Interpretation of 17-hydroxyprogesterone levels in early neonatal period by dissociation-enhanced lanthanide fluorescent immunoassay technique in a tertiary care centre

Background: Mass screening for CAH is controversial worldwide because of the low positive predictive value. The cut off levels of 17 OHP in NBS are based on birth weight and or gestational age. Both RIAs and ELISAs have been almost replaced in most European countries by DELFIA. We used DELFIA technique. The aim and objective was to determine optimal cut off values of 17 OHP levels in early neonatal period based on gestational age and birth weight.Methods: The study was conducted in the neonatal unit of RSRM Hospital Stanley Medical College as Prospective cross sectional study. All new borns with a gestational age of 34 weeks or more were included in the study. Sample was collected after getting informed consent after 48 hours of age till 7 days of age. 1695 babies who met the inclusion criteria were enrolled, the blood sample were collected by heel prick on filter paper. Neonates less than 34 weeks of gestational age, babies mothers who had received antenatal steroids, babies who had received blood transfusion prior to sampling and refusal of consent were excludedResults: As the gestational age increases the mean 17 OHP values declines and plateaus at 37 weeks and beyond. Similarly analysis based on weight shows a decline in mean values of 17 OHP with increasing birth weight and plateaus from 2500 gm.Conclusions: The study demonstrates clearly that there is linear trend in mean 17 OHP values in relationship to gestational age when compared to birth weight.

Retinopathy of prematurity in a tertiary care center: A study of prevalence, risk factors, and outcomes

Background: Retinopathy of prematurity (ROP) is a serious complication of prematurity treatment and can lead to blindnessunless recognized and treated early. Objectives: The objectives were to estimate the prevalence of ROP in preterm infants in theneonatal intensive care unit (NICU), to identify the risk factors which predispose to ROP, and to assess the outcome of these cases.Methodology: A retrospective screening survey was performed enrolling all premature neonates admitted to the NICU betweenJanuary and December 2016, with a gestational age of 32 weeks or less at birth and a birth weight of 1500 g or less. Infants whosegestational age was >32 weeks or birth weight was >1500 g were included if they were exposed to oxygen therapy for more than7 days. A total of 344 neonates had a retinal evaluation by indirect ophthalmoscopy from the fourth postnatal week and followedup periodically. Perinatal risk factors for ROP were assessed using univariate and multivariate analysis. Infants who progressedto Stage 3 ROP were given laser therapy. Results: Out of the studied 344 neonates, 66 (19.2%) developed ROP in one or botheyes; 36 (54.5%) cases had Stage 1, 18 (27.3%) cases Stage 2, and 12 (18.2%) cases had Stage 3 ROP. None had Stages 4 and5 ROP. The 12 cases diagnosed as ROP Stage 3 underwent LASER therapy. Univariate analysis showed a significant relationshipbetween the occurrence of ROP and gestational age (p=0.001), sepsis (p=0.004), oxygen therapy (p=0.018), and frequent bloodtransfusions (p=0.030). However, an insignificant relationship was found between the occurrence of ROP and factors such asgender, mode of delivery, birth weight, respiratory distress syndrome, patent ductus arteriosus, intraventricular hemorrhage,hypotension, phototherapy, and duration of oxygen therapy, mechanical ventilation, and continuous positive airway pressure.Gestational age, sepsis, oxygen therapy, and frequent blood transfusions remained significant variables after logistic regressionanalysis. Conclusion: The prevalence of ROP in this study was 19.2%; low gestational age, sepsis, oxygen therapy, and frequentblood transfusions were significant risk factors for ROP. LASER was effective in the treatment and decreasing the progression ofROP

Clinical profile and factors determining outcome of intramural very low birth weight babies in a tertiary care centre: a retrospective study

Background: Very low birth weight (VLBW) babies are at increased risk of a number of complications both immediate and late. Worldwide it has been observed that these babies contribute to a significant extent to neonatal mortality and morbidity. Aim of the study was to study the risk factors contributing to mortality in VLBW babies and to evaluate the morbidity pattern in these infants.Methods: A retrospective analysis of data retrieved from the case records of VLBW babies admitted in the NICU of Kilpauk Medical College between January 2015 to December 2015. Out of the 2360 intramural babies admitted during the study period, 99 babies were less than 1500 gms. The risk factors for these babies were analyzed for their association with the outcome. Data were statistically analyzed.Results: In present study, we found that sex of the baby, gestational age, obstetric score, birth asphyxia, pulmonary haemorrhage, ROP and presence of shock were found to be associated with increased mortality. By logistic regression analysis it was observed that birth weight of the baby (p value 0.002), duration of stay (p value 0.0006), presence of shock (p<0.0001), were the risk factors significantly associated with poor outcome.Conclusions: Among the maternal and neonatal factors analyzed in the study using logistic regression analysis, birth weight, duration of hospital stay and presence of shock were significantly related to poor outcome. Of these presence of shock was the single most important factor that predicted increased mortality

