Prophylactic Probiotics in Premature Infants (C3P)
Death, Nosocomial Infection
About this trial
This is an interventional prevention trial for Death focused on measuring probiotics, lactobacillus reuteri, preterm infants, nosocomial infection, necrotizing enterocolitis
Eligibility Criteria
Inclusion Criteria:
- Admission to the NICU
- Written parental consent
- Birth weight < 2000 grams
- Hemodynamically stable
- < 48 hours of age
Exclusion Criteria:
- 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
- Anticipated transfer to a NICU not involved in the study
Sites / Locations
- Hospital San Vicente de Paul
- Hospital San Ignacio, Universidad Javeriana
- Policlinico del Olaya
- Clinica San Luis
- Hospital Universitario de Santander
- Clinica los Farallones
- Clinica Los Remedios
- Fundacion Valle de Lilli
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
1
2
5 drops of an available oil suspension without Lactobacillus reuteri will be given once per day until discharge from the hospital. Patients fed through NG tube will be administered 5 drops of placebo through the NG tube followed by a 0.5 cc of a normal saline flush. Patients taking PO feeds will be administered 5 drops of placebo in posterior oropharynx after secretions have been suctioned.
5 drops of Lactobacillus reuteri DSM 17938 from an oil based suspension will be administered once a day until death or discharge home. Patients with NG feeds will be administered the probiotic in the amount of 5 drops through the NG tube followed by 0.5 cc of a normal saline flush. Patients with PO feeds will be administered 5 drops of the probiotics in the posterior oropharynx after secretions have been suctioned. If feeds are temporarily suspended because of feeding intolerance or NEC, the probiotic may be re-started once feeds are re-started.