Ivan Hand

COVERS Neonatal Pain Scale: Development and Validation

Newborns and infants are often exposed to painful procedures during hospitalization. Several different scales have been validated to assess pain in specific populations of pediatric patients, but no single scale can easily and accurately assess pain in all newborns and infants regardless of gestational age and disease state. A new pain scale was developed, the COVERS scale, which incorporates 6 physiological and behavioral measures for scoring. Newborns admitted to the Neonatal Intensive Care Unit or Well Baby Nursery were evaluated for pain/discomfort during two procedures, a heel prick and a diaper change. Pain was assessed using indicators from three previously established scales (CRIES, the Premature Infant Pain Profile, and the Neonatal Infant Pain Scale), as well as the COVERS Scale, depending upon gestational age. Premature infant testing resulted in similar pain assessments using the COVERS and PIPP scales with an r = 0.84. For the full-term infants, the COVERS scale and NIPS scale resulted in similar pain assessments with an r = 0.95. The COVERS scale is a valid pain scale that can be used in the clinical setting to assess pain in newborns and infants and is universally applicable to all neonates, regardless of their age or physiological state.

Premedication Use Before Nonemergent Intubation in the Newborn Infant.

OBJECTIVE In 2010, an American Academy of Pediatrics (AAP) clinical report recommended that except for emergent situations, premedication should be used for all endotracheal intubations in newborns. The purpose of this study is to ascertain the current practice of premedication before elective intubation. STUDY DESIGN An online, survey-based questionnaire on the practice of premedication before nonemergent intubations was distributed via e-mail to neonatologists who are members of the Perinatal Section of the AAP. RESULTS Although 72% of respondents believed premedication should be used in nonemergent intubations, only 34% of the respondents report frequently premedicating before intubation with significant variation among the neonatal units (46% among level 4 units and 27% in level 3 and 2 units) p = 0.000. About 44% of respondents report having a written protocol or guideline on premedication which significantly correlated with the use of premedication (62% in level 4, 33% in level 3, and 16% in level 2 units), p = 0.000. CONCLUSION Despite a recent AAP clinical report recommending the use of premedication before nonemergent endotracheal intubation, only one-third of neonatologists report frequent use of premedication and less than half of the institutions have a written protocol on premedication.

Respiratory syncytial virus immunoprophylaxis in an urban population: a comparison of delivery strategies and outcomes.

Prophylaxis with palivizumab has been shown to decrease hospitalizations in at-risk infants. Compliance was higher with a home-based rather than a clinic-based system and was associated with decreased hospitalizations and unscheduled medical visits. Home-based delivery of respiratory syncytial virus prophylaxis may be more efficacious in preventing disease through increased compliance and decreased exposure of the high-risk infant to the clinic environment.

Breastfeeding, Hospitalizations, and the Role of Ethnicity

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Re: Time to Change NRP

We commend the authors for this randomized controlled study and their finding that infants aged <28 weeks who received room air resuscitation had higher mortality than those given 100% oxygen. These results are similar to those of SUPPORT (Surfactant Positive Airway Pressure and Pulse Oximetry Trial), which found that infants … E-mail: lnoble613{at}yahoo.com

Steady-state pharmacokinetics of oral linezolid suspension in a premature infant with osteomyelitis

