Quality improvement initiative 'S-A-F-H' to reduce healthcare-associated neonatal sepsis in a tertiary neonatal care unit.

BACKGROUND: Neonatal sepsis is a leading cause of morbidity and mortality among admitted neonates. Healthcare-associated infection (HAI) is a significant contributor in this cohort. LOCAL PROBLEM: In our unit, 16.1% of the admissions developed sepsis during their stay in the unit. METHOD: We formed a team of all stakeholders to address the issue. The problem was analysed using various tools, and the main contributing factor was low compliance with hand hygiene and handling of intravenous lines. INTERVENTIONS: The scrub the hub/aseptic non-touch technique/five moments of hand hygiene/hand hygiene (S-A-F-H) protocol was formulated as a quality improvement initiative, and various interventions were done to ensure compliance with hand hygiene, five moments of hand hygiene, aseptic non-touch technique. The data were collected and analysed regularly with the team members, and actions were planned accordingly. RESULTS: Over a few months, the team could reduce the incidence of HAI by 50%, which has been sustained for over a year. The improvement in compliance with the various aspects of S-A-F-H increased. CONCLUSIONS: Compliance with hand hygiene steps, five moments of hand hygiene and an aseptic non-touch technique using quality improvement methodology led to a reduction in neonatal sepsis incidence in the unit. Regular reinforcement is required to maintain awareness of asepsis practices and implementation in day-to-day care and to bring about behavioural changes.

Hemodynamic effects of noradrenaline in neonatal septic shock: a prospective cohort study.

BACKGROUND: The incidence of neonatal septic shock in low-income countries is 26.8% with a mortality rate of 35.4%. The evidence of the hemodynamic effects of noradrenaline in neonates remains sparse. This study was carried out to evaluate the effects of noradrenaline in neonates with septic shock. METHODS: This was a single-center prospective cohort study in a tertiary care hospital's level III neonatal intensive care unit. Neonates with septic shock and those who received noradrenaline as a first-line vasoactive agent were included. Clinical and hemodynamic parameters were recorded before and after one hour of noradrenaline infusion. The primary outcomes were: response at the end of one hour after starting noradrenaline infusion and mortality rate. RESULTS: A total of 21 babies were analyzed. The cohort comprised 17 preterm neonates. The mean age of presentation with septic shock was 74.3 h. Resolution of shock at one hour after starting noradrenaline was achieved in 76.2% of cases. The median duration of hospital stay was 14 days. The mean blood pressure improved after the initiation of noradrenaline from 30.6 mm of Hg [standard deviation (SD) 6.1] to 37.8 mm of Hg (SD 8.22, p < 0.001). Fractional shortening improved after noradrenaline initiation from 29% (SD 13.5) to 45.1% (SD 21.1, p < 0.001). The mortality rate was 28.6% in our study. CONCLUSION: Noradrenaline is a potential drug for use in neonatal septic shock, with improvement in mean blood pressure and fractional shortening; however, further studies with larger sample sizes are needed to confirm our findings before it can be recommended as first-line therapy in neonatal septic shock.

Neonatal sepsis is one of the leading causes of neonatal mortality. In neonates with septic shock, mortality is high at 35.4% in low- and middle-income countries. The evidence of the hemodynamic effects of noradrenaline in neonates is still sparse, so we carried out a study in our tertiary care neonatal intensive care unit to evaluate the effects of noradrenaline in neonates with septic shock. Neonates with septic shock and those who received noradrenaline as a first-line vasoactive agent were included. Clinical and hemodynamic parameters were recorded before and after one hour of noradrenaline infusion. The primary outcomes were: response at the end of one hour after starting noradrenaline infusion and mortality rate. A total of 21 babies were analyzed. We found that there was a statistically significant improvement in the mean blood pressure and fractional shortening after noradrenaline initiation. The mortality rate was 28.6% in our study. We conclude that noradrenaline is a relatively safe and effective drug for the treatment of neonatal septic shock. However, further studies with larger sample sizes are needed to confirm our findings before it can be recommended as first-line therapy in neonatal septic shock.

Diagnostic utility of lung ultrasound in predicting the need for surfactant therapy in preterm neonates with respiratory distress.

