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The present study explores the association between linear growth and neurobehavioral outcome in preterm (<34 weeks) when evaluated by NAPI score (Neurobehavioral Assessment of Preterm Infants) at term gestational age (GA). 80 preterm neonates were enrolled for this study and divided into two groups based on the increase in length/week at term corrected gestational age (CGA). Anthropometric parameters were calculated at various time points of study and Z scores were calculated. Neurobehavioral assessment of the enrolled infants was done by NAPI score at 37 and 40 weeks of CGA. After controlling for GA, weight Z scores, and head circumference Z scores, the median score of NAPI-motor development-vigor at 37 weeks and NAPI alertness orientation at 40 weeks were positively related to length Z scores at 37 weeks (p = 0.04) and 40 weeks (p = 0.035), respectively. Neonates with suppressed linear growth have poor short-term neurological outcomes. We recommend linear growth monitoring along with weight gain in the developed countries and diminished linear growth in the neonate as a marker to predict deviation in cognitive outcome in the future.
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OBJECTIVE: Our aim was to refine the essential newborn care practices by employing the multidisciplinary peer team-led quality improvement (QI) projects. DESIGN: In 2017, concerning the same, the department focused on early initiation of breast feeding, prevention of hypothermia within an hour of life and rational usage of antibiotics among babies admitted to neonatal intensive care unit (NICU). Baseline data reported the rate of initiation of breast feeding, hypothermia and antibiotic exposure rate as 35%, 78% and 75%, respectively. Root causes were analysed and a series of Plan-Do-Study-Act cycles were conducted to test the changes. The process of change was studied through run charts (whereas control charts were used for study purpose). RESULT: After the implementation of the QI projects, the rate of initiation of breast feeding was found to be improved from 35% to 90%, the incidence of hypothermia got reduced from 78% to 10% and the antibiotic exposure rate declined from 75% to 20%. Along with the improvement in indicators related to essential newborn care, down the stream we found a decrease in the percentage of culture-positive sepsis rate in the NICU. CONCLUSION: Peer team-led QI initiatives in a resource-limited setting proved beneficial in improving essential newborn care practices.
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Hypothermia , Quality Improvement , Infant, Newborn , Infant , Female , Humans , Hypothermia/prevention & control , Hospitals, Teaching , India , Anti-Bacterial Agents/therapeutic use , Hospitals, PublicABSTRACT
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.
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COVID-19 , Quality Improvement , Humans , Pandemics , Health Personnel , Asia, EasternABSTRACT
INTRODUCTION: Infections are a common cause of paediatric morbidity. Antibiotics are vital in treating them. Erratic prescribing practices are an important cause for the development of antibiotic resistance. Our objective was to estimate the effectiveness of educational interventions to improve empirical antibiotic prescribing practices among paediatric trainees. We aimed to improve the compliance to antibiotic protocols and to sustain it over 6 months. METHODS: It is a time interrupted non-randomised trial conducted in a tertiary hospital in India. Initially, 200 admitted children were selected randomly. Their antibiotic prescriptions, adherence of prescriptions to the then existing antibiotics guidelines, course during hospital stay and the final outcome were noted. The existing antibiotic policy and its use were reviewed. It was then considered essential to prepare a fresh antibiotic policy based on national guidelines, local sensitivity patterns and with inputs from microbiologists. This was distributed to the residents through seminars, posters and cellphone friendly documents. Compliance to the policy was also tracked twice a week. The adherence to guideline was recorded in the subsequent 6 months. RESULTS: The adherence of empirical antibiotic prescriptions was 59% before intervention which improved to 72% in the first month, 90% in the second month, 86% and 78% in the third and sixth months, respectively. There was no significant difference in duration of stay and the outcome at discharge in the patients in adherent and non-adherent groups. CONCLUSION: Educational interventions and frequent monitoring improved antibiotic prescribing practices among residents with no negative impact on patient outcomes. Quality improvements need persistent reinforcement and frequent monitoring to be sustainable.