Sir, Linezolid has activity against a broad range of Gram-positive bacteria, including MRSA. As infections with these organisms have become more common in infants, linezolid may have an important role, particularly in preterm newborns. Most of the published data on pharmacokinetics, efficacy and safety of linezolid are from adult studies. It is established that the pharmacokinetics of linezolid, especially clearance, varies with age. Children younger than 12 years of age have a smaller AUC, faster clearance and shorter elimination half-life than adults. Paediatric data, including from neonates, are limited and were mainly evaluated using the intravenous (iv) formulation. – 6 These studies reported considerable interindividual variability in plasma concentrations within the study populations. To date, there are no steady-state pharmacokinetic studies assessing oral linezolid suspension in infants. We report the steady-state pharmacokinetic parameters of oral linezolid suspension in a premature infant with osteomyelitis. The project was approved by the institutional review board, informed consent was obtained and the research was conducted in accordance with the Declaration of Helsinki. A 4-month-old male infant born at 25 weeks gestation (birth weight 750 g) was being managed in the neonatal ICU for ongoing medical issues since birth; iv access proved challenging throughout the hospital course. On the 44th day of life, the infant developed a skin and soft-tissue infection of the left forearm at an old iv site, along with spontaneously draining pustules at the umbilicus. Cultures obtained from the forearm abscess grew MRSA with a vancomycin MIC of 2 mg/L. The isolate also was resistant to clindamycin. The infant was treated with vancomycin iv for 10 days, although a therapeutic trough was not achieved (3.6 mg/L). On the 89th day of life, the infant developed left ankle swelling at another old iv access site. Imaging revealed significant osteomyelitis of the distal tibia and fibula. Cultures from the bone grew a latex-negative Staphylococcus. However, further speciation and susceptibilities were not conducted as the laboratory discarded the sample. The infant was started on linezolid, iv at 10 mg/kg (29 mg) q8h. Treatment was monitored with serial serum inflammatory markers. Parenteral therapy was disrupted on several occasions as iv access was compromised. After 14 days of parenteral therapy, the infant was switched to oral linezolid suspension, 10 mg/kg q8h, for an additional 4 weeks. Blood samples obtained during the last week of oral linezolid therapy were analysed for quantification of linezolid using HPLC. Blood samples (0.5 mL) were obtained at time 0 before dosing and at 1, 1.5, 2, 4, 6 and 8 h after the oral dose of linezolid. An additional sample, 10 h after the prior dose and 2 h after the afternoon dose, also was obtained. Serum samples were shipped to the Infectious Disease Pharmacokinetics Laboratory in Gainesville (FL, USA) for serum concentration analysis. Linezolid concentrations were determined using a validated HPLC assay described previously. The plasma standard curve for linezolid ranged from 0.50 to 30 mg/L, with linearity extending below 0.50. The within-sample precision (percentage coefficient of variation) of validation in a single standard concentration was 0.69% and the overall validation precision across all standards was 1.04%–4.39%. Non-compartmental analysis of the data was performed with Phoenix software (v.6.4, Pharsight) to obtain the steady-state pharmacokinetic parameters. The 0 and 8 h sample concentrations (minimum plasma concentration, Cmin) were both 0.32 mg/L, confirming that steady-state had been achieved (Figure 1). The steady-state peak plasma concentration (Cmax) was 5.51 mg/L and the time to peak plasma concentration (Tmax) was 2 h. The second 2 h sample (10 h after the prior oral dose) was 3.99 mg/L, somewhat lower than the prior Cmax of 5.51 mg/L. This suggests that the rate of oral absorption varied from dose to dose. Typical linezolid peak concentrations are 12–26 mg/L 2 h after oral doses and trough concentrations are typically 3–9 mg/L. – 3 In this infant, despite q8h dosing, peak and trough concentrations were lower than typically seen. The volume of distribution divided by bioavailability (Vz/F), clearance divided by bioavailability (CL/F), elimination rate constant (kel, estimated with three concentrations), half-life (t1/2) and AUC0 – 8 were estimated at 3.48 L, 1.75 L/h, 0.50 h, 1.38 h and 16.56 mg.h/L, respectively. The pharmacokinetic profile of oral linezolid in our infant differed from what has been published in the literature for full-term infants. Full-term infants who received single doses of iv linezolid had much higher peak plasma concentrations, a larger AUC and a slower clearance. Our infant was born .3 months premature and was treated at a post-gestational age of 1 month (not equivalent to a full-term infant of the same age); therefore, direct correlation is challenging due to the differences in characteristics of the infants in the published studies. The Cmax and AUC were lower in our infant and apparent elimination t1/2 faster than what has been reported in full-term infants. Reasons for this may include incomplete absorption (F,1), faster clearance or a smaller actual volume of distribution. We were only able to estimate Vz/F, leaving our assessment of this parameter less than optimal. Pharmacokinetic data reported in studies in infants