Prophylactic Probiotics to Prevent Death or Sepsis in Preterm Infants in Colombia. A randomized, double-blind, multicenter trial.
Neonatal infections currently cause about 1.6 million deaths annually in developing countries. Preterm infants are especially vulnerable to infections because of their immature immune responses and their exposure to the hospital milieu, which promotes gastrointestinal colonization with Gram-negative...
- Autores:
- Tipo de recurso:
- Fecha de publicación:
- 2011
- Institución:
- Ministerio de Ciencia Tecnología e Innovación
- Repositorio:
- Repositorio Institucional de Minciencias
- Idioma:
- eng
- OAI Identifier:
- oai:repositorio.minciencias.gov.co:20.500.14143/40267
- Acceso en línea:
- https://repositorio.minciencias.gov.co/handle/20.500.14143/40267
- Palabra clave:
- Bajo peso al nacer
Mortalidad Neonatal
Neonato pretérmino
Probióticos
Sepsis neonatal
- Rights
- License
- Derechos Reservados - Pontificia Universidad Javeriana, 2021
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Prophylactic Probiotics to Prevent Death or Sepsis in Preterm Infants in Colombia. A randomized, double-blind, multicenter trial.Bajo peso al nacerMortalidad NeonatalNeonato pretérminoProbióticosSepsis neonatalNeonatal infections currently cause about 1.6 million deaths annually in developing countries. Preterm infants are especially vulnerable to infections because of their immature immune responses and their exposure to the hospital milieu, which promotes gastrointestinal colonization with Gram-negative pathogens. Multiple studies have shown that the colonization of the bowel with probiotics (nonpathogenic anaerobic bacteria) competitively inhibit the attachment of Gram-negative pathogens decreasing their likelihood for bacterial translocation and the development of life threatening infections. This potential high-impact, low-cost intervention may significantly improve the survival and morbidity of preterm infants around the world. We propose to use the Colombian Neonatal Research Network (CNRN), a well-established and successful clinical research network, to test this hypothesis.A multi-center, double-blind, randomized, placebo-controlled trial, will be conducted in eight neonatal care units in three cities in Colombia. Patients with birth weight < 2000 grams, hemodynamically stable, who are admitted to hospital at 48 hours of age or less, and whose parents provide written consent, will be included in the trial. Neonates with evidence or suspicion of congenital intestinal obstruction or perforation, prenatal or postnatal diagnosis of gastroschisis, large omphalocele, or congenital diaphragmatic hernia, major congenital heart defects or anticipated transfer to a NICU not involved in the study are to be excluded. Enrolled neonates will be stratified according to participating institutions (eight strata) and birth weight (< 1500 grams and 1501 to 2000 grams) and randomly assigned to treatment with probiotics or placebo by using a computerized stratified balanced block randomization design. Assignment to treatment will be accomplished using sealed, sequentially numbered, opaque envelopes, color-coded for strata, available in each NICU pharmacy. For those randomized to the treatment arm, L reuteri DSM 17938 will be administered at a dose of 108 colony-forming units in 5 drops of a commercially available oil suspension once per day until discharge from the hospital (Biogaia AB, Stockholm, Sweden). For those randomized to the placebo arm, patients will receive an equal number of drops from an identical vial containing only the oil base, but without the probiotic. Vials of probiotic and placebo will only be identified by the pharmacist and according to randomization The preparations will be administered even if the patient has not begun a feeding protocol, given that there are no contraindications for feeding.Textos en Ingles y Español.Pontificia Universidad JaverianaBogotá: Pontificia Universidad Javeriana, 2021Pontificia Universidad Javeriana (PUJ) (Bogotá, Colombia)COL 0016784 - Unidad de Epidemiologia Clinica y BioestadìsticaLozano Leòn, Juan Manuel2021-09-21T15:02:56Z2021-09-21T15:02:56Z2011-10-20Informe de investigaciónhttp://purl.org/coar/resource_type/c_18wsTextinfo:eu-repo/semantics/workingPaperhttps://purl.org/redcol/resource_type/INFhttp://purl.org/coar/version/c_970fb48d4fbd8a85http://purl.org/coar/resource_type/c_8042267 páginas.application/pdfapplication/pdfhttps://repositorio.minciencias.gov.co/handle/20.500.14143/40267engBogotá (Cundinamarca, Colombia)2007-2011Derechos Reservados - Pontificia Universidad Javeriana, 2021https://creativecommons.org/licenses/by-nc-nd/4.0/Atribución-NoComercial-SinDerivadas 4.0 Internacional (CC BY-NC-ND 4.0)http://purl.org/coar/access_right/c_abf2oai:repositorio.minciencias.gov.co:20.500.14143/402672023-11-29T17:45:59Z |
