RESUMEN
BACKGROUND: We aimed to assess safety, tolerability, and improvement in weight gain with an energy- and protein-enriched formula (EPEF) in infants with poor growth. METHODS: Infants aged 1-8 months with poor growth received EPEF for 16 weeks. Our primary objective was improvement in weight as measured by change in weight-for-age z-score (WAZ) and weight gain velocity (grams per day) ≥ median for age. Secondary objectives included improvement in other anthropometric z-scores, formula tolerance, and safety. RESULTS: Twenty-six patients with poor growth due to congenital heart disease (n = 15), other organic causes (n = 9), and nonorganic causes (n = 2) completed the study per protocol. Mean daily energy intake was 123 ± 32 kilocalories per kilogram of body weight, with >90% of energy coming from EPEF. Weight gain velocity exceeded the median for 83% (20 of 24) and 67% (16 of 24) of infants at ≥1 time point and for the overall study period, respectively. Mean ± SD WAZ improved from -2.92 ± 1.04 at baseline to -2.01 ± 1.12 at 16 weeks (P = 0.0001). Z-scores for weight-for-length and head circumference (P = 0.0001) and for length-for-age (P = 0.003) improved significantly at 16 weeks. Compared with baseline, stool consistency was different at 2, 4, and 16 weeks (P < 0.05). There were no significant differences in vomiting, fussiness, or daily number of stools while there was a decrease or no change in spit-up, flatulence, crying, or gassiness. CONCLUSION: EPEF is safe, well tolerated, and improves weight gain in infants with poor growth.
Asunto(s)
Desnutrición , Aumento de Peso , Antropometría , Humanos , Lactante , Fórmulas InfantilesRESUMEN
The efficacy of proton pump inhibitor (PPI) medications is highly dependent on plasma concentrations, which varies considerably due to cytochrome P450 (CYP2C19) genetic variation. We conducted a pragmatic, pilot study of CYP2C19 genotype-guided pediatric dosing of PPI medications. Children aged 5-17 years old with gastric-acid-related conditions were randomized to receive either conventional dosing of a PPI or genotype-guided dosing for a total of 12 weeks. Sixty children (30 in each arm) were enrolled and had comparable baseline characteristics. The mean daily omeprazole equivalent dose prescribed to participants across metabolizer phenotype groups was significantly different in the genotype-guided dosing arm (P < 0.001), but not in the conventional dosing arm. Prescribers waited for the genotype result before prescribing the PPI medication for 90% of the participants in the genotype-guided dosing arm. The number of participants who reported an infection was marginally lower in genotype-guided dosing vs. conventional dosing (20% vs. 44%; P = 0.07). Sinonasal symptoms were higher in the conventional dosing arm as compared with genotype-guided dosing arm: (2.6 (2.0, 3.4) vs. 1.8 (1.0, 2.3), P = 0.031). CYP2C19 genotype-guided PPI therapy is feasible in a clinical pediatric setting, well accepted by providers, resulted in differential PPI dosing, and may reduce PPI-associated infections. A future large scale randomized clinical trial of CYP2C19 genotype-guided pediatric dosing of PPI medications in children is warranted.
Asunto(s)
Citocromo P-450 CYP2C19/genética , Reflujo Gastroesofágico/tratamiento farmacológico , Medicina de Precisión/métodos , Inhibidores de la Bomba de Protones/administración & dosificación , Adolescente , Niño , Preescolar , Citocromo P-450 CYP2C19/metabolismo , Relación Dosis-Respuesta a Droga , Cálculo de Dosificación de Drogas , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Reflujo Gastroesofágico/genética , Técnicas de Genotipaje , Humanos , Masculino , Proyectos Piloto , Inhibidores de la Bomba de Protones/farmacocinéticaRESUMEN
The aims of this study are to examine in children: (i) obesity-related alterations in satiety factors such as leptin, ghrelin, and obestatin; (ii) the link between satiety factors and cardiometabolic risk factors; and (iii) the impact of a physical activity-based lifestyle intervention on the levels of these satiety factors in the obese. We studied a total of 21 adolescents (BMI percentile, 99.0 +/- 0.6 for 15 obese and 56.2 +/- 1.1 for 6 lean). The obese subjects underwent a 3-month randomized controlled physical activity-based lifestyle intervention. Leptin, soluble leptin receptor (sOB-R), ghrelin, and obestatin levels were determined as the primary outcome measures. Other markers of cardiometabolic disease such as inflammation and insulin resistance were also determined. Body composition was measured by dual-energy X-ray absorptiometry. The concentrations of ghrelin, obestatin, and sOB-R were significantly lower in the obese children compared to the lean controls, whereas that of leptin was higher (all P < 0.05). Although intervention led to a net increase in obestatin (P < 0.01) and no change in ghrelin levels, the balance between ghrelin and obestatin (ratio of ghrelin to obestatin, G/O) decreased (P < 0.02). Intervention reduced leptin and increased sOB-R (P < 0.01 for both). Significant associations between satiety factors and other cardiometabolic risk factors were also observed. Taken together, alterations in the levels of satiety factors are evident early in the clinical course of obesity, but physical activity-based lifestyle intervention either prevented their continued increase or normalized their levels. These beneficial effects appear to aid in the maintenance of body weight and reduction in cardiovascular risk.
Asunto(s)
Ejercicio Físico/fisiología , Ghrelina/sangre , Leptina/sangre , Obesidad/sangre , Receptores de Leptina/sangre , Saciedad , Adolescente , Biomarcadores/sangre , Peso Corporal , Enfermedades Cardiovasculares/prevención & control , Femenino , Humanos , Inflamación , Resistencia a la Insulina , Estilo de Vida , Masculino , Actividad Motora , Obesidad/terapiaRESUMEN
BACKGROUND: Single-stage PEG buttons (PEG-B) allow initial placement of a skin-level gastrostomy device for children who require enteral access. They offer significant advantages over traditionally placed PEG tubes (PEG-T) but have not been widely accepted into practice. OBJECTIVE: To review our experience with PEG-Bs compared with PEG-Ts. HYPOTHESIS: PEG-B shares a similar safety profile with PEG-T but delays the need for an initial device change well beyond the change that usually occurs at 6 to 8 weeks after PEG-T placement. DESIGN: Retrospective chart review. SETTING: Nemours Children's Clinic, Jacksonville, Florida. PATIENTS: All children undergoing both PEG procedures and attending our clinic from 1997 to 2002. MAIN OUTCOME MEASUREMENTS: Age, sex, weight, indications, postoperative complications, interval until first tube change and first tube change complications. RESULTS: Totals of 145 and 93 patients were identified in the PEG-B and PEG-T groups, respectively. Patient characteristics were similar in the 2 groups with respect to age, weight, indications, and postoperative complications. The interval until first tube change, however, was significantly longer in the PEG-B group (314 days) than in the PEG-T (78 days) (P < .0001). In addition, the PEG-B was found to be as safe as the PEG-T for small infants who weighed less than 5 kg. CONCLUSIONS: PEG-B placement should be considered as the procedure of choice over PEG-T placement for children. It offers similar safety profiles, even for small patients and a significantly longer interval until first device change.