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Anti-Bacterial Agents , Quality Improvement , Child , Humans , Anti-Bacterial Agents/therapeutic use , India , Tertiary Care Centers , Tertiary HealthcareABSTRACT
OBJECTIVE: The purpose was to increase use of alcoholic hand rub (AHR) in specialised newborn care unit (SNCU) to improve hand hygiene in order to reduce neonatal sepsis and mortality at Netaji Subhash Chandra Bose Medical College and Hospital, Jabalpur. DESIGN: A prospective interventional and observational study. METHODOLOGY: We formed a quality improvement (QI) team in our SNCU consisting of doctors, nurses, auxiliary staff and parents (a floating member) to improve proper use of AHR. To identify the barriers to the problem, we used fishbone analysis tool. The barriers which were not allowing the health providers to use AHR properly identified were amount of AHR in millilitres to be used per day per baby, how much and when the amount of AHR to be indented from the main store and what is the proper site to place the bottle. We used plan-do-study-act cycles to test and adapt solutions to these problems. Within 5-6 weeks of starting our project, AHR use increased from 44 mL to 92 mL per baby per day and this is sustained around 100 mL per baby per day for over 2 years now. RESULTS: Significant decrease in neonatal mortality was observed (reduced from median of 41.0 between August 2016 and April 2018 to 24.0 between May 2018 and December 2019). The neonates discharged alive improved from 41.2 to 52.3 as a median percentage value. The percentage of babies who were referred out and went Left Against Medical Advice (LAMA) deceased too. CONCLUSION: Multiple factors can lead to neonatal deaths, but the important factors are always contextual to facilities. QI methodology provides health workers with the skills to identify the major factors contributing to mortality and develop strategies to deal with them. Improving processes of care can lead to improved hand hygiene and saves lives.
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Hand Disinfection , Public Health , Health Personnel , Humans , Infant, Newborn , Prospective Studies , Quality ImprovementABSTRACT
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.
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Delivery of Health Care/standards , Patient Care/standards , Point-of-Care Systems , Quality Improvement , Quality of Health Care , COVID-19 , Health Facilities , Health Personnel , Humans , Implementation Science , India , PandemicsABSTRACT
Antibiotic misuse is the most common cause of antimicrobial resistance-a globally declared emergency. This necessitates the introduction of rational antibiotic usage management policy. The paediatrics department of a public teaching hospital with around 500 neonatal intensive care unit (NICU) admissions annually revealed 75% of NICU admission exposure to any antibiotics. The aim was to institute antibiotic stewardship programme (ASP) to optimise antibiotic usage from existing 75% to 40% in a 6-month period through a quality improvement (QI) project.A root cause analysis using fishbone diagram was performed to identify the possible reasons for the high antibiotic usage. Six Plan-Do-Study-Act cycles were conducted to implement the protocols for usage of antibiotics for well-defined indications; active laboratory engagement to decrease the turnaround time for blood culture results; a hard stop to all antibiotic orders after 72 hours; streamlining of antibiotic usage; strengthening universal aseptic practices; and confidence building of staff. The outcomes monitored were antibiotic exposure rates, average number of antibiotic days in all NICU admissions, sepsis rates and mortality.Institution of ASP had significantly reduced antibiotic exposure in NICU admissions, that is, from 75% in March to 41% in August 2018. Median (IQR) antibiotic days per infant in NICU went down from 3 to 0 (0-6). The per cent of NICU admission with culture-positive sepsis and all-cause mortality rate in NICU declined from 18% to 11.56% and 25% to 16%, respectively, over these 6 months.Thus, ASP for rationalising antibiotic usage was successfully instituted in NICU of a rural medical college in central India through QI, without any adverse effect on sepsis and mortality.
