Randomised control trial of oxygen assist module in preterm infants on high-flow nasal cannula support.

OBJECTIVE: To evaluate the efficacy of automatic oxygen control (A-FiO2) in reducing the extremes of oxygen saturations (SpO2<80% and SpO2>98%) in preterm infants on high-flow nasal cannula (HFNC) respiratory support using Vapotherm Precision Flow. DESIGN: A parallel-arm randomised controlled trial. SETTING: A level-III neonatal intensive care unit. PATIENTS: Preterm infants born <33 (23+0 to 32+6) weeks receiving HFNC as respiratory support. INTERVENTIONS: A-FiO2 versus manual (M-FiO2) oxygen control during the full course of HFNC support. OUTCOMES: The primary outcome of this study is percentage of time spent in extreme oxygen saturations (<80% and >98%) in preterm infants when receiving HFNC as respiratory support. Secondary outcomes were time with SpO2 between 90% and 95% plus time >95% without supplemental oxygen. RESULTS: 60 infants were randomised equally to either A-FiO2 or M-FiO2 arm. Their baseline characteristics were comparable. They spent a median of 5.3 (IQR: 2.0-8.4) and 6.5 (IQR: 2.9-13.7) days in the study, A-FiO2 and M-FiO2, respectively. The percentage of time spent in SpO2<80% (median of 0.4% (0.1%-0.8%) vs 1.6% (0.6%-2.6%), p=0.002) and >98% (median 0.2% (0.1%-0.9%) vs 1.9% (0.7%-4%), p<0.001) were significantly lower in A-FiO2 compared with M-FiO2. The difference in median percentage of time in target range between the two arms was 26% (81% (74%-93%) in A-FiO2 vs 55% (48%-72%) in M-FiO2). CONCLUSION: A-FiO2 was associated with statistically significant reduction in the percentage of time spent in extremes of saturation when compared with M-FiO2 in preterm infants receiving HFNC. TRIAL REGISTRATION NUMBER: NCT04687618.

Automatic oxygen control for reducing extremes of oxygen saturation: a randomised controlled trial.

OBJECTIVE: The objective of this study was to evaluate the efficacy of the automatic oxygen control (A-Fio2) in reducing the percentage of time spent in severe hypoxaemia (Spo2 <80%) in preterm infants for the time period on invasive ventilation and/or nasal continuous positive airway pressure (NCPAP) delivered by AVEA ventilator. DESIGN: A parallel arm randomised controlled trial. SETTING: A level-III neonatal intensive care unit. PATIENTS: Preterm infants (<33 weeks birth gestation) who received invasive ventilation or NCPAP in the first 72 hours of age. INTERVENTIONS: A-Fio2 vs manual (M-Fio2) oxygen control. OUTCOMES: The primary outcome of the study was percentage of time spent in severe hypoxaemia (Spo2 <80%). RESULTS: 44 infants were randomised to either A-Fio2 or M-Fio2 arm and continued in the study for the period of respiratory support (invasive ventilation and/or NCPAP). The total number of study days in A-Fio2 and M-Fio2 arm were 194 and 204 days, respectively. The percentage of time spent in Spo2 <80% was significantly lower with A-Fio2 compared with M-Fio2 (median of 0.1% (IQR: 0.07-0.7) vs 0.6% (0.2-2); p=0.03). The number of prolonged episodes (>60 s) of Spo2 <80% per day was also significantly lower in A-Fio2 (0.3 (0.0-2) vs 2 (0.6-6); p=0.02). CONCLUSION: A-Fio2 was associated with statistically significant reduction in the percentage of time spent in severe hypoxaemia when compared with M-Fio2 in preterm infants receiving respiratory support. TRIAL REGISTRATION NUMBER: NCT04223258.

National survey on caffeine use in neonatal units across the United Kingdom.

AIM: To understand the variations in practice for caffeine use among neonatal units in the United Kingdom. METHODS: An online survey was sent to every neonatal unit in the United Kingdom. RESULTS: We received a response from 92 neonatal units (47%) with the proportion of response from special care, Local neonatal units, neonatal intensive care units and neonatal surgical units were 23%, 34%, 23% and 21% respectively. All the units reported the use of caffeine, and 40 units (46%) initiated caffeine within 24 h of birth. Fifty-nine units (64%) reported routine use of caffeine for pre-term infants <32 weeks. Seventy-one units (77%) reported that they continue caffeine for infants needing mechanical ventilation. Thirty-one units (34%) discontinued caffeine at 34 weeks post-menstrual age, irrespective of the respiratory support. Ten units (11%) reported discontinuation of caffeine only after weaning off all respiratory support, and 40% of units had a variable practice of discontinuing caffeine depending on the individual baby. Seventy-nine units (86%) reported they would regularly optimise caffeine dose based on weight checks. CONCLUSION: Our survey showed some variation in practice with regards to the timing of caffeine initiation, gestational age cut-off for routine caffeine prescription and discontinuation.

