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Sepulveda C.,Institute of Maternal and Child Research | Urquidi C.,University of Chile | Pittaluga E.,Neonatology Unit | Iniguez G.,Institute of Maternal and Child Research | And 4 more authors.
Hormone Research in Paediatrics | Year: 2013

Background: Rapid early ponderal growth is associated with adverse metabolic risks in young adults born at term. Aim: To determine whether there are differences in body composition, resting energy expenditure (REE) and metabolic variables between preterm children born with very low birth weight (VLBW) either appropriate (AGA) or small (SGA) for gestational age and whether these differences are related to an early period of weight gain. Methods: 67 VLBW preterm (40 AGA, 27 SGA). Body composition by DEXA, REE by indirect calorimetry and blood sampling at age 6.7 ± 0.5 years. Results: VLBW SGA children were lighter, shorter, had a lower waist and hip circumference, HDL cholesterol and lipid oxidation rates than their AGA counterparts (adjusted for age, sex and BMI). Birth weight correlated negatively with total body and trunk fat mass. In a multivariate linear regression analysis, we found a positive association between weight gain in the first 3 months of life and total and trunk fat at age 6 years and a reciprocal association with REE at age 6 years. In contrast, the weight gain rate at 6-9 months of life was associated with higher REE and lipid oxidation rates at 6 years. A higher weight gain rate at 9-12 months was associated with a higher lean mass at 6 years. Conclusion: An early fast-pace weight gain in VLBW infants may have detrimental consequences for metabolic health later on. Copyright © 2013 S. Karger AG, Basel.

Khadilkar V.,Jehangir Hospital | Radjuk K.A.,Second Childrens Hospital | Bolshova E.,Ukrainian Academy of Sciences | Khadgawat R.,All India Institute of Medical Sciences | And 12 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2014

Background: Sustained-release GH formulations may provide a strategy for improving treatment compliance and persistence in GH-deficient patients. Objective: The aim of the study was to examine efficacy and safety of LB03002, a sustained-release GH formulation for once-weekly administration. Design: Weconducted a phase III, 12-month, multinational, randomized, open-label, comparatorcontrolled trial with a 12-month uncontrolled extension. Patients: Prepubertal GH treatment-naive GH-deficient children (mean age, 7.8 y) participated in the study. Intervention: We administered once-weekly LB03002 (n = 91) or daily GH (n = 87) for 1 year, followed by once-weekly LB03002 for all patients for another year (LB03002 throughout, n = 87; switched to LB03002, n = 80). Outcome Measures: Height, height velocity (HV), IGF-1, GH antibodies, and adverse events were determined throughout. Primary analysis was noninferiority of LB03002 vs daily GH at 1 year by analysis of covariance. Results: Mean ±SD HV during year 1 was 11.63 ± 2.60 cm/y with LB03002, and 11.97 ± 3.09 cm/y with daily GH, with increases from baseline of 8.94 ± 2.91 and 9.04 ± 3.19 cm/y, respectively. Theleast square mean HV difference for LB03002 - daily GH was - 0.43 cm/y (99% confidence interval, - 1.45 to 0.60 cm/y). Mean HV also remained above baseline in year 2 (8.33 ± 1.92 cm/y in the LB03002 throughout group, and 7.28 ± 2.34 cm/y in the switched to LB03002 group). Injection site reactions occurred more frequently in LB03002-treated patients but were considered mild to moderate in >90% of cases. Conclusions: Growth response with once-weekly LB03002 in GH-deficient children is comparable to that with daily GH, achieving expected growth rates for 24 months. Once-weekly LB03002 is a strong candidate for long-term GH replacement in GH-deficient children. (J Clin Endocrinol Metab 99: 126-132, 2014). © Copyright 2014 by The Endocrine Society.

Okuma C.,Institute of Neurosurgery Asenjo | Isabel Hernandez M.,Institute of Maternal and Child Research | Rodriguez P.,Institute of Neurosurgery Asenjo | Flores R.,Institute of Neurosurgery Asenjo | And 6 more authors.
Hormone Research in Paediatrics | Year: 2013

Background: Very low birth weight (VLBW) children have higher risk of neurologic disabilities and growth factors are essential for brain maturation. Aim: To assess whether there are differences in neurologic findings, psychometric parameters and microstructural brain morphology in 1-year-old VLBW infants versus term healthy controls and whether these differences are related to hormonal/growth changes. Methods: Prospective anthropometry, prefeed venous blood sample [insulin, insulin-like growth factor-I (IGF-I), insulin-like growth factor-II (IGF-II), leptin, glucose], neurologic and imaging assessment, at age 1 year in 34 VLBW infants (12 SGA; 10 M) and 10 healthy term controls (5 M). Results: IGF-I concentrations at 1 month of corrected age were 20% lower in SGA versus appropriate for gestational age VLBW (p < 0.02). Gray and white matter volume and fractional anisotropy in 15/27 regions were decreased (p < 0.001). Abnormal spectroscopy was observed in 4 zones in VLBW versus term controls (p < 0.001). Some of these changes were associated with different periods of first-year growth and IGF-I/IGF-II, leptin and HOMA-IR. Conclusions: VLBW infants show differences in brain volumes and microstructural brain morphology as compared to term controls, changes related to circulating growth factor and anthropometry changes in the first year. This apparent reorganization of the developing brain offers a unique opportunity to investigate the relationship between changes in cortical anatomy, cognitive and social impairments and periods of early growth. © 2013 S. Karger AG, Basel.

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