Effect of Domperidone on Breast Milk Production in Mothers of Sick Neonates: A Randomized, Double-Blinded, Placebo-Controlled Trial.

Objective: Mothers of many preterm babies are unable to produce sufficient milk for their babies during the prolonged hospitalization. Domperidone stimulates the release of prolactin, thereby increasing breast milk production. The primary outcome was to study the efficacy of domperidone in augmenting breast milk production in mothers with lactation failure (LF). The secondary outcomes included the effect of domperidone on prolactin levels, adverse effects of domperidone, and outcome on breastfeeding rates at discharge. Materials and Methods: This was a randomized, double-blinded, placebo-controlled trial where mothers with LF were either allocated domperidone (10 mg) or placebo, 2 tablets three times a day for 14 days. Milk volumes were recorded daily for 14 days. Serum prolactin levels were measured at the start and at day 7 of study. Results: Out of 166 women eligible for the study, 119 (71.7%) mothers were able to increase their breast milk production without pharmacological treatment after being counseled on the advantages of human milk and proper breastfeeding management. Forty-seven mothers were finally enrolled in the study; 24 in the domperidone group (DG) and 23 in the placebo group (PG). Breast milk production increased from a baseline of 156 + 141.1 to 400.9 + 239.2 mL in the DG and increased from a baseline of 175.8 + 150.7 to 260.5 + 237.5 mL in the PG, after 14 days (p < 0.01). The prolactin levels in the DG and PG increased from 72.85 (22.2-167.15) and 42.33 (14.02-93.54) ng/mL, respectively, to 223.4 (49.79-280.2) ng/mL (p = 0.005) in the DG and 60.08 (14.31-132.14) ng/mL (p = 0.232) in the PG on the 7th day of treatment. No adverse effects were recorded. Ninety-five percent of babies in the DG were exclusively breastfeeding at hospital discharge, compared with 52.4% in the PG (p = 0.008). Conclusion: Domperidone treatment can result in an increase in breast milk production with no adverse effects. The study was registered with the Thai Clinical Trials Registry ID TCTR2020091008.

Comparison of Breast Milk Compositions Among Mothers Delivering Small-for-Gestational Age, Appropriate-for-Gestational Age, and Large-for-Gestational Age Infants.

OBJECTIVES: The aim of this study was to compare the breast milk compositions of mothers who delivered babies in three different birth weight categories. MATERIALS AND METHODS: We collected 75 breast milk samples from mothers of small-for-gestational age (SGA), appropriate-for-gestational age (AGA), and large-for-gestational age (LGA) term infants (25 per group) on the 11th-28th day postpartum using a manual or electric breast pump. Homogenized samples were analyzed using a mid-infrared human milk analyzer within 2 hours of collection, and protein, carbohydrate (CHO), fat, and energy levels were compared. RESULTS: Of 75 participants (median maternal age: 29 years), there was a significant difference in maternal body mass index (BMI), gestational age, and birth weight among the three groups. However, we found no significant variation in breast milk true protein, crude protein, fat, or energy. The CHO composition of breast milk in mothers of SGA infants (7.1 g/100 mL, range: 6.6-7.3 g/100 mL) was significantly lower than that in the AGA (7.3 g/100 mL, range: 7.1-7.5 g/100 mL) and LGA (7.2 g/100 mL, range: 6.7-7.4 g/100 mL) groups. After post hoc multiple comparison, only CHO levels between the SGA and AGA groups were significantly different (p = 0.025), whereas no significant correlation was found between maternal BMI, gestational age, and CHO. CONCLUSIONS: The CHO component in breast milk from mothers of SGA infants was significantly lower compared with the AGA and LGA groups, but with no clinical significance. Breast milk compositions of mothers of LGA infants were comparable to those of SGA and AGA infants. Therefore, fetal growth status does not significantly influence maternal breast milk nutrients.

Comparison of incidence and cost of influenza between healthy and high-risk children <60 months old in Thailand, 2011-2015.