Interpretation of 17-hydroxyprogesterone levels in early neonatal period by dissociation-enhanced lanthanide fluorescent immunoassay technique in a tertiary care centre

Background: Mass screening for CAH is controversial worldwide because of the low positive predictive value. The cut off levels of 17 OHP in NBS are based on birth weight and or gestational age. Both RIAs and ELISAs have been almost replaced in most European countries by DELFIA. We used DELFIA technique. The aim and objective was to determine optimal cut off values of 17 OHP levels in early neonatal period based on gestational age and birth weight. Methods: The study was conducted in the neonatal unit of RSRM Hospital Stanley Medical College as Prospective cross sectional study. All new borns with a gestational age of 34 weeks or more were included in the study. Sample was collected after getting informed consent after 48 hours of age till 7 days of age. 1695 babies who met the inclusion criteria were enrolled, the blood sample were collected by heel prick on filter paper. Neonates less than 34 weeks of gestational age, babies mothers who had received antenatal steroids, babies who had received blood transfusion prior to sampling and refusal of consent were excluded Results: As the gestational age increases the mean 17 OHP values declines and plateaus at 37 weeks and beyond. Similarly analysis based on weight shows a decline in mean values of 17 OHP with increasing birth weight and plateaus from 2500 gm. Conclusions: The study demonstrates clearly that there is linear trend in mean 17 OHP values in relationship to gestational age when compared to birth weight. [Int J Res Med Sci 2016; 4(5.000): 1522-1528

Transcriptomic profile of adverse neurodevelopmental outcomes after neonatal encephalopathy

A rapid and early diagnostic test to identify the encephalopathic babies at risk of adverse outcome may accelerate the development of neuroprotectants. We examined if a whole blood transcriptomic signature measured soon after birth, predicts adverse neurodevelopmental outcome eighteen months after neonatal encephalopathy. We performed next generation sequencing on whole blood ribonucleic acid obtained within six hours of birth from the first 47 encephalopathic babies recruited to the Hypothermia for Encephalopathy in Low and middle-income countries (HELIX) trial. Two infants with blood culture positive sepsis were excluded, and the data from remaining 45 were analysed. A total of 855 genes were significantly differentially expressed between the good and adverse outcome groups, of which RGS1 and SMC4 were the most significant. Biological pathway analysis adjusted for gender, trial randomisation allocation (cooling therapy versus usual care) and estimated blood leukocyte proportions revealed over-representation of genes from pathways related to melatonin and polo-like kinase in babies with adverse outcome. These preliminary data suggest that transcriptomic profiling may be a promising tool for rapid risk stratification in neonatal encephalopathy. It may provide insights into biological mechanisms and identify novel therapeutic targets for neuroprotection

Parental and professional perceptions of informed consent and participation in a time-critical neonatal trial: a mixed-methods study in India, Sri Lanka and Bangladesh

Introduction Time-critical neonatal trials in low-and-middle-income countries (LMICs) raise several ethical issues. Using a qualitative-dominant mixed-methods design, we explored informed consent process in Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial conducted in India, Sri Lanka and Bangladesh.Methods Term infants with neonatal encephalopathy, aged less than 6 hours, were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed A-V records of the consent process using a 5-point Likert scale on three parameters—empathy, information and autonomy. In addition, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 healthcare professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts.Results A total of 294 A-V records of the HELIX trial were analysed. Median (IQR) score for empathy, information and autonomy was 5 (0), 5 (1) and 5 (1), respectively. However, thematic analysis suggested that the consenting was a ceremonial process; and parental decision to participate was based on unreserved trust in the treating doctors, therapeutic misconception and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial nor the nature of the intervention. Professionals showed a strong bias towards cooling therapy and reported time constraints and explaining to multiple family members as key challenges.Conclusion Despite rigorous research governance and consent process, parental decisions were heavily influenced by situational incapacity and a trust in doctors to make the right decision on their behalf. Further research is required to identify culturally and context-appropriate strategies for informed trial participation

Additional file 4: of Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial

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Hypothermia for moderate or severe neonatal encephalopathy in low-income and middle-income countries (HELIX): a randomised controlled trial in India, Sri Lanka, and Bangladesh

Copyright (c) 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license