| dc.title.none.fl_str_mv |
Prophylactic Probiotics to Prevent Death or Sepsis in Preterm Infants in Colombia. A randomized, double-blind, multicenter trial. |
| title |
Prophylactic Probiotics to Prevent Death or Sepsis in Preterm Infants in Colombia. A randomized, double-blind, multicenter trial. |
| spellingShingle |
Prophylactic Probiotics to Prevent Death or Sepsis in Preterm Infants in Colombia. A randomized, double-blind, multicenter trial. Bajo peso al nacer Mortalidad Neonatal Neonato pretérmino Probióticos Sepsis neonatal |
| title_short |
Prophylactic Probiotics to Prevent Death or Sepsis in Preterm Infants in Colombia. A randomized, double-blind, multicenter trial. |
| title_full |
Prophylactic Probiotics to Prevent Death or Sepsis in Preterm Infants in Colombia. A randomized, double-blind, multicenter trial. |
| title_fullStr |
Prophylactic Probiotics to Prevent Death or Sepsis in Preterm Infants in Colombia. A randomized, double-blind, multicenter trial. |
| title_full_unstemmed |
Prophylactic Probiotics to Prevent Death or Sepsis in Preterm Infants in Colombia. A randomized, double-blind, multicenter trial. |
| title_sort |
Prophylactic Probiotics to Prevent Death or Sepsis in Preterm Infants in Colombia. A randomized, double-blind, multicenter trial. |
| dc.contributor.none.fl_str_mv |
Pontificia Universidad Javeriana (PUJ) (Bogotá, Colombia) COL 0016784 - Unidad de Epidemiologia Clinica y Bioestadìstica |
| dc.subject.none.fl_str_mv |
Bajo peso al nacer Mortalidad Neonatal Neonato pretérmino Probióticos Sepsis neonatal |
| topic |
Bajo peso al nacer Mortalidad Neonatal Neonato pretérmino Probióticos Sepsis neonatal |
| description |
Neonatal infections currently cause about 1.6 million deaths annually in developing countries. Preterm infants are especially vulnerable to infections because of their immature immune responses and their exposure to the hospital milieu, which promotes gastrointestinal colonization with Gram-negative pathogens. Multiple studies have shown that the colonization of the bowel with probiotics (nonpathogenic anaerobic bacteria) competitively inhibit the attachment of Gram-negative pathogens decreasing their likelihood for bacterial translocation and the development of life threatening infections. This potential high-impact, low-cost intervention may significantly improve the survival and morbidity of preterm infants around the world. We propose to use the Colombian Neonatal Research Network (CNRN), a well-established and successful clinical research network, to test this hypothesis. |
| publishDate |
2011 |
| dc.date.none.fl_str_mv |
2011-10-20 2021-09-21T15:02:56Z 2021-09-21T15:02:56Z |
| dc.type.none.fl_str_mv |
Informe de investigación http://purl.org/coar/resource_type/c_18ws Text info:eu-repo/semantics/workingPaper https://purl.org/redcol/resource_type/INF |
| dc.type.coarversion.fl_str_mv |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| dc.type.coar.fl_str_mv |
http://purl.org/coar/resource_type/c_8042 |
| dc.identifier.none.fl_str_mv |
https://repositorio.minciencias.gov.co/handle/20.500.14143/40267 |
| url |
https://repositorio.minciencias.gov.co/handle/20.500.14143/40267 |
| dc.language.none.fl_str_mv |
eng |
| language |
eng |
| dc.rights.none.fl_str_mv |
Derechos Reservados - Pontificia Universidad Javeriana, 2021 https://creativecommons.org/licenses/by-nc-nd/4.0/ Atribución-NoComercial-SinDerivadas 4.0 Internacional (CC BY-NC-ND 4.0) |
| dc.rights.coar.fl_str_mv |
http://purl.org/coar/access_right/c_abf2 |
| rights_invalid_str_mv |
Derechos Reservados - Pontificia Universidad Javeriana, 2021 https://creativecommons.org/licenses/by-nc-nd/4.0/ Atribución-NoComercial-SinDerivadas 4.0 Internacional (CC BY-NC-ND 4.0) http://purl.org/coar/access_right/c_abf2 |
| dc.format.none.fl_str_mv |
267 páginas. application/pdf application/pdf |
| dc.coverage.none.fl_str_mv |
Bogotá (Cundinamarca, Colombia) 2007-2011 |
| dc.publisher.none.fl_str_mv |
Pontificia Universidad Javeriana Bogotá: Pontificia Universidad Javeriana, 2021 |
| publisher.none.fl_str_mv |
Pontificia Universidad Javeriana Bogotá: Pontificia Universidad Javeriana, 2021 |
| institution |
Ministerio de Ciencia Tecnología e Innovación |
| repository.name.fl_str_mv |
|
| repository.mail.fl_str_mv |
|
| _version_ |
1860676510231298048 |