INTRODUCTION: Thailand recommends influenza vaccination for children aged 6 months to <36 months, but investment in vaccine purchase is limited. To inform policy decision with respect to influenza disease burden and associated cost in young children and to support the continued inclusion of children as the recommended group for influenza vaccination, we conducted a prospective cohort study of children in Bangkok hospital to estimate and compare influenza incidence and cost between healthy and high-risk children. METHODS: Caregivers of healthy children and children with medical conditions ('high-risk') aged <36 months were called weekly for two years to identify acute respiratory illness (ARI) episodes and collect illness-associated costs. Children with ARI were tested for influenza viruses by polymerase chain reaction. Illnesses were categorized as mild or severe depending on whether children were hospitalized. Population-averaged Poisson models were used to compare influenza incidence by risk group. Quantile regression was used to examine differences in the median illness expenses. RESULTS: During August 2011-September 2015, 659 healthy and 490 high-risk children were enrolled; median age was 10 months. Incidence of mild influenza-associated ARI was higher among healthy than high-risk children (incidence rate ratio [IRR]: 1.67; 95% confidence interval [CI]: 1.13-2.48). Incidence of severe influenza-associated ARI did not differ (IRR: 0.40; 95% CI: 0.11-1.38). The median cost per mild influenza-associated ARI episode was $22 among healthy and $25 among high-risk children (3-4% of monthly household income; difference in medians: -$1; 95% CI for difference in medians: -$9 to $6). The median cost per severe influenza-associated ARI episode was $232 among healthy and $318 among high-risk children (26-40% and 36-54% of monthly household income, respectively; difference in medians: 110; 95% CI for difference in medians: -$352 to $571). CONCLUSIONS: Compared to high-risk children, healthy children had higher incidence of mild influenza-associated ARI but not severe influenza-associated ARI. Costs of severe influenza-associated ARI were substantial. These findings support the benefit of annual influenza vaccination in reducing the burden of influenza and associated cost in young children.

Iloprost inhalation for the treatment of severe persistent pulmonary hypertension of the newborn, experience at QSNICH.

BACKGROUND: Persistent pulmonary hypertension of the newborn (PPHN) is the most serious condition that causes high mortality in term and post term infants. The authors have an experience of using high frequency oscillatory ventilation (HFOV) and inhaled nitric oxide (iNO) for treatment of this condition with a good result. However, due to high cost of iNo, other pulmonary vasodilators have been use. Sildenafil had some side effects of systemic hypotension. Thus, inhaled iloprost was introduced for treatment of PPHN at our institute. OBJECTIVE: To evaluate the outcome of inhaled iloprost for the treatment of PPHN. MATERIAL AND METHOD: This was a retrospective study. The data from medical records of newborns, diagnosed as persistent pulmonary hypertension of the newborn and had received inhaled iloprost from October 1st, 2008-October 31st, 2012, were reviewed. RESULTS: Nineteen cases of PPHN treated with inhaled iloprost were reviewed. Male to female ratio was 1.3 7:1 (11:8). Mean birth weight and gestational age of these patients were 2,997 ± 531.63 grams and 37.9 ± 2.51 weeks, respectively. Meconium aspiration syndrome was the leading underlying cause of this condition. The mortality rate in this study was 21% (4 from 19 cases). After the addition of inhaled iloprost, the oxygen index (OI) in the survivor group decreased significantly at one hour after treatment (from 32.89 to 22.06, 18.76, 13. 76 at 1, 6, 12 hours, respectively). Oxygen saturation (SpO2) continued increasing after treatment in the survivor group (from 82.40% to 92.20%, 95.00%, 95.80% at 1, 6, 12 hours, respectively) with significant difference at one hour. There was a significant difference of OI and SpO2 between the survivor and non-survivor groups after treatment. Low Apgar score at 5 minutes and early diagnosis of PPHN were found statistically significant different in the non-survivor compared to the survivor groups. CONCLUSION: Inhaled iloprost could be used as an alternative treatment of PPHN without side effects of systemic hypotension.

