Cranberry and enterocolitis in premature infants
| ISRCTN | ISRCTN20343063 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20343063 |
| Secondary identifying numbers | EC10-240 |
- Submission date
- 07/12/2010
- Registration date
- 06/04/2011
- Last edited
- 11/10/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jose Uberos
Scientific
Scientific
Hospital Clínico San Cecilio
UCIPyN (9ª Planta)
Granada
18012
Spain
Study information
| Study design | Randomised double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised analysis, double blind and controlled with placebo of the utility of the extract of cranberry in the prevention of the enterocolitis of premature infants |
| Study objectives | The blueberry extract has been used by mankind for over 200 years for indications related to the inhibition of bacterial adherence to epithelia, during this period, no adverse side effects have been reported. Through the prism of non-stick and anti-inflammatory activity of the polyphenols contained in the bilberry extract and its proven utility in the prophylaxis of other processes we propose the following hypothesis: 1. The blueberry extract (Vaccinium macrocarpon) is effective in the prevention of necrotising enterocolitis (NEC) in preterm infants, the equivalent of multimodal therapy given by G. Schmolze et. al., thus resulting in a reduced risk of NEC in more than 3.8%, without prescribing antibiotics 2. The microbiological changes of the intestinal flora induced premature newborn blueberry extract are in the spirit of fostering a proper bowel movements and digestive tolerance earlier than the placebo |
| Ethics approval(s) | Ethics Committee San Cecilio Hospital (Spain) - not provided at time of registration |
| Health condition(s) or problem(s) studied | Necrotising enterocolitis |
| Intervention | 1. Receive a dose of 0.5 ml of the prepared speech in the Pharmacy Department as unidosis in opaque vials. Opaque nasogastric administration every 12 hours. 2. (Placebo) - Receive a dose of 0.5 ml of the prepared speech in the Pharmacy Department as unidosis in opaque vials. Opaque nasogastric administration every 12 hours. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Blueberry extract (Vaccinium macrocarpon) |
| Primary outcome measure | 1. Enterocolitis 2. The follow-up of each patient is 1 month 3. The total test duration is 3 years |
| Secondary outcome measures | 1. Poliphenols in urine 2. The follow-up of each patient is 1 month 3. The total test duration is 3 years |
| Overall study start date | 01/01/2011 |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 238 |
| Key inclusion criteria | 1. Preterm infants less than 1800 g birth weight, either sex 2. Infants with gestational age less than 32 weeks (depending FUR) |
| Key exclusion criteria | 1. Newborns multiple malformations 2. Early neonatal sepsis 3. Does not provide consent to participate in the study |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Clínico San Cecilio
Granada
18012
Spain
18012
Spain
Sponsor information
Department of Health [Ministerio de Sanidad] (Spain)
Government
Government
Unidad de Subvenciones para la Investigación
Dirección General de Farmacia y Productos Sanitarios
Ministerio de Sanidad y Política Social
C/ Paseo del Prado 18-20
Madrid
281071
Spain
| Website | http://www.msps.es/en/home.htm |
|---|---|
"ROR" |
https://ror.org/00y6q9n79 |
Funders
Funder type
Government
Ministerio de Sanidad (Spain)
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 |
