Search results for: hypotonic neonate

Authors: Lisa Bennett, Cynthia Walters, Cynthia Argani, Andy Satin, Geeta Sood, Kerri Huber, Lisa Grubb, Woodrow Noble, Melissa Eichelberger, Darlene Zinalabedini, Eric Ausby, Jeffrey Snyder, Kevin Kirchoff

Abstract:

Background: Surgical site infections (SSIs) within the obstetric population pose a variety of complications, creating clinical and personal challenges for the new mother and her neonate during the postpartum period. Our journey to achieve compliance with the SSI core measure for cesarean sections revealed many opportunities to improve these outcomes. Objective: Achieve and sustain core measure compliance keeping surgical site infection rates below the national benchmark pooled mean of 1.8% in post-operative patients, who delivered via cesarean section at the Johns Hopkins Bayview Medical Center. Methods: A root cause analysis was performed and revealed several environmental, pharmacologic, and clinical practice opportunities for improvement. A multidisciplinary approach led by the OB Safety Nurse, OB Medical Director, and Infectious Disease Department resulted in the implementation of fourteen interventions over a twenty-month period. Interventions included: post-operative dressing changes, standardizing operating room attire, broadening pre-operative antibiotics, initiating vaginal preps, improving operating room terminal cleaning, testing air quality, and re-educating scrub technicians on technique. Results: Prior to the implementation of our interventions, the SSI quarterly rate in Obstetrics peaked at 6.10%. Although no single intervention resulted in dramatic improvement, after implementation of all fourteen interventions, the quarterly SSI rate has subsequently ranged from to 0.0% to 2.70%. Significance: Taking an introspective look at current practices can reveal opportunities for improvement which previously were not considered. Collectively the benefit of these interventions has shown a significant decrease in surgical site infection rates. The impact of this quality improvement project highlights the synergy created when members of the multidisciplinary team work in collaboration to improve patient safety, and achieve a high quality of care.

Keywords: cesarean section, surgical site infection, collaboration and teamwork, patient safety, quality improvement

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Authors: Rebecca Greenberg, Nipa Chauhan, Rashad Rehman

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Paternalism, in its traditional form, seems largely incompatible with Western medicine. In contrast, Family-Centred Care, a partial response to historically authoritative paternalism, carries its own challenges, particularly when operationalized as family-directed care. Specifically, in neonatology, decision-making is left entirely to Substitute Decision Makers (most commonly parents). Most models of shared decision-making employ both the parents’ and medical team’s perspectives but do not recognize the inherent asymmetry of information and experience – asking parents to act like physicians to evaluate technical data and encourage physicians to refrain from strong medical opinions and proposals. They also do not fully appreciate the difficulties in adjudicating which perspective to prioritize and, moreover, how to mitigate disagreement. Introducing a mild form of paternalism can harness the unique skillset both parents and clinicians bring to shared decision-making and ultimately work towards decision-making in the best interest of the child. The notion expressed here is that within the model of shared decision-making, mild paternalism is prioritized inasmuch as optimal care is prioritized. This mild form of paternalism is known as Beneficent Paternalism and justifies our encouragement for physicians to root down in their own medical expertise to propose treatment plans informed by medical expertise, standards of care, and the parents’ values. This does not mean that we forget that paternalism was historically justified on ‘beneficent’ grounds; however, our recommendation is that a re-integration of mild paternalism is appropriate within our current Western healthcare climate. Through illustrative examples from the NICU, this paper explores the appropriateness and merits of Beneficent Paternalism and ultimately its use in promoting family-centered care, patient’s best interests and reducing moral distress. A distinctive feature of the NICU is the fact that communication regarding a patient’s treatment is exclusively done with substitute decision-makers and not the patient, i.e., the neonate themselves. This leaves the burden of responsibility entirely on substitute decision-makers and the clinical team; the patient in the NICU does not have any prior wishes, values, or beliefs that can guide decision-making on their behalf. Therefore, the wishes, values, and beliefs of the parent become the map upon which clinical proposals are made, giving extra weight to the family’s decision-making responsibility. This leads to why Family Directed Care is common in the NICU, where shared decision-making is mandatory. However, the zone of parental discretion is not as all-encompassing as it is currently considered; there are appropriate times when the clinical team should strongly root down in medical expertise and perhaps take the lead in guiding family decision-making: this is just what it means to adopt Beneficent Paternalism.

