High-Dose Oral Ibuprofen in Treatment of Patent Ductus Arteriosus in Full-Term Neonates

Background:

Patent ductus arteriosus (PDA) is an important risk for heart failure due to left to right shunt in term neonates.

Objectives:

In this study, we evaluated the effect of high dose ibuprofen in closure of PDA in term neonates.

Patients and Methods:

We used double dose ibuprofen (20 mg/kg, 10 mg/kg, and 10 mg/kg) for 3 - 30 day old term neonates with PDA who were admitted in the neonatal wards of Shiraz University of Medical Sciences. The results of this study were compared to the data of the previous study in our center which used the low dose of ibuprofen (10 mg/kg, 5 mg/kg, and 5 mg/kg).

Results:

29 full term neonates received high-dose ibuprofen, in 18 neonates, PDA was closed after 4 days (62.1% versus 43.3% for the standard dose and 4.7% for the control group in the previous study) (P = 0.001). The results showed no significant correlation between the closure rate and gestational age, postnatal age, sex, and weight. In the 4^th day of treatment, size of the pulmonic end of ductus arteriosus decreased from 2.09 mm to 0.77 mm compared to 1.68 mm to 0.81 mm in the standard dose of oral ibuprofen and 2.1 mm to 1.4 mm in the control group (P = 0.046).

Conclusions:

This study indicated that high-dose oral ibuprofen was more effective in closing or decreasing the size of PDA.     

Extended interval dosing of gentamicin in premature neonates ≤ 28‐week gestation

Aim: To evaluate an extended interval dosing (EID) regimen of gentamicin in neonates ≤28‐week gestation. Methods: In 2008, an EID regimen for gentamicin was introduced for all neonates admitted to the NICU in Calgary. The dosing interval was based on a 22 h level after the first dose of 5mg/kg. We conducted an observational study in 33 infants ≤28‐week gestation on the EID regimen from the first day of life and compared gentamicin peak and trough levels with a historical control of 34 infants who received gentamicin in a dose of 2.5 mg/kg every 24 h (TID, traditional interval dosing). Results: In the EID group, based on the 22 h level, dosing interval was 36 h in 20 neonates and 48 h in 13 neonates. All neonates, except one, achieved therapeutic peak and trough levels. Compared to the TID group, the EID group had higher peak levels (median 9.8 μg/mL vs. 4.6 μg/mL, p < 0.001) with no difference in trough levels. With target peak levels of 5–12 μg/mL and trough levels of <2 μg/mL, a higher proportion of neonates in the TID group would need dose adjustment. Conclusion: In neonates ≤ 28‐week gestation, an EID regimen from day one of life, using a single level 22 h after the first dose for dosing interval, achieves therapeutic peak and trough levels and more optimum peak levels as compared to a TID regimen.     

Cord Blood Alkaline Phosphatase as an Indicator of Neonatal Jaundice

Background:

Management of hyperbilirubinemia remains a challenge for neonatal medicine because of the risk of neurological complications related to the toxicity of severe hyperbilirubinemia.

Objectives:

The purpose of this study was to examine the validity of cord blood alkaline phosphatase level for predicting neonatal hyperbilirubinemia.

Patients and Methods:

Between October and December 2013 a total of 102 healthy term infants born to healthy mothers were studied. Cord blood samples were collected for measurement of alkaline Phosphatase levels immediately after birth. Neonates were followed-up for the emergence of jaundice. Newborns with clinical jaundice were recalled and serum bilirubin levels measured. Appropriate treatment based on serum bilirubin level was performed. Alkaline phosphatase levels between the non-jaundiced and jaundiced treated neonates were compared.

Results:

The incidence of severe jaundice that required treatment among followed-up neonates was 9.8%. The mean alkaline phosphatase level was 309.09 ± 82.51 IU/L in the non-jaundiced group and 367.80 ± 73.82 IU/L in the severely jaundiced group (P = 0.040). The cutoff value of 314 IU/L was associated with sensitivity 80% and specificity 63% for predicting neonatal hyperbilirubinemia requiring treatment.

Conclusions:

The cord blood alkaline phosphatase level can be used as a predictor of severe neonatal jaundice.     

