Prolonged Tracheal Intubation and the Association Between Patent Ductus Arteriosus and Bronchopulmonary Dysplasia: A Secondary Analysis of the PDA-TOLERATE trial.

In the PDA-TOLERATE trial, persistent (even for several weeks) moderate to large patent ductus arteriosus (PDA) was not associated with an increased risk of BPD when the infant required <10 days of intubation. However, in infants requiring intubation for ≥10 days, prolonged PDA exposure (≥11 days) was associated with an increased risk of moderate/severe BPD.

Concentración de vitamina D en niños sanos de 12 a 24 meses que recibieron suplementación con vitamina D hasta el año en Turquía / Vitamin D levels of 12-24-month-old healthy children in Turkey who received vitamin D supplementation until the age of one year

Introducción. El objetivo fue evaluar la concentración de vitamina D en niños sanos de 12 a 24 meses suplementados con vitamina D (400 UI/día) durante el primer año.Métodos. Estudio descriptivo transversal entre junio de 2015 y mayo de 2016 en Estambul. Se incluyó a niños de 12 a 24 meses en seguimiento en la clínica del niño sano y con suplementación con vitamina D durante el primer año. Se midió calcio, fósforo, fosfatasa alcalina, hormona paratiroidea y 25-hidroxivitamina D [25(OH)D]. Se definió suficiencia (>20 ng/ml), insuficiencia (15-20 ng/ml) y deficiencia (<15 ng/ml) de vitamina D.Resultados. El estudio incluyó 197 niños. El 26,9 % (n = 53) siguió recibiendo suplementación después del año (dosis media: 491 ± 267 UI/día). La concentración media de 25(OH)D fue 38,0 ± 13,9 ng/ml. La ingesta regular de vitamina D en menores de un año (p = 0,008) y la continuación de suplementación después del año (p = 0,042) aumentaron la concentración de 25(OH)D en niños de 12 a 24 meses. Hubo deficiencia en 4,1 % e insuficiencia en 7,1 %. El nivel educativo materno (p = 0,009) y la leche maternizada (p = 0,012) fueron factores protectores contra deficiencia o insuficiencia.Conclusiones. La concentración de 25(OH)D era suficiente en el 88,8 % de los niños de 12 a 24 meses con suplementación con vitamina D (400 UI/día) durante el primer año. Los niños sanos de 12 a 24 meses con una suplementación correcta de vitamina D en el primer año podrían no requerir suplementación.

Introduction. The aim of this study was to evaluate vitamin D levels between 12-24 month-old healthy children supplemented with vitamin D (400 IU/day) during the first year.Methods. Descriptive-sectional study conducted between June 2015, and May 2016, in Istanbul (latitude 41ºN). Children aged 12-24 months followed up by the well-child clinic who had vitamin D supplementation in the first year were included in the study. The levels of calcium, phosphorus, alkaline phosphatase, parathyroid hormone and 25-hydroxyvitamin D [25(OH)D] were measured. Vitamin D status was defined as >20 ng/mL: sufficiency, 15-20 ng/mL: insufficiency and <15 ng/mL: deficiency.Results. The study was completed with 197 children. 26.9 % of children (n = 53) went on receiving supplementation after one year (mean dose 491 ± 267 IU/day). The mean 25(OH)D level was 38.0 ± 13.9 ng/mL. It was found that regular vitamin D intake under one year of age (p = 0.008) and continued support after one year of age (p = 0.042) increased level of 25(OH)D in children aged 12-24 months. Vitamin D deficiency was found in 4.1 % and vitamin D insufficiency in 7.1 %. Mother's education (p = 0.009) and use of formula (p = 0.012) were protective factors in relation to development of vitamin D deficiency or insufficiency.Conclusions. The level of 25(OH)D was sufficient in 88.8 % of children aged 12-24 months receiving 400 IU/day vitamin D supplementation in the first year. Vitamin D supplementation could not be required in healthy children aged 12-24 months who received properly vitamin D supplementation in the first year.

Vitamin D levels of 12-24-month-old healthy children in Turkey who received vitamin D supplementation until the age of one year. / Concentración de vitamina D en niños sanos de 12 a 24 meses que recibieron suplementación con vitamina D hasta el año en Turquía.

INTRODUCTION: The aim of this study was to evaluate vitamin D levels between 12-24 monthold healthy children supplemented with vitamin D (400 IU/day) during the first year. METHODS: Descriptive-sectional study conducted between June 2015, and May 2016, in Istanbul (latitude 41ºN). Children aged 12-24 months followed up by the well-child clinic who had vitamin D supplementation in the first year were included in the study. The levels of calcium, phosphorus, alkaline phosphatase, parathyroid hormone and 25-hydroxyvitamin D [25(OH)D] were measured. Vitamin D status was defined as >20 ng/mL: sufficiency, 15-20 ng/mL: insufficiency and <15 ng/mL: deficiency. RESULTS: The study was completed with 197 children. 26.9 % of children (n = 53) went on receiving supplementation after one year (mean dose 491 ± 267 IU/day). The mean 25(OH)D level was 38.0 ± 13.9 ng/mL. It was found that regular vitamin D intake under one year of age (p = 0.008) and continued support after one year of age (p = 0.042) increased level of 25(OH)D in children aged 12-24 months. Vitamin D deficiency was found in 4.1 % and vitamin D insufficiency in 7.1 %. Mother's education (p = 0.009) and use of formula (p = 0.012) were protective factors in relation to development of vitamin D deficiency or insufficiency. CONCLUSIONS: The level of 25(OH)D was sufficient in 88.8 % of children aged 12-24 months receiving 400 IU/day vitamin D supplementation in the first year. Vitamin D supplementation could not be required in healthy children aged 12- 24 months who received properly vitamin D supplementation in the first year.