Keywords: care, ethics, expertise, NICU, paternalism

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Authors: Michael Vieth, Aric Schadler, Hubert Ballard, J. A. Bauer, Pratibha Thakkar

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Introduction: Congenital diaphragmatic hernia (CDH) is a condition characterized by the herniation of abdominal contents into the thoracic cavity requiring postnatal surgical repair. Previous literature suggests improved CDH outcomes at high-volume regional referral centers compared to low-volume centers. The purpose of this study was to examine CDH outcomes at Kentucky Children’s Hospital (KCH), a low-volume center, compared to the Congenital Diaphragmatic Hernia Study Group (CDHSG). Methods: A retrospective chart review was performed at KCH from 2007-2019 for neonates with CDH, and then subdivided into two cohorts: those requiring ECMO therapy and those not requiring ECMO therapy. Basic demographic data and measures of mortality and morbidity including ventilator days and length of stay were compared to the CDHSG. Measures of morbidity for the ECMO cohort including duration of ECMO, clinical bleeding, intracranial hemorrhage, sepsis, need for continuous renal replacement therapy (CRRT), need for sildenafil at discharge, timing of surgical repair, and total ventilator days were collected. Statistical analysis was performed using IBM SPSS Statistics version 28. One-sample t-tests and one-sample Wilcoxon Signed Rank test were utilized as appropriate.Results: There were a total of 27 neonatal patients with CDH at KCH from 2007-2019; 9 of the 27 required ECMO therapy. The birth weight and gestational age were similar between KCH and the CDHSG (2.99 kg vs 2.92 kg, p =0.655; 37.0 weeks vs 37.4 weeks, p =0.51). About half of the patients were inborn in both cohorts (52% vs 56%, p =0.676). KCH cohort had significantly more Caucasian patients (96% vs 55%, p=<0.001). Unadjusted mortality was similar in both groups (KCH 70% vs CDHSG 72%, p =0.857). Using ECMO utilization (KCH 78% vs CDHSG 52%, p =0.118) and need for surgical repair (KCH 95% vs CDHSG 85%, p =0.060) as proxy for severity, both groups’ mortality were comparable. No significant difference was noted for pulmonary outcomes such as average ventilator days (KCH 43.2 vs. CDHSG 17.3, p =0.078) and home oxygen dependency (KCH 44% vs. CDHSG 24%, p =0.108). Average length of hospital stay for patients treated at KCH was similar to CDHSG (64.4 vs 49.2, p=1.000). Conclusion: Our study demonstrates that outcome in CDH patients is independent of center’s case volume status. Management of CDH with a standardized approach in a low-volume center can yield similar outcomes. This data supports the treatment of patients with CDH at low-volume centers as opposed to transferring to higher-volume centers.

Keywords: ECMO, case volume, congenital diaphragmatic hernia, congenital diaphragmatic hernia study group, neonate

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Authors: Pushp Lata Sankhwar