Background: Lung ultrasound is an accurate and early predictor for surfactant replacement therapy in respiratory distress syndrome (RDS) as compared to clinical parameters and chest x-ray. However, lung pathologies for respiratory distress at birth have overlapping symptomatology and low middle-income countries have a higher incidence of congenital pneumonia, in addition to RDS, making the immediate diagnosis difficult. Thus, there is a need for assessing a cutoff for lung ultrasound scores in the given setting. Objectives: The primary objective was to determine the diagnostic accuracy of the lung ultrasound score (LUS) in predicting the need for surfactant therapy in preterm neonates with respiratory distress. Secondary objectives were to correlate LUS with corresponding oxygen saturation to the fraction of inspired oxygen ratio (SpO2/FiO2), arterial/Alveolar oxygen pressure ratio (a/A), and chest x-ray (CXR) findings. Methodology: A prospective observational study was carried out at a tertiary-level neonatal intensive care unit in India in 2022 enrolling 100 neonates <34 weeks gestational age with respiratory distress at birth. After initial stabilization of the neonate, LUS was performed and baseline parameters were noted. Surfactant was administered as per the 2019 European Consensus guidelines and LUS was repeated after 6 h of therapy. Results: The mean gestation of enrolled neonates was 31.06 ± 2.12 weeks and the mean birthweight was 1,412 ± 391 g. Approximately 58% were diagnosed with RDS and 30% had congenital pneumonia. Surfactant was administered to 40% of neonates. The cutoff LUS for surfactant therapy was 7 [area under the curve (AUC) 0.977; 95% CI, 0.947-1; P < 0.001; with sensitivity 92.5%, specificity 96.67%, PPV 94.87%, and NPV 95.08%] and the cutoff LUS for the second dose of surfactant was 10 (AUC 0.964; 95% CI, 0.913-1; P < 0.001). The score decreased by 3.24 (2.44-4.05) after 6 h of the first dose and correlated significantly with SpO2/FiO2 ratio (-0.750), a/A ratio (-0.650), and CXR findings (0.801). Conclusion: The study predicted an optimal LUS cutoff of 7 and 10 for the need for the first dose of surfactant and re-treatment, respectively, in neonates <34 weeks gestational age with respiratory distress.

Creating and sustaining a digital community of practice for quality improvement in South-East Asia during the COVID-19 pandemic.

INTRODUCTION: Ensuring quality of care in Low and Middle Income countries (LMICs) is challenging. Despite the implementation of various quality improvement (QI) initiatives in public and private sectors, the sustenance of improvements continues to be a major challenge. A team of healthcare professionals in India developed a digital community of practice (dCoP) focusing on QI which now has global footprints. METHODOLOGY: The dCoP was conceptualised as a multitiered structure and is operational online at www.nqocncop.org from August 2020 onwards. The platform hosts various activities related to the quality of care, including the development of new products, and involves different cadres of healthcare professionals from primary to tertiary care settings. The platform uses tracking indicators, including the cost of sustaining the dCoP to monitor the performance of the dCoP. RESULT: Since its launch in 2020, dCoP has conducted over 130 activities using 13 tools with 25 940 registration and 13 681 participants. From April 2021, it has expanded to countries across the South-East Asia region and currently has participants from 53 countries across five continents. It has developed 20 products in four thematic areas for a targeted audience. dCoP is supporting mentoring of healthcare professionals from five countries in the South-East Asia region in their improvement journey. Acquiring new knowledge and improvement in their daily clinical practice has been reported by 93% and 80% of participants, respectively. The dCoP and its partners have facilitated the publication of nearly 40 articles in international journals. CONCLUSION: This dCoP platform has become a repository of knowledge for healthcare professionals in the South-East Asia region. The current paper summarises the journey of this innovative dCoP in an LMIC setting for a wider global audience.

Oral versus intravenous sildenafil for pulmonary hypertension in neonates: a randomized trial.

