A Quality Improvement Initiative to Reduce Prescription Error in a Pediatrics Outpatient Department at a Secondary-Level Community Hospital.

Background Medication errors are common, especially by new trainees in primary care settings. Our study aimed at reducing the rate of prescription error in the pediatric outpatient department (OPD) of a secondary healthcare center in suburban north India using a quality improvement methodology. Methods Based on a survey and focused group discussion (FGD) involving all stakeholders, the identified problems and difficulties faced during outpatient prescriptions, interventions, and outcome parameters were drafted. The primary outcome measure was the prescription error rate evaluated by a senior resident (SR) of pediatrics, and the secondary outcome measures included the frequency of antibiotic prescriptions and investigations. Intervention Two cycles of Plan-Do-Study-Act (PDSA) were conducted on accessible drug formularies and standard treatment protocols for common pediatric conditions. Results The mean baseline prescription error was 72.2% (95% confidence interval (CI): 63.2-81.1). After the implementation of the first PDSA cycle, the mean error rate was 46.5% (95% CI: 36.6-56.5). There were eight consecutive points of prescription error below the control limit (63.2% and 81.1%) of the baseline. The PDSA-2 cycle showed the same shift to below the control limit (36.6% and 56.5%). The mean error rate found at the end of the PDSA-2 cycle was 22.5% (95% CI 15.7-29.5). There was no clinically significant difference in the number of investigations or antibiotics prescribed. Conclusion The application of standardized drug formularies and standard treatment protocols (STPs) can help reduce prescription errors, especially in a primary care setting. Expansion of such techniques to other centers could be particularly useful.

Developing Standard Treatment Workflows-way to universal healthcare in India.

Primary healthcare caters to nearly 70% of the population in India and provides treatment for approximately 80-90% of common conditions. To achieve universal health coverage (UHC), the Indian healthcare system is gearing up by initiating several schemes such as National Health Protection Scheme, Ayushman Bharat, Nutrition Supplementation Schemes, and Inderdhanush Schemes. The healthcare delivery system is facing challenges such as irrational use of medicines, over- and under-diagnosis, high out-of-pocket expenditure, lack of targeted attention to preventive and promotive health services, and poor referral mechanisms. Healthcare providers are unable to keep pace with the volume of growing new scientific evidence and rising healthcare costs as the literature is not published at the same pace. In addition, there is a lack of common standard treatment guidelines, workflows, and reference manuals from the Government of India. Indian Council of Medical Research in collaboration with the National Health Authority, Govt. of India, and the WHO India country office has developed Standard Treatment Workflows (STWs) with the objective to be utilized at various levels of healthcare starting from primary to tertiary level care. A systematic approach was adopted to formulate the STWs. An advisory committee was constituted for planning and oversight of the process. Specialty experts' group for each specialty comprised of clinicians working at government and private medical colleges and hospitals. The expert groups prioritized the topics through extensive literature searches and meeting with different stakeholders. Then, the contents of each STW were finalized in the form of single-pager infographics. These STWs were further reviewed by an editorial committee before publication. Presently, 125 STWs pertaining to 23 specialties have been developed. It needs to be ensured that STWs are implemented effectively at all levels and ensure quality healthcare at an affordable cost as part of UHC.

Feasibility, Sustainability, and Effectiveness of the Implementation of "Facility-Team-Driven" Approach for Improving the Quality of Newborn Care in South India.

