The efficacy of probiotics for prevention of necrotising enterocolitis in very low birth weight infants: a randomised clinical trial
| ISRCTN | ISRCTN67165178 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67165178 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/08/2007
- Registration date
- 17/08/2007
- Last edited
- 02/02/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Taciana Duque-Braga
Scientific
Scientific
IMIP - UTI Neonatal
Rua dos Coelhos, 300
Recife
50070-550
Brazil
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Necrotising enterocolitis is an inflammatory bowel disease. It is the most common gastrointestinal emergency in neonates mainly associated with prematurity and inappropriate gastrointestinal colonisation by bacteria. The study hypothesis is that the use of probiotics - Lactobacillus casei and Bifidobacterium breve - will have a positive impact on very low birth weight infants related to: 1. The reduction of the risk of necrotising enterocolitis 2. The reduction of the time span to reach the full enteral intake 3. The reduction of pathogenic bacteria in the faeces culture |
| Ethics approval(s) | Ethical Committee in Research of the Institute for Maternal/Infant Health (Instituto Materno Infantil de Pernambuco [IMIP]) (Brazil) (c/o Prof Fernando Figueira) approved in August 2006. |
| Health condition(s) or problem(s) studied | Necrotising enterocolitis in very low birth weight infants. |
| Intervention | The participants will be randomised into two groups of 315 infants: Control group: 3 ml of pasteurised human milk once a day on the second to the 30th day of life, or at the discharge if it happens before the 30th day. Intervention group: Lactobacillus casei and Bifidobacterium breve (Yakult - LB) diluted with 3 ml of pasteurised human milk once a day on the second to the 30th day of life, or at the discharge if it happens before the 30th day. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Probiotics (Lactobacillus casei and Bifidobacterium breve) |
| Primary outcome measure | To compare the frequency of the necrotising enterocolitis classified as higher or equal to 2 according to Bells criteria modified by Walsh and Kleigman during the first 30 days of life. |
| Secondary outcome measures | 1. To compare the frequency of pathogenic bacteria in the faeces tested weekly during the first month of life, in neonates treated with or without antibiotics; collecting stool samples (rectal swab) on 1, 7, 14 and 30 days of life, under sterile conditions and immediately transported to the bacteriology laboratory situated in the same building for processing 2. To compare the duration of birth weight recovery; assessment of the weight of the infants daily during the hospital stay 3. To compare the time taken to reach full enteral feeds - defined as a daily intake of 120 ml/Kg; across the diary registration of the enteral feeds volumes during the hospital stay 4. To compare the duration of hospital stay; the time between the admission and the discharge |
| Overall study start date | 01/09/2007 |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Not Specified |
| Target number of participants | 630 |
| Key inclusion criteria | Infants with birth weight from 750 g to 1500 g admitted in the Neonatal intensive Care Unit of the Institute for Maternal/Infant Health (Instituto Materno Infantil de Pernambuco [IMIP]). |
| Key exclusion criteria | 1. Newborns with severe congenital malformations 2. Newborns with severe chromosomal abnormalities |
| Date of first enrolment | 01/09/2007 |
| Date of final enrolment | 01/05/2009 |
Locations
Countries of recruitment
- Brazil
Study participating centre
IMIP - UTI Neonatal
Recife
50070-550
Brazil
50070-550
Brazil
Sponsor information
Institute for Maternal/Infant Health (Instituto Materno Infantil de Pernambuco [IMIP]) (Brazil)
Hospital/treatment centre
Hospital/treatment centre
Rua dos Coelhos
300 - Boa Vista
Recife
50070-550
Brazil
| Website | http://www.imip.org.br/ |
|---|---|
"ROR" |
https://ror.org/01rtyyz33 |
Funders
Funder type
Government
Laboratorio Yakult (www.yakultfarma.com.br) (Brazil) - providing the probiotics treatments
No information available
Institute for Maternal/Infant Health (Instituto Materno Infantil [IMIP]) (Brazil) - c/o Prof Fernando Figueira, where study and assessments will be carried out
No information available
The National Council of Scientific and Technologic Development (CNPq) (Brazil) - granted financial support to the research project
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 | 01/01/2011 | Yes | No |