Effects of temperature and time delay on arterial blood gas and electrolyte measurements.

OBJECTIVE: To determine the changes in pH, PaO2, PaCO2 and Na, K, Cl in arterial blood samples stored at room temperature or on ice, at 0, 15, 30, 45 and 60 minutes. MATERIAL AND METHOD: Arterial blood samples were collected in heparinized capillary tubes and stored at room temperature (24-26 degrees C) and on ice (0-4 degrees C). ABG and electrolytes were measured at 0, 15, 30, 45 and 60 minute intervals. RESULTS: There were significant decreases in the pH, PaO2, Na, Cl and significant increases in PaCO2 and K over time in both groups. The changes were greater and faster at room temperature. The significant decrease in pH over time was not found until 30 minutes at room temperature and 45 minutes on ice. There were significant decreases in PaO2, concurrent with significant increases in PaCO2 from 15 minutes onwards in both groups. Both Na and K exhibited a significant change at 60 minutes in the room temperature group. Significant decreases of Cl over time were not found until 15 minutes at room temperature, and 30 minutes on ice. CONCLUSION: For ABG and electrolytes analysis, the blood sample should be analyzed within 15 minutes and be stored at either room temperature or on ice.

Compare severity of bronchopulmonary dysplasia in neonates with respiratory distress syndrome treated with surfactant to without surfactant.

BACKGROUND: The utilization of surfactant replacement therapy had been limited in treatment of respiratory distress syndrome (RDS) due to the high cost especially in developing countries. Nowadays, the National Health Insurance Policy has covered the cost of surfactant for the patients. Therefore, bronchopulmonary dysplasia (BPD) may be found increasing due to increased survival in patients with severe RDS. OBJECTIVE: To compare immediate treatment outcome of severity of BPD and outcome after hospital discharge in neonates with RDS who were treated with or without surfactant. STUDY DESIGN: Retrospective cohort study. MATERIAL AND METHOD: The data of 54 infants who developed BPD after RDS at Queen Sirikit National Institute of Child Health between January 1st, 2003 and December 31th, 2005 were kept in database format. The database was analyzed for difference between groups and the outcome of immediate treatment, severity of BPD and outcome after hospital discharge were compared. The study group was BPD cases from RDS treated with surfactant compared to control (BPD cases from RDS treated without surfactant) groups. RESULTS: Forty-three (80%) from fifty-four cases had completed data and were included into the present study. There was no statistically significant difference in maternal conditions and neonatal conditions between groups. Antenatal steroid was prescribed more often in RDS without surfactant group than surfactant group. The mean birth weight and gestational age in surfactant and without surfactant groups were 1,179.1 +/- 274.3 gm vs. 1,114.4 +/- 338.3 gm and 29 +/- 1.6 weeks vs. 29.2 +/- 2.7 weeks respectively, but no significant differences were observed between groups. To compare the severity of RDS, only 17.6% of moderate to severe RDS in the control group was found, whereas 100% was found in the study group. Moderate to severe BPD cases were found more often in the control group (70.6%) than in the study group (61.6%), but no statistically significant difference was shown. The immediate complications, e.g. pneumothorax (5.9%) and pneumomediastinum (5.9%) were found in the control group, but pulmonary hemorrhage occurred more often in the study group than the control group (11.5% vs. 5.9%). For long-term follow-up, the development outcome was not different between groups. CONCLUSION: The present study revealed no statistically significant difference in severity of BPD in neonates with RDS treated with and without surfactant groups. In addition, surfactant was useful in moderate to severe RDS because no early complication such as air leak syndrome was found in this group.

Outcome of oral sildenafil therapy on persistent pulmonary hypertension of the newborn at Queen Sirikit National Institute of Child Health.