BACKGROUND: Sildenafil is the drug of choice for neonatal pulmonary hypertension in developing countries where inhaled nitric oxide is not available. Available as oral and intravenous preparation - no study has been done in the past to compare the two forms. Each has its own benefits - but requires comparison in terms of efficacy and safety. This study was done to compare the efficacy of oral versus intravenous (IV) sildenafil in infants with mild to moderate pulmonary hypertension. METHODS: An open labelled randomized trial was conducted in a neonatal intensive care unit of urban tertiary hospital in western India between February 2019 to December 2020. Infants born after 34 weeks of gestation with Pulmonary arterial pressure (PAP) > 25 mm Hg measured by echocardiography, within 72 h of birth, were enrolled for the study. Participants were randomly assigned to receive sildenafil either orally or by intravenous route. Primary outcome was the time taken for PAP to decrease below 25 mm Hg. Secondary outcomes were time taken for oxygenation index to decrease by 25%, duration of invasive and non-invasive mechanical ventilation, nasal oxygen, hospital stay, time to achieve full feeds, mortality, and side effects. RESULTS: Forty patients were enrolled. The baseline characteristics of neonates in both groups were similar except for APGAR scores at 1 min and 5 min, with oral group having lower score [MEDIAN (IQR) 5.00 (4.00- 7.00) and 7.00 (6.00- 8.00)] compared to IV group [MEDIAN (IQR) 7.00 (6.00-8.00) and 9.00 (8.00-9.00)] respectively. Time taken for PAP to decrease below 25 mm was not statistically different between the oral and intravenous groups. Systemic hypotension occurred in 4 neonates of the intravenous group but none in the oral group. CONCLUSION: Oral and intravenous sildenafil had equal efficacy at reducing PAP in neonatal pulmonary hypertension, albeit intravenous sildenafil use was associated with a greater complication rate. TRIAL REGISTRATION: Trial was registered in the clinical trials registry of India [ CTRI/2019/04/018781 ][25/04/2019].

Sirolimus used for treatment of retroperitoneal arteriovenous malformation in a premature neonate.

We describe a case of a premature infant with antenatally detected retroperitoneal arteriovenous malformation (AVM) with extensive intraspinal extension. Treatment of the malformation with embolectomy and sclerotherapy was not feasible in view of intraspinal extensions and small size of vessels of the lesion. During a trial of propranolol over 20 days, the lesion progressed in size, roughly doubling in volume and was accompanied with deranged coagulation parameters. Treatment was therefore switched to oral prednisolone and sirolimus. The steroid was stopped after 6 weeks and sirolimus was continued with serum drug level monitoring and serial imaging of the malformation. After 4 months of sirolimus, the AVM remained at the same size as at the start of treatment, thus we propose that the drug may have arrested the growth of the lesion. This case highlights the use of sirolimus in management of AVMs in infants.

Perinatal transmission of SARS-CoV-2 and transfer of maternal IgG/neutralizing anti-SARS-CoV-2 antibodies from mothers with asymptomatic infection during pregnancy.

PURPOSE: COVID-19 pandemic remains a serious public health threat worldwide. In view of the limited data on the risk of perinatal transmission of SARS-CoV-2 and transfer of maternal anti-SARS-CoV-2 antibodies, the present study was undertaken. METHODS: A prospective study including 57 pregnant women with a positive SARS-CoV-2 RNA test (SARS-CoV-2-RNA+) and 59 neonates born to them was conducted at Pune, India. 39 viral RNA negative (SARS-CoV-2-RNA-negative) pregnant women and their 39 neonates were included as controls. Neonatal nasal swab/cord blood samples were subjected to SARS-CoV-2 RNA detection by RT-PCR for investigation of perinatal transmission. Transfer of maternal antibodies was studied using ELISA and PRNT. RESULTS: 10/57 SARS-CoV-2-RNA+ mothers were symptomatic. The duration between COVID-19 diagnosis and delivery was ≤ 7 days for 82.4%. Perinatal transmission as evidenced by viral RNA in the neonatal nasal swab/cord blood (CB) was 3.6%. IgG-anti-SARS-CoV-2 positivity was 21.6%. Of the 39 neonates born to SARS-CoV-2-RNA-negative mothers, 20 (51%) and none, respectively, were positive for IgG-anti-SARS-CoV-2 and viral RNA. Preterm deliveries were higher in SARS-CoV-2-RNA+ (18.6%) than SARS-CoV-2 RNA-negative (0/39) mothers (p < 0.005). Respiratory distress at birth (< 4 h) was higher among neonates of SARS-CoV-2-RNA+ (20/59, 33.9%) than SARS-CoV-2-RNA-negative mothers (3/39, 7.7%; p < 0.001). ~ 75% IgG-positives exhibited neutralization potential with mean PRNT titers of 42.4 ± 24 (SARS-CoV-2-RNA+) and 72.3 ± 46.7 (SARS-CoV-2 RNA-negative); higher in the latter (p < 0.05). CONCLUSION: The rate of perinatal transmission was low. Transfer of maternal antibodies was lower among SARS-CoV-2-RNA+ mothers than SARS-CoV-2-RNA-negative mothers with subclinical infection during pregnancy. Presence of neutralizing antibodies in majority of IgG-positives suggests protection from SARS-CoV-2 in early life.

