Dataset Information

Maternal Hemoglobin Concentration during Gestation and Risk of Anemia in Infancy: Secondary Analysis of a Randomized Controlled Trial.

ABSTRACT: This study examined the relationship between maternal hemoglobin (Hb) concentration and the risk of anemia in infancy.This analysis included 17?193 women who entered the trial when they were ?20 years of age, no more than 20 weeks of gestation, had mild or no anemia, and delivered singleton live births. Maternal Hb concentrations were measured in the first trimester and during 24-28 weeks of gestation; infant Hb concentrations were measured at 5-7 months and 11-13 months of life. The associations between maternal Hb concentrations and infant Hb concentrations were examined.Maternal Hb concentrations measured during 24-28 weeks of gestation, but not in the first trimester, were correlated with infant Hb concentrations measured at either of the 2 post-partum periods. The risk of infant anemia at 5-7 months of age increased when maternal Hb concentration was ?109 g/L during 24-28 weeks of gestation (aOR, 1.95; 95% CI, 1.59-2.40) and 11-13 months of age (aOR, 1.72; 95% CI, 1.36-2.18), whereas the risk of anemia during 5-7 months of age as well as 11-13 months in infancy decreased when maternal Hb level at 24-28 weeks of gestation was 120-129 g/L (aOR for 5-7 months, 0.74 [95% CI, 0.64-0.85]; aOR for 11-13 months, 0.72 [95% CI, 0.61-0.85]), or ?130 g/L (aOR for 5-7 months, 0.75 [95% CI, 0.63-0.90]; aOR for 11-13 months, 0.89 [95% CI, 0.73-1.08]).Low maternal Hb concentration during 24-28 weeks of gestation was associated with an increased risk of anemia in infancy, whereas high maternal Hb concentration was associated with a reduced risk of anemia.Clinicaltrials.gov: NCT00133744.

SUBMITTER: Zhang Y

PROVIDER: S-EPMC4981517 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Maternal Hemoglobin Concentration during Gestation and Risk of Anemia in Infancy: Secondary Analysis of a Randomized Controlled Trial.

Zhang Yiting Y Jin Lei L Liu Jian-Meng JM Ye Rongwei R Ren Aiguo A

The Journal of pediatrics 20160602

<h4>Objective</h4>This study examined the relationship between maternal hemoglobin (Hb) concentration and the risk of anemia in infancy.<h4>Study design</h4>This analysis included 17 193 women who entered the trial when they were ≥20 years of age, no more than 20 weeks of gestation, had mild or no anemia, and delivered singleton live births. Maternal Hb concentrations were measured in the first trimester and during 24-28 weeks of gestation; infant Hb concentrations were measured at 5-7 months an ...[more]

PMID: 27263403

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Project description:Importance:Iron-deficiency anemia (IDA) affects millions of persons worldwide, and is associated with impaired neurodevelopment in infants and children. Ferrous sulfate is the most commonly prescribed oral iron despite iron polysaccharide complex possibly being better tolerated. Objective:To compare the effect of ferrous sulfate with iron polysaccharide complex on hemoglobin concentration in infants and children with nutritional IDA. Design, Setting, and Participants:Double-blind, superiority randomized clinical trial of infants and children aged 9 to 48 months with nutritional IDA (assessed by history and laboratory criteria) that was conducted in an outpatient hematology clinic at a US tertiary care hospital from September 2013 through November 2015; 12-week follow-up ended in January 2016. Interventions:Three mg/kg of elemental iron once daily as either ferrous sulfate drops or iron polysaccharide complex drops for 12 weeks. Main Outcomes and Measures:Primary outcome was change in hemoglobin over 12 weeks. Secondary outcomes included complete resolution of IDA (defined as hemoglobin concentration >11 g/dL, mean corpuscular volume >70 fL, reticulocyte hemoglobin equivalent >25 pg, serum ferritin level >15 ng/mL, and total iron-binding capacity <425 ?g/dL at the 12-week visit), changes in serum ferritin level and total iron-binding capacity, adverse effects. Results:Of 80 randomized infants and children (median age, 22 months; 55% male; 61% Hispanic white; 40 per group), 59 completed the trial (28 [70%] in ferrous sulfate group; 31 [78%] in iron polysaccharide complex group). From baseline to 12 weeks, mean hemoglobin increased from 7.9 to 11.9 g/dL (ferrous sulfate group) vs 7.7 to 11.1 g/dL (iron complex group), a greater difference of 1.0 g/dL (95% CI, 0.4 to 1.6 g/dL; P?<?.001) with ferrous sulfate (based on a linear mixed model). Proportion with a complete resolution of IDA was higher in the ferrous sulfate group (29% vs 6%; P?=?.04). Median serum ferritin level increased from 3.0 to 15.6 ng/mL (ferrous sulfate) vs 2.0 to 7.5 ng/mL (iron complex) over 12 weeks, a greater difference of 10.2 ng/mL (95% CI, 6.2 to 14.1 ng/mL; P?<?.001) with ferrous sulfate. Mean total iron-binding capacity decreased from 501 to 389 ?g/dL (ferrous sulfate) vs 506 to 417 ?g/dL (iron complex) (a greater difference of -50 ?g/dL [95% CI, -86 to -14 ?g/dL] with ferrous sulfate; P?<?.001). There were more reports of diarrhea in the iron complex group than in the ferrous sulfate group (58% vs 35%, respectively; P?=?.04). Conclusions and Relevance:Among infants and children aged 9 to 48 months with nutritional iron-deficiency anemia, ferrous sulfate compared with iron polysaccharide complex resulted in a greater increase in hemoglobin concentration at 12 weeks. Once daily, low-dose ferrous sulfate should be considered for children with nutritional iron-deficiency anemia. Trial Registration:clinicaltrials.gov Identifier: NCT01904864.

