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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53107700 |
| Secondary identifying numbers | N/A |
- Submission date
- 20/08/2007
- Registration date
- 06/09/2007
- Last edited
- 15/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Paolo Manzoni
Scientific
Scientific
Neonatology and Neonatal Intensive Care Unit
Saint Anna Hospital
C. Spezia 60
Torino
10126
Italy
| manzonipaolo@hotmail.it |
Study information
| Study design | Multicentre prospective randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific 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 |
| Study acronym | LF+LGG/PRETERMS |
| Study objectives | 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(s) | Ethical Committee of the Saint Anna Foundation (Fondazione Crescere Insieme al Santa Anna - ONLUS) on behalf of each participating institution, 18/06/2007 |
| Health condition(s) or problem(s) studied | Bacterial and fungal colonization and infection, and Necrotising EnteroColitis (NEC) in Very Low Birth Weight (VLBW) neonates |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | LactobacillusGG , lactoferrin |
| Primary outcome measure | 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 measures | No secondary outcome measures |
| Overall study start date | 01/10/2007 |
| Completion date | 31/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 219 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 31/07/2008 |
Locations
Countries of recruitment
- Italy
Study participating centre
Saint Anna Hospital
Torino
10126
Italy
10126
Italy
Sponsor information
Saint Anna Foundation (Fondazione Crescere Insieme al Santa Anna [ONLUS]) (Italy)
Charity
Charity
Corso Spezia 60
Torino
10126
Italy
| d.farina@infinito.it | |
| Website | http://www.fondazionesantanna.it/ |
"ROR" |
https://ror.org/00k065b17 |
Funders
Funder type
Industry
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.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 07/10/2009 | Yes | No | |
| Results article | results | 01/01/2012 | Yes | No | |
| Results article | results | 01/03/2014 | Yes | No | |
| Other publications | secondary analysis | 01/02/2018 | Yes | No |
Editorial Notes
15/02/2018: Publication reference added.