Shock and dyselectrolytemia in a neonate with late-onset COVID-19 infection.

Most reports of COVID-19 in neonates suggest that they are infected postnatally and present with gastrointestinal or respiratory symptoms. We describe a neonate who had community-acquired COVID-19, and presented with late-onset sepsis and developed dyselectrolytemia. The 26-day-old male baby had fever, feed refusal and shock. Rapid antigen test for SARS-CoV-2 by nasopharyngeal swab was positive and levels of circulating inflammatory markers were high. The baby was supported with antibiotics, and inotropic and vasopressor drugs. He had seizures and bradycardia due to dyselectrolytemia on day 2 of admission. On day 3, he had respiratory distress, with non-specific chest radiographic findings, and was managed with non-invasive support for 24 hours. The baby was discharged after 8 days. On serial follow-up, he was breastfeeding well and gaining weight appropriately with no morbidity. Our report highlights a unique presentation of COVID-19, with late-onset infection and shock-like features along with dyselectrolytemia and seizures.

Development of a framework of intervention strategies for point of care quality improvement at different levels of healthcare delivery system in India: initial lessons.

BACKGROUND: Inadequate quality of care has been identified as one of the most significant challenges to achieving universal health coverage in low-income and middle-income countries. To address this WHO-SEARO, the point of care quality improvement (POCQI) method has been developed. This paper describes developing a dynamic framework for the implementation of POCQI across India from 2015 to 2020. METHODS: A total of 10 intervention strategies were designed as per the needs of the local health settings. These strategies were implemented across 10 states of India, using a modification of the 'translating research in practice' framework. Healthcare professionals and administrators were trained in POCQI using a combination of onsite and online training methods followed by coaching and mentoring support. The implementation strategy changed to a fully digital community of practice platform during the active phase of the COVID-19 pandemic. Dashboard process, outcome indicators and crude cost of implementation were collected and analysed across the implementation sites. RESULTS: Three implementation frameworks were evolved over the study period. The combined population benefitting from these interventions was 103 million. A pool of QI teams from 131 facilities successfully undertook 165 QI projects supported by a pool of 240 mentors over the study period. A total of 21 QI resources and 6 publications in peer-reviewed journals were also developed. The average cost of implementing POCQI initiatives for a target population of one million was US$ 3219. A total of 100 online activities were conducted over 6 months by the digital community of practice. The framework has recently extended digitally across the South-East Asian region. CONCLUSION: The development of an implementation framework for POCQI is an essential requirement for the initiative's successful country-wide scale. The implementation plan should be flexible to the healthcare system's needs, target population and the implementing agency's capacity and amenable to multiple iterative changes.

Improving donor human milk collection in a hospital without a human milk bank: a quality improvement initiative at an urban tertiary-care teaching hospital.