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INTRODUCTION: Maternal Hypothyroidism is the most frequent endocrine disorder in pregnancy and varies from 2.5% in the west to 11.0% in India. Maternal Hypothyroidism can have detrimental maternal effects like increased risk of preterm labor, PPROM leading to increased maternal morbidity and also on the neonate in the form of prematurity and its complications, prolonged hospital stay, neurological developmental problems, delayed milestones and mental retardation etc. Henceforth, the study was planned to evaluate the role of Hypothyroidism in preterm labor and its effect on neonates. AIMS AND OBJECTIVES: To Correlate Overt Hypothyroidism, Subclinical Hypothyroidism and Isolated Hypothyroxinemia With Preterm Labor and the neonatal outcome. Material and Methods: A case-control study of singleton pregnancy was performed over a year, in which a total of 500 patients presenting in the emergency with preterm labor were enrolled. The thyroid profile of these patients was sent at the time of admission, on the basis of which they were divided into Cases – Hypothyroidic mothers and Controls – Euthyroid mothers. The cases were further divided into subclinical, overt Hypothyroidism and isolated hypothyroxinemia. The neonatal outcome of these groups was also compared on the basis of the incidence and severity of neonatal morbidity, neonatal respiratory distress, the incidence of neonatal Hypothyroidism and early complications. The feto-maternal data was collected and analysed. RESULTS: In the study, a total of 500 antenatal patients with a history of preterm labor were enrolled, out of which 67 (13.8%) patients were found to be hypothyroid. The majority of the mothers had Subclinical Hypothyroidism (12.2%), followed by Overt Hypothyroidism seen in 1% of the mothers and isolated hypothyroxinemia in 0.6% of cases. The neonates of hypothyroid mothers had higher levels of cord blood TSH, and the mean cord blood TSH levels were highest in the case of neonates of mothers with Overt Hypothyroidism. The need for resuscitation of the neonates at the time of birth was higher in the case of neonates of hypothyroid mothers, especially with Subclinical Hypothyroidism. Also, it was found that the requirement of oxygen therapy in the form of oxygen by nasal prongs, oxygen by a hood, CPAP, CPAP along with surfactant therapy and mechanical ventilation along with surfactant therapy was significantly higher in the case of neonates of hypothyroid mothers. CONCLUSION: The results of our study imply that uncontrolled and untreated maternal Hypothyroidism may also lead to preterm delivery. The neonates of mothers with Hypothyroidism have higher cord blood TSH levels. The study also shows that there is an increased incidence and severity of respiratory distress in the neonates of hypothyroid mothers with untreated subclinical Hypothyroidism. Hence, we propose that routine screening for thyroid dysfunction in pregnant women should be done to prevent thyroid-related feto-maternal complications.

Keywords: high-risk pregnancy, thyroid, dysfunction, hypothyroidism, Preterm labor

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Authors: Elif Erdem, Nalan Kaya, Gonca Ozan, Durrin Ozlem Dabak, Enver Ozan

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This study was carried out to determine the histological and biochemical changes in the lungs of the rat pups exposed to tobacco smoke during pregnancy period and to investigate the protective effects of alpha lipoic acid, which is administered during pregnancy, on these changes. In our study, 24 six-week old Spraque-Dawley female rats weighing 160 ± 10 g were used (n:7). Rats were randomly divided into four equal groups: group I (control), group II (tobacco smoke), group III (tobacco smoke + alpha lipoic acid) and group IV (alpha lipoic acid). Rats in the group II, group III were exposed to tobacco smoke twice a day for one hour starting from eight weeks before mating and during pregnancy. In addition to tobacco smoke, 20 mg/kg of alpha lipoic acid was administered via oral gavage to the rats in the group III. Only alpha lipoic acid was administered to the rats in the group IV. Once after the delivery, all administrations were stopped. On the 7 and 21th days, the seven pups of all groups were decapitated. A portion of the lung was taken and stained with HE, PAS and Masson. In addition to immunohistochemical staining of surfactant protein A, vascular endothelial growth factor, caspase-3, TUNEL method was also used to determine apoptosis. Biochemical analyzes were performed with some part of the lung tissue specimens. In the histological evaluations performed under light microscopy, inflammatory cell increase, hemorrhagic areas, edema, interalveolar septal thickening, alveolar numbers decrease, degeneration of some bronchi and bronchial epithelium, epithelial cells that were fallen into the lumen and hyaline membrane formation were observed in tobacco smoke group. These findings were ameliorated in tobacco smoke + ALA group. Hyaline membrane formation was not detected in this group. The TUNEL positive cell numbers a significant increase was detected in the tobacco smoke group, whereas a significant decrease was detected in the tobacco smoke + ALA group. In terms of the immunoreactivity of both SP-A and VEGF, a significant decrease was observed in the tobacco smoke group, and a significant increase was observed in the tobacco smoke + ALA group. Regarding the immunoreactivity of caspase-3, there was a significant increase in the group of tobacco smoke and a significant decrease in the group of tobacco smoke + ALA. The malondialdehyde levels were determined to be significantly increased in the tobacco smoke group, and a significant decreased in the tobacco smoke + ALA. Glutathione and superoxide dismutase enzyme activities showed a significant decrease in the group of tobacco smoke and a significant increase in the tobacco smoke + ALA group. In conclusion, we suggest that the exposure to tobacco smoke during pregnancy leads to morphological, histopathological and functional changes on lung development by causing oxidative damage in lung tissues of neonatal rats and the maternal use of alpha lipoic acid can provide a protective effect on the neonatal lung development against this oxidative stress originating from tobacco smoke.

