A call for a streamlined ethics review process for multijurisdictional, child health research studies.

To be time and resource efficient in neonatal research and to answer clinically relevant questions with validity and generalizability, large numbers of infants from multiple hospitals need to be included. Multijurisdictional research in Canada is currently fraught with research ethics review process hurdles that lead to delays, administrative costs, and possibly termination of projects. We describe our experience applying for ethics review to 13 sites in 7 provinces for a project comparing two standard of care therapies for preterm born infants with respiratory distress syndrome. We welcome the current opportunity created by the Institute of Human Development Child and Youth Health and the Institute for Genetics, to collaboratively identify practical solutions that would benefit Canadian researchers, Research Ethics Boards, and children and families.

Effect of an Educational Presentation about Extremely Preterm Infants on Knowledge and Attitudes of Health Care Providers.

Objective To determine healthcare providers' knowledge (HCP) about survival rates of extremely preterm infants (EPI) and attitudes toward resuscitation before and after an educational presentation and, to examine the relationship between knowledge and attitudes toward resuscitation. Study Design Participants completed a survey before and after attending a presentation detailing evidence-based estimates of survival rates and surrounding ethical issues. Respondents included neonatologists, obstetricians, pediatricians, maternal-fetal medicine specialists, trainees in pediatrics, obstetrics, neonatal-perinatal medicine and neonatal and obstetrical nurses. Results In total, 166 participants attended an educational presentation and 130 participants completed both pre- and postsurveys (response rate 78%). Prepresentation, for all gestations, ≤ 50% of respondents correctly identified survival/intact survival rates. Postpresentation, correct responses regarding survival/intact survival rates ranged from 49 to 86% (p < 0.001) and attitudes shifted toward being more likely to resuscitate at all gestations regardless of parental wishes. There was a weak-to-modest relationship (Spearman's coefficient 0.24-0.40, p < 0.001-0.004) between knowledge responses and attitudes. Conclusion Attendance at an educational presentation did improve HCP knowledge about survival and long term outcomes for EPI, but HCP still underestimated survival and were not always willing to resuscitate in accordance with parental wishes. These findings may represent barriers to some experts' recommendation to use shared decision-making with parents when considering the resuscitation options for their EPI.

Utility of the 21-month neurodevelopmental outcome for predicting neurodevelopmental impairment at 36 months for preterm infants <29 weeks gestation.

OBJECTIVE: To determine the sensitivity and specificity of the 21-month neurodevelopmental outcome for predicting the presence of neurodevelopmental impairment at 36 months corrected age in a population of preterm infants under 29 weeks gestation. STUDY DESIGN: This is a retrospective observational cohort study. Preterm infants born under 29 weeks gestation who were followed up at both 18-21 months and 36 months corrected age with outcome data available were enrolled. RESULTS: Overall, 713 preterm infants <29 weeks gestation and were included in the final analysis. The specificity of the 21-month assessment for predicting neurodevelopmental impairment at 36 months corrected age was 66% (95% confidence interval[CI] 62-71%) with a positive predictive value of 61% (95% CI 56-66%). CONCLUSION: In preterm neonates born <29 weeks gestation, the 18-21 months corrected neurodevelopmental outcome had low specificity and positive predictive value for predicting the presence of neurodevelopmental impairment at 36 months corrected age.

Association of inotrope use with neurodevelopmental outcomes in infants <29 weeks gestation: a retrospective cohort study.

OBJECTIVE: The primary objective was to compare neurodevelopmental (ND) outcomes at 18-24 months in preterm infants <29 weeks gestational age (GA) who received versus those who did not receive inotropes in the first week of life. The secondary objective was to assess ND outcomes according to the duration of inotropic support in the first week of life (≤3 or >3 days). STUDY DESIGN: Retrospective population-based cohort study of preterm infants <29 weeks GA admitted to participating neonatal intensive care units (NICUs) of the Canadian Neonatal Network (CNN) from January 2010 to September 2011 with follow-up data available at 18-24 months. Neurodevelopmental outcomes were assessed using the Bayley Scales of Infant and Toddler Development-Third Edition (BSID-III). Long-term outcomes were categorized as neurodevelopmental impairment (NDI) and significant neurodevelopmental impairment (sNDI), and effect modification due to other neonatal morbidities including receipt of antenatal steroids, GA, small for gestational age (SGA) status, sex, score for neonatal acute physiology (SNAP-II) >20, postnatal steroids, bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH) grade ≥3/periventricular leukomalacia (PVL), early- and late-onset sepsis, retinopathy of prematurity (ROP) and necrotizing enterocolitis (NEC) was assessed. Maternal and infant demographic characteristics and short- and long-term outcomes were compared using Pearson's Chi-square test for categorical variables and Student's t-test or the Wilcoxon rank test for continuous variables. Adjusted odds ratios (AORs) and 95% confidence intervals (CIs) were calculated using multivariable regression analysis. RESULTS: Of the 491 (18.7%) eligible preterm infants who received inotropes during the first week of life, 314 (64%) survived to NICU discharge and 245 (78%) had ND outcome data available. A total of 1775 eligible preterm infants did not receive inotropes in the first week of life; 1647 (92.7%) survived to NICU discharge and 1149 (70%) had ND outcome data. Maternal and infant characteristics associated with infants receiving inotropes included: younger maternal age, clinical chorioamnionitis, no antenatal steroids, outborn, lower GA, BW and Apgar scores at both one and five minutes; and higher SNAP-II scores (p < .05). Infants who received inotropes in the first week of life were more likely to be require postnatal steroids, had higher rates of BPD, IVH grade ≥3/PVL, early- and late-onset sepsis, ROP, NEC and mortality (p < .05). Infants who received inotropes in the first week of life also had higher rates of sensorineural or mixed hearing loss with an AOR (95% CI) of 1.99 (1.13, 3.49). After adjusting for confounding variables, there was no difference in the risk of NDI or sNDI between infants who did and did not receive inotropes in the first week of life. Of the infants with neurodevelopmental outcome data available, 186 received inotropes for ≤3 days and 59 for >3 days. After adjusting for confounding variables there was no difference in the risk of NDI or sNDI. Infants who received inotropes for >3 days were more likely to have lower BSID-III cognitive [AOR 2.43 95% CI (1.03, 5.76)] and motor scores <85 [AOR 2.38 95% CI (1.07, 5.30)] respectively. CONCLUSIONS: In this large, population-based cohort, infants who received inotropes in the first week of life were at increased risk for sensorineural or mixed hearing loss. There was no difference in NDI or sNDI after adjusting for confounding variables. A longer duration of inotrope use in the first week of life was associated with lower BSID-III cognitive and motor scores, but no difference in overall NDI or sNDI.

Neonatal Thyrotoxicosis with Tricuspid Valve Regurgitation and Hydrops in a Preterm Infant Born to a Mother with Graves' Disease.

Neonatal hyperthyroidism is rare disorder due to the passage of thyroid receptor antibodies (TRBs) from the mother to the fetus. Neonatal thyrotoxicosis can present in several ways and if unrecognized, can be fatal. We present a preterm neonate who developed fetal hydrops and tricuspid regurgitation in utero. The mother had a history of treated Grave's disease. The infant responded to maternal treatment antenatally and postnatal anti-thyroid treatment, with resolution of both the tricuspid regurgitation and hydrops. To our knowledge, this is the first case report of tricuspid regurgitation associated with fetal and neonatal thyrotoxicosis. Our case also highlights the importance of obtaining a detailed and accurate history in a mother with previous Grave's disease, even if treated.