Dose escalation study of bovine lactoferrin in preterm infants: getting the dose right.

Lactoferrin as a nutritional enteral supplement has emerged as a novel preventative therapy against serious infections in preterm infants, although neonatal studies have demonstrated variable results, in part due to the lack of pharmacokinetic data and differences in the products tested. We conducted a prospective, dose escalation (100, 200, and 300 mg·kg-1·day-1) safety study of bovine lactoferrin (Glanbia Nutritionals, USA) dissolved in sterile water (100 mg·mL-1) for 30 days in preterm infants with birth weight <1500 g. Safety related to adverse events (AEs), tolerability, and exposure-response of lactoferrin was assessed. We enrolled 31 patients [10, 10, and 11 patients, for the lactoferrin treatment groups (100, 200, and 300 mg·kg-1·day-1, respectively)] over a 10-month period. No AEs related to the study solution occurred, and lactoferrin was tolerated by each group. During lactoferrin supplementation, one bloodstream infection occurred in each group, but there were no incidences of urinary tract infections and no cases of necrotizing enterocolitis. Postnatal cytomegalovirus acquisition was detected in the group treated with 200 mg·kg-1·day-1 (n = 2). There were no adverse effects on hepatic, renal, or hematologic function. All of the patients survived to discharge. Bovine lactoferrin at doses up to 300 mg·kg-1·day-1 is safe in preterm infants. Future studies examining higher doses of lactoferrin, length of treatment, and potency of different products will aid in determining the optimal approach for the use of lactoferrin to prevent infections in preterm infants.

Ventilation of Preterm Infants during Delayed Cord Clamping (VentFirst): A Pilot Study of Feasibility and Safety.

Background Establishing lung inflation prior to umbilical cord clamping may improve the cardiovascular transition and reduce the risk of intraventricular hemorrhage in preterm infants. We developed a pilot feasibility and safety study in which infants < 33 weeks' gestation received assisted ventilation during delayed cord clamping (DCC). Methods Infants born between 24 0/7 and 32 6/7 weeks' gestation whose mothers consented were enrolled. All infants received continuous positive airway pressure or positive pressure ventilation during 90 seconds of DCC. Outcomes included feasibility (ability to complete protocol and maintain a sterile field during cesarean deliveries) and safety variables (Apgar scores, umbilical cord pH and base deficit, admission temperature, and postcesarean infection). Results A total of 29 infants were enrolled, including one set of twins (median gestation: 30 weeks; 72% cesarean births). In all cases, the protocol was completed. Heart rate at 60 seconds was more than 100 beats per minute in all infants. Apgar scores, cord blood gas values, and admission temperature were comparable to other preterm deliveries at our institution. Conclusion Assisting ventilation of very preterm infants during 90 seconds of DCC is challenging but feasible and appears to be safe in this small pilot study. A randomized clinical trial is warranted to determine clinical benefit.

Human factors related to time-dependent infection control measures: "Scrub the hub" for venous catheters and feeding tubes.

BACKGROUND: The use of catheter hub decontamination protocols is a common practice to reduce central line-associated bloodstream infections. However, few data exist on the most effective disinfection procedure prior to hub access accounting for human factors and time-dependent practices in real time in the clinical setting. METHODS: An observational design with a multimodal intervention was used in this study in a neonatal intensive care unit. Direct observations on nurse compliance of scrub times with decontamination when accessing of venous catheter and feeding tube hubs were conducted during 3 phases: (1) baseline period prior to any interventions; (2) during an educational intervention phase; and (3) during a timer intervention period when using a timing device, either an actual timer or music button. RESULTS: Overall, both education and the timing device interventions increased the mean scrub time ± SD of venous catheter hubs. Mean baseline scrub times of 10 ± 5 seconds were lower compared with 23 ± 12 seconds after educational intervention (P < .002) and 31 ± 8 seconds with timer or music button use (P < .001). Timer intervention scrub time was also more effective than education alone (P < .05). Similar findings were observed with scrub times of feeding tubes. CONCLUSIONS: Time-based infection control measures, such as scrubbing the hub, must be implemented with aids that qualify specific times to account for human factors, to ensure adherence to time-dependent measures aimed at decreasing nosocomial infections.