Keywords: alpha lipoic acid, lung, neonate, tobacco smoke, pregnancy

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Authors: Oluwafunmibi Omotayo Fasanya, Augustine Kena Adjei

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Physiological changes during pregnancy, such as alterations in the circulatory, respiratory, and musculoskeletal systems, can negatively impact daily physical activity. This reduced activity is often associated with an increased risk of adverse maternal health outcomes, particularly gestational diabetes mellitus (GDM) and excessive weight gain. This meta-analysis aims to evaluate the effectiveness of structured physical exercise interventions during pregnancy in reducing the risk of GDM and managing maternal weight gain. A comprehensive search was conducted across six major databases: PubMed, Cochrane Library, EMBASE, Web of Science, ScienceDirect, and ClinicalTrials.gov, covering the period from database inception until 2023. Randomized controlled trials (RCTs) that explored the effects of physical exercise programs on pregnant women with low physical activity levels were included. The search was performed using EndNote and results were managed using RevMan (Review Manager) for meta-analysis. RCTs involving healthy pregnant women with low levels of physical activity or sedentary lifestyles were selected. These RCTs must have incorporated structured exercise programs during pregnancy and reported on outcomes related to GDM and maternal weight gain. From an initial pool of 5,112 articles, 65 RCTs (involving 11,400 pregnant women) met the inclusion criteria. Data extraction was performed, followed by a quality assessment of the selected studies using the Cochrane Risk of Bias tool. The meta-analysis was conducted using RevMan software, where pooled relative risks (RR) and weighted mean differences (WMD) were calculated using a random-effects model to address heterogeneity across studies. Sensitivity analyses, subgroup analyses (based on factors such as exercise intensity, duration, and pregnancy stage), and publication bias assessments were also conducted. Structured physical exercise during pregnancy led to a significant reduction in the risk of developing GDM (RR = 0.68; P < 0.001), particularly when the exercise program was performed throughout the pregnancy (RR = 0.62; P = 0.035). In addition, maternal weight gain was significantly reduced (WMD = −1.18 kg; 95% CI −1.54 to −0.85; P < 0.001). There were no significant adverse effects reported for either the mother or the neonate, confirming that exercise interventions are safe for both. This meta-analysis highlights the positive impact of regular moderate physical activity during pregnancy in reducing the risk of GDM and managing maternal weight gain. These findings suggest that physical exercise should be encouraged as a routine part of prenatal care. However, more research is required to refine exercise recommendations and determine the most effective interventions based on individual risk factors and pregnancy stages.

Keywords: gestational diabetes, maternal weight management, meta-analysis, randomized controlled trials

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Authors: Aakriti Chetan Shah, Elle Sein

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Background/purpose: Group B Streptococcus(GBS) is the leading cause of severe early onset infection in newborns, with the incidence of Early Onset Group B Streptococcus (EOGBS) in the UK and Ireland rising from 0.48 to 0.57 per 1000 births from 2000 to 2015. A WHO study conducted in 2017, has shown that 38.5% of cases can result in stillbirth and infant deaths. This is an important problem to consider as 20% of women worldwide have GBS colonisation and can suffer from these detrimental effects. Current Royal College of Obstetricians and Midwives (RCOG) guidelines do not recommend bacteriological screening for pregnant women due to its low sensitivity in antenatal screening correlating with the neonate having GBS but advise a patient information leaflet be given to pregnant women. However, a Healthcare Safety Investigation Branch (HSIB) 2019 learning report found that only 50% of trusts and health boards reported giving GBS information leaflets to all pregnant mothers. Therefore, this audit aimed to assess current practices of information dissemination about GBS at Chelsea & Westminster (C&W) Hospital. Methodology: A quantitative cross-sectional study was carried out using a questionnaire based on the RCOG GBS guidelines and the HSIB Learning report. The study was conducted in antenatal clinics at Chelsea & Westminster Hospital, from 29th January 2021 to 14th February 2021, with twenty-two practicing obstetricians and midwives participating in the survey. The main outcome measure was the proportion of obstetricians and midwives who disseminate information about GBS to pregnant women, and the reasons behind why they do or do not. Results: 22 obstetricians and midwives responded with 18 complete responses. Of which 12 were obstetricians and 6 were midwives. Only 17% of clinical staff routinely inform all pregnant women about GBS, and do so at varying timeframes of the pregnancy, with an equal split in the first, second and third trimester. The primary reason for not informing women about GBS was influenced by three key factors: Deemed relevant only for patients at high risk of GBS, lack of time in clinic appointments and no routine NHS screening available. Interestingly 58% of staff in the antenatal clinic believe it is necessary to inform all women about GBS and its importance. Conclusion: It is vital for obstetricians and midwives to inform all pregnant women about GBS due to the high prevalence of incidental carriers in the population, and the harmful effects it can cause for neonates. Even though most clinicians believe it is important to inform all pregnant women about GBS, most do not. To ensure that RCOG and HSIB recommendations are followed, we recommend that women should be given this information at 28 weeks gestation in the antenatal clinic. Proposed implementations include an information leaflet to be incorporated into the Mum and Baby app, an informative video and end-to-end digital clinic documentation to include this information sharing prompt.

