Serum ferritin values in neonates <29 weeks' gestation are highly variable and do not correlate with reticulocyte hemoglobin content.

OBJECTIVES: To compare serum ferritin and RET-He values among extremely low gestational age neonates ELGANs with other markers of iron-deficient erythropoiesis. STUDY DESIGN: This is a secondary analysis of the NICHD Darbepoetin Trial. Study data from placebo recipients who had a serum ferritin, a RET-He, and a mean corpuscular volume (MCV) measurement within a 24-hour period were analyzed for correlation. RESULTS: Mixed linear regression models showed no association between ferritin and RET-He at both early (ß = 0.0016, p = 0.40) and late (ß = -0.0001, p = 0.96) time points. Positive associations were observed between RET-He and MCV at baseline, early, and late time points (p < 0.01, =0.01, <0.001, respectively), while ferritin was not associated with MCV at any time point. CONCLUSIONS: Our study shows that RET-He is better correlated with MCV as a marker of iron-limited erythropoiesis than ferritin. The results suggest that ferritin is limited as a marker of iron sufficiency in premature infants. STUDY IDENTIFICATION: FDA IND Number 100138; ClinicalTrials.gov number NCT03169881; NRN ID number NICHD-NRN-0058 (Darbe).

Nurses' Knowledge, Communication Needs, and Future Directions in Neonatal Research: Results of an International Survey.

BACKGROUND: Preterm birth is a significant contributor to neonatal morbidity and mortality. Despite legislative efforts to increase pediatric drug development, neonatal clinical trials continue to be infrequent. The International Neonatal Consortium (INC) includes nurses as key stakeholders in their mission to accelerate safe and effective therapies for neonates. PURPOSE: INC developed a survey for nurses, physicians, and parents to explore communication practices and stakeholders' perceptions and knowledge regarding clinical trials in neonatal intensive care units (NICUs). METHODS: A stepwise consensus approach was used to solicit responses to an online survey. The convenience sample was drawn from INC organizations representing the stakeholder groups. Representatives from the National Association of Neonatal Nurses and the Council of International Neonatal Nurses, Inc, participated in all stages of the survey development process, results analysis, and publication of results. RESULTS: Participants included 188 nurses or nurse practitioners, mainly from the United States, Canada, the European Union, and Japan; 68% indicated some level of research involvement. Nurses expressed a lack of effective education to prepare them for participation in research. Results indicated a lack of a central information source for staff and systematic approaches to inform families of studies. The majority of nurses indicated they were not asked to provide input into clinical trials. Nurses were uncertain about research consent and result disclosure processes. IMPLICATIONS FOR PRACTICE AND RESEARCH: This study indicates the need to educate nurses in research, improve NICU research communication through standardized, systematic pathways, and leverage nurse involvement to enhance research communication.

Measuring and controlling medical record abstraction (MRA) error rates in an observational study.

BACKGROUND: Studies have shown that data collection by medical record abstraction (MRA) is a significant source of error in clinical research studies relying on secondary use data. Yet, the quality of data collected using MRA is seldom assessed. We employed a novel, theory-based framework for data quality assurance and quality control of MRA. The objective of this work is to determine the potential impact of formalized MRA training and continuous quality control (QC) processes on data quality over time. METHODS: We conducted a retrospective analysis of QC data collected during a cross-sectional medical record review of mother-infant dyads with Neonatal Opioid Withdrawal Syndrome. A confidence interval approach was used to calculate crude (Wald's method) and adjusted (generalized estimating equation) error rates over time. We calculated error rates using the number of errors divided by total fields ("all-field" error rate) and populated fields ("populated-field" error rate) as the denominators, to provide both an optimistic and a conservative measurement, respectively. RESULTS: On average, the ACT NOW CE Study maintained an error rate between 1% (optimistic) and 3% (conservative). Additionally, we observed a decrease of 0.51 percentage points with each additional QC Event conducted. CONCLUSIONS: Formalized MRA training and continuous QC resulted in lower error rates than have been found in previous literature and a decrease in error rates over time. This study newly demonstrates the importance of continuous process controls for MRA within the context of a multi-site clinical research study.