Subject(s)
Antimicrobial Stewardship , Intensive Care Units, Neonatal , Anti-Bacterial Agents/therapeutic use , Child , Hospitals, Teaching , Humans , Infant , Infant, Newborn , Quality ImprovementABSTRACT
BACKGROUND: Late-onset neonatal sepsis (LONS) is a significant contributor to morbidity and mortality in very low birthweight (VLBW) neonates with indwelling central lines. Compliance to central line care bundles is suboptimal in low-and-middle-income country settings. Point of care quality improvement (POCQI) method may be used to improve the compliance gap. We used the POCQI method to achieve an improvement in compliance to central line care bundles with an aim to reduce LONS in a subset of VLBW neonates. METHODS: A pre and post-intervention study consisting of three phases was conducted in a tertiary care neonatal intensive care unit. A root-cause analysis was undertaken to find the causes of LONS in VLBW babies with central lines. Multiple change ideas were identified and tested using sequential Plan-Do-Study-Act (PDSA) cycles to address the issue of reduced compliance to the central line care bundles. The change ideas tested in PDSA cycles which were successful were adopted. Compliance to the insertion and maintenance bundles was measured as process indicators. LONS, central line associated bloodstream infections and all-cause mortality rates were measured as outcome indicators. RESULTS: A total of 10 PDSA cycles testing multiple change ideas (staff education, audio-visual aids, supply issues) were undertaken during the study duration. Bundles were not being used in the study setting prior to the initiation of the study. Insertion bundle compliance was above 90% and maintenance bundle compliance increased from 23.3% to 42.2% during the intervention and sustenance phases, respectively. A 43.3% statistically significant reduction in LONS rates was achieved at the end of the study. No effect on mortality was seen. CONCLUSION: POCQI method can be used to improve compliance to central line care bundles which can lead to a reduction of LONS in VLBW neonates with central lines in situ.
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Catheterization, Central Venous , Neonatal Sepsis , Patient Care Bundles , Humans , Infant , Infant, Newborn , Infant, Very Low Birth Weight , Intensive Care Units, Neonatal , Neonatal Sepsis/epidemiology , Neonatal Sepsis/prevention & controlABSTRACT
Abnormal prolonged labour and its effects are important contributors to maternal and perinatal mortality and morbidity worldwide. E-partograph is a modern tool for real-time computerised recording of labour data which improves maternal and neonatal outcome. The aim was to improve the rates of e-partograph plotting in all eligible women in the labour room from existing 30% to achieve 90% in 6 months through a quality improvement (QI) process.A team of nurses, obstetricians, postgraduates and a data entry operator did a root cause analysis to identify the possible reasons for the drop in e-partograph plotting to 30%. The team used process flow mapping and fish bone analysis. Various change ideas were tested through sequential Plan-Do-Study-Act (PDSA) cycles to address the issues identified.The interventions included training labour room staff, identification of eligible women and providing an additional computer and internet facility for plotting and assigning responsibility of plotting e-partographs. We implemented these interventions in five PDSA cycles and observed outcomes by using control charts. A set of process, output and outcome indicators were used to track if the changes made were leading to improvement.The rate of e-partograph plotting increased from 30% to 93% over the study period of 6 months from August 2018 to January 2019. The result has been sustained since the last PDSA cycle. The maternal outcome included a decrease in obstructed and prolonged labour with its associated complications from 6.2% to 2.4%. The neonatal outcomes included a decrease in admissions in the neonatal intensive care unit for birth asphyxia from 8% to 3.4%. It can thus be concluded that a QI approach can help in improving adherence to e-partography plotting resulting in improved maternal health services in a rural maternity hospital in India.
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Labor, Obstetric , Maternal Health Services , Female , Hospitals, Maternity , Humans , Infant, Newborn , Pregnancy , Quality Improvement , Rural PopulationABSTRACT
OBJECTIVE: Hub and spoke model has been used across industries to augment peripheral services by centralising key resources. This exercise evaluated the feasibility of whether such a model can be developed and implemented for quality improvement across rural and urban settings in India with support from a network for quality improvement. METHODS: This model was implemented using support from the state and district administration. Medical colleges were designated as hubs and the secondary and primary care facilities as spokes. Training in quality improvement (QI) was done using WHO's point of care quality improvement methodology. Identified personnel from hubs were also trained as mentors. Both network mentors (from QI network) and hub-mentors (from medical colleges) undertook mentoring visits to their allotted facilities. Each of the participating facility completed their QI projects with support from mentors. RESULTS: Two QI training workshops and two experience sharing sessions were conducted for implementing the model. A total of 34 mentoring visits were undertaken by network mentors instead of planned 14 visits and rural hub-mentors could undertake only four visits against planned 18 visits. Ten QI projects were successfully completed by teams, 80% of these projects started during the initial intensive phase of mentoring. The projects ranged from 3 to 10 months with median duration being 5 months. DISCUSSION: Various components of a health system must work in synergy to sustain improvements in quality of care. Quality networks and collaboratives can play a significant role in creating this synergy. Active participation of district and state administration is a critical factor to produce a culture of quality in the health system.