Keywords: group B Streptococcus, early onset sepsis, Antenatal care, Neonatal morbidity, GBS

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Authors: Anteneh Berhane Yeyi, Tefera Belachew

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Any woman who could become pregnant is at risk of having a baby with neural tube defects (NTDs). A spontaneous aborted women with immediately preceding pregnancy may have an increased risk of develop NTDs. Ethiopia has one of the highest rates of micronutrient deficiencies, including folate and iron deficiency. Currently, in Ethiopia, NTDs is emerged as a public health concern. Even if Ethiopia, has implement different strategies for reducing maternal and neonatal mortality and morbidity, there is no room in the health care system and lack of integration for preventing the risk of NTDs for those women who aborted spontaneously and women who discontinue long acting contraception to become pregnant. The purpose of this study was to evaluate the effect of preconception picture-based nutrition education on knowledge and adherence to iron-folic acid supplement (IFAS) intake to reduce the risk of developing neural tube defects (NTDs) and iron deficiency anemia (IDA) among women who had a planned to pregnancy in Ethiopia, a country with a high burden of NTDs. Methodology: This study was conducted in Eastern Ethiopia. A double blinded parallel randomized controlled trial design was employed among women in the age group of 18-45 years who requested to interrupt modern contraceptive who have an intention to be pregnant and women with spontaneous abortion who refused to take a contraceptive. The interventional arm (n=122) received a preconception picture-based nutrition education with iron-folic acid supplement, and the control arm (n=122) received only preconception IFAS. In this study male partners were participated. Result: After three months of intervention the proportion of adherence to IFAS was 23% (n=56). With regard to adherence within the groups, 42.6% (n=52) in the intervention group and 3.3% (n=4) in the control group and the intervention group were significantly higher than in control group. In the intervention group the proportion of adherence to IFAS intake among participants increased by 40.1% and there were statistically difference (P<0.0001). The difference in difference between the two groups of adherence to IFAS intake was 37.6% and there were a statistical significance (P<0.0001). Level of knowledge between the groups did differ before and after intervention (P= 0.87 Vs P<0.0001). The overall the mean change in knowledge Mean (+SE) between group was 0.9 (+3.04 SE) and there were significant differences between two groups (P<0.001). Conclusion: In general this intervention is effective toward adherence to IFAS and a critical milestone to improve maternal health and reduce the neonate mortality due to NTDs and other advert effect of pregnancy and birth outcomes. This intervention is very short, simple, and cost effective and has potential for adaptation, feasible development to large-scale implementation in the existing health care system. Furthermore, this type of interventional approach has the potential to reduce the country's ANC program dropout rates and increase male partner’s participation on reproductive health.