Reference range for cerebrospinal fluid values in neonates: 5-year retrospective study.

BACKGROUND: Cerebro spinal fluid (CSF) parameters (white blood cell count, protein, glucose) in the diagnosis of neonatal bacterial meningitis. OBJECTIVES: To report the reference range of CSF parameters (white blood cell count, protein, glucose) in both term and preterm infants. METHODS: This was a single center retrospective study over a period of 5 years (2015-2020). We included infants aged 0-3 months admitted to the neonatal unit and infants ≤28 days attending pediatric acute care and who underwent Lumbar Puncture. We excluded infants with evidence of CSF bacteremia, viral infection and traumatic lumbar puncture defined as CSF Red Blood Cell >500 cells/µL. Clinical, demographic, and microbiological data were collected from the hospital database. The study was approved by ethics committee. RESULTS: We identified a total of 518 CSF samples, with 232 CSF samples available for final analysis. 54% of excluded samples were traumatic. Median birth gestation and birth weight of the study cohort were 38 (IQR 35-40) weeks and 3030 (IQR 1965-3565) grams respectively. Median RBC, WBC count, protein and glucose were 15 (IQR 3-85)/µL, 3(IQR 0-8.5)/µL, 0.72 (0.53-1.06) g/L and 2.8 (2.4-3.3) mmol/L respectively. There was no difference in CSF WBC cell count between preterm and term infants. Higher CSF protein content was noted in preterm infants and infants in the first 7 days of life. Use of antibiotics prior to LP was associated with higher CSF protein. Presence of any CSF RBC (including <500 cells/µL) influenced the CSF WBC count and protein content. CONCLUSION: We have provided a reference range of CSF parameters in neonates without meningitis. CSF WBC count between preterm and term infants were similar with higher CSF protein content in preterm infants and for infants in the first seven days of life. Presence of any CSF RBC influenced CSF parameters.

Automated Oxygen Delivery in Neonatal Intensive Care.

Oxygen is the most common drug used in the neonatal intensive care. It has a narrow therapeutic range in preterm infants. Too high (hyperoxemia) or low oxygen (hypoxemia) is associated with adverse neonatal outcomes. It is not only prudent to maintain oxygen saturations in the target range, but also to avoid extremes of oxygen saturations. In routine practice when done manually by the staff, it is challenging to maintain oxygen saturations within the target range. Automatic control of oxygen delivery is now feasible and has shown to improve the time spent with in the target range of oxygen saturations. In addition, it also helps to avoid extremes of oxygen saturation. However, there are no studies that evaluated the clinical outcomes with automatic control of oxygen delivery. In this narrative review article, we aim to present the current evidence on automatic oxygen control and the future directions.

Outcomes of Preterm Infants Who Experienced Unplanned Extubation.

BACKGROUND: Unplanned extubation (UE) is associated with adverse outcomes. The aim of the study was to compare the clinical outcomes in preterm infants who experienced at least one UE to those who did not experience any UE. METHODS: The matched cohort study compared ventilated preterm infants < 32 weeks who experienced UE to those who did not experience any UE. The main outcomes were duration of mechanical ventilation after matching, duration of hospital stay, retinopathy of prematurity (ROP) requiring intervention, and bronchopulmonary dysplasia (BPD). RESULTS: Forty-seven infants were included in each group. The groups were matched for mechanical ventilation duration before UE, birth gestation, and birthweight. The duration of mechanical ventilation after matching (adjusted odds ratio [aOR] 14.8 [11.2-18.4], P = <.001), the total length of stay in the hospital (aOR 16.4 [3.7-29.2], P = .01), and severe ROP (aOR 6.7 [1.7-27.0], P = .007) were significantly higher in infants who experienced UE. After adjusting for mechanical ventilation duration, UE was not associated with ROP or BPD. However, infants who spent longer time on mechanical ventilation had higher odds of developing ROP (aOR 1.1 [1.0-1.2], P = .004) and BPD (aOR 1.5 [1.1-2.1], P = .01). Sensitivity analysis including infants who had UE and managed on noninvasive respiratory support showed significant association between UE and the outcomes of duration of mechanical ventilation, hospital length of stay, ROP, and BPD. CONCLUSIONS: Infants who experienced UE had higher odds of spending longer time on mechanical ventilation and spent significantly more days in the hospital.