Starting subcutaneous insulin doses in a paediatric population with newly diagnosed type 1 diabetes

BACKGROUND:

Starting subcutaneous insulin doses in children with newly diagnosed type 1 diabetes vary widely from 0.2 units/kg/day to 0.8 units/kg/day.

AIM:

To determine whether there are correlations between starting insulin dose and diabetes-related outcomes.

METHODS:

By reviewing the charts of children newly diagnosed with type 1 diabetes, the prevalence of hypoglycemia in the first 48 h was compared between those who received low (0.5 units/kg/day or less) and those who received high (greater than 0.5 units/kg/day) starting insulin doses.

RESULTS:

Forty-two children were initially prescribed a low dose of insulin, and 55 children were given a high dose. Approximately one-third of children (36.4%) younger than six years of age who received a high starting dose of insulin had mild hypoglycemia within 48 h of subcutaneous insulin initiation, compared with 16.0% of children six to 10 years of age and 5.3% of children older than 10 years of age.

CONCLUSIONS:

Hypoglycemia was not more frequent among children given high-insulin starting doses. However, children younger than six years of age remained at increased risk for hypoglycemia.     

Gentamicin in neonates at risk for sepsis – peak serum concentrations are not necessary

BACKGROUND:

Serum gentamicin concentrations (GSCs) are frequently obtained before and after gentamicin administration to newborns with, or at high risk for, sepsis.

OBJECTIVE:

To determine whether performing a peak GSC assay when the trough GSC is within the guidelines for care would add clinically relevant information for health care workers.

METHODS:

A retrospective review of the IWK Health Centre (Halifax, Nova Scotia) laboratory database for peak and trough GSC for infants <28 days after birth was performed.

RESULTS:

Of 5253 paired samples of trough and peak GSCs, 3001 (57%) had trough GSCs ≤2 μg/mL. Of these, only nine (0.3%) had a peak GSC >10 μg/mL.

CONCLUSIONS:

Performing a peak GSC measurement does not provide further clinically important data and increases patient morbidity and hospital costs.     

Eradication of Helicobacter pylori in Children by Triple Therapy Regimens of Amoxicillin,Omeprazole, and Clarithromycin or Azithromycin

Background and Objectives:

The present study aimed to evaluate the effect of classical and azithromycin-containing triple therapy eradication regimen against H. Pylori in children, and to determine the level of patients’ tolerance.

Patients and Methods:

This single clinical trial was performed in 2014 on 2 to 15 years old children. All children, in whom H. Pylori infection was confirmed through multiple biopsies of the stomach and required treatment, were enrolled in the study. H. Pylori-positive patients were treated alternately with two different drug regimens; Group OCA received clarithromycin 7.5 mg/kg/day every 12 hours for 10 days, amoxicillin 50 mg/kg/day every 12 hours for 10 days, and omeprazole 1 mg/kg/day every 12 hours for two weeks, and Group OAA received azithromycin 10 mg/kg/day once a day (before meal) for 6 days along with amoxicillin and omeprazole. Four to six weeks after completion of treatment, patients’ stool was tested for H. Pylori through the monoclonal method using the Helicobacter antigen quick kit.

Results:

There were no significant differences between the two groups regarding gender and age of patients. Based on ITT analysis, the therapeutic response in the OAA and OCA groups were 56.2% and 62.5%, respectively (P = 0.40). Drug adverse effects were 15.6% in the OCA and 3.1% in the OAA group (P = 0.19).

Conclusions:

The therapeutic response was seen in more than half of the patients treated with triple therapy of H. Pylori eradication regimen including azithromycin or clarithromycin, and there was no significant difference between the two treatment groups.     

Pre-Discharge Screening Trans-Cutaneous Bilirubinometry in Healthy Newborns in Mahdieh Hospital,Tehran

Background:

Incidence of jaundice is high in newborn infants. Since well appearing newborns are rapidly and routinely discharged from hospital, performing an inexpensive noninvasive pre-discharge screening test for evaluation of jaundice seems to be necessary.

Objectives:

This study was conducted to compare the accuracy of cutaneous v/s serum bilirubin measurements in this regard.

Patients and Methods:

This was a prospective cross sectional study conducted in Mahdieh hospital, Tehran. 613 neonates weighing ≥ 1,800 g with gestational age of ≥ 35 weeks were enrolled. A pre discharge transcutaneous bilirubin test (TcB) was performed in all. Serum samples were taken from neonates with TcB ≥ 5 mg/dL in first and > 8 mg/dL in second 24 hours. Decision for treatment or recheck of bilirubin level after discharge was made based on serum bilirubin results.

Results:

Based on the study protocol, among 613 studied neonates, 491 (80%) revealed high TcB, of them 240 (49%) cases showed TBC ≥ 5 mg/dL in first and 251 (51 %) in second pre-discharge 24 hours. TcB ranged 3.3 - 17.1, mean TcB in first 24 hours was 6.9 ± 1 .7 (mode 6) and in second 24 hours 9.1 ± 2.1 (mode 10). Of 491 neonates with high TcB, capillary serum sample was taken as the second step and 398 neonates revealed high total serum bilirubin (TsB) with the same protocol for TcB. 108 (27.1%) neonates showed TsB ≥ 5 mg/dL in first and 290 (72.9%) in second 24 hours. According to the study results TcB has a 81% positive predictive value (PPV) in diagnosis of hyperbilirubinemia. Correlation coefficient of TcB and TsB in highest rate is equal to 72% (P value < 0.001).

Conclusions:

TcB is an inexpensive, noninvasive and precise pre-discharge screening test for evaluation of hyperbilirubinemia, with a high PPV. It is highly recommended to be performed routinely due to high incidence of hyperbilirubinemia in neonates.     

Safety and Efficacy of Intravenous Colistin in Neonates With Culture Proven Sepsis

Background:

Although it is well described among adults, intravenous colistin use and its associated toxicities in newborns are poorly understood.

Objectives:

We present our experience of efficacy and safety of intravenous colistin in the treatment of sepsis in term and preterm neonates.

Patients and Methods:

The records of neonates who received colistin between January 2013 and February 2014 were retrospectively reviewed. All neonates with culture proven nosocomial infections due to multidrug resistant organisms and treated continuously with colistin for more than 72 hours were included in the study.

Results:

Patients were evaluated for clinical and microbiological response to the drug and its and side effects. Twelve newborn infants with mean 31.8 ± 3.5 weeks gestational age and median 1482 (810 - 3200) gram birth weight were included. 11/12 (91.7%) patients showed microbiological clearance with intravenous colistin. One patient who had recurrent cerebrospinal fluid positive culture was treated with intraventricular colistin. The major side effects observed was hyponatremia and hypokalemia in 2 (16.6%) patients, all infants required magnesium supplementation.

Conclusions:

Intravenous colistin administration appears to be safe and efficacious for multidrug-resistant gram-negative infections in neonates, including preterm infants. However, we believe that large prospective controlled studies are needed to confirm its efficacy and safety in neonates.     

Prednisolone versus dexamethasone in croup: a randomised equivalence trial

Background

Croup remains a common respiratory problem presenting to emergency departments. A single oral treatment of oral dexamethasone results in improved outcome. Prednisolone has similar pharmacokinetic properties and has a significant advantage in that it is commercially available in liquid preparations.

Objective

To ascertain whether a single oral dose of prednisolone was equivalent to a single oral dose of dexamethasone (matched for potency) in children with mild to moderate croup.

Design

A double blind, randomised, controlled equivalence trial

Setting

Tertiary paediatric emergency department.

Patients

133 children aged 3 to 142 months presenting with mild to moderate croup.

Interventions

Children received either a single oral dose of dexamethasone 0.15 mg/kg or single oral dose of prednisolone 1 mg/kg.

Outcome

The main outcome measure was unscheduled re‐presentation to medical care as determined by telephone follow up at 7 to 10 days. Croup score, adrenaline (epinephrine) use, time spent in the emergency department, and duration of croup and viral symptoms were secondary outcome measures.

Results

Children treated with prednisolone were more likely to re‐present: 19 of 65 children (29%) reattended medical care compared with 5 of 68 (7%) from the dexamethasone group. The confidence intervals around this 22% difference in outcome were 8% to 35%, outside the 0% to 7.5% range of equivalence. There were no significant differences in other outcome measures.

Conclusion

A single oral dose of prednisolone is less effective than a single oral dose of dexamethasone in reducing unscheduled re‐presentation to medical care in children with mild to moderate croup.     

Feeding problems with the first feed in neonates with meconium-stained amniotic fluid

OBJECTIVE:

To compare the incidence of feeding problems at the first feed between neonates born with meconium-stained amniotic fluid (MSAF) and those born without MSAF.

DESIGN:

A prospective observational study conducted over a one-year period.

SETTING:

A level 2 neonatal unit.

POPULATION STUDIED:

A total of 2828 neonates were studied, including 275 neonates with MSAF. All neonates were born after more than 34 weeks of gestation, and had no birth asphyxia, hemodynamic, respiratory distress or major congenital anomalies. The neonates were offered a feed within 1 h of birth, and the incidence of early feeding problems (ie, retching, vomiting, slow feeding or poor suck) was studied.

RESULTS:

Feeding problems at the first feed developed in 55 infants (13 of 275 with MSAF and 42 of 2533 without MSAF). Feeding problems were more common in infants with MSAF (P=0.001, relative risk=2.8, 95% CI 1.45 to 5.63), regardless of the type of MSAF (thin or thick). Although fetal distress was more frequent in the MSAF group, there were no differences in the 1 and 5 min Apgar scores whether meconium was present. Maternal sedation was not found to be a contributing factor. The mechanical and chemical actions of meconium inside the stomach requires further study.

CONCLUSION:

Feeding problems at the first feed are 2.8 times more frequent in neonates born with MSAF, regardless of the consistency of the amniotic fluid. Mothers of such infants need to be informed and supported during feeding to minimize discouragement. The demands on the nursing staff must be anticipated accordingly.     

Two hour blood glucose levels in at-risk babies: An audit of Canadian guidelines

BACKGROUND:

The Canadian guidelines recommend blood glucose (BG) screening starting at 2 h of age in asymptomatic ‘at-risk’ babies (including small-for-gestational-age [SGA] and large-for-gestational-age [LGA] infants), with intervention cut-offs of 1.8 mmol/L and 2.6 mmol/L. The present study reviews and audits this practice in full-term newborn populations.

METHODS:

A literature review meta-analyzed BG values in appropriate-for-gestational age (AGA) term newborns to establish normal 1 h, 2 h and 3 h values. A clinical review audited screening of ‘at-risk’ SGA and LGA term newborns, evaluating both clinical burden and validity.

RESULTS:

The review included six studies, although none clearly defined the plasma glucose standard. The pooled mean (plasma) BG level in AGA babies 2 h of age was 3.35 mmol/L (SD=0.77), significantly higher than 1 h levels (3.01 mmol/L, SD=0.96). In the audit, 78 SGA and 142 LGA babies each had an average of 6.0 and 4.7 BG tests, respectively. The mean 2 h BG levels for SGA (3.42 mmol/L, SD=1.02) and LGA (3.31 mmol/L, SD=0.66) babies did not differ significantly from the AGA pooled mean. Receiver operating characteristic curves showed that 2 h BG levels in LGA and SGA babies predicted later hypoglycemia (defined as a BG level lower than 2.6 mmol/L), but sensitivities and specificities were poor.

CONCLUSIONS:

Published 2 h BG levels for AGA babies are higher than 1 h values and are similar to audited 2 h levels in SGA and LGA babies. Clinically, 2 h levels are predictive of later hypoglycemia but may require repeat BG testing. Audit is an important tool to validate national guidelines, to minimize their burden and to maximize their utility.     

Congenital Hypothyroidism Screening Program in Iran; a Systematic Review and Metaanalysis

Objective:

Unrecognized congenital hypothyroidism (CH) leads to mental retardation. Newborn screening and thyroid therapy started within 2 weeks of age can normalize cognitive development. In this systematic review, the local results of the national CH screening program in different provinces in Iran are reviewed and evaluated.

Methods:

Literature on the CH screening, the national databases including SID, Medlib, Iran Medex, Magiran as well as international databases including PubMed/Medline, ISI Web of Knowledge and web of science, EMBASE, SCOPUS and Google Scholar. Appraisal was guided by a checklist assessing clarity of aims and research questions. The 95% confidence intervals were calculated by I-square models. Meta regression was introduced to explore the heterogeneity between studies.

Findings:

We identified 25 samples including 1425124 neonates in our country. Data were Meta analyzed using random-effects models, and we found a TSH levels of 19633 babies in the first sampling were greater than the cut-off level (TSH ≥5mIU/L). The pooled recall rate was 0.014 (95 % CI: 0.013 – 0.015). According to Meta analysis the overall incidence of CH was 2/1000 (95% CI: .002 – .002). The incidence of CH did not appear to be increasing over time (P=0.08).

Conclusion:

Considering TSH ≥5mIU/L as a cut-off point for recalling neonates and low positive predictive value (14%) of this point shows that more investigation and research is needed for establishing accurate level of TSH as a criterion for recalling patients.     

3-Day versus 5-Day Course of Intravenous Antibiotics for Suspected Early Onset Neonatal Sepsis: A Randomized Controlled Trial

Objective:

The objective of this randomized controlled trial was to compare the treatment failure of suspected early onset neonatal sepsis with either 3-day or 5-day course of empirical antibiotic therapy.

Methods:

Infants with birth weight over 1500 g and/or gestational age over 34 weeks within 7 days postnatal age with clinical symptoms of neonatal sepsis received empirical antibiotics (Ampicillin + Amikacin) in two neonatal intensive care units. After 72 hours if the result of blood culture was negative and symptoms resolved they were randomly allocated to 3-day or 5-day groups. The main outcome was treatment failure which was defined as reappearance of symptoms of sepsis within two weeks after discontinuation of antibiotics. Infants with congenital anomalies, localized infections, asphyxia, those undergoing surgery or when serum C-reactive protein levels remained abnormal despite treatment, were not included. Randomization was accomplished with simple randomization procedure.

Findings:

Sixty patients were randomized in a 1:1 ratio to either group. Baseline characteristics were similar between two groups. The follow-up period was 2 weeks with no lost to follow-up. One infant in 3-day group had treatment failure compared with no treatment failure in 5-day group (P=0.5). No serious harm was observed due to our empirical antibiotic regimen.

Conclusion:

The results of this study indicated no evidence that treatment failure differs between 3-day and 5-day course antibiotic therapy for suspected early onset uncomplicated neonatal sepsis in late preterm and term newborns.     

Usefulness of Serum Brain Natriuretic Peptide Level for Screening Hemodynamically Significant Patent Ductus Arteriosus in Preterm Neonates

Objective:

We studied usefulness of serum B-type natriuretic peptide level as a screening tool for detecting hemodynamically significant patent ductus arteriosus in the preterm neonates.

Methods:

Sixty admitted preterm neonates with gestational age ≤34 weeks, birth weight ≤2500 gr, and age of >3 days have been enrolled in this study. We measured serum B-type natriuretic peptide levels at the beginning and after completion of drug therapy for ductus occlusion.

Findings:

Mean±SD gestational age and weight was 31±1.9 weeks and 1680±350 gr, respectively. The peptide levels in the neonates with significant duct (n=13) were significantly higher than in those with insignificant duct (n=17) or no duct (n=30) (1667±821 pg/ml versus 667±666 and 309±171, respectively). The peptide level dropped significantly after ibuprofen administration in the neonates with significant PDA (n=13), (1667±1165 pg/ml to 429±386).

Conclusion:

At a cutoff point of 450 pg/ml, B-type natriuretic peptide level had a sensitivity of 92% and specificity of 87%, the negative predictive value of 98.5%, the positive likelihood ratio of 6.92 and the negative likelihood ratio of 0.089 for detecting significant patent duct. Levels below this can eliminate the need for echocardiography.     

Effects of exclusive formula or breast milk feeding on oxidative stress in healthy preterm infants

Background

Compared to formula, breast milk is considered to have superior antioxidant properties and consequently may reduce the occurrence of a number of diseases of prematurity associated with oxidative stress.

Aims

To test whether the antioxidant properties of breast milk in healthy premature infants are different to those of formula milk by comparing vitamin E levels in milk and determining the excretion of malondialdehyde (MDA) in urine.

Methods

Vitamin E was measured in the breast milk of 20 mothers who had given birth prematurely. Urinary MDA was measured in 10 exclusively breast milk fed and 10 exclusively formula fed healthy preterm infants receiving no vitamin supplements. MDA was measured after derivatisation with 2,4‐dinitrophenylhydrazine and consecutive HPLC with UV detection.

Results

Urinary MDA concentrations were consistently very low (0.074±0.033 μM/mM Cr and 0.078±0.026 μM/mM Cr in breast and formula fed infants respectively) and not significantly different between healthy breast milk and formula fed infants. Both breast and formula milk contained satisfactory levels (0.3–3.0 mg/100 ml) of vitamin E.

Conclusion

Antioxidant properties of both breast milk and formulae are sufficient to prevent significant lipid peroxidation in healthy premature infants.     

Short Term Outcome of Neonates Born With Abnormal Umbilical Cord Arterial Blood Gases

Background:

Umbilical arterial blood gas (UABG) analysis is more objective than other methods for predicting neonatal outcome. Acidemic neonates may be at risk for unfavorable outcome after birth, but all neonates with abnormal arterial blood gas (ABG) analysis do not always have poor outcome.

Objectives:

This study was carried out to determine the short term outcome of the neonates born with an abnormal ABG.

Patients and Methods:

In a cohort prospective study 120 high risk mother-neonate pairs were enrolled and UABG was taken immediately after birth. All neonates with an umbilical cord pH less than 7.2 were considered as case group and more than 7.2 as controls. Outcomes like need to resuscitation, admission to newborn services and/or NICU), seizure occurrence, hypoxic ischemic encephalopathy (HIE), delayed initiation of oral feeding and length of hospital stay were recorded and compared between the two groups. P value less than 0.05 was considered as being significant.

Results:

Comparison of short term outcomes between normal and abnormal ABG groups were as the fallowing: need for advanced resuscitation 4 vs. 0 (P = 0.001), NICU admission 16 vs. 4 (P = 0.001), convulsion 2 vs. 0 (P = 0.496), HIE 17 vs. 4 (P = 0.002), delay to start oral feeding 16 vs. 4 (P = 0.001), mean hospital stay 4 vs. 3 days (P = 0.001). None of the neonates died in study groups.

Conclusions:

An umbilical cord PH less than 7.2 immediately after birth can be used as a prognostic factor for unfavorable short term outcome in newborns.     

Blood lead and cadmium levels in children: A study conducted in Changchun,Jilin Province,China

OBJECTIVES:

Exposure to lead and cadmium in developing countries is considered to be a public health emergency. The present study was designed to investigate children’s exposure to lead and cadmium in Changchun, China.

METHODS:

A total of 1619 blood samples were collected at random from 1426 children between one and 14 years of age, and 204 adults from Changchun, China. Blood lead and cadmium levels were determined using atomic absorption spectrophotometry.

RESULTS:

The average blood lead level in children was 60.29 μg/L, with boys exhibiting higher blood lead levels than girls. The average blood cadmium level in children was 1.26 μg/L, and differences were not observed between boys and girls.

CONCLUSIONS:

Children from Changchun exhibited relatively low blood lead and cadmium levels compared with children from other cities, and higher lead and lower cadmium levels than adults. This may be related to leaded gasoline environmental pollution and children’s hand-to-mouth activities.     

A Randomized Clinical Trial of Insulin Glargine and Aspart,Compared to NPH and Regular Insulin in Children with Type 1 Diabetes Mellitus

Objective

Appropriate treatment of patients with Type 1 diabetes mellitus (T1DM) is necessary to avoid further complications. This study was performed to compare the efficacy of insulin Glargine and Aspart with NPH insulin and regular insulin regimen in a group of children with T1DM.

Methods

Forty patients with T1DM were enrolled in this study. During run-in, all subjects were treated with conventional therapy consisting of twice-daily NPH and thrice-daily regular. Following randomization, 20 subjects received Glargine and Aspart and 20 subjects received NPH and Regular insulin.

Findings

Mean HbA1c was 8.8% and 8.6% at first and 8.4% and 8.2% at the end of study for subjects randomized initially to Glargine and Aspart and for those randomized to NPH and Regular, respectively (P>0.05). Mean fasting blood glucose (FBS) of the subjects randomized initially to Glargine and Aspart was 217±101 mg/dL, with no significant difference to 196±75 mg/dL for those randomized to NPH and Regular (P=0.48). This was also true at the end of the study. The difference in total cholesterol and triglyceride between the two groups in the beginning of study and at the end did not show any significance.

Conclusion

The current study showed no significant difference in glycemic control [Glycated hemoglobin (HbA1c) and FBS] and lipid profile (total cholesterol and triglyceride) between two regimes.     

Comparative efficacy and safety of caffeine and aminophylline for apnea of prematurity in preterm (≤34 weeks) neonates: A randomized controlled trial

Objective

To compare the efficacy and safety of standard doses of Caffeine and Aminophylline for Apnea of prematurity.

Study design

Randomized controlled trial.

Setting

Tertiary-care referral centre and a teaching institution in Southern India. Trial was conducted from February 2012 to January 2015.

Participants

240 preterm (≤34 wk) neonates with apnea of prematurity.

Interventions

Neonates randomized into two groups: Caffeine group received loading dose of caffeine citrate (20 mg/kg) followed by 5 mg/kg/day maintenance dose every 24 hour. Aminophylline group received loading dose of Aminophylline–5 mg/kg and maintenance dose of 1.5 mg/kg 8-hourly.

Outcome measures

Difference in apneic spells, associated respiratory morbidity, and acute adverse events were assessed. Association of efficacy with therapeutic drug levels was also evaluated.

Results

Infants on aminophylline experienced less apnea spells in 4-7 days of therapy (P=0.03). Mean apnea rate and isolated desaturations were similar in 1-3, 4-7 and 8-14 days of therapy. No difference was noted in duration of Neonatal Intensive Care Unit stay and hospital stay. Mean heart rate was significantly high in Aminophylline group (P<0.001). Risk of developing tachycardia was less (RR 0.30; 95% CI range 0.15 to 0.60; P<0.001) in Caffeine- over Aminophylline-treated infants.

Conclusion

Aminophylline is as effective as caffeine for prevention of apneic spells in preterm neonates; however, dosage optimization needs to be done to reduce toxicity.

     

Does a paediatric after-hours clinic use evidence-based guidelines in the management of acute otitis media?

OBJECTIVE:

To determine whether a paediatric after-hours clinic uses evidence-based management in the treatment of acute otitis media, and compare this management with that provided in a paediatric emergency department and a general hospital emergency department.

METHODS:

A retrospective chart review of 573 patients (aged six months to five years) with a discharge diagnosis of acute otitis media was conducted in three after-hours settings: a paediatric after-hours clinic, a tertiary paediatric hospital emergency department and a secondary general hospital emergency department. The patients’ age, weight, sex and allergy to antibiotics were recorded as baseline characteristics. The physicians’ antibiotic choice, dose and duration, and the use of investigations were recorded as outcome variables.

RESULTS:

Amoxicillin was prescribed to 68% of patients at both the paediatric after-hours clinic and the paediatric hospital emergency department, compared with 53% of patients at the general hospital emergency department (P<0.01). The mean dose of amoxicillin prescribed at the paediatric after-hours clinic and the paediatric hospital emergency department were similar (43.4±9.7 mg/kg per day and 42.4±14.3 mg/kg per day, respectively) and higher than that prescribed at the general hospital emergency department (38.6±8.8 mg/kg per day, P<0.01). The paediatric after-hours clinic used investigations less often than did emergency departments (0.5% of cases compared with 9% and 20%, P<0.01).

CONCLUSION:

The paediatric after-hours clinic provided a high level of adherence to a clinical practice guideline and had a low utilization of resource intensive investigations.