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Quality Improvement/organization & administration , Quality of Health Care/standards , Education/methods , Feasibility Studies , Humans , India , Mentoring/methods , Pilot Projects , Program Evaluation/methods , Quality Improvement/statistics & numerical data , Quality of Health Care/statistics & numerical dataABSTRACT
INTRODUCTION: Timing of cord clamping and other cord management strategies may improve outcomes at preterm birth. However, it is unclear whether benefits apply to all preterm subgroups. Previous and current trials compare various policies, including time-based or physiology-based deferred cord clamping, and cord milking. Individual participant data (IPD) enable exploration of different strategies within subgroups. Network meta-analysis (NMA) enables comparison and ranking of all available interventions using a combination of direct and indirect comparisons. OBJECTIVES: (1) To evaluate the effectiveness of cord management strategies for preterm infants on neonatal mortality and morbidity overall and for different participant characteristics using IPD meta-analysis. (2) To evaluate and rank the effect of different cord management strategies for preterm births on mortality and other key outcomes using NMA. METHODS AND ANALYSIS: Systematic searches of Medline, Embase, clinical trial registries, and other sources for all ongoing and completed randomised controlled trials comparing cord management strategies at preterm birth (before 37 weeks' gestation) have been completed up to 13 February 2019, but will be updated regularly to include additional trials. IPD will be sought for all trials; aggregate summary data will be included where IPD are unavailable. First, deferred clamping and cord milking will be compared with immediate clamping in pairwise IPD meta-analyses. The primary outcome will be death prior to hospital discharge. Effect differences will be explored for prespecified participant subgroups. Second, all identified cord management strategies will be compared and ranked in an IPD NMA for the primary outcome and the key secondary outcomes. Treatment effect differences by participant characteristics will be identified. Inconsistency and heterogeneity will be explored. ETHICS AND DISSEMINATION: Ethics approval for this project has been granted by the University of Sydney Human Research Ethics Committee (2018/886). Results will be relevant to clinicians, guideline developers and policy-makers, and will be disseminated via publications, presentations and media releases. REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12619001305112) and International Prospective Register of Systematic Reviews (PROSPERO, CRD42019136640).
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Fetal Blood/physiology , Premature Birth , Umbilical Cord/physiology , Constriction , Delivery, Obstetric , Female , Humans , Infant, Newborn , Meta-Analysis as Topic , Network Meta-Analysis , Placenta/physiology , Pregnancy , Research Design , Systematic Reviews as TopicABSTRACT
Purpose: To record central corneal thickness and corneal diameter in preterm and term newborns within first week of their birth and in preterm neonates at term age. Methods: Babies born at ≤34 weeks of gestation period (n = 100), term babies who have a gestation period of >37 weeks (n = 100) and preterm neonates at term age (38-42 weeks) who were born at ≤34 weeks (n = 100) were included in this hospital based observational descriptive study. Corneal diameter was taken by Castroviejo Calipers. Central corneal thickness was measured using portable ultrasonic pachymeter (Pachette 3). Refractive status of the eyes was measured using streak Wellch Allyn retinoscope under cyclopentolate cycloplegia. Results: Measure of central corneal thickness and corneal diameter in preterm newborns was found to be 633.5 ± 2.8 µm and 8.1 ± 0.6 mm, in full term newborns it was 555.1 ± 2.7 µm and 9.5 ± 0.6 mm, and in preterm neonates at term age, it was 563.5 ± 2.5 µm and 9.6 ± 0.5 mm, respectively. Mean central corneal thickness was found to be more in preterm newborns 633.5 um then term newborns 555.1 um and the difference was statistically significant (P =0.001). Mean corneal diameter was found to be maximum (9.6 mm) in preterm neonates at term age. Conclusion: Preterm babies have thick corneas and small corneal diameters. This study is useful with respect to the analysis of glaucoma in children and using preterm corneas as donor corneas in penetrating keratoplasty.