OBJECTIVES: The primary objective of the study was to assess the feasibility and sustainability of the implementation of the point of care quality improvement (POCQI) methodology for improving the quality of neonatal care at the level 2 special newborn care unit (SNCU). Additional objective was to evaluate the effectiveness of the quality improvement (QI) and preterm baby package training model. METHODS: This study was conducted in a level-II SNCU. The study period was divided into baseline; intervention and sustenance phases. The primary outcome i.e., feasibility was defined as completion of training for 80% or more health care professionals (HCPs) through workshops, their attendance in subsequent review meetings and, successful accomplishment of at least two plan-do-study-act (PDSA) cycles in each project. RESULTS: Of the total, 1217 neonates were enrolled during the 14 mo study period; 80 neonates in the baseline, 1019 in intervention and 118 in sustenance phases. Feasibility of training was achieved within a month of initiation of intervention phase; 22/24 (92%) nurses and 14/15 (93%) doctors attended the meetings. The outcomes of individual projects suggested an improvement in proportion of neonates being given exclusive breast milk on day 5 (22.8% to 78%); mean difference (95% CI) [55.2 (46.5 to 63.9)]. Neonates on any antibiotics declined, proportion of any enteral feeds on day one and duration of kangaroo mother care (KMC) increased. Proportion of neonates receiving intravenous fluids during phototherapy decreased. CONCLUSIONS: The present study demonstrates the feasibility, sustainability, and effectiveness of a facility-team-driven QI approach augmented with capacity building and post-training supportive supervision.

Comparison of regional versus global growth charts for the classification of small-for-gestational age neonates.

OBJECTIVE: To compare the performance of regional versus global charts for identifying small-for-gestational age (SGA) neonates with short-term adverse outcomes. DESIGN: Prospective cohort study. SETTING: Level-3 neonatal unit in India. PATIENTS: Neonates were categorised into SGA and appropriate-for-gestational age (AGA; 10th-90th centile) using four charts, namely, the AIIMS, Lubchenco, Fenton and Intergrowth 21st charts. They were followed up for adverse outcomes until 28 days. OUTCOMES: We evaluated the (1) burden of SGA, (2) sensitivity and diagnostic OR (DOR), (3) relative risk (RR) and number needed to screen (NNS) to detect adverse outcomes in SGA versus 'optimal' AGA (50th-90th centile) and (4) RR of morbidities in 'additional SGA' (ie, classified as SGA by others but not by AIIMS chart). RESULTS: Among 1367 neonates, 19.6%, 4.5% and 12.5% were classified as SGA by Intergrowth 21st, AIIMS and Lubchenco charts, respectively. Intergrowth 21st had the highest sensitivity (39.1%) but the least DOR (2.6) to detect adverse outcomes; AIIMS chart had low sensitivity (19.3%) but higher DOR (4.3). RR and NNS were 3.7 and 14; 4.4 and 7; 4.0 and 8; 3.6 and 10 with Intergrowth 21st, AIIMS, Lubchenco and Fenton charts, respectively. 'Additional SGA' identified by Intergrowth 21st had lower risk of adverse outcomes than SGA identified by both the charts (RR 0.39; 95% CI 0.19 to 0.82). CONCLUSIONS: Compared with AIIMS and Lubchenco charts, Intergrowth 21st runs the risk of overdiagnosing SGA neonates who may not be at a higher risk of short-term morbidities.

Improving the Quality of Health Care in Special Neonatal Care Units of India: A Before and After Intervention Study.

BACKGROUND: We evaluated the efficacy of training health care workers (HCWs) in point-of-care quality improvement (POCQI) and a preterm newborn health care package (PHCP), followed by remote mentoring and supportive supervision in improving health care practices, neonatal survival, and morbidities in special neonatal care units (SNCUs). METHODS: This pre- and postintervention quality improvement study was conducted at 3 SNCUs in Madhya Pradesh, India from February 2017 to February 2019. Clinical care teams comprising doctors and nurses from the study sites were trained in POCQI and the PHCP. The teams identified, prioritized, and analyzed problems and designed quality improvement initiatives at their respective health facilities. Change ideas were tested by the local teams using sequential plan-do-study-act cycles. Facilitators maintained contact with the teams through quarterly review meetings, fortnightly videoconferencing, on-demand phone calls, and group chat service. State SNCU coordinators made follow-up visits to supplement coaching. Study research staff independently collected data on admissions, health care practices, and outcomes of neonates. FINDINGS: A total of 156 HCWs were trained in the POCQI methodology and PHCP. Sixteen quality improvement projects were formulated and implemented. Among 13,821 enrolled neonates (birth weight 2275±635 g; gestation: 35.8±2.8 weeks), improvement was seen in reduction of use of oxygen (36.1% vs. 48.0%; adjusted odds ratio [aOR]=0.60, 95% confidence interval [CI]=0.55, 0.66), antibiotics (29.4% vs. 39.0%; aOR=0.76, 95% CI=0.68, 0.85), and dairy milk (33.8% vs. 49.4%; aOR=0.34, 95% CI=0.31 to 0.38). Enteral feeds were started within 24 hours of admission in a larger number of neonates, resulting in fewer days to reach full feeds. There was no effect on survival at discharge from the hospital (aOR=0.93; 95% CI=0.80, 1.09). CONCLUSION: A collaborative cross-learning quality improvement approach with remote mentoring, coaching, and supportive supervision was successful in improving the quality of care at SNCUs.

