Purpose-To determine the safety of oropharyngeal administration of own mother's colostrum to ELBW infants in first days of life. A secondary purpose was to investigate the feasibility of (1) delivering this intervention to ELBW infants in the first days of life, and (2) measuring concentrations of secretory immunoglobulin A (sIgA) and lactoferrin in tracheal aspirate secretions and urine of these infants.Subjects-Five ELBW infants (mean BW and gestational age = 657 grams and 25.5 weeks, respectively).Design-Quasi experimental, one group, pretest-posttest design.Methods-Subjects received 0.2 mL of OMC administered oropharyngeally every two hours for 48 consecutive hours, beginning at 48 hours of life. Concentrations of sIgA and lactoferrin were measured in tracheal aspirates and urine of each subject at baseline, at the completion of the intervention and again 2 weeks later.Results-All infants completed the entire treatment protocol, each receiving 24 treatments. A total of 15 urine specimens were collected and 14 were sufficient in volume for analysis. A total of 15 tracheal aspirates were collected, but only 7 specimens (47%) were sufficient in volume for analysis. There was wide variation in concentrations of sIgA and lactoferrin in urine and tracheal aspirates among the five infants; however several results were outside the limits of assay detection. All infants began to suck on the endotracheal tube during the administration of colostrum drops. Oxygen saturation measures remained stable or increased slightly during each of the treatment sessions. There were no episodes of apnea, bradycardia, hypotension or other adverse effects associated with the administration of colostrum.Conclusions-Oropharyngeal administration of OMC is easy, inexpensive, and well-tolerated by even the smallest and sickest ELBW infants. Future research should continue to examine the optimal procedure for measuring the direct immune effects of this therapy, as well as the clinical outcomes such as infections, particularly ventilator-associated pneumonia (VAP). of infants born at 24 weeks of gestation will survive to discharge, compared to 50% just 15 years ago. 1 However, the survival of these infants is associated with significant short and long-term morbidity, including nosocomial infection, 2, 3 necrotizing enterocolitis, 4 intraventricular hemorrhage, 4,5 periventricular leukomalacia 6 and adverse long-term neurodevelopmental sequelae including cognitive and motor disabilities, visual and/or hearing impairment, and cerebral palsy. [7][8][9] Nosocomial infection, an acquired infection after 48 hours of hospital admission, is particularly important because of its high prevalence and its association with other morbidities including poor growth, 10, 11 adverse long-term neurological sequelae, 10 increased length of hospital stay, 12 and a substantial cost 12 to families, hospitals, and society. The risk of acquiring a nosocomial infection is inversely related to birth weight and gestational age, and directly related to the severi...

No abstract

BackgroundExtremely premature (birth weight < 1250 g) infants are at high risk for acquiring late-onset sepsis and necrotizing enterocolitis, which are associated with significant mortality and morbidity. Own mother's milk contains protective (immune and trophic) biofactors which provide antimicrobial, anti-inflammatory, antioxidant, and immunomodulatory functions, enhance intestinal microbiota, and promote intestinal maturation. Many of these biofactors are most highly concentrated in the milk expressed by mothers of extremely premature infants. However, since extremely premature infants do not receive oral milk feeds until 32 weeks post-conceptional age, they lack the potential benefit provided by milk (biofactor) exposure to oropharyngeal immunocompetent cells, and this deficiency could contribute to late-onset sepsis and necrotizing enterocolitis. Therefore, oropharyngeal administration of own mother's milk may improve the health outcomes of these infants.ObjectivesTo compare the effects of oropharyngeal administration of mother’s milk to a placebo, for important clinical outcomes, including (1A) reducing the incidence of late-onset sepsis (primary outcome) and (1B) necrotizing enterocolitis and death (secondary outcomes). To identify the biomechanisms responsible for the beneficial effects of oropharyngeal mother’s milk for extremely premature infants, including; (2A) enhancement of gastrointestinal (fecal) microbiota (2B) improvement in antioxidant defense maturation or reduction of pro-oxidant status, and (2C) maturation of immunostimulatory effects as measured by changes in urinary lactoferrin.Methods/DesignA 5-year, multi-center, double-blind, randomized controlled trial designed to evaluate the safety and efficacy of oropharyngeal mother’s milk to reduce the incidence of (1A) late-onset sepsis and (1B) necrotizing enterocolitis and death in a large cohort of extremely premature infants (n = 622; total patients enrolled). Enrolled infants are randomly assigned to one of 2 groups: Group A infants receive 0.2 mL of own mother's milk, via oropharyngeal administration, every 2 hours for 48 hours, then every 3 hours until 32 weeks corrected-gestational age. Group B infants receive a placebo (0.2 mL sterile water) following the same protocol. Milk, urine, oral mucosal swab, and stool samples are collected at various time points, before, during and after the treatment periods. Health outcome and safety data are collected throughout the infant’s stay.Trial registrationClinicalTrials.gov identifier: NCT02116699 on 11 April 2014. Last updated: 26 May 2015