Testing the Feasibility of Skype and FaceTime Updates With Parents in the Neonatal Intensive Care Unit.

BACKGROUND: Effective provider-parent relationships are essential during critical illness when treatment decisions are complex, the environment is crowded and unfamiliar, and outcomes are uncertain. OBJECTIVES: To evaluate the feasibility of daily Skype or FaceTime updates with parents of patients in the neonatal intensive care unit (NICU) and to assess the intervention's potential for improving parent-provider relationships. METHODS: A pre/post mixed-methods approach was used. NICU parent participants received daily Skype or FaceTime updates for 5 days and completed demographic and feasibility surveys. Parents also completed Penticuff's Parents' Understanding survey before and after the intervention. Nurses and physicians completed feasibility surveys after each update. RESULTS: Twenty-six parents were enrolled and 15 completed the study. More than 90% of providers and parents perceived the intervention to be reliable and easy to use, and about 80% of parents and providers rated video and audio quality as either excellent or good. Frozen screens and missed updates due to scheduling problems were challenges. Two of the 4 subscores on the Parents' Understanding survey improved significantly. Qualitative data favor the intervention as meaningful for parents. CONCLUSIONS: Real-time videoconferencing via Skype or FaceTime is feasible for providing updates for parents when they cannot be present in the NICU and can be used to include parents in bedside rounds. Videoconferencing updates may improve relationships between parents and the health care team.

Nonsterile glove use in addition to hand hygiene to prevent late-onset infection in preterm infants: randomized clinical trial.

IMPORTANCE: Late-onset infections commonly occur in extremely preterm infants and are associated with high rates of mortality and neurodevelopmental impairment. Hand hygiene alone does not always achieve the desired clean hands, as microorganisms are still present more than 50% of the time. We hypothesize that glove use after hand hygiene may further decrease these infections. OBJECTIVE: To determine if nonsterile glove use after hand hygiene before all patient and intravenous catheter contact, compared with hand hygiene alone, prevents late-onset infections in preterm infants. DESIGN, SETTINGS, AND PARTICIPANTS: A prospective, single-center, clinical, randomized trial was conducted in infants admitted to the neonatal intensive care unit who weighed less than 1000 g and/or had a gestational age of less than 29 weeks and were less than 8 days old. There were 175 eligible infants, of which 120 were enrolled during a 30-month period from December 8, 2008, to June 20, 2011. INTERVENTIONS: Infants were randomly assigned to receive care with nonsterile gloves after hand hygiene (group A) or care after hand hygiene alone (group B) before all patient and intravenous line (central and peripheral) contact. Study intervention was continued while patients had central or peripheral venous access. MAIN OUTCOMES AND MEASURES: One or more episodes of late-onset (>72 hours of age) infection in the bloodstream, urinary tract, or cerebrospinal fluid or necrotizing enterocolitis. RESULTS: The 2 groups were similar in baseline demographic characteristics. Late-onset invasive infection or necrotizing enterocolitis occurred in 32% of infants (19 of 60) in group A compared with 45% of infants (27 of 60) in group B (difference, -12%; 95% CI, -28% to 6%; P = .13). In group A compared with group B, there were 53% fewer gram-positive bloodstream infections (15% [9 of 60] vs 32% [19 of 60]; difference, -17%; 95% CI, -31% to -1%; P = .03) and 64% fewer central line-associated bloodstream infections (3.4 vs 9.4 per 1000 central line days; ratio, 0.36; 95% CI, 0.16 to 0.81; P = .01). CONCLUSIONS AND RELEVANCE: Glove use after hand hygiene prior to patient and line contact is associated with fewer gram-positive bloodstream infections and possible central line-associated bloodstream infections in preterm infants. This readily implementable infection control measure may result in decreased infections in high-risk preterm infants. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01729000.