Simulation Based vs Conventional Training for Initial Steps in Delivery Room Care of Preterm Neonates: An Open Label Randomized Trial.

OBJECTIVE: To assess whether simulation based education (SBE) improves the practices and knowledge of junior residents for stabilization of a preterm neonate in delivery room as compared to conventional education (CE). METHODS: This trial randomized 24 pediatric residents to either SBE (n=12) or CE (n=12) groups. One-time SBE was imparted to the SBE group. Both the groups had similar facilitator participant ratio and equally timed sessions. The individual skills scores and performance by preterm stabilization performance evaluation (PSPE) score in real time were recorded using a validated tool within 8 weeks of the training. Knowledge gain was evaluated using pre and post-test scores. RESULTS: The mean (SD) skill and PSPE scores were comparable between the two groups (skill score 51.1 (8.1), 46.5 (7.8), respectively mean difference 4.6; 95% CI -2.1 to 11.3; PSPE-score 80.2 (14.2) vs. 82.9 (10.3); mean difference -2.68; 95% CI -8.35 to 13.71). The mean (SD) knowledge gain was similar in the groups [4.4 (1.9), 5.3 (4.1); mean difference 0.91; 95% CI, -1.81 to 3.64. CONCLUSION: In junior residents, a one-time SBE session, when compared to conventional task training, did not lead to improvement in the performance of the initial steps of neonatal resuscitation.

Strengthening emergency care systems to improve patient care for ST-elevation myocardial infarction (STEMI) at a high-volume tertiary care centre in India.

BACKGROUND: ST-elevation myocardial infarction (STEMI) is a highly time-sensitive and life-threatening condition. Early recognition and timely management are challenging in a busy emergency department (ED), especially in low/middle-income countries where emergency systems are often fragmented. The aim of our quality improvement (QI) project was to increase the percentage of patients with STEMI undergoing primary percutaneous coronary intervention (PCI) with door to balloon (D2B) time of <90 min by 30% over 12 months. METHODS: As part of the first step in QI, baseline data were collected at different points in the process of care. Using process maps and fishbone analysis, delays in patient registration, ECG and communication with cardiology were identified as some bottlenecks, and change ideas were tested using plan-do-study-act cycles using point-of-care QI methodology. The majority of the change ideas focused on interventions in the ED like strengthening triage, training frontline staff, early diagnosis and quick transportation of patients. RESULTS: During the baseline phase, 22.22% of patients were found to have a D2B time of <90 min. We achieved an increase of 47.78% in patients receiving PCI within 90 min and hence increased to 70% at the end of the intervention phase. Data collected for 4 months after the intervention phase were found to have sustained the effort. CONCLUSION: Significant improvement in the door to reperfusion time resulted from a meticulous assessment of emergency care processes by drawing process flow chart and implementation of change ideas like introduction of fast-track policy for patients with chest pain, reducing staff turnover in the triage area, formal training of staff, continuous engagement with cardiology team and by interchanging of processes which led to a reduction in time to ECG.

Secular Trends in Birthweights in Two Epochs Over 40 Years in a Tertiary Care Center.