Keywords: NTDs, IFAS, WRA, Ethiopia

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Authors: Huda Abdelrhman Osman Ahmed, Paul Feyi Waboso

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Introduction: Placenta accreta spectrum (PAS) disorders present a significant challenge in obstetric management due to the high risk of hemorrhage and potential complications at delivery. This case describes a 27+3 weeks gestation in a patient with placenta accreta managed with classical cesarean section and peripartum hysterectomy. Case Description: AGravida 4P3 patient presented at 27+3 weeks gestation with painless, unprovoked vaginal bleeding and an estimated blood loss (EBL) of 300 mL. At the 20+5 week anomaly scan, a placenta previa was identified anterior, covering the os anterior uterus and containing lacunae with signs of myometrial thinning. At a 24+1 week scan conducted at a tertiary center, further imaging indicated placenta increta with invasion into the myometrium and potential areas of placenta percreta. The patient’s past obstetric history included three previous cesarean sections, with no significant medical or surgical history. Social history revealed heavy smoking but no alcohol use. No drug allergies were reported. Given the risks associated with PAS, a management plan was formulated, including an MRI at a later stage and cesarean delivery with a possible hysterectomy between 34-36 weeks. However, at 27+3 weeks, the patient experienced another episode of vaginal bleeding EBL 500 ml, necessitating immediate intervention. Management: As the patient was unstable, she was not transferred to the tertiary center. Completed and informed consent was obtained. MDT planning-group and cross-matching 4 units, uterotonics. Tranexamic acid blood products, cryo, cell salvage, 2 obstetric consultants and an anesthetic consultant, blood bank aware and hematologist. HDU bed and ITU availability. This study assisted in performing a classical Caesarean section, Where the urologist inserted JJ ureteric stents. Following this, we also assisted in a total abdominal hysterectomy with the conservation of ovaries. 4 units RBC and 1 unit FFP were transfused. The total blood loss was 2.3 L. Outcome: The procedure successfully achieved hemostasis, and the neonate was delivered with subsequent transfer to a neonatal intensive care unit for management. The patient’s postoperative course was monitored closely with no immediate complications. Discussion: This case highlights the complexity and urgency in managing placenta accreta spectrum disorders, particularly with the added challenges posed by remote location and limited tertiary support. The need for rapid decision-making and interdisciplinary coordination is emphasized in such high-risk obstetric cases. The case also underscores the potential for surgical intervention and the importance of family involvement in emergent care decisions. Conclusion: Placenta accreta spectrum disorders demand meticulous planning and timely intervention. This case contributes to understanding PAS management at earlier gestational ages and provides insights into the challenges posed by access to tertiary care, especially in urgent situations.

Keywords: Accreta, Hysterectomy, 3MDT, prematurity

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Authors: Priyanka Yadav, Umesh Bnasal, Yashvinder Kumar

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The placenta is an important structure that provides oxygen and nutrients to the growing fetus in utero. It is usually thrown away after birth, but it has a therapeutic role in the regeneration of tissue. It is covered by the amniotic membrane, which can be easily separated into the amnion layer and the chorion layer—the amnion layer act as a biofilm for the healing of burn wound and non-healing ulcers. The freshly collected membrane has stem cells, cytokines, growth factors, and anti-inflammatory properties, which act as a biofilm for the healing of wounds. It functions as a barrier and prevents heat and water loss and also protects from bacterial contamination, thus supporting the healing process. The application of Amnion membranes has been successfully used for wound and reconstructive purposes for decades. It is a very cheap and easy process and has shown superior results to allograft and xenograft. However, there are very few case reports of amnion membrane grafting in newborns; we intend to highlight its therapeutic importance in burn injuries in newborns. We present a case of 9 days old male neonate who presented to the neonatal unit of Maulana Azad Medical College with a complaint of fluid-filled blisters and burns wound on the body for six days. He was born outside the hospital at 38 weeks of gestation to a 24-year-old primigravida mother by vaginal delivery. The presentation was cephalic and the amniotic fluid was clear. His birth weight was 2800 gm and APGAR scores were 7 and 8 at 1 and 5 minutes, respectively. His anthropometry was appropriate for gestational age. He developed respiratory distress after birth requiring oxygen support by nasal prongs for three days. On the day of life three, he developed blisters on his body, starting from than face then over the back and perineal region. At a presentation on the day of life nine, he had blisters and necrotic wound on the right side of the face, back, right shoulder and genitalia, affecting 60% of body surface area with full-thickness loss of skin. He was started on intravenous antibiotics and fluid therapy. Pus culture grew Pseudomonas aeuroginosa, for which culture-specific antibiotics were started. Plastic surgery reference was taken and regular wound dressing was done with antiseptics. He had a storming course during the hospital stay. On the day of life 35 when the baby was hemodynamically stable, amnion membrane grafting was done on the wound site; for the grafting, fresh amnion membrane was removed under sterile conditions from the placenta obtained by caesarean section. It was then transported to the plastic surgery unit in half an hour in a sterile fluid where the graft was applied over the infant’s wound. The amnion membrane grafting was done twice in two weeks for covering the whole wound area. After successful uptake of amnion membrane, skin from the thigh region was autografted over the whole wound area by Meek technique in a single setting. The uptake of autograft was excellent and most of the areas were healed. In some areas, there was patchy regeneration of skin so dressing was continued. The infant was discharged after three months of hospital stay and was later followed up in the plastic surgery unit of the hospital.

