Project description:Background: Micronutrient deficiencies remain common worldwide, but the consequences to growth and development in early infancy (under six months of age) are not fully understood. We present a systematic review of micronutrient interventions in term infants under six months of age, with a specific focus on iron supplementation. Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Ovid) and Embase (Ovid) from January 1980 through December 2019. Interventions included iron or multiple micronutrients (MMNs). Results: Of 11,109 records identified, 32 publications from 23 trials were included (18 iron and five MMN supplementation trials). All 23 trials evaluated the effect of supplementation on biochemical outcomes, ten reported on growth, 14 on morbidity and/or mortality and six on neuro-behavioural development. Low- and middle- income countries made up 88% (21/24) of the total trial locations. Meta-analysis was not possible due to extensive heterogeneity in both exposure and outcome measures. However, these trials indicated that infants less than six months of age benefit biochemically from early supplementation with iron, but the effect of additional nutrients or MMNs, along with the impacts on growth, morbidity and/or mortality, and neuro-behavioural outcomes remain unclear. Conclusions: Infants less than six months of age appear to benefit biochemically from micronutrient supplementation. However, well-powered randomised controlled trials are required to determine whether routine supplementation with iron or MMNs containing iron should commence before six months of life in exclusively breast-fed infants in low-resource settings.
Project description:BackgroundPneumonia is a leading cause of morbidity and mortality in children younger than five years of age. Most deaths occur during infancy and in low-income countries. Daily zinc supplements have been reported to prevent acute lower respiratory tract infection (LRTI) and reduce child mortality. This is an update of a review first published in 2010.ObjectivesTo evaluate the effectiveness of zinc supplementation in the prevention of pneumonia in children aged two to 59 months.Search methodsWe searched CENTRAL (Issue 21 October 2016), MEDLINE (1966 to October 2016), Embase (1974 to October 2016), LILACS (1982 to October 2016), CINAHL (1981 to October 2016), Web of Science (1985 to October 2016) and IMSEAR (1980 to October 2016).Selection criteriaRandomised controlled trials (RCTs) evaluating zinc supplementation for the prevention of pneumonia in children aged from 2 months to 59 months.Data collection and analysisTwo review authors independently assessed trial quality and extracted data.Main resultsWe did not identify any new studies for inclusion in this update. We included six studies that involved 5193 participants.Analysis showed that zinc supplementation reduced the incidence of pneumonia by 13% (fixed-effect risk ratio (RR) 0.87; 95% confidence interval (CI) 0.81 to 0.94, six studies, low-quality evidence) and prevalence of pneumonia by 41% (random-effects RR 0.59; 95% CI 0.35 to 0.99, one study, n = 609, low-quality evidence). On subgroup analysis, we found that zinc reduced the incidence of pneumonia defined by specific clinical criteria by 21% (i.e. confirmation by chest examination or chest radiograph) (fixed-effect RR 0.79; 95% CI 0.0.71 to 0.88, four studies, n = 3261), but had no effect on lower specificity pneumonia case definition (i.e. age-specific fast breathing with or without lower chest indrawing) (fixed-effect RR 0.95; 95% CI 0.86 to 1.06, four studies, n = 1932).Authors' conclusionsZinc supplementation in children is associated with a reduction in the incidence and prevalence of pneumonia.
Project description:Exclusive breastfeeding (EBF) to six months is one of the World Health Organization's (WHOs) infant and young child feeding (IYCF) core indicators. Single 24 h recall method is currently in use to measure exclusive breastfeeding practice among children of age less than six months. This approach overestimates the prevalence of EBF, especially among small population groups. This justifies the need to look for alternative measurement techniques to have a valid estimate regardless of population characteristics.The study involved 422 infants of age less than six months, living in Gurage zone, Southern Ethiopia. The study was conducted from January to February 2016. Child feeding practices were measured for seven consecutive days using 24 h recall method. Recall since birth, was used to measure breastfeeding practices from birth to the day of data collection. Data on EBF obtained by using single 24 h recall were compared with seven days repeated 24 h recall method. McNemar's test was done to assess if a significant difference existed in rates of EBF between measurement methods.The mean age of infants in months was 3 (SD -1.43). Exclusive breastfeeding prevalence was highest (76.7%; 95% CI 72.6, 80.8) when EBF was estimated using single 24 h recall. The prevalence of EBF based on seven repeated 24 h recall was 53.2% (95% CI: 48.3, 58.0). The estimated prevalence of EBF since birth based on retrospective data (recall since birth) was 50.2% (95% CI 45.4, 55.1). Compared to the EBF estimates obtained from seven repeated 24 h recall, single 24 h recall overestimated EBF magnitude by 23 percentage points (95% CI 19.2, 27.8). As the number of days of 24 h recall increased, a significant decrease in overestimation of EBF was observed.A significant overestimation was observed when single 24 h recall was used to estimate prevalence of EBF compared to seven days of 24 h recall. By increasing the observation days we can significantly decrease the degree of overestimation. Recall since birth presented estimates of EBF that is close to seven repeated 24 h recall. This suggests that a week recall could be an alternative indicator to single 24 h recall.
