Abstract Objective We studied the reliability and validity of the COMFORTneo scale, designed to measure neonatal prolonged pain. Study design This prospective observational study evaluated four clinimetric properties of the COMFORTneo scale from NICU nurses’ assessments of neonates’ pain. Intra-rater reliability was determined from three video fragments at two time points. Inter-rater reliability and construct validity were determined in five neonates per nurse with the COMFORTneo and numeric rating scales (NRS) for pain and distress. Pain scores using N-PASS were correlated with COMFORTneo scores to further evaluate construct validity. Result Intra-rater reliability: Twenty-two nurses assessed pain twice with an intraclass correlation coefficient (ICC) of 0.70. Inter-rater reliability: The ICC for 310 COMFORTneo scores together with 62 nurses was 0.93. Construct validity: Correlation between COMFORTneo and NRS pain, distress and N-PASS was 0.34, 0.72 and 0.70, respectively. Conclusion The COMFORTneo can be used to reliably and validly assess pain in NICU patients.
OBJECTIVE: To assess whether corticosteroids, used as adjunctive therapy for pediatric severe sepsis, is associated with improved outcomes.DESIGN: Retrospective cohort study examining the clinical database derived from the RESOLVE (REsearching severe Sepsis and Organ dysfunction in children: a gLobal perspective, F1K-MC-EVBP) trial of activated protein C for pediatric severe sepsis.SETTING: A total of 104 pediatric centers in 18 countries from which data were originally gathered.SUBJECTS: Children with severe sepsis (n = 477), requiring both vasoactive-inotropic infusions and mechanical ventilation. Within this cohort, 193 children received corticosteroids during their septic episode and 284 did not.INTERVENTIONS: None.MEASUREMENTS AND MAIN RESULTS: Baseline summary characteristics demonstrated that children receiving or not receiving corticosteroids had similar demographics and disease severity as indicated by age, gender, mean Pediatric Risk of Mortality scores, and mean number of organ dysfunctions. Use of adjunctive corticosteroids increased during the F1K-MC-EVBP trial. Indications for corticosteroid prescription were therapeutic (89%, mostly shock) and prophylactic (13%). All cause 28-day mortality among children receiving and not receiving corticosteroids was 15.1% and 18.8%, respectively, p = .30. There was no difference in mean vasoactive-inotropic infusion days between the corticosteroid and no corticosteroid groups, 4.5 days vs. 4.3 days, respectively, p = .59. Similarly there was no difference in mean ventilator days between the corticosteroid and no corticosteroid groups, 8.3 days vs. 7.7 days, respectively, p = .38.CONCLUSIONS: Children with severe sepsis who received adjunctive corticosteroid therapy exhibited similar illness severity compared with those who did not. No definitive improvement in outcomes can be attributable to adjunctive corticosteroid therapy in the largest pediatric sepsis trial conducted to date. PMID: 20228689 Funding information This work was supported by: NICHD NIH HHS, United States Grant ID: 5U10 HD049945
BACKGROUND: Bronchiolitis is one of the most common respiratory problems in the first year of life. The sputum of infants with bronchiolitis has increased deoxyribonucleic acid (DNA) content, leading to mucous plugging and airway obstruction. Recombinant human deoxyribonuclease (rhDNase), an enzyme that digests extracellular DNA, might aid the clearance of mucus and relieve peripheral airway obstruction.OBJECTIVES: To determine the effect of nebulised rhDNase on the severity and duration of viral bronchiolitis in children younger than 24 months of age in the hospital setting.SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2012, Issue 7 which includes the Acute Respiratory Infections Group's Specialised Register, MEDLINE (1966 to July Week 4, 2012), EMBASE (1974 to August 2012) and LILACS (1982 to August 2012).SELECTION CRITERIA: Randomised controlled trials (RCTs) using nebulised rhDNase alone or with concomitant therapy in children younger than 24 months of age hospitalised with acute bronchiolitis.DATA COLLECTION AND ANALYSIS: Two review authors independently performed literature searches, assessed trial quality and extracted data. We obtained unpublished data from trial authors. We used Review Manager 5.1 to pool treatment effects expressed as the mean difference (MD) or standardised mean difference (SMD) with 95% confidence intervals (CI).MAIN RESULTS: Three RCTs (333 participants) were identified, two of which were multicentre trials comprising only participants positive for respiratory syncytial virus (RSV). The other trial enrolled participants clinically diagnosed with bronchiolitis from a hospital in Italy. All studies used 2.5 mL (1 mg/mL) of nebulised rhDNase compared with placebo either as a daily or a twice daily dose. Adjunctive therapy included nebulised salbutamol, steroids, supplemental oxygen, intravenous fluids or tube feeding, nasal washing, nasal decongestants and antibiotics.Overall, nebulised rhDNase showed no benefit in clinically meaningful outcomes. Meta-analysis favoured the control group with a shorter duration of hospital stay (MD 0.50; 95% CI 0.10 to 0.90, P = 0.01) and better clinical score improvement (SMD -0.24; 95% CI -0.50 to 0.01, P = 0.06). The largest trial showed no difference in supplemental oxygen use or intensive care unit (ICU) admission.In one RCT, four out of 11 patients in the treatment group had atelectasis. Two of these patients showed distinctive clinical improvement after nebulised rhDNase.There was no significant difference in adverse events. These included temporary desaturation, temporary coughing, increased coughing, facial rash, hoarseness, dyspnoea and bad taste, reported in a total of 11 patients from both treatment groups.AUTHORS' CONCLUSIONS: The results based on the three included studies in this review did not support the use of nebulised rhDNase in children under 24 months of age hospitalised with acute bronchiolitis. In these patients, treatment did not shorten the length of hospitalisation or improve clinical outcomes. It might have a role in severe bronchiolitis complicated by atelectasis, but further clinical studies would need to be performed. PMID: 23152257
Read the full review for this Faculty Opinions recommended article: Risk factors for neonatal sepsis and perinatal death among infants enrolled in the prevention of perinatal sepsis trial, Soweto, South Africa.
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