BACKGROUND: Persistent pulmonary hypertension of the newborn (PPHN) is a common problem in the neonates with a high mortality rate. The prevalence ranges from 0.38-0.99 per 1,000 live births at Queen Sirikit National Institute of Child Health. The survival rate has improved after the advent of high-frequency ventilation and inhaled nitric oxide. However, inhaled nitric oxide is expensive and unavailable in most neonatal centers in Thailand. Sildenafil is a phosphodiesterase inhibitor type 5 that selectively reduces pulmonary vascular resistance and hence may play a role in the treatment of PPHN. OBJECTIVE: To evaluate effectiveness and short-term side effects of oral sildenafil for infants > 36 weeks gestational age who have PPHN. MATERIAL AND METHOD: The present study was conducted between January 2006 and December 2008 in the neonatal intensive care unit (NICU) at Queen Sirikit National Institute of Child Health. All infants > or = 36 weeks gestational age who were diagnosed as PPHN by echocardiogram and had an oxygenation index > or = 20 were included in the study. Oral sildenafil was given as per study protocol with a starting dose of 0.25-0.5 mg/kg/dose. Oxygenation index (OI), oxygen saturations (SpO2), alveolar arterial oxygen gradient (A-aDO2) and mean arterial blood pressure (MAP) were monitored serially. RESULTS: A total of 40 infants were diagnosed with PPHN during this period. Eleven infants were included in the present study. The initial median OI was 31.95 (24.25-48.25). All infants received standard therapy with mechanical ventilation, sedation and inotropic drugs. OI decreased 4.6% from base line after the first hour of starting oral sildenafil and progressively decreased by 13%, 27%, 37%, 41% and 90% at 2, 4, 6, 12 and 24 hours respectively. Oral sildenafil was discontinued in one infant. It was combined with inhaled iloprost in 2 infants due to systemic hypotension and with inhaled nitric oxide in one infant due to deterioration. One infant died during the present study. CONCLUSION: Oral sildenafil may be effective in improving oxygenation in some infants with persistent pulmonary hypertension of the newborn. Systemic hypotension was a cause for concern in the present study. Further studies are needed to assess the pharmacokinetics, efficacy and long-term side effects of this drug.

Growth and development of very low birth weight infants aged 18-24 months at Queen Sirikit National Institute of Child Health.

BACKGROUND: The number of very low birth weight (VLBW) births is increasing worldwide. Despite better care in recent years, they have a high incidence of delayed growth and development. There are no previous studies regarding the growth and development of these infants at Queen Sirikit National Institute of Child Health (QSNICH). OBJECTIVE: To study growth and developmental outcome of VLBW infants, aged 18-24 months who were discharged from QSNICH. MATERIAL AND METHOD: VLBW infants who were discharged from QSNICH during the year 2007 were recruited in the study. Patients with chromosomal abnormalities, major congenital anomalies, definite congenital infections and positive maternal anti-HIV tests were excluded. At the corrected age of 18-24 months, the parents were called upon to bring their infants for complete physical examination and developmental evaluation on 2 occasions, two months apart. RESULTS: There were 111 cases of VLBW infants who were discharged from QSNICH during the year 2007. Fifty-four patients were eligible for the present study. Thirty cases (55.56%) were contacted for the first examination. During this examination, there were 3 cases (10%) with low head circumference, 1 case (3.33%) with poor weight gain, 5 cases (16.67%) with visual defect, 1 case (3.33%) with moderately severe hearing loss, 1 case (3.33%) with cerebral palsy and 7 cases (23.33%) with delayed development. Twenty-one cases could be recalled for a second evaluation. Two of the 5 cases had delayed language development. There were no cases with hydrocephalous, blindness or profound hearing loss. CONCLUSION: VLBW infants at QSNICH had much better survival during recent years. Most of these survivors had normal growth and development. Those with delayed growth and development need aggressive intervention and long-term follow-up for enhancement of quality of their lives.