Keywords: amnion membrane grafting, autograft, meek technique, newborn, regeneration of skin

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Authors: Prem K. Mony, Bharadwaj Amrutur, Prashanth Thankachan, Swarnarekha Bhat, Suman Rao, Maryann Washington, Annamma Thomas, N. Sheela, Hiteshwar Rao, Sumi Antony

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The disease burden among mothers and newborns is caused mostly by a handful of avoidable conditions occurring around the time of childbirth and within the first month following delivery. Real-time monitoring of vital parameters of mothers and neonates offers a potential opportunity to impact access as well as the quality of care in vulnerable populations. We describe the design, development and testing of an innovative wearable device for remote biomonitoring (RBM) of body temperatures in mothers and neonates in a hospital in southern India. The architecture consists of: [1] a low-cost, wearable sensor tag; [2] a gateway device for ‘real-time’ communication link; [3] piggy-backing on a commercial GSM communication network; and [4] an algorithm-based data analytics system. Requirements for the device were: long battery-life upto 28 days (with sampling frequency 5/hr); robustness; IP 68 hermetic sealing; and human-centric design. We undertook pre-clinical laboratory testing followed by clinical trial phases I & IIa for evaluation of safety and efficacy in the following sequence: seven healthy adult volunteers; 18 healthy mothers; and three sets of babies – 3 healthy babies; 10 stable babies in the Neonatal Intensive Care Unit (NICU) and 1 baby with hypoxic ischaemic encephalopathy (HIE). The 3-coin thickness, pebble-design sensor weighing about 8 gms was secured onto the abdomen for the baby and over the upper arm for adults. In the laboratory setting, the response-time of the sensor device to attain thermal equilibrium with the surroundings was 4 minutes vis-a-vis 3 minutes observed with a precision-grade digital thermometer used as a reference standard. The accuracy was ±0.1°C of the reference standard within the temperature range of 25-40°C. The adult volunteers, aged 20 to 45 years, contributed a total of 345 hours of readings over a 7-day period and the postnatal mothers provided a total of 403 paired readings. The mean skin temperatures measured in the adults by the sensor were about 2°C lower than the axillary temperature readings (sensor =34.1 vs digital = 36.1); this difference was statistically significant (t-test=13.8; p<0.001). The healthy neonates provided a total of 39 paired readings; the mean difference in temperature was 0.13°C (sensor =36.9 vs digital = 36.7; p=0.2). The neonates in the NICU provided a total of 130 paired readings. Their mean skin temperature measured by the sensor was 0.6°C lower than that measured by the radiant warmer probe (sensor =35.9 vs warmer probe = 36.5; p < 0.001). The neonate with HIE provided a total of 25 paired readings with the mean sensor reading being not different from the radian warmer probe reading (sensor =33.5 vs warmer probe = 33.5; p=0.8). No major adverse events were noted in both the adults and neonates; four adult volunteers reported mild sweating under the device/arm band and one volunteer developed mild skin allergy. This proof-of-concept study shows that real-time monitoring of temperatures is technically feasible and that this innovation appears to be promising in terms of both safety and accuracy (with appropriate calibration) for improved maternal and neonatal health.

Keywords: public health, remote biomonitoring, temperature surveillance, wearable sensors, mothers and newborns

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