Diagnostic accuracy of foot length measurement for identification of preterm newborn in rural Sindh, Pakistan.

INTRODUCTION: Assessing gestational age accurately is crucial for saving preterm newborns. In low and middle-income countries, such as Pakistan, where access to antenatal ultrasonography (A-USG) is limited, alternative methods are needed. This study evaluated the diagnostic accuracy of foot length (FL) measurement for identifying preterm newborns in rural Pakistan using A-USG as the reference standard. METHODS: A test validation study was conducted between January and June 2023 in rural Sindh, Pakistan, within the catchment area of the Global Network for Maternal Newborn Health Registry, Thatta. Singleton newborns whose mothers had an A-USG before 20 weeks of gestation were enrolled. A research assistant measured FL three times using a rigid transparent plastic ruler within 48 hours of birth and the average FL was reported. Sensitivity, specificity, positive and negative predictive values (PPV, NPV) and likelihood ratios were calculated. The optimal FL cut-off for the identification of preterm newborns was determined using the Youden Index. RESULTS: A total of 336 newborns were included in the final analysis, of whom 75 (22.3%) were born before 37 weeks of gestation. The median gestational age of the newborns was 38.2 weeks, and the median FL was 7.9 cm. The area under the curve was 97.6%. The optimal FL cut-off for identifying preterm newborns was considered as ≤7.6 cm with a sensitivity of 90.8%, specificity of 96.0%, PPV of 86.7% and NPV of 97.3%. A lower cut-off of ≤7.5 cm had a sensitivity of 95.4%, specificity of 84.0%, PPV of 63.1% and NPV of 98.5%. CONCLUSION: In conclusion, this study highlights the utility of FL measurement for identifying preterm newborns in rural settings where A-USG is unavailable before 20 weeks of gestation. Optimal cut-offs of ≤7.6 and ≤7.5 cm provide a simple, cost-effective and reliable tool for clinicians and frontline healthcare providers in rural areas, respectively. TRIAL REGISTRATION NUMBER: NCT05515211.

Pediatric Appendicitis Score for Identifying Acute Appendicitis in Children Presenting With Acute Abdominal Pain to the Emergency Department.

OBJECTIVE: To determine the diagnostic accuracy of Pediatric Appendicitis Score (PAS) in predicting appendicitis in children presenting with acute abdominal pain to the Emergency Department (ED) of a private hospital in Pakistan. METHODS: This validation study was through retrospective chart review of children between 4-18 years of age with clinical suspicion of acute appendicitis, presenting to the pediatric ED. Diagnostic accuracy was determined using sensitivity, specificity, predictive values, and area under the curve (AUC). RESULTS: 104 children (76% boys) with mean (SD) age of 10.9 (3.5) years met the eligibility criteria. 91% (n=95) patients had moderate to high PAS (score ³4), and 95% (n=99) had biopsy-proven appendicitis. The likelihood ratio calculated for low, equivocal and high-risk PAS was 0.10, 2.17 and 2.53, respectively. An equivocal PAS (score 4-6) showed a sensitivity of 96.8%, specificity of 80%, positive predictive value of 98.9% and AUC of 0.84 for predicting acute appendicitis. CONCLUSION: PAS showed good diagnostic accuracy in predicting acute appendicitis in children presenting to the ED.

Simplified antibiotic regimens for the management of clinically diagnosed severe infections in newborns and young infants in first-level facilities in Karachi, Pakistan: study design for an outpatient randomized controlled equivalence trial.

BACKGROUND: Infection in young infants is a major cause of morbidity and mortality in low-middle income countries, with high neonatal mortality rates. Timely case management is lifesaving, but the current standard of hospitalization for parenteral antibiotic therapy is not always feasible. Alternative, simpler antibiotic regimens that could be used in outpatient settings have the potential to save thousands of lives. METHODS: This trial aims to determine whether 2 simplified antibiotic regimens are equivalent to the reference therapy with 7 days of once-daily (OD) intramuscular (IM) procaine penicillin and gentamicin for outpatient management of young infants with clinically presumed systemic bacterial infection treated in primary health-care clinics in 5 communities in Karachi, Pakistan. The reference regimen is close to the current recommendation of the hospital-based intravenous ampicillin and gentamicin therapy for neonatal sepsis. The 2 comparison arms are (1) IM gentamicin OD and oral amoxicillin twice daily for 7 days; and (2) IM penicillin and gentamicin OD for 2 days, followed by oral amoxicillin twice daily for 5 days; 2250 "evaluable" infants will be enrolled. The primary outcome of this trial is treatment failure (death, deterioration or lack of improvement) within 7 days of enrollment. Results are expected by early 2014. DISCUSSION: This trial will determine whether simplified antibiotic regimens with fewer injections in combination with high-dose amoxicillin are equivalent to 7 days of IM procaine penicillin and gentamicin in young infants with clinical severe infection. Results will have program and policy implications in countries with limited access to hospital care and high burden of neonatal deaths.