Comparison outcomes of surfactant therapy in respiratory distress syndrome in two periods.

BACKGROUND: Exogenous surfactant replacement therapy has been a part of the routine care of preterm neonates with respiratory distress syndrome (RDS) since 1990s. In Thailand, the utilization of surfactant replacement therapy had been limited due to the high cost until the National Health Insurance Policy began in 2003 which covered the cost of surfactant. Nowadays surfactant replacement therapy is more frequently used at Queen Sirikit National Institute of Child Health, so the authors were interested in evaluating its use in RDS. OBJECTIVES: To compare the outcome and complications of surfactant replacement therapy in newborns who were diagnosed with moderate to severe RDS during two times period. STUDY DESIGN: Retrospective study. MATERIAL AND METHOD: The data of infants who were diagnosed as moderate to severe RDS and treated with surfactant at Queen Sirikit National Institute of Child Health between January 1st, 2003 and December 31th, 2005 were reviewed. The outcome of this study (Group II) was compared to the previous study conducted in 1999-2002 (Group I). The complications, mortality rate, association time of start surfactant and duration of ventilation were reviewed. RESULTS: The data of ninety-one moderate to severe RDS patients who received surfactant replacement therapy were reviewed. The mean birth weight and gestational age in this group were 1250 +/- 435.57 gm and 29.38 +/- 2.2 week less than in the first group 1,344 +/- 452.37gm and 29.69 +/- 2.61 week. The second group showed statistical differences in antepartum hemorrhage (4.4%) and pregnancy induced hypertension (PIH) (17.6%) while the first group had 33.3% ofantepartum hemorrhage and 3% of PIH. In neonatal conditions, there were statistical significant differences in anemia 28.6% in group II compared to 9% in group I and patent ductus arteriosus 67% in group II compared to 39.4% in group I. Surfactant was given earlier in life (4.75 +/- 2.76 hours) in the second group compared to the first group (7.21 +/- 4.92 hour) and the overall duration ofpatients on mechanical ventilation in Group II (6 days) was shorter than in Group I (16 days). This was especially more evident in patients who received surfactant within the first six hours of life. The immediate complication, pulmonary hemorrhage was found in more cases in Group I (33.3%) than in Group II (12.1%) but bronchopulmonary dysplasia (BPD) was found to be a late complication in more cases in Group II (46.1%) than in Group I (21.2%). The mean length of admission was longer in Group II (61.23 +/- 41.08 days) compared to Group I (38.5 +/- 23.48 days) and the mortality rate in Group II was 18.7% (17 cases) lower than Group I 33.3% (11 cases). CONCLUSION: Surfactant therapy in moderate to severe RDS can shorten the duration of ventilation and decrease the mortality rate, but has no effect in decreasing the incidence of chronic lung disease. Nevertheless the earlier the surfactant therapy is started, the higher the survival rate.

Prophylaxis of symptomatic patent ductus arteriosus with oral ibuprofen in very low birth weight infants.

BACKGROUND: Patent ductus arteriosus (PDA) is a common cause of mortality and morbidity among very low birth weight infants. Oral ibuprofen suspension has been shown to have the same efficacy and safety as intravenous indomethacin in the prevention and treatment of symptomatic PDA. With lower dosage, the prevalence of side effects may decrease without changes in efficacy. OBJECTIVE: To evaluate the efficacy and side effects of low dose ibuprofen suspension for prevention of symptomatic PDA in very low birth weight infants. PATIENTS AND METHOD: A prospective, double blind, randomized controlled trial was conducted on premature neonates with gestational ages between 28-32 weeks, birth weight 1500 grams or less, at the Neonatal Unit, Queen Sirikit National Institute of Child Health (QSNICH) during October 2005 to October 2006. Only infants who had PDA on echocardiogram were included in the study. Three doses of ibuprofen suspension or placebo were randomly given at the dosage of 10, 5, 5 mg/kg every 24 hours. Daily physical examination, serial laboratory evaluation and echocardiogram were used to evaluate symptomatic PDA, complications and side effects. RESULTS: Sixty-two infants were recruited in the study and randomly assigned into the study and control group. The gestational age and birthweight of the 2 groups were similar The prevalence of symptomatic PDA was less in the ibuprofen group than in placebo group (9.86% vs. 35.48%; p = 0.015). There were no differences in the prevalence of complications and adverse effects between the two groups. CONCLUSION: Prophylactic oral ibuprofen suspension at lower dosage results in less symptomatic PDA without significant side-effects.