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Cornea/anatomy & histology , Infant, Premature , Term Birth , Birth Weight , Female , Gestational Age , Humans , Infant, Newborn , Male , Organ Size , RetinoscopyABSTRACT
OBJECTIVE: To study the effect of maternal pre-eclampsia on the short-term neurobehavioral outcomes in late preterm neonates using Neurobehavioral Assessment of Preterm Infants (NAPI) score. METHODS: 30 late preterm neonates born to mothers with preeclampsia, and thirty controls born to mothers without pre-eclampsia were enrolled, and followed up to 40 weeks of post-menstrual age. They were evaluated by NAPI score of MDV (Motor development-vigor) and AO (Alertness orientation) at 40 wk. RESULTS: The mean NAPI score of MDV in cases was 60.1 (9.56) as compared to 70.0 (11.48) in controls (P <0.001). The mean NAPI score of AO in cases was 37.45 (11.04) as compared to 45.6 (13.33) in controls (P=0.006). CONCLUSION: Late preterm neonates born to mothers with pre-eclampsia have poor short term neurobehavioral outcomes.
Subject(s)
Infant, Premature, Diseases/etiology , Neurodevelopmental Disorders/etiology , Pre-Eclampsia , Case-Control Studies , Female , Follow-Up Studies , Humans , Infant, Newborn , Infant, Premature , Infant, Premature, Diseases/diagnosis , Male , Neurodevelopmental Disorders/diagnosis , Neuropsychological Tests , Pregnancy , Risk FactorsABSTRACT
Background: The State of Meghalaya, India, has some of the worst newborn health outcomes in the country. State health authorities commissioned an assessment of newborn service delivery to improve services. This study proposes bottleneck analysis (BNA) and quality improvement (QI) methods as a combined method to improve compliance with evidence-based neonatal interventions in newborn health facilities. Methods: An adapted Every Newborn BNA tool was applied to collect data on barriers to providing quality care in five district hospitals. Subsequently, health workers were coached to use QI methodology to overcome identified bottlenecks. Data from QI projects were analysed using run charts. Results: BNA revealed that interventions directed toward basic newborn care and special newborn care facilities needed attention. Facilities that undertook QI projects showed an improvement in neonates having early initiation of breastfeeding within the first hour of birth, from 64% to a peak of 94% in one facility and from 75% to 91% in another. Skin-to-skin contact increased from 49% to a peak of 78% and is sustained at 58%. Improved performance has been sustained in some facilities. Conclusions: The combination of BNA and QI is a successful method for identifying and overcoming bottlenecks in newborn care in resource-limited settings.
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Infant Care/standards , Quality Improvement/organization & administration , Evidence-Based Medicine/organization & administration , Feasibility Studies , Health Services Research , Hospitals, District , Humans , India , Infant, NewbornABSTRACT
India contributes to the largest pool of the global neonatal and under-five mortalities. The current healthcare delivery services have a scope for improvement in terms of the quality of care at the point of delivery. In this era of resource constraints across the low- and middle-income countries (LMIC), quality improvement techniques can be a game changer to positively address the common bottlenecks of health service delivery and increase community participation. Globally, networks of quality of care and collaboratives have demonstrated significant impact in improving processes of care and the quality of services delivered to the end user. The Nationwide quality of care network (NQOCN) is a self-sustaining network of quality improvement teams, which have cohesively led the spread and adoption of simple quality improvement strategies across the Indian subcontinent. The current perspective apprises the reader about NQOCN, its relevance and impact in current times.
