scholarly journals Premature or Small for Gestational Age Discrimination: International Multicenter Trial Protocol for Classification of the Low-Birth-Weight Newborn Through the Optical Properties of the Skin

10.2196/16477 ◽  
2020 ◽  
Vol 9 (7) ◽  
pp. e16477
Author(s):  
Zilma Reis ◽  
Gabriela Vitral ◽  
Rodney Guimarães ◽  
Juliano Gaspar ◽  
Enrico Colosimo ◽  
...  

Background A low birth weight is an independent risk factor for adverse infant outcomes and a predictor of chronic disease in adulthood. In these situations, differentiating between prematurity and small for gestational age (SGA) or simultaneous conditions is essential to ensuring adequate care. Such diagnoses, however, depend on reliable pregnancy dating, which can be challenging in developing countries. A new medical optoelectronic device was developed to estimate gestational age (GA) at birth based on newborn skin reflection. Objective This study will aim to evaluate the device’s ability to detect prematurity or SGA, or both conditions simultaneously as well as predict short-term pulmonary complications in a cohort of low-birth-weight newborns. Methods This study protocol was designed for a multicenter cohort including referral hospitals in Brazil and Mozambique. Newborns weighing 500-2500 g will be eligible for inclusion with the best GA available, considering the limited resources of low-income countries. Comparator-GA is based on reliable last menstrual period dating or ultrasound assessment before 24 weeks’ gestation. Estimated GA at birth (Test-GA) will be calculated by applying a novel optoelectronic device to the newborn’s skin over the sole. The average difference between Test-GA and Comparator-GA will be analyzed, as will the percentage of newborns who are correctly diagnosed as preterm or SGA. In addition, in a nested case–control study, the accuracy of skin reflection in the prediction of prematurity-related respiratory problems will be evaluated. The estimated required sample size is 298 newborns. Results Teams of health professionals were trained, and standard operating procedures were developed following the good practice guidelines for the clinical investigation of medical devices for human participants. The first recruitment started in March 2019 in Brazil. Data collection is planned to end in December 2020, and the results should be available in March 2021. Conclusions The results of this clinical study have the potential to validate a new device to easily assess postnatal GA, supporting SGA identification when pregnancy dating is unreliable or unknown. Trial Registration ReBec: RBR-33rnjf; http://www.ensaiosclinicos.gov.br/rg/RBR-33rnjf/ International Registered Report Identifier (IRRID) DERR1-10.2196/16477

2019 ◽  
Author(s):  
Zilma Reis ◽  
Gabriela Vitral ◽  
Rodney Guimarães ◽  
Juliano Gaspar ◽  
Enrico Colosimo ◽  
...  

BACKGROUND A low birth weight is an independent risk factor for adverse infant outcomes and a predictor of chronic disease in adulthood. In these situations, differentiating between prematurity and small for gestational age (SGA) or simultaneous conditions is essential to ensuring adequate care. Such diagnoses, however, depend on reliable pregnancy dating, which can be challenging in developing countries. A new medical optoelectronic device was developed to estimate gestational age (GA) at birth based on newborn skin reflection. OBJECTIVE This study will aim to evaluate the device’s ability to detect prematurity or SGA, or both conditions simultaneously as well as predict short-term pulmonary complications in a cohort of low-birth-weight newborns. METHODS This study protocol was designed for a multicenter cohort including referral hospitals in Brazil and Mozambique. Newborns weighing 500-2500 g will be eligible for inclusion with the best GA available, considering the limited resources of low-income countries. Comparator-GA is based on reliable last menstrual period dating or ultrasound assessment before 24 weeks’ gestation. Estimated GA at birth (Test-GA) will be calculated by applying a novel optoelectronic device to the newborn’s skin over the sole. The average difference between Test-GA and Comparator-GA will be analyzed, as will the percentage of newborns who are correctly diagnosed as preterm or SGA. In addition, in a nested case–control study, the accuracy of skin reflection in the prediction of prematurity-related respiratory problems will be evaluated. The estimated required sample size is 298 newborns. RESULTS Teams of health professionals were trained, and standard operating procedures were developed following the good practice guidelines for the clinical investigation of medical devices for human participants. The first recruitment started in March 2019 in Brazil. Data collection is planned to end in December 2020, and the results should be available in March 2021. CONCLUSIONS The results of this clinical study have the potential to validate a new device to easily assess postnatal GA, supporting SGA identification when pregnancy dating is unreliable or unknown. CLINICALTRIAL ReBec: RBR-33rnjf; http://www.ensaiosclinicos.gov.br/rg/RBR-33rnjf/ INTERNATIONAL REGISTERED REPORT DERR1-10.2196/16477


Nutrients ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1853
Author(s):  
María A. Reyes-López. ◽  
Carla P. González-Leyva ◽  
Ameyalli M. Rodríguez-Cano ◽  
Carolina Rodríguez-Hernández ◽  
Eloisa Colin-Ramírez ◽  
...  