Better general paediatric and neonatal palliative care skills: simulation teaching.

OBJECTIVES: To assess the role of simulation to teach 'palliative care' skills to the multidisciplinary team (MDT) within general paediatric and neonatal settings. METHODS: Five simulation sessions were undertaken. The themes were acute presentation of a patient with a deteriorating life-limiting condition with no advance care plan (ACP) in place and parents not wishing for escalation of treatment; putting wishes expressed in an ACP in place for a dying child; managing an expected death; putting an antenatal ACP into place at delivery; and withdrawal of life-sustaining respiratory support in an extremely preterm neonate. Simulations were attended by the MDT. Participants completed feedback rating enjoyment, organisation, quality and relevance of sessions, and likelihood of attending further paediatric palliative medicine (PPM) simulation sessions, alongside a 10-point confidence scale rating confidence in dealing with 'palliative care' scenarios and talking to families about death. RESULTS: Participants reported they enjoyed the sessions (mean score 4.5, range 1-5) and felt they were well organised (4.7/5, range 1-5) and of high quality (4.7/5, range 1-5). They felt sessions were relevant to their training (4.6/5, range 1-5) and that they would attend further simulation training in the area of PPM (mean 4.8/5, range 1-5). Confidence in managing PPM scenarios increased by a mean of 2.3 confidence points (range -1 to 5) and confidence in talking about death increased by a mean of 1.7 confidence points (range 0-5). CONCLUSIONS: PPM simulation training was acceptable to participants and effective in increasing confidence with PPM skills. Training in PPM simulation should be a routine part of paediatric and neonatal training across the MDT.

Comparison of volume guarantee and volume-controlled ventilation both using closed loop inspired oxygen in preterm infants: a randomised crossover study (CLIO-VG study).

OBJECTIVE: The objective of this study was to compare two different modes of ventilation in maintaining oxygen saturation (SpO2) in target range (90%-95%) in ventilated preterm infants cared for with automatic control of oxygen delivery (A-FiO2). DESIGN: A single-centre randomised crossover study. SETTINGS: A level III neonatal intensive care unit. PATIENTS: Preterm infants receiving mechanical ventilation and oxygen requirement >21%. INTERVENTIONS: Volume guarantee (VG) vs volume controlled ventilation (VCV) modes with automatic oxygen control (A-FiO2). OUTCOMES: The primary outcome of this study was the proportion of time spent with oxygen saturations in the target range (90%-95%) . RESULTS: Nineteen preterm infants with a median gestation age 25 weeks (IQR: 24-28) and birth weight 685 g (IQR: 595-980) were enrolled in the study. There was no significant difference in primary outcome of median proportion of time spent in target saturation between the two arms (72% (57-81) in VG vs 75% (58-83) in VCV; p=0.98). There was no significant difference in the secondary outcomes of time spent in SpO2 <80% (0.03% vs 0.14%; p=0.51), time spent in SpO2 >98% (0.50% vs 0.08%; p=0.54), the median FiO2 (31% vs 29%; p=0.51) or manual adjustments carried out between VG and VCV, respectively. The number of episodes of prolonged hypoxaemia and hyperoxaemia were similar in the two groups. CONCLUSION: There was no significant difference in time spent in target SpO2 range between VG and VCV when A-FiO2 was used as the FiO2 controller in this crossover randomised control study. TRIAL REGISTRATION NUMBER: NCT03865069.

Multiple thromboses in a late preterm infant present at birth.

A late preterm infant was born to a diabetic mother on a background of reduced fetal movements and a poor CTG. It was noted immediately at birth that there was pathology in both upper limbs. Targeted investigation led to the diagnosis of bilateral upper limb arterial thromboses. Prompt assessment and multidisciplinary discussion led to an individualised management plan resulting in a positive outcome.

Permanent childhood hearing impairment in infants admitted to the neonatal intensive care unit: nested case-control study.