OBJECTIVE: To compare the average birthweights and the weight centiles of the 'new' growth charts with the 'old' (1974) charts developed in the same unit four decades ago. METHODS: Birthweight and gestation data of the eligible 12,355 singleton neonates born between 2009 and 2016 at a level-3 neonatal unit at a public sector hospital were used to develop the new growth chart. We then compared the prevalence of small for gestational age (SGA) and large for gestational age (LGA) classified by the new charts and the old charts, the incidence of short-term adverse outcomes among them, and the diagnostic performance of both the charts to identify the adverse outcomes in a separate validation cohort. RESULTS: The mean birthweights of boys and girls across all gestations were higher by 150-200 g and 100-150 g, respectively, in the new chart. The prevalence of SGA doubled (9.8% vs 4.7%), but LGA decreased by one-third (17.5% vs 25.9%) with the new chart. However, the proportion of SGA and LGA having one or more short-term adverse outcomes, and the diagnostic performance of both the charts to identify neonates with short-term adverse outcomes, were comparable. CONCLUSION: There was an upward shift in the birthweights by about 150 g across all gestations in the new chart compared to the old chart developed 40 years ago. The findings imply the need to consider using updated growth charts to ensure accurate classification of size at birth of neonates.

Identification of Human Case of Avian Influenza A(H5N1) Infection, India.

A 11-year-old boy with acute myeloid leukemia was brought for treatment of severe acute respiratory infection in the National Capital Region, New Delhi, India. Avian influenza A(H5N1) infection was laboratory confirmed. Complete genome analysis indicated hemagglutinin gene clade 2.3.2.1a. We found the strain to be susceptible to amantadine and neuraminidase inhibitors.

Periodic change of body position under phototherapy in term and preterm neonates with hyperbilirubinaemia.

BACKGROUND: Phototherapy is the mainstay of treatment of neonatal hyperbilirubinaemia. Periodic change in position of the neonate under phototherapy (from supine to prone or lateral positions) may improve the efficiency of phototherapy by hastening the access of phototherapy light to bilirubin deposited in different parts of the skin and subcutaneous tissue. OBJECTIVES: To evaluate the effects of periodic change of body position during phototherapy as compared to no prescribed change in body position, on serum total bilirubin level and duration of treatment in neonates with unconjugated hyperbilirubinaemia during the first 28 days of life. Secondary objectives of the review included evaluation of the efficacy of periodic change of body position on the need for or number of exchange transfusions, incidence of bilirubin-induced neurological damage (BIND), side effects of phototherapy, and sudden infant death syndrome (SIDS). SEARCH METHODS: We used the standard search strategy of Cochrane Neonatal to run comprehensive searches in the Cochrane Central Register of Controlled Trials (CENTRAL; 2021, Issue 3) in the Cochrane Library and Ovid MEDLINE and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions on 5 March 2021. We also searched clinical trials databases and the reference lists of included studies and relevant reviews for randomised controlled trials (RCTs) and quasi-RCTs. SELECTION CRITERIA: We included RCTs and quasi-RCTs if they enrolled neonates (term and preterm) of either gender with unconjugated hyperbilirubinaemia requiring phototherapy and compared periodic change of the body position of the infant under phototherapy with no prescribed change in body position. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data, consulting with a third review author in the case of disagreement. We used standard Cochrane methodological procedures, including assessing the risk of bias of included studies. We used the GRADE approach to assess the certainty of evidence. Primary outcomes were the duration of phototherapy and rate of fall of serum bilirubin at 24 hours. Secondary outcomes included the need for exchange transfusion, number of exchange transfusions, incidence of BIND, and SIDS. MAIN RESULTS: We included five studies (343 neonates) with an overall high risk of bias in the review. The body position under phototherapy was changed every two hours or every two-and-a-half hours in two studies each, and every three hours in one study. Three of the five studies included healthy term neonates, whilst the other two studies also included preterm neonates (≥ 33 weeks' gestation); however, separate data about review outcomes in preterm neonates were not available. Periodic change in body position may lead to little or no difference in the duration of phototherapy (mean difference (MD) 1.71 hours, 95% confidence interval (CI) -3.17 to 6.59 hours; I² = 58%; 4 studies, 231 participants; low certainty evidence). Only one study reported the rate of fall of serum total bilirubin at 24 hours of starting the phototherapy. Periodic change in body position may lead to little or no difference in the rate of fall of serum total bilirubin at 24 hours (MD 0.02 mg/dL/h, 95% CI -0.02 to 0.06 mg/dL/h; 1 study, 100 participants; low certainty evidence). We downgraded the certainty of evidence to low due to risk of bias and imprecision. None of the included studies reported the need for or number of exchange transfusions, incidence of BIND, or SIDS. Lack of separate data precluded subgroup analysis. AUTHORS' CONCLUSIONS: The available evidence is insufficient to determine the effects of periodic change of body position compared with no prescribed change of body position under phototherapy. There is low certainty evidence that there may be little or no difference in the duration of phototherapy and rate of fall in bilirubin at 24 hours of starting phototherapy between periodic change in body position and no prescribed change of body position under phototherapy in term and preterm neonates. None of the included studies reported the effect of change of position on the need for or number of exchange transfusions, incidence of BIND, or SIDS. One study is awaiting classification and could not be included in the review. Further studies are needed to evaluate the effect of periodic change in body position under phototherapy, especially in neonates with haemolytic hyperbilirubinaemia and in very preterm neonates. The results of this systematic review apply mainly to neonates born at late-preterm or term gestation receiving phototherapy for non-haemolytic hyperbilirubinaemia.