Scientific rationale for study design of community-based simplified antibiotic therapy trials in newborns and young infants with clinically diagnosed severe infections or fast breathing in South Asia and sub-Saharan Africa.

BACKGROUND: Newborns and young infants suffer high rates of infections in South Asia and sub-Saharan Africa. Timely access to appropriate antibiotic therapy is essential for reducing mortality. In an effort to develop community case management guidelines for young infants, 0-59 days old, with clinically diagnosed severe infections, or with fast breathing, 4 trials of simplified antibiotic therapy delivered in primary care clinics (Pakistan, Democratic Republic of Congo, Kenya and Nigeria) or at home (Bangladesh and Nigeria) are being conducted. METHODS: This article describes the scientific rationale for these trials, which share major elements of trial design. All the trials are in settings of high neonatal mortality, where hospitalization is not feasible or frequently refused. All use procaine penicillin and gentamicin intramuscular injections for 7 days as reference therapy and compare this to various experimental arms utilizing comparatively simpler combination regimens with fewer injections and oral amoxicillin. CONCLUSION: The results of these trials will inform World Health Organization policy regarding community case management of young infants with clinical severe infections or with fast breathing.

Community-based management and outcome of omphalitis in newborns in Karachi, Pakistan.

OBJECTIVES: To describe the clinical profile and outcome in newborns with omphalitis managed with home or clinic-based therapy. METHODS: The descriptive study was conducted from September 2004 to August 2007 in three low-income communities in Karachi, Pakistan. Newborns with omphalitis detected by community health workers through active surveillance were referred to local clinics. Those with physician-confirmed omphalitis were treated for 7 days with topical gentian violet or oral cephalexin (as monotherapy) or topical gentian violet and oral cephalexin (combination therapy) at physician discretion, or injectable therapy (procaine penicillin and gentamicin) if clinical signs of sepsis were also present and family refused hospital referral. Follow-up was at 48-72 hours and 7 days. SPSS 16 was used for statistical analysis. RESULTS: Among 1083 newborns with omphalitis, 578 (53.4%) had peri-umbilical cellulitis without purulent discharge; 365 (33.7%) had purulent discharge (with or without cellulitis); and 140 (13%) had omphalitis with sepsis Review of outcome data at one week showed that among 943 newborns without signs of sepsis, 938 (99.5%) had improved; 2 (0.2%) died, and 2 (0.2%) were lost to follow-up. There were 5 (3.6%) therapy failures, among 140 newborns with omphalitis and sepsis managed with parenteral antibiotics at 48 hours, but 139 (99.2%) had improved by one week, while 1 (0.8%) died. CONCLUSION: In resource-constrained environments, omphalitis can be managed in the community with minimal need for hospital referral. Further research to define optimal therapeutic regimens is needed.

Accidental poisoning in children.

OBJECTIVE: To assess the pattern of acute poisoning in children at Liaquat National Hospital, Karachi. METHODS: The one-year descriptive study was conducted in the Paediatric Emergency Unit of the Liaquat National Hospital, Karachi, from April 1, 2006 to March 31, 2007, involving all patients under 12 years of age who visited the unit with a history of accidental exposure to toxic substances. Demographic data and all other relevant information were obtained mainly by retrieving hospital records and the admission register. Immediate outcomes were analysed in terms of admission, discharge and 'left against medical advice' (LAMA). RESULTS: During the study period, 43 cases of accidental poisoning were registered, constituting 0.58% of the total emergency visits. Most (46.5%) were less than 3 years of age. Pharmaceutical products (34.9%) were the leading cause of ingestion followed by kerosene oil (25.6%), organophosphorous (16.3%), alkali (9.3%) and acid (7%). Regarding the outcome of these cases, 29 were admitted, 7 were discharged and 7 patients left against medical advice. CONCLUSION: In our study, a small percentage of children presented with acute poisoning. Pharmacologic agents were a common source of poisoning in children. There is a need to further study and identify risk factors of acute poisoning in children.

Community-based treatment of serious bacterial infections in newborns and young infants: a randomized controlled trial assessing three antibiotic regimens.