Feed intolerance and necrotising enterocolitis (NEC) are challenges while treating sick neonates. These can be reduced by giving human milk, but adequate availability of mother's own milk or pasteurised donor human milk (PDHM) is a challenge in neonatal setups, like ours, without an attached human milk bank. Hence, this quality improvement initiative was taken to improve donor human milk collection in our urban tertiary-care teaching hospital, to at least 500 mL per week in 4 weeks. After analysing the problem, our quality improvement team identified a shortage of human milk donation that was due to low awareness among the stakeholders and lack of a system to collect and store human milk and transport it to a milk bank. The team first established a system of supplies needed for milk collection, storage and transportation. It then tested change idea of information, education and counselling to increase milk donation. The team carried out a few plan-do-study-act cycles (individual and group counsellings, and usage of videos and information leaflets) to test the change ideas and adapted a few and abandoned some. During this journey, the milk collection increased to above the target amount. Various challenges were addressed, and there was a need for constant motivation of the stakeholders, especially the mothers, and now there is sustained milk donation in the setup. This is incorporated in the standard operating procedure and as a quality indicator of the unit for sustaining the changes in the unit. Our initiative can be replicated in other setups for increasing collection of donor human milk. Greater PDHM availability for sick neonates will, in effect, reduce NEC and feeding intolerance rates, leading to reduced hospital stay, morbidity, mortality and economic burden.

Focal congenital hyperinsulinism resulting from biallelic loss of function of KCNJ11 gene.

Congenital hyperinsulinism (CHI) characterised by inappropriate secretion of insulin despite low blood glucose can result in irreversible brain damage if not promptly treated. The most common genetic cause of hyperinsulinism is the pathogenic variants in ABCC8 and KCNJ11, causing dysregulated insulin secretion. Rapid testing is crucial for all patients because finding a mutation significantly impacts this condition's clinical management. We report a rare case of focal CHI after a homozygous KCNJ11 mutation who underwent a selective lesionectomy and required octreotide for euglycaemia.

Functional Neonatal Echocardiography: Indian Experience.

INTRODUCTION: Functional echocardiography, as opposed to echocardiography as performed by the cardiologist, is the bedside utilization of cardiac ultrasound to take after functional and haemodynamic changes longitudinally. Information reflecting cardiovascular capacity and systemic and pulmonary blood flow in sick preterm and term neonates can be observed utilizing this strategy. Information is lacking on its use in neonatal units in India. AIM: To characterize the impact of Functional neonatal echocardiography (FnECHO) programme on decision making in a tertiary care centre in India by evaluating its frequency of use, patient characteristics, and indications. MATERIALS AND METHODS: Prospective observational study of neonates in a tertiary Neonatal Intensive Care Unit (NICU) in Pune (India) from February 2014 to January 2015. All the neonates undergoing FnECHO during this 12 month period based on clinical findings were included in the study. Data extracted from the review of the clinical notes included gestational age, birth-weight, mode of delivery, Apgar scores, details of respiratory and cardiovascular support, timing of FnECHO and any other clinical diagnosis. The findings of echocardiography were recorded and correlated with the clinical and other laboratory or X-ray findings. If these findings indicated a change in management, it was instituted. RESULTS: A total of 348 echocardiographic studies were performed in 187 neonates (mean 1.86; SD 2.02). The most frequent indication was Patent Ductus Arteriosus (PDA) assessment (n= 174, 50%), followed by haemodynamic instability (n=43, 12.36%). The results of FnECHO modified treatment in 148 cases (42.50%) in the form of addition and/or change in the treatment or avoidance of unnecessary intervention. CONCLUSION: FnECHO is frequently used in the NICU setting and may be a useful tool to guide treatment. PDA assessment and haemodynamic instability are the most frequent indications. To validate its usefulness, well co-ordinated large prospective studies are needed.

Propranolol for infantile hemangioma (PINCH): an open-label trial to assess the efficacy of propranolol for treating infantile hemangiomas and for determining the decline in heart rate to predict response to propranolol.

BACKGROUND: Propranolol has emerged as front-line therapy for infantile hemangiomas (IHs). However, a well-defined protocol for administering and predicting response to propranolol is unavailable. METHODS: In this open-label trial, 31 children with IH (median age=5 mo; range,1 mo to 9 y) were administered propranolol (2 mg/kg/d) for a median duration of 28 weeks (12 to 50 wk). They were compared with 14 historical controls with IH who did not receive any treatment. An image-based scoring system was used to assess involution. RESULTS: Propranolol (28/31, 90.3%) produced better and faster response compared with control treatment (4/14, 28.6%). With propranolol, 65% to 80% involution was obtained in the first 8 weeks, with an additional 2% to 10% involution until 20 weeks. After 20 weeks, the changes in IH were insignificant. Response was more pronounced among infants ≤6 months of age who attained a peak involution score of 1.86, suggesting >80% involution of IH. The similar score in the cohort aged 6 to 36 months was 3.31. The heart rate (HR) decline after propranolol treatment was significantly higher among patients whose hemangioma responded to propranolol than in those who did not respond (P=0.0006). Decline in HR by >20%, 2 weeks after propranolol administration, was predictive of IH involution (relative risk=0.11; 95% confidence interval, 0.02-0.51; P=0.036). CONCLUSIONS: Propranolol is efficacious in patients with IH. The most pronounced response is seen in the first 8 weeks and in infants aged 6 months or younger. A decline in HR >20% is an early marker of response to propranolol.