Acute critical care course for interns to develop competence.

Background All medical graduates must know how to stabilize and manage critically ill patients. A 2-day intensive course, called the acute critical care course (ACCC), was conducted to train interns in technical and non-technical skills for managing a patient whose condition is deteriorating. This analysis aims to assess the feasibility and effectiveness of ACCC for interns. Methods We developed and conducted the ACCC to train interns. It included lectures and skill stations. Twenty-four interns participated in the course. Immediate, post-course, quantitative and qualitative feedback was taken online. Qualitative information was also collected verbally and later by email. These data were analysed both quantitatively and qualitatively. Thematic analysis was used to identify, analyse and report the patterns of responses and behaviour. Results The average score for the utility of the course was 4.7 and for the skill stations it was 4.6 on a scale of 5. The qualitative analysis of the feedback emphasized the need for the course before the clinical posting and more skill-based modules rather than lectures. The interactive style of teaching and training in communication using role-play was appreciated. Few suggestions to improve the course were provided. Conclusions Implementing the ACCC needed simulation, interactive discussions, role-play, modified Pendleton's feedback, and reflective exercise that form the basis of a range of educational principles. The blended learning set of objectives of ACCC were the pillars for this successful internship training programme.

Communication skills training through 'role play' in an acute critical care course.

Background: . Effective patient-doctor communication is a key component of patient-centred care, which is one of the six pillars of quality healthcare delivery. Structured and effective communication skills training for healthcare providers is the need of hour in medical education. We assessed the efficacy of role play and simulation in developing communication skills. Methods: . As a key component of an acute critical care course (ACCC), communication skills are taught using role play models and simulation. Live feedback is critical in learning during this course as per the principles of adult learning (andragogy). Quantitative and qualitative data were collected to assess the efficacy of ACCC. Results: . The 19th ACCC was introduced to interns at the All India Institute of Medical Sciences, New Delhi in December 2018. The teaching methodology and objective-oriented structured training in ACCC were much appreciated for training in human factors with emphasis on communication. A positive response was obtained from the candidates 3 weeks after they completed the course to assess whether interns are able to make use of this training in their day-to-day clinical practice amounting to a reliable evidence level of Kirkpatrick's 'return of investment'. Conclusion: . The use of 'role play' to teach communication skills is effective and superior to lecture-based teaching. Further structured and interactive programmes in communication skills training will improve patient care, relatives' satisfaction and the image of medical profession.

'NOPAIN-ROP' trial: Intravenous fentanyl and intravenous ketamine for pain relief during laser photocoagulation for retinopathy of prematurity (ROP) in preterm infants: A randomised trial.

OBJECTIVES: To investigate if intravenous fentanyl or intravenous ketamine can provide adequate analgesia in preterm infants undergoing laser photocoagulation for retinopathy of prematurity (ROP). DESIGN: Open-label randomised trial. SETTING: Tertiary care institution. PARTICIPANTS: Preterm infants who underwent laser photocoagulation for ROP. INTERVENTIONS: Infants were randomised to receive fentanyl as intravenous bolus dose of 2 µg/kg, followed by an intravenous infusion of 1 µg/kg/hour increased to a maximum of 3 µg/kg/hour or intravenous ketamine as bolus dose of 0.5 mg/kg, followed by further intermittent intravenous bolus doses of 0.5 mg/kg to a maximum of 2 mg/kg in the initial phase and intravenous fentanyl (bolus of 2 µg/kg followed by infusion of 2 µg/kg/hour to a maximum of 5 µg/kg/hour) or intravenous ketamine (bolus dose of 1 mg/kg followed by intermittent bolus doses of 0.5 mg/kg to a maximum of 4 mg/kg) in the revised regimen phase. MAIN OUTCOME MEASURES: Proportion of infants with adequate analgesia defined as the presence of both: (1) all the Premature Infant Pain Profile-Revised scores measured every 15 min less than seven and (2) proportion of the procedure time the infant spent crying less than 5%.Secondary outcomes included apnoea, cardiorespiratory or haemodynamic instability, feed intolerance and urinary retention requiring catheterisation during and within 24 hours following the procedure. RESULTS: A total of 97 infants were randomised (fentanyl=51, ketamine=46). The proportions of infants with adequate analgesia were 16.3% (95% CI 8.5% to 29%) with fentanyl and 4.5% (95% CI 1.3% to 15.1%) with ketamine. Ten infants (19.6%) in the fentanyl group and seven infants (15.2%) in the ketamine group had one or more side effects. In view of inadequate analgesia with both the regimens, the study steering committee recommended using a higher dose of intravenous fentanyl and intravenous ketamine. Consequently, we enrolled 27 infants (fentanyl=13, ketamine=14). With revised regimens, the proportions of infants with adequate analgesia were higher: 23.1% (95% CI 8.2% to 50.2%) with fentanyl and 7.1% (95% CI 1.3% to 31.5%) with ketamine. However, higher proportions of infants developed apnoea (n=4; 30.7%), need for supplemental oxygen (n=5, 38.4%) and change in cardiorespiratory scores (n=7; 53.8%) with fentanyl but none with ketamine. CONCLUSIONS: Fentanyl-based and ketamine-based drug regimens provided adequate analgesia only in a minority of infants undergoing laser photocoagulation for ROP. More research is needed to find safe and effective regimens that can be employed in resource constrained settings. TRIAL REGISTRATION NUMBER: CTRI/2018/03/012878.

Rationalising oxygen usage in a level II special newborn care unit in Madhya Pradesh, India.

Non-judicious oxygen use in preterm infants is associated with increased risk of retinopathy of prematurity, bronchopulmonary dysplasia and longer hospital stay. Despite established guidelines on oxygen therapy, compliance with the best oxygen practices remains suboptimal. Excessive use of oxygen also consumes a large proportion of the annual maintenance budget of special newborn care units (SNCUs) in the districts. In this project, we aimed to reduce the oxygen consumption in the SNCU at Sehore, Madhya Pradesh, India from eight to four cylinders per day, by rationalising the indications, monitoring and method of oxygen delivery.We tested two sets of interventions using the Plan-Do-Study-Act (PDSA) approach. The first intervention was the introduction of a written 'oxygen policy' regarding indications of starting/stopping oxygen and the use of saturation targets. The second was using short binasal infant prongs (at 0.5-1 L/min), instead of oxygen hoods as the primary method of oxygen delivery in spontaneously breathing neonates requiring oxygen. In the first PDSA cycle, we assessed the feasibility of the intervention in a small set (n=30) of neonates and later scaled up to all eligible neonates in the second phase.We observed a significant reduction in oxygen consumption (from median (IQR) 8 (7-8) to 3 (3-4) cylinders per day) that can lead to a direct saving of 590 000 Indian rupees (US$9000) per year. There was a significant reduction in the number of neonates on oxygen support on a given day. We did not observe any increase in mortality or nasal injury. The change was sustained for the next 8 months.We conclude that by having a contextual oxygen policy and using nasal prongs instead of oxygen hoods as the preferred delivery method, we can achieve a sustainable reduction in oxygen consumption.