A high-quality diet during pregnancy may have positive effects on fetal growth and nutritional status at birth, and it may modify the risk of developing chronic diseases later in life. The aim of this study was to evaluate the association between diet quality and newborn nutritional status in a group of pregnant Mexican women. As part of the ongoing Mexican prospective cohort study, OBESO, we studied 226 healthy pregnant women. We adapted the Alternated Healthy Eating Index-2010 for pregnancy (AHEI-10P). The association between maternal diet and newborn nutritional status was investigated by multiple linear regression and logistic regression models. We applied three 24-h recalls during the second half of gestation. As the AHEI-10P score improved by 5 units, the birth weight and length increased (β = 74.8 ± 35.0 g and β = 0.3 ± 0.4 cm, respectively, p < 0.05). Similarly, the risk of low birth weight (LBW) and small for gestational age (SGA) decreased (OR: 0.47, 95%CI: 0.27–0.82 and OR: 0.55, 95%CI: 0.36–0.85, respectively). In women without preeclampsia and/or GDM, the risk of stunting decreased as the diet quality score increased (+5 units) (OR: 0.62, 95%IC: 0.40–0.96). A high-quality diet during pregnancy was associated with a higher newborn size and a reduced risk of LBW and SGA in this group of pregnant Mexican women.


2020 ◽  
Vol 149 ◽  
pp. 105154 ◽  
Author(s):  
Elaine Luiza Santos Soares de Mendonça ◽  
Mateus de Lima Macêna ◽  
Nassib Bezerra Bueno ◽  
Alane Cabral Menezes de Oliveira ◽  
Carolina Santos Mello

PEDIATRICS ◽  
1982 ◽  
Vol 69 (1) ◽  
pp. 130-130
Author(s):  
Evelyn Lipper ◽  
Kwang-sun Lee ◽  
Lawrence M. Gartner ◽  
Bruce Grellong

All of the infants entered into the study were low-birth-weight infants (&lt;2,500 gm). The majority of infants had a gestational age less than 37 completed weeks, and, of these, some were also small for gestational age. Sixteen infants had a gestational age of ≥37 weeks but were included in the study because their birth weight was below the tenth percentile for their gestational age. We agree with Drs Knobloch and Malone's comment about the interrelationship of all three figures: as gastation advances, birth weight and head circumference increase.


PEDIATRICS ◽  
1972 ◽  
Vol 50 (2) ◽  
pp. 236-245 ◽  
Author(s):  
Avroy A. Fanaroff ◽  
Michael Wald ◽  
Howard S. Gruber ◽  
Marshall H. Klaus

Insensible water loss (IWL) was determined from measurements of insensible weight loss during the first 7 weeks of life on 30 immature and nine small-for-gestational age, low birth weight infants. Under standard conditions (single-walled incubator, infant nude, gavage feeding), 10 infants with birth weights less than 1,250 gm, gestational age &lt; 230 days (32 weeks) and postnatal age &lt;10 days lost &gt;2.5 gm/kg/hr (equivalent to 60-120 ml/kg/day), considerably higher than previously reported. Studies following the insertion of a plastic heat shield revealed a 25% reduction in IWL. The heat shield facilitates achievement of neutral thermal environment and reduced water losses in low birth weight infants. IWL measurements in infants with birth weights &gt;1,500 gm and those small-for-gestational age were similar to previously reported studies. Because of the known limited ability of small immature infants to increase metabolic rate, these extremely high losses are believed to represent disproportionately larger water losses from skin. Skin factors predisposing to large water loss in immature infants include thinner epidermis, increased water content, and increased permeability.


PEDIATRICS ◽  
1981 ◽  
Vol 67 (3) ◽  
pp. 407-411
Author(s):  
R. K. Chandra

Groups of healthy, small-for-gestational age (SGA) and preterm appropriate-for-gestational age (AGA) infants were studied at birth, 1 month, 3 months, and 12 months of age. Serum thymic hormone (TH) activity was assayed, the number of T lymphocytes in the peripheral blood was counted, and in vitro lymphocyte stimulation responses to phytohemagglutinin (PHA) were evaluated. TH activity was decreased in 1-month-old SGA infants. T cells were reduced in all low birth weight infants; the number reverted to normal by 3 months of age in preterm AGA infants, whereas it remained low for at least 12 months in the SGA group. Lymphocyte stimulation response was decreased in low birth weight infants; the extent of depression paralleled reduction in T lymphocyte number. These observations indicate that cell-mediated immunity is impaired in low birth weight newborns and reduced TH activity may be one of the pathogenetic factors involved. Persistent depression of immunocompetence may underlie the increased susceptibility of SGA infants to infection-related morbidity and mortality.


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