Project description:Ciprofloxacin is used in neonates with suspected or documented Gram-negative serious infections. Currently, its use is off-label partly because of lack of pharmacokinetic studies. Within the FP7 EU project TINN (Treat Infection in NeoNates), our aim was to evaluate the population pharmacokinetics of ciprofloxacin in neonates and young infants <3 months of age and define the appropriate dose in order to optimize ciprofloxacin treatment in this vulnerable population. Blood samples were collected from neonates treated with ciprofloxacin and concentrations were quantified by high-pressure liquid chromatography-mass spectrometry. Population pharmacokinetic analysis was performed using NONMEM software. The data from 60 newborn infants (postmenstrual age [PMA] range, 24.9 to 47.9 weeks) were available for population pharmacokinetic analysis. A two-compartment model with first-order elimination showed the best fit with the data. A covariate analysis identified that gestational age, postnatal age, current weight, serum creatinine concentration, and use of inotropes had a significant impact on ciprofloxacin pharmacokinetics. Monte Carlo simulation demonstrated that 90% of hypothetical newborns with a PMA of <34 weeks treated with 7.5 mg/kg twice daily and 84% of newborns with a PMA ?34 weeks and young infants receiving 12.5 mg/kg twice daily would reach the AUC/MIC target of 125, using the standard EUCAST MIC susceptibility breakpoint of 0.5 mg/liter. The associated risks of overdose for the proposed dosing regimen were <8%. The population pharmacokinetics of ciprofloxacin was evaluated in neonates and young infants <3 months old, and a dosing regimen was established based on simulation.
Project description:Candida infections represent a major threat in neonatal intensive care units. This is the first prospective study to obtain caspofungin plasma levels and safety data for neonates and very young infants. Patients of <3 months of age receiving intravenous amphotericin B for documented or highly suspected candidiasis were enrolled in a single-dose (n = 6) or subsequent multiple-dose (n = 12) panel; all received caspofungin at 25 mg/m(2) once daily as a 1-hour infusion. Caspofungin plasma levels were measured by high-performance liquid chromatography and compared to historical data from adults. Patient chronological ages ranged from 1 to 11 weeks, and weights ranged from 0.68 to 3.8 kg. Gestational ages ranged from 24 to 41 weeks. Geometric mean (GM) peak (C(1 h)) and trough (C(24 h)) caspofungin levels were 8.2 and 1.8 microg/ml, respectively, on day 1, and 11.1 and 2.4 microg/ml, respectively, on day 4. GM ratios for C(1 h) and C(24 h) for neonates/infants relative to adults receiving caspofungin at 50 mg/day were 1.07 and 1.36, respectively, on day 1, and 1.18 and 1.21, respectively, on day 4. Clinical and laboratory adverse events occurred in 17 (94%) and 8 (44%) patients, respectively. Five patients (28%) had serious adverse events, none of which were considered drug related. Caspofungin at 25 mg/m(2) once daily was well tolerated in this group of neonates/infants of <3 months of age and appears to provide relatively similar plasma exposure to that obtained in adults receiving 50 mg/day. However, the small number of patients studied precludes any definitive recommendations about caspofungin dosing for this group comprising a broad range of ages and weights.
Project description:BackgroundStudies suggest infants may be at increased risk of severe coronavirus disease 2019 (COVID-19) relative to older children, but few data exist regarding the incidence of COVID-19 episodes and associated risk factors. We estimate incidence rates and describe characteristics associated with medically attended COVID-19 episodes among infants younger than 6 months of age.MethodsWe analyzed electronic medical record data from a cohort of infants born March 1, 2020-February 28, 2021. Data from 3 health care delivery systems included demographic characteristics, maternal and infant outpatient visit and hospitalization diagnoses and severe acute respiratory syndrome coronavirus syndrome 2 (SARS-CoV-2) test results. Medically attended COVID-19 episodes were defined by positive SARS-CoV-2 clinical tests and/or COVID-19 diagnosis codes during medical care visits. Unadjusted and site-adjusted incidence rates by infant month of age, low and high SARS-CoV-2 circulation periods and maternal COVID-19 diagnosis were calculated.ResultsAmong 18,192 infants <6 months of age whose mothers received prenatal care within the 3 systems, 173 (1.0%) had medically attended COVID-19 episodes. Incidence rates were highest among infants under 1 month of age (2.0 per 1000 person-weeks) and 1 month (2.0 per 1000 person-weeks) compared with older infants. Incidence rates were also higher for infants born to women with postpartum COVID-19 compared with women without known COVID-19 and women diagnosed with COVID-19 during pregnancy.ConclusionsInfants of women with postpartum COVID-19 had a higher risk of medically attended COVID-19 than infants born to mothers who were diagnosed during pregnancy or never diagnosed underscoring the importance of COVID-19 prevention measures for their household members and caregivers to prevent infections in infants.