Procedural sedation associated displacement of sharp oesophageal foreign body.

Oesophageal foreign body is a common clinical problem. The therapeutic intervention varies from endoscopic removal to observation for spontaneous passage of foreign body. The authors illustrate a case of sharp board pin ingestion by a child, which stayed impacted at C(7)-T(1) level for 8 h with indentation of tracheal mucosa. However, upon administration of midazolam and ketamine for procedural sedation, the pin spontaneously advanced to stomach when muscle relaxation had set in. A few oesophageal mucosal erosions were noted on the endoscopy. The foreign body could not be retrieved by the procedure and was spontaneously egested impacted in faeces. This case presents a distinctive hazard associated with procedural sedation for a foreign body in aero-digestive tract, where the associated muscle relaxation can lead to complications due to spontaneous movement of foreign body.

Isolated idiopathic unilateral paralysis of soft palate and pharynx.

Isolated unilateral palatal (velopalatopharyngeal) palsy is a clinical rarity. We report this entity in a 10 year old boy, two weeks after an episode of acute tonsillitis. The child was managed with a short course of prednisolone with complete recovery in eleven days.

Treating subglottic haemangioma with methylprednisolone and interferonα-2a.

Subglottic haemangiomas are benign vascular malformations presenting in early infancy with respiratory distress due to progressive airway obstruction. The lesion, after undergoing proliferation during the first few months, naturally involutes by an age of 2-3 years. Due to high incidence of mortality, therapy should be initiated immediately. Multiple therapeutic options, such as steroids, interferon, surgery and laser ablation, are available but the best treatment is controversial. This report describes an infant presenting with respiratory distress and cutaneous haemangioma who was detected to have airway obstructive haemangioma from the subglottis to the carina. Due to the massive size, surgical and laser ablation could not be exercised. Also, the infant showed no response to dexamethasone, prednisolone or interferon. Following failure of these modalities, the infant was successfully managed with concurrent administration of daily interferon and pulse methylprednisolone. The regime resulted in rapid shrinkage of the haemangioma and resolution of symptoms, with no recurrence up to 24 months of age.

Establishment of nomograms and reference ranges for intra-cranial ventricular dimensions and ventriculo-hemispheric ratio in newborns by ultrasonography.

AIM: To establish normal ranges for the lateral, third, and fourth ventricular dimensions and the ventriculo-hemispheric ratio (VHR) in neonates using cranial ultrasonography. METHOD: Intra-cranial ventricles were assessed ultrasonographically using anterior fontanelle as acoustic window. Data were analyzed to determine correlation, coefficient of determination (R2), regression equations and plotted against gestational age (GA). RESULTS: Of total 1483 neonates (25-42 w GA), 372(25%) had GA < 34 weeks. GA strongly correlated with anterior horn width (AHW; 0.92), thalamo-occipital distance (TOD; 0.94), and third (0.78) and fourth (0.89) ventricular widths. The R2 values were 0.85, 0.88, 0.66 and 0.80, respectively. VHR had weak correlation (0.12, R(2)= 0.005) with GA and stayed constant (0.27-0.28) across GA. Nomograms of AHW, TOD, and third and fourth ventricular widths were constructed with respect to GA. CONCLUSION: Intra-cranial ventricles increase in size with GA but this increase is limited to only a few mm and is proportional to increment in brain tissue. Nomograms and regression equations of AHW, TOD and widths of third and fourth ventricles can assist in objectively assessing ventricular sizes. The almost uniform VHR can be used to screen ventricle size while suspecting hydrocephalus.