Project description:Anemia, defined as a low hemoglobin concentration, has a large impact on the health of the world's population. We describe the use of a ubiquitous device, the smartphone, to predict hemoglobin concentration and screen for anemia. This was a prospective convenience sample study conducted in Emergency Department (ED) patients of an academic teaching hospital. In an algorithm derivation phase, images of both conjunctiva were obtained from 142 patients in Phase 1 using a smartphone. A region of interest targeting the palpebral conjunctiva was selected from each image. Image-based parameters were extracted and used in stepwise regression analyses to develop a prediction model of estimated hemoglobin (HBc). In Phase 2, a validation model was constructed using data from 202 new ED patients. The final model based on all 344 patients was tested for accuracy in anemia and transfusion thresholds. Hemoglobin concentration ranged from 4.7 to 19.6 g/dL (mean 12.5). In Phase 1, there was a significant association between HBc and laboratory-predicted hemoglobin (HBl) slope = 1.07 (CI = 0.98-1.15), p<0.001. Accuracy, sensitivity, and specificity of HBc for predicting anemia was 82.9 [79.3, 86.4], 90.7 [87.0, 94.4], and 73.3 [67.1, 79.5], respectively. In Phase 2, accuracy, sensitivity and specificity decreased to 72.6 [71.4, 73.8], 72.8 [71, 74.6], and 72.5 [70.8, 74.1]. Accuracy for low (<7 g/dL) and high (<9 g/dL) transfusion thresholds was 94.4 [93.7, 95] and 86 [85, 86.9] respectively. Error trended with increasing HBl values (slope 0.27 [0.19, 0.36] and intercept -3.14 [-4.21, -2.07] (p<0.001) such that HBc tended to underestimate hemoglobin in higher ranges and overestimate in lower ranges. Higher quality images had a smaller bias trend than lower quality images. When separated by skin tone results were unaffected. A smartphone can be used in screening for anemia and transfusion thresholds. Improvements in image quality and computational corrections can further enhance estimates of hemoglobin.

Project description:BackgroundAnemia is the most important complication during major surgery and transfusion of red blood cells is the mainstay to compensate for life threating blood loss. Therefore, accurate measurement of hemoglobin (Hb) concentration should be provided in real-time. Blood Gas Analysis (BGA) provides rapid point-of-care assessment using smaller sampling tubes compared to central laboratory (CL) services.ObjectiveThis study aimed to investigate the accuracy of BGA hemoglobin testing as compared to CL services.MethodsData of the ongoing LIBERAL-Trial (Liberal transfusion strategy to prevent mortality and anemia-associated ischemic events in elderly non-cardiac surgical patients, LIBERAL) was used to assess the bias for Hb level measured by BGA devices (ABL800 Flex analyzer®, GEM series® and RapidPoint 500®) and CL as the reference method. For that, we analyzed pairs of Hb level measured by CL and BGA within two hours. Furthermore, the impact of various confounding factors including age, gender, BMI, smoker status, transfusion of RBC, intraoperative hemodilution, and co-medication was elucidated. In order to ensure adequate statistical analysis, only data of participating centers providing more than 200 Hb pairs were used.ResultsIn total, three centers including 963 patients with 1,814 pairs of Hb measurements were analyzed. Mean bias was comparable between ABL800 Flex analyzer® and GEM series®: - 0.38 ± 0.15 g/dl whereas RapidPoint 500® showed a smaller bias (-0.09 g/dl) but greater median absolute deviation (± 0.45 g/dl). In order to avoid interference with different standard deviations caused by the different analytic devices, we focused on two centers using the same BGA technique (309 patients and 1,570 Hb pairs). A Bland-Altman analysis and LOWESS curve showed that bias decreased with smaller Hb values in absolute numbers but increased relatively. The smoker status showed the greatest reduction in bias (0.1 g/dl, p<0.001) whereas BMI (0.07 g/dl, p = 0.0178), RBC transfusion (0.06 g/dl, p<0.001), statins (0.04 g/dl, p<0.05) and beta blocker (0.03 g/dl, p = 0.02) showed a slight effect on bias. Intraoperative substitution of volume and other co-medications did not influence the bias significantly.ConclusionMany interventions like substitution of fluids, coagulating factors or RBC units rely on the accuracy of laboratory measurement devices. Although BGA Hb testing showed a consistently stable difference to CL, our data confirm that BGA devices are associated with different bias. Therefore, we suggest that hospitals assess their individual bias before implementing BGA as valid and stable supplement to CL. However, based on the finding that bias decreased with smaller Hb values, which in turn are used for transfusion decision, we expect no unnecessary or delayed RBC transfusion, and no major impact on the LIBERAL trial performance.

Dataset Information

Maternal Hemoglobin Concentration during Gestation and Risk of Anemia in Infancy: Secondary Analysis of a Randomized Controlled Trial.

Publications

Maternal Hemoglobin Concentration during Gestation and Risk of Anemia in Infancy: Secondary Analysis of a Randomized Controlled Trial.

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