Project description:A double-blind, randomized clinical trial was conducted to determine the effects of prevention of zinc deficiency on cognitive and sensorimotor development during infancy. At 6 mo of age, infants were randomly assigned to be administered a daily liquid supplement containing 10 mg/d of zinc (zinc sulfate), 10 mg/d of iron (ferrous sulfate), and 0.5 mg/d of copper (copper oxide), or an identical daily liquid supplement containing only 10 mg/d of iron and 0.5 mg/d of copper. Various controls were implemented to ensure adherence to the supplement protocol. A battery of developmental assessments was administered from 6 to 18 mo of age that included a visual habituation/recognition memory task augmented with heart rate at 6, 9, and 12 mo of age; the Bayley Scales of Infant Development, 2nd edition (BSID2) at 6, 12, and 18 mo; the A-not-B error task at 9 and 12 mo; and free-play attention tasks at 12 and 18 mo. Only infants supplemented with zinc had the normative decline in look duration from 6 to 12 mo during habituation and a normative decline in shifting between objects on free-play multiple-object attention tasks from 12 to 18 mo of age. The 2 groups did not differ on any of the psychophysiologic indices, the BSID2, or the A-not-B error task. The findings are consistent with zinc supplementation supporting a profile of normative information processing and active attentional profiles during the first 2 y of life. This trial was registered at clinicaltrials.gov as NCT00589264.
Project description:BACKGROUND:Mass azithromycin distribution reduces under-5 child mortality. Trachoma control programs currently treat infants aged 6 months and older. Here, we report findings from an infant adverse event survey in 1-5 month olds who received azithromycin as part of a large community-randomized trial in Niger. METHODS AND PRINCIPAL FINDINGS:Active surveillance of infants aged 1-5 months at the time of treatment was conducted in 30 randomly selected communities from within a large cluster randomized trial of biannual mass azithromycin distribution compared to placebo to assess the potential impact on child mortality. We compared the distribution of adverse events reported after treatment among azithromycin-treated versus placebo-treated infants. From January 2015 to February 2018, the caregivers of 1,712 infants were surveyed. Approximately one-third of caregivers reported at least one adverse event (azithromycin: 29.6%, placebo: 34.3%, risk ratio [RR] 0.86, 95% confidence interval [CI] 0.68 to 1.10, P = 0.23). The most commonly reported adverse events included diarrhea (azithromycin: 19.3%, placebo: 28.1%, RR 0.68, 95% CI 0.49 to 0.96, P = 0.03), vomiting (azithromycin: 15.9%, placebo: 21.0%, RR 0.76, 95% CI 0.56 to 1.02, P = 0.07), and skin rash (azithromycin: 12.3%, placebo: 13.6%, RR 0.90, 95% CI 0.59 to 1.37, P = 0.63). No cases of infantile hypertrophic pyloric stenosis were reported. CONCLUSIONS:Azithromycin given to infants aged 1-5 months appeared to be safe. Inclusion of younger infants in larger azithromycin-based child mortality or trachoma control programs could be considered if deemed effective. TRIAL REGISTRATION:ClinicalTrials.gov NCT02048007.
Project description:AAP guidelines recommend infants less than 6 months of age are monitored for at least 2 hours following surgery. This retrospective study evaluated if adherence to the 2-hour monitoring guideline decreased the risk of adverse events associated with ambulatory procedures in infants younger than 6 months.MethodsWe queried the hospital's electronic medical record to identify patients younger than 6 months of age who received anesthetic care from January 2015 to March 2020. Demographic data, intraoperative adverse events, and returns to the emergency department (ED) or urgent care within 7 days were captured for each patient. We calculated the number and frequency for categorical data and median and interquartile range (IQR) for continuous data. Chi-square or Fisher's exact test were used to compare patients who experienced an adverse event to those that did not.ResultsOne thousand one hundred seventy-seven patients who had 1,261 unique anesthetic encounters were analyzed. Forty-four adverse events were identified, 20 (1.6%) before discharge, including 3 unplanned admissions, and 24 (1.9%) returns to the ED/UC within 7 days postoperatively. We did not observe differences in postoperative recovery time in patients who experienced an adverse event and those who did not (88 min vs. 77 min, respectively, P = 0.078). None of the ED/UC returns would have been avoided by a longer PACU stay.ConclusionsWith the appropriate patient selection, once physiological discharge readiness is met, adherence to a strict 2-hour time-based discharge criteria does not increase safety for infants younger than 6 months of age after ambulatory procedures.