Inhaled nitric oxide in newborns with severe hypoxic respiratory failure.

BACKGROUND: Respiratory failure in term and near term infants is often associated with persistent pulmonary hypertension of the newborn and contributes to hypoxemia in these infants. Inhaled nitric oxide (iNO) is currently used as a pulmonary vasodilator to improve oxygenation in neonates with severe respiratory failure. OBJECTIVE: To determine outcome of administration of iNO in severe hypoxic respiratory failure. MATERIAL AND METHOD: The present study was conducted from 1999 to 2004 in the neonatal intensive care unit (NICU) at Queen Sirikit National Institute of Child Health. Patients were selected from all infants > or = 34 weeks gestational age who required high frequency oscillatory ventilation (SLE 2000 HFO, SLE, UK) or conventional mechanical ventilation for hypoxemic respiratory failure caused by PPHN. Diagnosis was confirmed by 2-D echocardiogram visualization with right to left shunt through the foramen ovale or patent ductus arteriosus. Inhaled nitric oxide was given as standard therapy in patients who had two oxygenation indices > or = 20 at least 30 minutes apart after being on a mechanical ventilator. RESULTS: Fifty-five cases were enrolled and male to female ratio was 22.2 tol. The survival rate was 76.4 percent. Inhaled nitric oxide significantly improved oxygenation index, arterial alveolar oxygen tension ratio (a/A O2), and alveolar arterial oxygen gradient in survivors at one hour after treatment. The earliest improvement in oxygen saturation was within ten minutes. Meconium aspiration syndrome was the most common underlying cause of PPHN. No acute complication was found during nitric oxide administration. Chronic lung diseases, delayed development and severe hearing loss in long-term follow up were found in 10, 5, and 2 cases, respectively. CONCLUSION: Inhaled nitric oxide should be used early in severe hypoxic respiratory failure with persistent pulmonary hypertension of newborn and can improve survival rates without any major immediate side effects.

Outcome of maternal syphilis at Rajavithi Hospital on offsprings.