Preterm White Matter Injury: A Prospective Cohort Study.

OBJECTIVE: To determine the incidence and risk factors of preterm white matter injury [WMI; periventricular-intraventricular hemorrhage (PIVH) and/or periventricular leukomalacia (PVL)]. DESIGN: Prospective cohort study. SETTING: Level-3 neonatal intensive care unit. PATIENTS: Inborn preterm neonates (n=140) delivered at <32 weeks gestation or birthweight <1500 g. METHODS: Serial cranial ultrasounds were performed at postnatal ages of 3 days (±12 hour), 7 (±1) days, 21 (±3) days and 40 (±1) weeks postmenstrual age (PMA). PIVH and PVL were graded as per Volpe and De-Vries criteria, respectively. Univariate followed by multivariate analysis was done to evaluate risk factors for PIVH and PVL. OUTCOME MEASURES: The primary outcome was the incidence of preterm WMI. The secondary outcomes were evaluation of risk factors and natural course of WMI. RESULTS: The mean (range) gestation and birth weight of enrolled neonates were 29.7 (24-36) weeks and 1143 (440-1887) g, respectively. PIVH occurred in 25 (17.8%) neonates. PVL occurred in 34 (24.3%) neonates. None of them were grade III or IV PVL. Preterm WMI (any grade PIVH and/or PVL) occurred in 52 (37.1%) neonates. Severe PIVH (grade III) and cystic PVL occurred in 7 (5%) and 5 (3.6%) neonates, respectively. On multivariate analysis, none of the presumed risk factors were associated with PIVH. However, hemodynamically significant patent ductus arteriosus, and apnea of prematurity were significantly associated with increased risk of PVL. CONCLUSIONS: Significant WMI occurred only in one-third of the cohort, which is comparable to that described in literature from the developed countries.

Fortification of Breast Milk With Preterm Formula Powder vs Human Milk Fortifier in Preterm Neonates: A Randomized Noninferiority Trial.

Importance: Fortification of expressed breast milk (EBM) using commercially available human milk fortifiers (HMF) increases short-term weight and length in preterm very low-birth-weight (VLBW) neonates. However, the high cost and increased risk of feed intolerance limit their widespread use. Preterm formula powder fortification (PTF) might be a better alternative in resource-limited settings. Objective: To demonstrate that fortification of EBM by preterm formula powder is noninferior to fortification by HMF, in terms of short-term weight gain, in VLBW neonates. Design, Setting, and Participants: Open-label, noninferiority, randomized trial conducted from December 2017 to June 2019 at a level 3 neonatal unit in India. The trial enrolled preterm (born at or before 34 weeks of gestation) VLBW neonates receiving at least 100 mL/kg/d of feeds and consuming 75% of milk or more as EBM. Interventions: Neonates were randomly assigned to receive fortification by either PTF or HMF. Calcium, phosphorus, iron, vitamin D, and multivitamins were supplemented in PTF and only vitamin D in the HMF group to meet the recommended dietary allowances. Main Outcomes and Measures: The primary outcome was the weight gain until discharge from the hospital or 40 weeks' postmenstrual age, whichever was earlier; the prespecified noninferiority margin was 2 g/kg/d. Secondary outcomes included morbidities such as necrotizing enterocolitis, feed intolerance, and extrauterine growth restriction (<10th percentile on the Fenton chart at 40 weeks' postmenstrual age). Results: Of the 123 neonates enrolled, 60 and 63 were randomized to the PTF and HMF groups, respectively. The mean gestation (30.5 vs 29.9 weeks) and birth weight (1161 vs 1119 g) were comparable between the groups. There was no difference in the mean (SD) weight gain between the PTF and HMF groups (15.7 [3.9] vs 16.3 [4.0] g/kg/d; mean difference, -0.5 g/kg/d; 95% CI, -1.9 to 0.7). The lower bound of 95% CI did not cross the noninferiority margin. The incidence of feed intolerance was lower in the PTF group (1.4 vs 6.8 per 1000 patient-days; incidence rate ratio 0.19; 95% CI, 0.04 to 0.95), and fewer neonates required withholding of fortification for 24 hours or more (5% vs 22%; risk ratio, 0.22; 95% CI, 0.07 to 0.75). The incidence of necrotizing enterocolitis stage II or more (0 vs 5%) and extrauterine growth restriction (73% vs 81%) was comparable between the groups. Conclusions and Relevance: Fortification with preterm formula powder is not inferior to fortification with human milk fortifiers in preterm neonates. Given the possible reduction in feed intolerance and lower costs, preterm formula might be a better option for fortification, especially in resource-restricted settings. Trial Registration: Clinical Trial Registry, India Identifier: CTRI/2017/11/010593.