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Delivery of Health Care/standards , Intersectoral Collaboration , Quality Improvement , Quality of Health Care/standards , Humans , India , Infant, NewbornABSTRACT
BACKGROUND/PURPOSE: The anal position index (API) defines the normal anal position as the ratio of fourchette-anal distance to fourchette-coccyx distance for females and the scrotum-anal distance to scrotum-coccyx distance for males. In this study, measurement of the API in newborns and infants with anorectal malformations (ARM), using the center of the midline anal dimple (AD) to represent the center of the proposed neoanus, was performed to assess whether or not the AD was located in a significantly abnormal position as correlated with the normal anal position. METHODS: The cases comprised 65 consecutive newborn and infants with ARM, divided into 2 age-based groups (Group A: 1st day to 1month; Group B: 1-12months), without sacral or significant perineal abnormalities. Controls included an equal number of age and gender matched patients admitted for other conditions. The characteristics of the AD ('well developed' or 'moderately developed') as well as those of the midline perineal raphé in males and the perineal groove in females were also recorded. RESULTS: Combining both age groups, the mean API±SD was 0.41±0.012 in male cases and 0.53±0.07 in male controls (p value 0.003). The corresponding values for female cases and controls were 0.31±0.09 and 0.36±0.07 respectively (p = 0.040). In male newborns, the API in cases was significantly lower than the API in controls (p<0.001). Combining both males and female newborns, the differences between the API in cases and controls was also statistically significant (p<0.001). In older boys as well as in girls from both age groups, apart from cases of persistent cloaca, the API was lower in cases than in controls, especially in boys, although the difference was not statistically significant. On comparing the API in individual male ARM with that in male controls, cases of rectobulbar urethral fistula (RBUF) and rectovesical fistula had a statistically significant lower API (p<0.001). In the 4 cases of persistent cloaca, the mean API (0.40±0.1) was higher than the mean API in female controls and the AD was well developed with a well-delineated, narrow perineal groove. The majority (53/65; 81.53%) of patients had a 'well developed' AD. Twelve patients (18.47%) had a 'moderately developed' AD including 10 females and 2 males. There were 15 patients with a depressed AD (anal fossette); of these 12 (80%) were females. All boys had a well delineated perineal raphé in contrast to 10 girls (29.4% of total female ARM) who had a poorly delineated midline perineal groove. CONCLUSIONS: During definitive surgery for ARM, if the AD is taken as the site of the proposed neoanus, the neoanal position is likely to be anterior to the normal anal position in both males and females and especially so in males. Overall, girls with ARM appear to be more likely to have a relatively poorly developed and/ or depressed AD and a poorly delineated perineal groove. TYPE OF STUDY: Clinical Research. LEVEL OF EVIDENCE: Level III.
Subject(s)
Anal Canal/abnormalities , Anorectal Malformations/diagnosis , Perineum/abnormalities , Anal Canal/anatomy & histology , Female , Humans , Infant , Infant, Newborn , Male , Perineum/anatomy & histology , Prospective StudiesABSTRACT
BACKGROUND: Orofacial clefts (OFC) are linked with several genetic and environmental factors. The aim of this study was to explore the association of potential risk factors with OFCs in India. METHODS: This was a hospital-based, matched case-control (1:4 ratio; matching done for parity) study conducted in Hyderabad, Bengaluru, and Delhi-National Capital Region. Cases (nonsyndromic clefts) were recruited from treatment centers, while controls (live births) were recruited from maternity centers. Information on exposures was collected during personal interviews. Exposures of interest included folic acid supplementation during the peri-conceptional period, consanguineous marriage, exposure to drugs, infections during pregnancy, family history of OFC, and dietary factors. RESULTS: A total of 785 participants were included in the study: 157 cases and 628 controls. A family history of cleft lip/palate (adjusted odds ratio [AOR], 15.48; 95% confidence interval [CI], 4.36-54.96; p value = 0.001), exclusive vegetarianism (AOR, 4.47; 95% CI, 1.83-10.98; p value = 0.001), and delayed first conception (AOR, 2.55, 95% CI, 1.25-5.21, p = 0.01) were found to be strongly associated with higher risk of OFCs. Supplementation with folic acid during first 3 months of pregnancy was not found to be protective against OFCs (AOR, 1.24; 95% CI, 0.59-2.58; p value = 0.56). CONCLUSION: Our study confirmed the importance of family history as a risk factor for OFC. Our study did not show an association with folic acid supplementation but was underpowered to detect small effects. Our finding of higher risk among vegetarians requires replication. Birth Defects Research 109:1284-1291, 2017. © 2017 The Authors. Birth Defects Research Published by Wiley Periodicals, Inc.