BACKGROUND: Syphilis remains an important sexually transmitted disease and continues to be an important problem in Thailand. Despite the clinical efficiency of penicillin in the treatment of pregnant patients with syphilis, infants with congenital syphilis are still encountered. Congenital syphilis poses significant challenges for the clinician because infants may be asymptomatic at birth or present with a highly variable clinical picture. OBJECTIVES: To evaluate the outcomes of neonates born to syphilitic mothers, the efficacy of antepartum treatment in the prevention of congenital syphilis and treatment for congenital syphilis after delivery. MATERIAL AND METHOD: The surveillance conducted from September 1st, 2002 to December 31st, 2003, involved 63 mothers who were diagnosed with syphilis and their offsprings at Rajavithi Hospital, Bangkok, Thailand. Sixty-four infants had complete physical examination, growth, development and laboratory evaluation at Queen Sirikit National Institute of Child Health at the time of delivery and at the ages of 1, 2, 4 and 6 months. RESULTS: There were 63 mothers and 64 infants recruited in the present study. Fifty-three mothers had prenatal care (84.13%). The VDRL was positive in the first prenatal care visit in 42 mothers (66.67%) and 11 mothers (17.46%) had seroconversion later on. Maternal treatment for syphilis included adequate penicillin 23 cases (36.51%), inadequate penicillin 5 cases (7.94%), erythromycin 9 cases (14.29%) and 26 mothers (41.27%) received no treatment at all. The mean maternal age, mean gestation age at treatment for syphilis and at delivery were 30.31 +/- 5.60 years, 32.75 +/- 6. 73 weeks and 38.60 +/- 1.57 weeks respectively. Failure rate in the adequate penicillin group was 8.7%. The mean birth weight of the 64 infants was 3034 +/- 495 grams, no syphilitic stillbirth occurred. Nine infants (14.06%) were identified with presumptive congenital syphilis. The manifestation include hepatomegaly (55.56%), desquamation of palms and soles (44.44%), radiological changes (33.33%) and abnormal cerebrospinal fluid (25%). The fluorescent treponemal antibody absorption immunoglobulin M (FTA-ABS IgM) tests of the infants were positive in 2 out of 9 cases (22.22%). The range of maternal and neonatal VDRL titer were between weakly reactive to 1.32 and nonreactive to 1:32 respectively. Fifty infants (78.13%) including 9 presumptive cases were followed-up, all had normal growth. Thirty-four infants (68%) who had re-evaluation for VDRL titers, were seronegative. CONCLUSION: Penicillin is the effective treatment of pregnant patients with syphilis and infants with congenital syphilis. The high risk of congenital syphilis correlates with untreated mothers and inadequate maternal syphilis treatment.

Medication errors at Queen Sirikit National Institute of Child Health.

BACKGROUND: In the past two years, medication errors have been recognized as having been unacceptably high among hospitalized patients. OBJECTIVE: To determine the incidence and type of medication errors, severity of events, patient outcomes and categories of drugs involved in the largest pediatric hospital in Thailand over a fifteen-month-period. PATIENTS AND METHOD: Retrospective review of in-patient medication errors documented in standard reporting forms from September 2001 to November 2002. Main outcome measure was the incidence of errors reported. RESULTS: Medication errors occurred in 1 per cent of admissions (322 errors of 32,105 admissions). The most common error type was prescription error (35.40%). The majority of errors were detected and prevented before the drugs were administered (76.71%). There was only one case of permanent brain damage; no deaths occurred in the study period. The most common group of drugs involved in medication errors was antibiotics and the most common route of administration was oral. CONCLUSION: Medication errors are not uncommon. There is a need to change the behaviors of recognizing and acknowledging clinical errors, including drug errors. Careful review of errors highlights the many opportunities to change how drug errors are addressed and to make them less likely.

Effect of cisapride on corrected QT interval in neonates.

OBJECTIVE: To evaluate the effect of cisapride on corrected QT (QTc) interval in neonates at the Queen Sirikit National Institute of Child Health. METHOD: A prospective study was performed to see the effects of cisapride on QTc interval in 20 neonates between 1st July 2001 and 31st January 2002. QTc interval was determined just before, 48 hours, 7 days and 15 days after the start of treatment with cisapride. QTc interval was calculated by averaging QT/square root(RR) values obtained from 5 consecutive beats in lead II of the EKG. Baseline electrolyte and calcium levels were drawn on all infants before treatment of cisapride. Drug dose ranged from 0.1-0.2 mg/kg every 6 to 8 hours. RESULTS: Twenty infants were enrolled in the survey but complete data was obtained on 18 infants only. QTc interval of > 0.45 seconds was not found in any neonate. There was no significant difference of QTc interval before and 48 hours, 7 days and 15 days after cisapride administration (p = 0.861). There were also no statistically significant effects of age at starting cisapride, weight, gestational age and dose on QTc interval (p = 0.581, 0.65, 0.8, and 0.497). There were no adverse effects such as diarrhea or jaundice during the study. CONCLUSION: Term and preterm infants using cisapride at the doses of 0.4-0.8 mg/kg/day did not develop QTc prolongation, arrhythmias or adverse effects. In the absence of risk factors, cisapride may be safe for use in neonates.