The prevalence of permanent childhood hearing impairment (PCHI) in infants admitted to a neonatal intensive care unit (NICU) is higher than that in the general population. Our study objective was to identify risk factors associated with PCHI in infants who required admission to the NICU for more than 48 h. We performed a case-control study, including infants of all gestational ages who were admitted to NICU for more than 48 h and who underwent newborn hearing screening between 2005 and 2019. Infants admitted to NICU and diagnosed with PCHI by formal audiology were classified as "cases". The "controls" were infants who were admitted to NICU and did not have PCHI. Cases and controls (1:4) were matched based on their birth gestation, birthing place, and treating NICU. The prevalence of PCHI in infants admitted to NICU was 6.3% as compared with our general population prevalence of 0.25%. There were 77 cases and 269 controls during the study period. The median age at diagnosis of PCHI in these infants was 132 days (interquartile range 75.5-518.5). Using regression analysis, "any ventilation episodes", presence of seizures, and major congenital anomalies were significantly associated with PCHI in infants of all gestational ages. There were higher prevalence of PCHI in preterms (<32 weeks) who received furosemide and lower prevalence with antenatal use of magnesium sulphate.Conclusions: In our study, the prevalence of hearing loss was high in infants admitted to NICU. Gestation-specific risk factors identified in this case-control study would help in counselling of parents. What is Known: • In the UK, 1-2/1000 infants are born with hearing loss and infants admitted to the neonatal unit for 48 h or more have increased prevalence of hearing loss (1 in 100 live births). • Identification of risk factors in infants admitted to neonatal unit would help with risk stratification and further management. What is New: • In our study, infants admitted to the neonatal unit had higher prevalence of hearing loss (6.3 in 100 live births). • In infants across all gestational age "any ventilation episodes", presence of seizures, and severe congenital anomalies were associated with a statistically significant increase in prevalence of hearing loss. Higher prevalence of hearing loss was noted in preterm infants (<32 weeks) who received furosemide treatment and lower prevalence was noted with antenatal use of magnesium sulphate.

General Movement Assessment Predicts Neuro-Developmental Outcome in Very Low Birth Weight Infants at Two Years - A Five-Year Observational Study.

OBJECTIVE: To assess the value of general movements (GMs) in predicting the neurodevelopmental outcome using Bayley Scale of Infant Development III (BSID-III) at two years of age in very low birth weight (VLBW) infants. METHODS: This is a five-year observational study (January 2012-June 2017). Two hundred twenty-seven VLBW infants were assessed in the neurodevelopmental clinic between Jan 2012 and June 2017. Of these 137 infants had GMs assessments at 3 mo post term (first visit to the clinic). RESULTS: Absence of fidgety movements (FMs) at 3 mo post term had high specificity and negative predictive value for moderate to severe neurodevelopmental outcome in motor, cognition and language domains (composite score less than 70 in the Bayley III scales of Infant development scores). At 3 mo post term, absent FMs had high sensitivity, specificity and negative predictive value (NPV) for cerebral palsy (CP). CONCLUSIONS: GMs assessment at 3 mo post term could be considered as an important screening tool for early identification of VLBW infants who are at risk of neurodevelopmental impairment/cerebral palsy.

Phased Quality Improvement Interventions in Reducing Unplanned Extubation in the Neonatal ICU.

BACKGROUND: Unplanned extubation (UE) is a common adverse event and is an important measure of quality and patient safety in the neonatal ICU. It is well recognized that UEs occur more frequently in neonates than in any other group of ventilated patients. The objective of this study was to evaluate the effectiveness of the quality improvement interventions in reducing the rates of UE in a tertiary neonatal ICU. METHODS: A retrospective audit performed on ventilated infants showed a rate of 7.2 unplanned extubations per 100 ventilation days in a 12-month period (April 2016 to March 2017). We evaluated the common factors associated with UEs, with the primary reasons being loose fixation and providing care without assistance. We introduced sequential interventions focusing on better practices. Standardizing endotracheal tube fixation, continuous scrutiny of fixation through checks, 2-person technique for providing care, and adverse event reporting were a few of the important interventions. Rates of UE for each month were collected and analyzed. RESULTS: With interventions, UE rates reduced by 80% (from 7.2 per 100 ventilated days in the pre-implementation period to 1.4 per 100 ventilated days in the post-implementation period) in 12-18 months. CONCLUSIONS: Significant reductions in UE rates were achieved by implementing quality improvement interventions. It is important to analyze critical event rates continuously and for longer periods of time to determine the true change.

Analgesic and anti-inflammatory activities of Bulbophyllum neilgherrense Wight. pseudobulb: A folklore plant.

BACKGROUND: Bulbophyllum neilgherrense Wight. is an epiphytic orchid used extensively by the tribes of Karnataka in various diseases such as heart disease, leukoderma, skin allergy and rheumatism. It is used both internally and as an external application. In rheumatism, pseudobulbs chopped and boiled in coconut oil are applied externally. AIM: This study aims to evaluate analgesic and anti-inflammatory activities of B. neilgherrense Wight. pseudobulb powder in experimental animals. MATERIALS AND METHODS: Shade-dried pseudobulb were pulverized into fine powder. The analgesic activity of test drug was evaluated with tail-flick response and formalin-induced paw licking and anti-inflammatory activity with carrageenan-induced paw edema and formaldehyde-induced edema in Charles Foster albino rats. Statistically, the values were assessed with one-way analysis of variance followed by Dunnett's multiple t-test and Student's t-test for paired and unpaired data. RESULTS: Administration of pseudobulb powder showed significant increase in tail-flick response at 30 min (51.75%), at 60 min (108.24%), 120 min (81.12%), and 180 min (23.84%). Test drug produced nonsignificant inhibition of carrageenan-induced paw edema at 1 h (37.25%) and 5 h (15.67%) compared to control group and did not produced any effect in formalin-induced edema. CONCLUSION: The present study concluded that the test drug has central analgesic activity against radiant heat-induced pain, moderate anti-inflammatory activity against carrageenan-induced acute inflammation.

Persistent Left Superior Vena Cava.

Persistent left superior vena cava (PLSVC) is a common cardiac anomaly associated with congenital heart diseases. A diagnosis of PLSVC usually warrants a detailed fetal echocardiography. Lesser known associations are the extra cardiac anomalies notably the upper airway and the gastrointestinal tract anomalies. We highlight here the importance of detailed fetal assessment for extra cardiac anomalies in addition to fetal echocardiography in fetuses diagnosed with PLSVC. We hereby present a preterm infant who presented with a triad of PLSVC, laryngeal atresia, and esophageal atresia.

Quality Improvement Study on New Endotracheal Tube Securing Device (Neobar) in Neonates.

OBJECTIVES: To examine the rate of unplanned extubation (UE) after the introduction of NeoBar (endotracheal tube stabilization device) compared to the previous tapping method and to analyze the factors associated with UE in the neonatal intensive care unit (NICU). METHODS: A quality improvement study was conducted in a tertiary NICU between October 2011 and December 2013. In October 2012, after many educational sessions NeoBar was introduced as a tool for securing endotracheal tube. The UE rate was compared one year before and one year after the introduction of NeoBar. The UE rate was reported as UE per 100 intubation days. Statistical process control charts were used for understanding the special cause variation. The authors used Standards for Quality Improvement Reporting Excellence (SQUIRE) method of reporting for this project. RESULTS: The UE rate decreased from 1.47 per 100 intubation days to 1.17 per 100 intubation days following the introduction of NeoBar (p=0.91). The UE rate was consistently below/at the mean, showing a stable change following the introduction of NeoBar, despite no statistically significant difference in UE rate. The common factors associated with UE were retaping/adjustment of endotracheal tube, infant agitation and performance of other procedures in both time periods. CONCLUSIONS: Use of NeoBar as endotracheal tube securing device was associated with similar UE rates compared to taping method. Large prospective studies are required to assess whether NeoBar reduces the UE rate.

Azithromycin and other macrolides for prevention of bronchopulmonary dysplasia: a systematic review and meta-analysis.

BACKGROUND AND OBJECTIVE: Ureaplasma spp. infection has been associated with bronchopulmonary dysplasia (BPD) in preterm infants. Macrolides have been used for the treatment of Ureaplasma spp. infection, with an intention to prevent BPD. The objective of this meta-analysis is to evaluate the use of macrolides in the prevention of BPD in preterm infants. METHODS: We searched MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials, abstracts of the major pediatric society meetings and bibliographies of retrieved articles. We included randomized controlled trials assessing the effects of macrolides therapy on BPD in preterm infants. A random/fixed-effect model was used to synthesize predefined outcomes. RESULTS: Six studies involving 469 preterm infants were eligible for the analysis. Macrolides when used prophylactically (4 studies) did not show significant reduction in BPD (risk ratio, RR, 0.88, 95% confidence interval, CI, 0.75-1.03), death (RR 0.89, 95% CI 0.79-1.01) or in the composite outcome of BPD/death. Similarly, there was no significant reduction in BPD (RR 0.64, 95% CI 0.31-1.31) or the composite outcome of BPD/death (RR 0.41, 95% CI 0.05-3.13), when macrolides were used in Ureaplasma-positive infants. However, prophylactic azithromycin therapy (3 studies) was associated with significant reduction in BPD (RR 0.83, 95% CI 0.71-0.97; number needed to treat, NNT, 10) and composite outcome of BPD/death (RR 0.86, 95% CI 0.77-0.97; NNT 10). CONCLUSION: This meta-analysis demonstrates prophylactic azithromycin therapy was associated with statistically significant reduction in BPD and the composite outcome of BPD/death in preterm infants. However, given the limited information on pharmacokinetics and potential harmful effects, further studies should be done before routine use of azithromycin in the neonatal population.

Probiotics and prebiotics: role in prevention of nosocomial sepsis in preterm infants.

Nosocomial sepsis is associated with increased mortality and morbidity including neurodevelopmental impairment and prolonged hospital stay. Prevention of sepsis especially in the preterm infants in the neonatal intensive care unit remains a major challenge. The gastrointestinal tract is an important source of potential pathogens causing nosocomial sepsis as the immature intestinal epithelium can permit translocation of bacteria and yeast. The intestinal tract and its microflora play an important role in the immunity. Altering the gut microflora has been extensively studied for immunomodulation in preterm infants. Probiotics are live microorganisms which when administered in adequate amounts confer a health benefit on the host. Probiotics have been used for prevention and treatment of various medical conditions in children and adults. Studies on probiotics in premature infants have focused on normalizing intestinal flora, improvement in feeding intolerance, prevention of necrotizing enterocolitis and sepsis. In this paper, we discuss the intestinal bacterial colonization pattern; the rational for probiotics and prebiotic therapy with special focus on the prevention of nosocomial sepsis in preterm infants.

Neonatal withdrawal syndrome due to maternal codeine use.

Neonatal withdrawal from maternal drugs and medications is not uncommon. Codeine-containing analgesic preparations given to pregnant mothers for headache have been identified as a cause of neonatal withdrawal syndrome. The present case highlights the importance of obtaining a detailed maternal drug history including prescription and nonprescription drugs, and highlights the need for prenatal counselling for women who are taking narcotic-containing analgesics.

Il n'est pas rare de sevrer un nouveau-né des drogues et médicaments qu'a consommés la mère. Il est établi que les préparations analgésiques qui contiennent de la codéine et qui sont données aux femmes enceintes pour soulager les maux de tête représentent une cause de syndrome de sevrage néonatal. Le présent cas fait ressortir l'importance d'obtenir les antécédents détaillés de la mère quant à ses médicaments, qu'ils soient sur ordonnance ou en vente libre, ainsi que la nécessité de donner des conseils prénatals aux femmes qui prennent des analgésiques contenant des narcotiques.

Randomised controlled study-efficacy of clonidine versus carbamazepine in children with ADHD.

BACKGROUND: Attention deficit hyperactivity disorder (ADHD) is one of the most common childhood psychiatric disorder with a prevalence of 8-12%. Even though psychostimulants remain the treatment of choice, its cost and availability in developing countries limits the usage of the drug. In view of free availability and low cost, a Randomized controlled study was carried out using two second line drugs (clonidine and carbamazepine) in a tertiary care hospital, Pondicherry, South India. OBJECTIVE: To compare the efficacy of clonidine and carbamazepine in children with ADHD. METHOD: With approval of ethics committee, a prospective, Double-blind, Randomized controlled study of clonidine and carbamazepine was conducted with 50 children with ADHD (age group 4-12 years), over a period of 2 years (2005-07) in a tertiary care hospital, Pondicherry, South India. RESULTS: Clonidine was effective in improving the hyperactivity and impulsivity symptoms in children with ADHD as compared to carbamazepine. Statistical significant improvement was not noted with respect to inattention symptoms and other comorbid conditions. CONCLUSION: Clonidine can be a safer and cheaper alternative in treatment of children with ADHD, with a predominant effect on their hyperactivity and impulsivity symptoms.