Condition category
Pregnancy and Childbirth
Date applied
07/12/2010
Date assigned
06/04/2011
Last edited
11/10/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jose Uberos

ORCID ID

Contact details

Hospital Clínico San Cecilio
UCIPyN (9ª Planta)
Granada
18012
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EC10-240

Study information

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

Acronym

Study hypothesis

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

Ethics Committee San Cecilio Hospital (Spain) - not provided at time of registration

Study design

Randomised double blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase III

Drug names

Blueberry extract (Vaccinium macrocarpon)

Primary outcome measures

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 trial start date

01/01/2011

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Preterm infants less than 1800 g birth weight, either sex
2. Infants with gestational age less than 32 weeks (depending FUR)

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

238

Participant exclusion criteria

1. Newborns multiple malformations
2. Early neonatal sepsis
3. Does not provide consent to participate in the study

Recruitment start date

01/01/2011

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Clínico San Cecilio
Granada
18012
Spain

Sponsor information

Organisation

Department of Health [Ministerio de Sanidad] (Spain)

Sponsor details

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

Sponsor type

Government

Website

http://www.msps.es/en/home.htm

Funders

Funder type

Government

Funder name

Ministerio de Sanidad (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes