Omer Erdeve

Surfactant administration via thin catheter during spontaneous breathing: randomized controlled trial.

BACKGROUND: The primary aim of this randomized study was to describe the feasibility of early administration of surfactant via a thin catheter during spontaneous breathing (Take Care) and compare early mechanical ventilation (MV) requirement with the InSurE (Intubate, Surfactant, Extubate) procedure. METHODS: Preterm infants, who were <32 weeks and stabilized with nasal continuous positive airway pressure (nCPAP) in the delivery room, were randomized to receive early surfactant treatment either by the Take Care or InSurE technique. Tracheal instillation of 100 mg/kg poractant α via 5-F catheter during spontaneous breathing under nCPAP was performed in the intervention group. In the InSurE procedure, infants were intubated, received positive pressure ventilation for 30 seconds after surfactant instillation, and placed on nCPAP immediately. RESULTS: One hundred infants in each group were analyzed. The MV requirement in the first 72 hours of life was significantly lower in the Take Care group when compared with the InSurE group (30% vs 45%, P = .02, odds ratio –0.52, 95% confidence interval –0.94 to –0.29). Mean duration of both nCPAP and MV were significantly shorter in the Take Care group (P values .006 and .002, respectively). Bronchopulmonary dysplasia rate was significantly lower among the infants treated with the Take Care technique (relative risk –0.27, 95% confidence interval –0.1 to –0.72) CONCLUSIONS: The Take Care technique is feasible for the treatment of respiratory distress syndrome in infants with very low birth weight. It significantly reduces both the need and duration of MV, and thus the bronchopulmonary dysplasia rate in preterm infants.

Efficacy and Safety of Oral Versus Intravenous Ibuprofen in Very Low Birth Weight Preterm Infants with Patent Ductus Arteriosus

OBJECTIVE To compare oral ibuprofen with intravenous ibuprofen for closure of patent ductus arteriosus in very low birth weight (VLBW) preterm infants. STUDY DESIGN In a prospective, randomized study, 102 VLBW preterm infants with patent ductus arteriosus received either intravenous or oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 hours. The success rate and evaluation of renal tolerance using cystatin-C were the major outcomes. RESULTS Patent ductus arteriosus closure rate was significantly higher with oral ibuprofen (84.6% versus 62%) after the first course of the treatment (P = .011). The cystatin-C level increased significantly after treatment in the oral group (P = .001), but did not change with intravenous ibuprofen (P = .4). CONCLUSIONS Oral ibuprofen is more effective than intravenous ibuprofen for ductal closure in VLBW infants. The increase in the cystatin-C level with oral treatment suggests that patients with borderline renal function should be evaluated and followed closely.

Intravenous Paracetamol Treatment in the Management of Patent Ductus Arteriosus in Extremely Low Birth Weight Infants

Background: Treatment options for the closure of a hemodynamically significant patent ductus arteriosus (hsPDA) include medical therapy such as ibuprofen and indomethacin and surgical ligation. Objective: To evaluate the efficacy of intravenous paracetamol in preterm infants with hsPDA whose feeding was contraindicated or had feeding intolerance. Methods: Preterm infants with hsPDA were started on intravenous paracetamol treatment with parental consent. Paracetamol was administered at a dose of 60 mg/kg/day, in four divided doses, for a period of 3 days. In the absence of closure of hsPDA, treatment was extended up to 6 days, after which echocardiographic examination was performed. Results: A total of 10 preterm infants were included in the study with a median gestational age of 274/7 weeks (minimum–maximum: 24–29) and a median birth weight of 775 g (590–990). The first dose of intravenous paracetamol was given after a median of 6 days (2–15). On echocardiographic examination, median internal ductal diameter was 2 mm (1.5–3), with a median left atrium-to-aortic root ratio of 1.95 (1.6–2.2). Intravenous paracetamol resulted in successful closure of hsPDA in all patients. Conclusions: This study is the first case series in the literature which used intravenous paracetamol treatment for hsPDA. We believe that intravenous paracetamol could be used as an alternative drug for infants. Further prospective randomized-controlled trials are needed to evaluate the efficacy of intravenous paracetamol for the closure of hsPDA.

Oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosus in preterm infants: a randomized controlled trial.

OBJECTIVE To compare the efficacy and safety of oral paracetamol and oral ibuprofen for the pharmacological closure of patent ductus arteriosus (PDA) in preterm infants. STUDY DESIGN This prospective, randomized, controlled study enrolled 90 preterm infants with gestational age ≤ 30 weeks, birthweight ≤ 1250 g, and postnatal age 48 to 96 hours who had echocardiographically confirmed significant PDA. Each enrolled patient received either oral paracetamol (15 mg/kg every 6 hours for 3 days) or oral ibuprofen (initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 hours). RESULTS Spontaneous closure rate for the entire study group was 54%. After the first course of treatment, the PDA closed in 31 (77.5%) of the patients assigned to the oral ibuprofen group vs 29 (72.5%) of those enrolled in the oral paracetamol group (P = .6). The reopening rate was higher in the paracetamol group than in the ibuprofen group, but the reopening rates were not statistically different (24.1% [7 of 29] vs 16.1% [5 of 31]; P = .43). The cumulative closure rates after the second course of drugs were high in both groups. Only 2 patient (2.5%) in the paracetamol group and 3 patients (5%) in the ibuprofen group required surgical ligation. CONCLUSION This randomized, controlled clinical study compared oral paracetamol with ibuprofen in preterm infants and demonstrated that paracetamol may be a medical alternative in the management of PDA.

The probiotic effect of Saccharomyces boulardii in a pediatric age group.

The aim of this study was to determine the efficacy of S. boulardii in diarrhea associated with commonly used antibiotics such as sulbactam-ampicillin (SAM) and azithromycin (AZT). Four hundred and sixty-six patients were assigned to four different groups as follows: group 1:117 patients receiving SAM alone; group 2:117 patients receiving SAM and S. boulardii, group 3:105 patients receiving AZT alone; group 4:127 patients receiving AZT and S. boulardii. Antibiotic-associated diarrhea was seen in 42 of the 222 patients (18.9 per cent) receiving an antibiotic without the probiotic, and in 14 of the 244 patients (5.7 per cent) who received both the probiotic and the antibiotic (p < 0.05). In the group receiving SAM where S. boulardii use was found to be significant, the use of S. boulardii decreased the diarrhea rate from 32.3 to 11.4 per cent in the 1-5 years age group (p < 0.05). This is a pioneering study investigating combined antibiotic and probiotic use in pediatric diarrhea patients.

Lactobacillus Reuteri for the prevention of necrotising enterocolitis in very low birthweight infants: a randomised controlled trial

Objective To evaluate the effect of oral Lactobacillus reuteri (L reuteri) first on the incidence and severity of Necrotising enterocolitis (NEC) and second on sepsis. Design Prospective randomised controlled study. Setting Tertiary neonatal intensive care unit. Patients and interventions Preterm infants with a gestational age of ≤32 weeks and a birth weight of ≤1500 g were included (n=400). Infants in the first group were given 100 million CFU/day (5 drops) of lyophilised L reuteri (DSM 17938) mixed in breast milk or formula, starting from first feeding until discharge. Participants in the control group were given a placebo. Main outcome measures To determine and compare the frequency of NEC and/or death after 7 days, frequency of proven sepsis, rates of feeding intolerance and duration of hospital stay. Results There was no statistically significant difference between groups in terms of frequency of NEC stage ≥2 (4% vs 5%; p=0.63) or overall NEC or mortality rates (10% vs 13.5%; p=0.27). Frequency of proven sepsis was significantly lower in the probiotic group compared to the control group (6.5% vs 12.5%; p=0.041). A significant difference was also observed with regard to rates of feeding intolerance (28% vs 39.5%; p=0.015) and duration of hospital stay (38 (10–131) vs 46 (10–180) days; p=0.022). Conclusions Our results show that oral L reuteri does not seem to affect the overall rates of NEC and/or death in preterm infants followed up in the neonatal intensive care unit, and significant reductions were observed in the frequency of proven sepsis, rates of feeding intolerance and duration of hospital stay. Trial registration number NCT01531179.

A different first-choice drug in the medical management of patent ductus arteriosus: oral paracetamol

Abstract Background and objectives: Patent ductus arteriosus (PDA) is a significant cause of morbidity and mortality in preterm infants. This case series was conducted to investigate the usefulness of paracetamol as a first choice for the treatment of PDA in preterm infants. Subjects and methods: Preterm infants were prospectively enrolled. Treatment with oral paracetamol was started at a dose of 15 mg/kg every 6 h for 3 d, with echocardiographic evaluation performed at the end of the treatment and 2 d after the treatment. Serum paracetamol levels were also evaluated for 24 h after the first dose to ensure the absorption and reaching the therapeutic level. Results: A total of six preterm infants were prospectively enrolled. Five infants with PDA were successfully treated with oral paracetamol. Only one patient did not respond to paracetamol treatment whereas another one received a second cure due to reopening of the ductus. Conclusion: Paracetamol may be a useful treatment option for the primer treatment of PDA in preterm infants. If paracetamol is shown to be effective in a large series, because of low risk of side effects, low cost and preparation is available in enteral form, it may be an advantageous alternative at PDA treatment.

What are the cut‐off levels for IL‐6 and CRP in neonatal sepsis?

Neonatal sepsis, characterized by systemic signs of infection in the first month of life, remains an important clinical syndrome. Despite advances in neonatology, it has high rates of mortality and morbidity. The combine or alone usage of interleukin‐6 (IL‐6) and C‐reactive protein (CRP) has recently been proven to be useful in the early diagnosis of sepsis in newborns. The study included 282 patients; there were 232 in Group I (170 proven and 62 clinical sepsis) and 50 in Group II (control group). The optimum cut‐off value in the diagnosis of neonatal sepsis was found to be 24.65 pg/ml for IL‐6 and 4.82 mg/l for CRP. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of this IL‐6 cut‐off for neonatal sepsis were 72, 84, 95, and 42%, respectively. Sensitivity, specificity, PPV, and NPV of the CRP cut‐off for neonatal sepsis were 67, 97, 99, and 39%, respectively. The combination of IL‐6 (>24.65 pg/ml) and CRP (>4.82 mg/l) in the diagnosis of neonatal sepsis gave sensitivity, specificity, PPV, and NPV of 53, 100, 100, and 33%, respectively. To our knowledge, this is the largest reported study seeking to determine cut‐off levels for IL‐6 and CRP in the diagnosis of neonatal sepsis. In conclusion, we think that it is useful to evaluate IL‐6 and CRP, in combination, for the early diagnosis of neonatal sepsis. J. Clin. Lab. Anal. 24:407–412, 2010.

An alternative drug (paracetamol) in the management of patent ductus arteriosus in ibuprofen-resistant or contraindicated preterm infants

The most commonly used drugs for closure of a haemodynamically significant patent ductus arteriosus (hsPDA) are cyclooxygenase inhibitors, mainly indomethacin and intravenous/oral ibuprofen. In contrast to high closure rates, several adverse effects have been reported with such medications, including gastrointestinal bleeding and perforation, weakened platelet aggregation, hyperbilirubinaemia and renal failure.1 ,2 The role of paracetamol as an …

Oral versus intravenous ibuprofen for patent ductus arteriosus closure: a randomised controlled trial in extremely low birthweight infants

Objective To compare the efficacy and safety of oral versus intravenous ibuprofen for the pharmacological closure of patent ductus arteriosus (PDA) in less mature preterm infants. Design Prospective, randomised controlled study. Setting Tertiary neonatal intensive care unit. Patients and interventions The study enrolled 80 preterm infants with gestational age ≤28 weeks, birth weight <1000 g, postnatal age 48 to 96 h, and had echocardiographically confirmed significant PDA. Seventy extremely low birthweight (ELBW) preterm infants received either intravenous or oral ibuprofen randomly as an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h. Main outcome measures The success rate and the safety of the drugs in ELBW preterm infants were the major outcomes. Results PDA closure rate was significantly higher with oral ibuprofen (83.3% vs 61.7%) after the first course of the treatment (p=0.04). Although the primary closure rate was marginally higher in the oral ibuprofen group, the need for a second course of ibuprofen during the whole hospitalisation was similar between groups: 11 of 36 in oral versus 15 of 34 in intravenous groups (p=0.24) because of a higher reopening rate in the oral group. In addition to no increase in side effects with oral ibuprofen use, the need for postnatal steroid use for chronic lung disease was significantly lower in oral ibuprofen group (p=0.001). Conclusions Oral ibuprofen is as effective as intravenous ibuprofen for PDA closure even in ELBW infants.