BACKGROUND: Sepsis in the neonatal period is a major cause of child mortality in low-income countries. Hospitalization and parenteral penicillin/ampicillin and gentamicin therapy are recommended for management. Many families, however, are unable to access hospital care, and most home-delivered newborns who develop sepsis die without receiving antibiotic therapy. Appropriate community-based therapy in such situations is undefined. We compared failure rates of 3 clinic-based antibiotic regimens in 0- to 59-day-old infants with possible serious bacterial infection whose families refused hospitalization in Karachi communities with high neonatal mortality rates>45/1000 live births. METHODS: Eligible infants were randomly assigned to 7 days of: (1) procaine penicillin [50,000 units/kg once daily (OD) by intramuscular injection (IM)] and gentamicin (5 mg/kg OD IM) reference arm, (2) ceftriaxone (50 mg/kg OD IM), or (3) oral trimethoprim-sulfamethoxazole (TMP-SMX) at 10 mg/kg/day divided twice daily and gentamicin IM OD. Primary outcome was treatment failure, defined as death, deterioration in clinical condition during therapy or no improvement after 2 days. RESULTS: Possible serious bacterial infection was diagnosed in 704 infants, among 5766 screened. Among 434 (61.6%) randomized to clinic-based therapy, there were 13 of 145 failures with penicillin-gentamicin, 22 of 145 with ceftriaxone and 26 of 143 with TMP-SMX-gentamicin. Treatment failure was significantly higher with TMP-SMX-gentamicin compared with penicillin-gentamicin [relative risk 2.03, 95% confidence interval: 1.09-3.79] by intention-to-treat analysis. Differences were not significant in the ceftriaxone versus penicillin-gentamicin comparison [relative risk 1.69, 95% confidence interval 0.89-3.23). By 14 days, there were 2 deaths in the penicillin-gentamicin group, 3 in the ceftriaxone group and 11 in the TMP-SMX-gentamicin group [relative risk 5.58, 95% confidence interval: 1.26-24.72 (group 3 versus 1)]. CONCLUSION: When hospitalization of sick infants is unfeasible, outpatient therapy with injectable antibiotics is an effective option. Procaine penicillin-gentamicin was superior to TMP-SMX-gentamicin. Ceftriaxone is a more expensive option, and may be less effective, although this requires further research.

Incidence and etiology of omphalitis in Pakistan: a community-based cohort study.

INTRODUCTION: Although omphalitis (umbilical infections) among newborns is common and a major cause of neonatal deaths in developing countries, information on its burden and etiology from community settings is lacking. This study aimed to determine the incidence and etiology of omphalitis in newborns in high neonatal mortality settings in Karachi, Pakistan. METHODOLOGY: Trained community health workers surveyed all new births in three low-income areas from September 2004 to August 2007. Pus samples from the umbilical stumps were obtained from babies with pre-defined signs of illness and subjected to culture and antimicrobial susceptibility testing. RESULTS: Among 6904 births, 1501 (21.7%) newborns were diagnosed with omphalitis. Of these, 325 (21.6%) were classified as mild, 1042 (69.4%) as moderate, and 134 (8.9%) as severe; 141 (9.3%) were associated with clinical signs of sepsis. The incidence of omphalitis was 217.4/1000 live births; moderate-severe omphalitis 170.3 per 1000 live births; and associated with sepsis 20.4 per 1000 live births. Of 853 infants with purulent umbilical discharge, 64% yielded 583 isolates. The most common pathogens were Staphylococcus aureus, of which 291 (95.7%) were methicillin-susceptible Staphylococcus aureus (MSSA) and 13 (4.2%) methicillin-resistant S. aureus (MRSA); Streptococcus pyogenes 105 (18%); Group B beta-hemolytic streptococci 59 (10 %); Pseudomonas spp., 52 (8.9 %); Aeromonas spp. 19 (3.2%); and Klebsiella spp. 12 (2%). CONCLUSIONS: A high burden of omphalitis can be associated with sepsis among newborns in low-income communities in Pakistan. S. aureus is the most common pathogen isolated from umbilical pus. Appropriate low-cost prevention strategies need to be implemented. 

Incidence of neonatal hyperbilirubinemia: a population-based prospective study in Pakistan.

OBJECTIVE: To estimate the incidence of neonatal jaundice and hyperbilirubinemia in a poor urban community in Karachi, where 70% of births occur at home. METHODS: Home-based pregnancy and newborn surveillance were conducted from September 2004 to July 2006 in a multi-ethnic population by trained community health workers. Newborns were visited several times at scheduled intervals until 59 days of life; any baby with jaundice was referred to the local clinic. Clinical assessments of jaundice were assigned by a physician and recorded using an adapted Kramer scale. Blood for plasma bilirubin was obtained if parents consented. RESULTS: Of a birth cohort of 1690 young infants during the study period, 466 infants (27.6%) were referred to our centre with jaundice. Of these, 64% were 0-6 days old. Bilirubin was measured in 125 of 466 (27%) jaundiced newborns. Overall detected rate of hyperbilirubinemia (bilirubin >5 mg/dl) among 1690 newborns was 39.7/1000 live births (95% CI 29.3-47.6). Rate of plasma bilirubin levels in the range of 15-20 mg/dl was 13/1000 live births (95% CI 7.6-18.4); levels >20 mg/dl were observed in 3.5/1000 live births (95% CI 0.4-5.5). The proportion of newborns with bilirubin > or =15 mg/dl was significantly higher among those assigned a Kramer score of 4-5 compared to those receiving a score of 1-3 (P-value 0.00004). CONCLUSION: A significant burden of untreated severe neonatal jaundice, causing potential neurological sequelae, exists in developing countries such as Pakistan. WHO guidelines are needed for screening and appropriate management of neonatal jaundice in developing countries.