Background: Anemia is common in premature infants. Due to risks with red blood cell transfusions, many anemic infants are not transfused. The implications of this pathophysiologic status, especially at times of increased metabolic demand (enteral feedings), is not well understood. Near-infrared spectroscopy (NIRS) allows for the noninvasive determination of regional oxygen saturations (rSO2) in tissues such as the brain and mesentery, giving insight into their oxygen sufficiency. Objective: We tested the hypothesis that during enteral feedings very low birth weight (VLBW) infants with a hematocrit ≤28% will experience a decrease in splanchnic rSO2 and splanchnic-cerebral oxygenation ratio (SCOR). Methods: This prospective, observational, 2-centered study included VLBW infants receiving full enteral feedings with a hematocrit ≤28%. Cerebral and splanchnic rSO2 were monitored via NIRS for 24 h. Average values were calculated for periods immediately preceding, during, and after each feeding. SCOR was calculated from these values (rSO2 splanchnic/rSO2 cerebral), and data were analyzed using a linear mixed effect model. Results: Fifty neonates with a median gestational age of 28 weeks (range 23-32), a birth weight of 1,118 ± 284 g (mean ± SD), and a hematocrit of 26 ± 2% (mean ± SD) were studied. During feedings, SCOR decreased significantly from baseline (0.72 ± 0.17 to 0.69 ± 0.17, p = 0.043). With feedings, there was a trend of decreased splanchnic rSO2 (47 ± 11 to 45 ± 10, p = 0.057) and no change in cerebral rSO2 (66 ± 8 to 66 ± 7, p = 0.597). Conclusions: VLBW infants with a hematocrit ≤28% had a decrease in SCOR and a trend towards decreased splanchnic rSO2 with enteral feedings.
BACKGROUND Despite therapeutic hypothermia, neonates with encephalopathy (NE) have high rates of death or disability. Darbepoetin alfa (Darbe) has comparable biological activity to erythropoietin, but has extended circulating half-life (t1/2). Our aim was to determine Darbe safety and pharmacokinetics as adjunctive therapy to hypothermia. STUDY DESIGN Thirty infants (n = 10/arm) ≥36wk gestation undergoing therapeutic hypothermia for NE were randomized to receive placebo, Darbe low dose (2 μg/kg), or high dose (10 μg/kg) given intravenously within 12 h of birth (first dose/hypothermia condition) and at 7 d (second dose/normothermia condition). Adverse events were documented for 1 mo. Serum samples were obtained to characterize Darbe pharmacokinetics. RESULTS Adverse events (hypotension, altered liver and renal function, seizures, and death) were similar to placebo and historical controls. Following the first Darbe dose at 2 and 10 μg/kg, t1/2 was 24 and 32 h, and the area under the curve (AUCinf) was 26,555 and 180,886 h*mU/ml*, respectively. In addition, clearance was not significantly different between the doses (0.05 and 0.04 l/h). At 7 d, t1/2 was 26 and 35 h, and AUCinf was 10,790 and 56,233 h*mU/ml*, respectively (*P < 0.01). CONCLUSION Darbe combined with hypothermia has similar safety profile to placebo with pharmacokinetics sufficient for weekly administration.
on behalf of the PENUT Trial Consortium* Objective To evaluate whether extremely low gestational age neonates (ELGANs) randomized to erythropoietin have better or worse kidney-related outcomes during hospitalization and at 22-26 months of corrected gestational age (cGA) compared with those randomized to placebo. Study designWe performed an ancillary study to a multicenter double-blind, placebo-controlled randomized clinical trial of erythropoietin in ELGANs. ResultsThe prevalence of severe (stage 2 or 3) acute kidney injury (AKI) was 18.2%. We did not find a statistically significant difference between those randomized to erythropoietin vs placebo for in-hospital primary (severe AKI) or secondary outcomes (any AKI and serum creatinine/cystatin C values at days 0, 7, 9, and 14). At 22-26 months of cGA, 16% of the cohort had an estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m 2 , 35.8% had urine albumin/creatinine ratio >30 mg/g, 23% had a systolic blood pressure (SBP) >95th percentile for age, and 40% had a diastolic blood pressure (DBP) >95th percentile for age. SBP >90th percentile occurred less often among recipients of erythropoietin (P < .04). This association remained even after controlling for gestational age, site, and sibship (aOR 0.6; 95% CI 0.39-0.92). We did not find statistically significant differences between treatment groups in eGFR, albumin/creatinine ratio, rates of SBP >95th percentile, or DBP >90th or >95th percentiles at the 2 year follow-up visit.Conclusions ELGANs have high rates of in-hospital AKI and kidney-related problems at 22-26 months of cGA.Recombinant erythropoietin may protect ELGANs against long-term elevated SBP but does not appear to protect from AKI, low eGFR, albuminuria, or elevated DBP at 22-26 months of cGA.
and for the PENUT Consortium BACKGROUND: Outcomes of extremely low gestational age neonates (ELGANs) may be adversely impacted by packed red blood cell (pRBC) transfusions. We investigated the impact of transfusions on neurodevelopmental outcome in the Preterm Erythropoietin (Epo) Neuroprotection (PENUT) Trial population. METHODS: This is a post hoc analysis of 936 infants 24-0/6 to 27-6/7 weeks' gestation enrolled in the PENUT Trial. Epo 1000 U/kg or placebo was given every 48 h × 6 doses, followed by 400 U/kg or sham injections 3 times a week through 32 weeks postmenstrual age. Six hundred and twenty-eight (315 placebo, 313 Epo) survived and were assessed at 2 years of age. We evaluated associations between BSID-III scores and the number and volume of pRBC transfusions. RESULTS: Each transfusion was associated with a decrease in mean cognitive score of 0.96 (95% CI of [−1.34, −0.57]), a decrease in mean motor score of 1.51 (−1.91, −1.12), and a decrease in mean language score of 1.10 (−1.54, −0.66). Significant negative associations between BSID-III score and transfusion volume and donor exposure were observed in the placebo group but not in the Epo group. CONCLUSIONS: Transfusions in ELGANs were associated with worse outcomes. We speculate that strategies to minimize the need for transfusions may improve outcomes.
Occupational back pain and injury are common and costly issues. Biomechanical models are often used to quantify job risk by estimating back muscle forces. In general, the most accurate models are also the most complex, creating demand for models that are both straightforward and accurate. An existing, basic hand-calculation back compressive force estimation model (HCBCF v1.0) was revised in two iterations to reduce the error induced by original simplifying assumptions. Lifting tasks (n = 6000) from observational data were used to compare the HCBCF models with the University of Michigan 3D Static Strength Prediction Program (3DSSPP TM ). The greatest r 2 (0.97) between the HCBCF v1.2 and the 3DSSPP TM was achieved with gender-specific equations designed to account for differences between males and females and a more detailed estimation of torso flexion angle and upper body mass center location. This gender-specific back compression and risk estimation model is a relatively simple alternative to computer-based back compressive force models. In addition the hand-calculation can be used as a general survey tool to determine which jobs should be analyzed with more sophisticated computer-based models.
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