Diagnostic Accuracy of WINROP, CHOP-ROP and ROPScore in Detecting Type 1 Retinopathy of Prematurity.

BACKGROUND: Algorithms for predicting retinopathy of prematurity (ROP) requiring treatment need to be validated in Indian settings to determine if the burden of screening can be reduced without compromising the sensitivity of existing gestation and weight-based cut offs. OBJECTIVE: To evaluate the performance of the available algorithms namely, WINROP (Weight, Insulin-like growth factor I, Neonatal ROP), CHOP-ROP (Children's Hospital of Philadelphia ROP) and ROPScore in predicting type 1 ROP and time from alarm to treatment by each algorithm. STUDY DESIGN: Ambispective observational. SETTING: Tertiary care neonatal intensive care unit in India. PARTICIPANTS: Neonates less than 32 weeks or less than 1500 g born between July, 2013 to June, 2019 (N=578), who underwent ROP screening. PRIMARY OUTCOME: Sensitivity, specificity and time from alarm to treatment by each algorithm. RESULTS: The sensitivity and specificity of WINROP was 85% and 36%, for CHOP-ROP it was 54% and 71%, and for ROPScore it was 73% and 67%, respectively in detecting type 1 ROP. A total of 50/51 (98%) of neonates with type 1 ROP underwent treatment at median gestation of 9 weeks and median time from alarm to treatment by WINROP, CHOP-ROP and ROPScore was 7, 7 and 3 weeks, respectively. CONCLUSION: WINROP, CHOP-ROP and ROPScore were not sensitive enough to replace the gestational age, weight and risk factor-based screening criteria for type 1 ROP.

Outcomes of Neonates Born to Mothers With Coronavirus Disease 2019 (COVID-19) - National Neonatology Forum (NNF) India COVID-19 Registry.

BACKGROUND: Limited evidence exists on perinatal transmission and outcomes of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in neonates. OBJECTIVE: To describe clinical outcomes and risk factors for transmission in neonates born to mothers with perinatal SARS-CoV-2 infection. DESIGN: Prospective cohort of suspected and confirmed SARS-CoV-2 infected neonates entered in National Neonatology Forum (NNF) of India registry. SUBJECTS: Neonates born to women with SARS-CoV-2 infection within two weeks before or two days after birth and neonates with SARS-CoV-2 infection. OUTCOMES: Incidence and risk factors of perinatal transmission. RESULTS: Among 1713 neonates, SARS-CoV-2 infection status was available for 1330 intramural and 104 extramural neonates. SARS-CoV-2 positivity was reported in 144 intramural and 39 extramural neonates. Perinatal transmission occurred in 106 (8%) and horizontal transmission in 21 (1.5%) intramural neo-nates. Neonates roomed-in with mother had higher transmission risk (RR1.16, 95% CI 1.1 to 2.4; P=0.01). No association was noted with the mode of delivery or type of feeding. The majority of neonates positive for SARS-CoV2 were asymptomatic. Intra-mural SARS-CoV-2 positive neonates were more likely to be symptomatic (RR 5, 95%CI 3.3 to 7.7; P<0.0001) and need resuscitation (RR 2, 95%CI 1.0 to 3.9; P=0.05) compared to SARS-CoV-2 negative neonates. Amongst symptomatic neonates, most morbidities were related to prematurity and perinatal events. CONCLUSIONS: Data from a large cohort suggests perinatal transmission of SARS-CoV-2 infection and increased morbidity in infected infants.