugs(s)/placebo will be recorded in the database, and their statistics will be limited to the days of administration exposure to intervention. |
| Primary outcome measure(s) |
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 outcome measure(s) | No secondary outcome measures |
| Sources of funding | Dicofarm S.p.A. will supply the LF, the LGG and placebo, and will provide financial support with a grant, but will not be involved in the concept, design, enrolment, data collection, analysis and interpretation of its results, and decision inherent the publication of the results. |
| Trial website | |
| Publications | 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19809023 |
| Contact name | Dr Paolo Manzoni |
| Address |
Neonatology and Neonatal Intensive Care Unit
Saint Anna Hospital C. Spezia 60 |
| City/town | Torino |
| Zip/Postcode | 10126 |
| Country | Italy |
| manzonipaolo@hotmail.it | |
| Sponsor | Saint Anna Foundation (Fondazione Crescere Insieme al Santa Anna [ONLUS]) (Italy) |
| Address | Corso Spezia 60 |
| City/town | Torino |
| Zip/Postcode | 10126 |
| Country | Italy |
| d.farina@infinito.it | |
| Sponsor website: | http://www.fondazionesantanna.it/ |
| Date applied | 20/08/2007 |
| Last edited | 13/10/2009 |
| Date ISRCTN assigned | 06/09/2007 |
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