Introducción. El objetivo fue evaluar la concentración de vitamina D en niños sanos de 12 a 24 meses suplementados con vitamina D (400 UI/día) durante el primer año. Métodos. Estudio descriptivo transversal entre junio de 2015 y mayo de 2016 en Estambul. Se incluyó a niños de 12 a 24 meses en seguimiento en la clínica del niño sano y con suplementación con vitamina D durante el primer año. Se midió calcio, fósforo, fosfatasa alcalina, hormona paratiroidea y 25-hidroxivitamina D [25(OH)D]. Se definió suficiencia (>20 ng/ml), insuficiencia (15-20 ng/ ml) y deficiencia (<15 ng/ml) de vitamina D. Resultados. El estudio incluyó 197 niños. El 26,9 % (n = 53) siguió recibiendo suplementación después del año (dosis media: 491 ± 267 UI/ día). La concentración media de 25(OH)D fue 38,0 ± 13,9 ng/ml. La ingesta regular de vitamina D en menores de un año (p = 0,008) y la continuación de suplementación después del año (p = 0,042) aumentaron la concentración de 25(OH)D en niños de 12 a 24 meses. Hubo deficiencia en 4,1 % e insuficiencia en 7,1 %. El nivel educativo materno (p = 0,009) y la leche maternizada (p = 0,012) fueron factores protectores contra deficiencia o insuficiencia. Conclusiones. La concentración de 25(OH)D era suficiente en el 88,8 % de los niños de 12 a 24 meses con suplementación con vitamina D (400 UI/día) durante el primer año. Los niños sanos de 12 a 24 meses con una suplementación correcta de vitamina D en el primer año podrían no requerir suplementación.

Lack of Equipoise in the PDA-TOLERATE Trial: A Comparison of Eligible Infants Enrolled in the Trial and Those Treated Outside the Trial.

The PDA: TO LEave it alone or Respond And Treat Early trial compared the effects of 2 strategies for treatment of patent ductus arteriosus (PDA) in infants <280/7 weeks of gestation; however 137 potentially eligible infants were not recruited and received treatment of their PDA outside the PDA-TOLERATE trial due to "lack-of-physician-equipoise" (LPE). Despite being less mature and needing more respiratory support, infants with LPE had lower rates of mortality than enrolled infants. Infants with LPE treated before day 6 had lower rates of late respiratory morbidity than infants with LPE treated ≥day 6. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01958320.

PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age.

OBJECTIVE: To compare early routine pharmacologic treatment of moderate-to-large patent ductus arteriosus (PDA) at the end of week 1 with a conservative approach that requires prespecified respiratory and hemodynamic criteria before treatment can be given. STUDY DESIGN: A total of 202 neonates of <28 weeks of gestation age (mean, 25.8 ± 1.1 weeks) with moderate-to-large PDA shunts were enrolled between age 6 and 14 days (mean, 8.1 ± 2.2 days) into an exploratory randomized controlled trial. RESULTS: At enrollment, 49% of the patients were intubated and 48% required nasal ventilation or continuous positive airway pressure. There were no differences between the groups in either our primary outcome of ligation or presence of a PDA at discharge (early routine treatment [ERT], 32%; conservative treatment [CT], 39%) or any of our prespecified secondary outcomes of necrotizing enterocolitis (ERT, 16%; CT, 19%), bronchopulmonary dysplasia (BPD) (ERT, 49%; CT, 53%), BPD/death (ERT, 58%; CT, 57%), death (ERT,19%; CT, 10%), and weekly need for respiratory support. Fewer infants in the ERT group met the rescue criteria (ERT, 31%; CT, 62%). In secondary exploratory analyses, infants receiving ERT had significantly less need for inotropic support (ERT, 13%; CT, 25%). However, among infants who were ≥26 weeks gestational age, those receiving ERT took significantly longer to achieve enteral feeding of 120 mL/kg/day (median: ERT, 14 days [range, 4.5-19 days]; CT, 6 days [range, 3-14 days]), and had significantly higher incidences of late-onset non-coagulase-negative Staphylococcus bacteremia (ERT, 24%; CT,6%) and death (ERT, 16%; CT, 2%). CONCLUSIONS: In preterm infants age <28 weeks with moderate-to-large PDAs who were receiving respiratory support after the first week, ERT did not reduce PDA ligations or the presence of a PDA at discharge and did not improve any of the prespecified secondary outcomes, but delayed full feeding and was associated with higher rates of late-onset sepsis and death in infants born at ≥26 weeks of gestation. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01958320.