The culture of research communication in neonatal intensive care units: key stakeholder perspectives.

OBJECTIVE: To assess the perspectives of neonatologists, neonatal nurses, and parents on research-related education and communication practices in the neonatal intensive care unit (NICU). STUDY DESIGN: Questionnaire circulated through interest groups and administered using the internet. RESULTS: 323 respondents responded to the survey. 52 were neonatologists, 188 were neonatal nurses, and 83 were parents of NICU graduates. Analysis was descriptive. Differences were noted between stakeholder groups with respect to whether current medications meet the needs of sick neonates, research as central to the mission of the NICU, availability of appropriate education/training for all members of the research team, and adequacy of information provided to parents before, during, and after a research study is completed. CONCLUSION: Engagement of nurses and parents at all stages of NICU research is currently suboptimal; relevant good practices, including education, should be shared among neonatal units.

Darbepoetin as a neuroprotective agent in mild neonatal encephalopathy: a randomized, placebo-controlled, feasibility trial.

OBJECTIVE: To assess the feasibility and safety of one dose of Darbepoetin alpha (Darbe) administered to neonates ≥34 weeks with mild neonatal encephalopathy (NE). METHODS: Randomized, masked, placebo-controlled study including neonates ≥34 weeks gestation with mild NE. Neonates were randomized to receive one dose of Darbe (10 µg/kg IV) or placebo. Clinical and laboratory maternal and newborn data were collected. The Bayley Scales of Infant and Toddler Development, third edition (Bayley-III) and a standardized neurological examination at 8-12 months of corrected age were assessed. RESULTS: There were no differences in baseline characteristics of the 21 infants randomized (9 Darbe, 12 placebo). Adverse events were not reported at any time. Bayley-III scores were average in both Darbe and placebo groups. CONCLUSION: This study demonstrates that a randomized, masked, placebo-controlled trial is safe and feasible. A large, randomized trial is warranted to assess the effect of Darbe in this population.

Development of a neonatal adverse event severity scale through a Delphi consensus approach.

BACKGROUND: Assessment of the seriousness, expectedness and causality are necessary for any adverse event (AE) in a clinical trial. In addition, assessing AE severity helps determine the importance of the AE in the clinical setting. Standardisation of AE severity criteria could make safety information more reliable and comparable across trials. Although standardised AE severity scales have been developed in other research fields, they are not suitable for use in neonates. The development of an AE severity scale to facilitate the conduct and interpretation of neonatal clinical trials is therefore urgently needed. METHODS: A stepwise consensus process was undertaken within the International Neonatal Consortium (INC) with input from all relevant stakeholders. The consensus process included several rounds of surveys (based on a Delphi approach), face-to-face meetings and a pilot validation. RESULTS: Neonatal AE severity was classified by five grades (mild, moderate, severe, life threatening or death). AE severity in neonates was defined by the effect of the AE on age appropriate behaviour, basal physiological functions and care changes in response to the AE. Pilot validation of the generic criteria revealed κ=0.23 and guided further refinement. This generic scale was applied to 35 typical and common neonatal AEs resulting in the INC neonatal AE severity scale (NAESS) V.1.0, which is now publicly available. DISCUSSION: The INC NAESS is an ongoing effort that will be continuously updated. Future perspectives include further validation and the development of a training module for users.

Identification and management of neonatal abstinence syndrome.

The nursing care of infants experiencing withdrawal from drug abuse through passive exposure is often challenging. These infants are at higher risk for many medical complications in addition to withdrawal itself. Often, infusion nurses play an important role in caring for an infant with drug withdrawal by providing infusion therapy for the infant's compromised medical condition, poor oral intake, and withdrawal symptoms. This article focuses on drug abuse during pregnancy, the withdrawal symptoms it may cause in the infant, ways to recognize an infant experiencing neonatal abstinence syndrome, and available scoring tools and treatment options.