Design and methods for the training in exercise activities and motion for growth (TEAM 4 growth) trial: A randomized controlled trial.

BACKGROUND: Growth is often impaired in infants with congenital heart disease. Poor growth has been associated with worse neurodevelopment, abnormal behavioral state, and longer time to hospital discharge. Nutritional interventions, drug therapy, and surgical palliation have varying degrees of success enhancing growth. Passive range of motion (PROM) improves somatic growth in preterm infants and is safe and feasible in infants with hypoplastic left heart syndrome (HLHS), after their first palliative surgery (Norwood procedure). METHODS: This multicenter, Phase III randomized control trial of a 21-day PROM exercise or standard of care evaluates growth in infants with HLHS after the Norwood procedure. Growth (weight-, height- and head circumference-for-age z-scores) will be compared at 4 months of age or at the pre-superior cavopulmonary connection evaluation visit, whichever comes first. Secondary outcomes include neonatal neurobehavioral patterns, neurodevelopmental assessment, and bone mineral density. Eligibility include diagnosis of HLHS or other single right ventricle anomaly, birth at ≥37 weeks gestation and Norwood procedure at <30 days of age, and family consent. Infants with known chromosomal or recognizable phenotypic syndromes associated with growth failure, listed for transplant, or expected to be discharged within 14 days of screening are excluded. CONCLUSIONS: The TEAM 4 Growth trial will make an important contribution to understanding the role of PROM on growth, neurobehavior, neurodevelopment, and BMD in infants with complex cardiac anomalies, who are at high risk for growth failure and developmental concerns.

High-dose dexmedetomidine sedation for pediatric MRI.

OBJECTIVES: To test the hypothesis that high-dose dexmedetomidine can be successfully used for pediatric magnetic resonance imaging (MRI) sedation without significant hemodynamic compromise. BACKGROUND: The dexmedetomidine dose required to achieve optimal sedation is often higher than its recommended dose. High doses of dexmedetomidine can lead to significant hemodynamic side effects. METHODS: Dexmedetomidine use for pediatric MRI over a 1-year period was retrospectively reviewed. A dexmedetomidine bolus of 2 µg·kg(-1) intravenous followed by 1 µg·kg(-1)·h(-1) infusion was used. Dexmedetomidine efficacy, side effects, timing of side effects, and additional use of medications were analyzed. Data were compared by t-test, Mann-Whitney rank-sum test, Fisher's exact test, and anova. RESULTS: High-dose dexmedetomidine was used in 77 patients, and MRI was completed in 76 (99%) patients. A second bolus of dexmedetomidine was required in 28 (36%) patients, and 22 (29%) patients required additional medications (midazolam, fentanyl, or ketamine) for adequate sedation. A 25% decrease in blood pressure (BP) was observed in 10.5%, a transient increase in BP in 3.9%, and a heart rate <60 min(-1) in 7.9% of cases. These side effects resolved spontaneously. There were no apneas or respiratory depression. Vital sign changes, recovery time, and discharge time were not significantly different in subgroups of patients receiving one or two boluses of dexmedetomidine with or without additional medications. Transient hypertension was more common in patients receiving two boluses of dexmedetomidine (P = 0.048). CONCLUSIONS: High-dose dexmedetomidine can be successfully used for pediatric MRI sedation, but a significant number of children require additional medications for optimal control. Hemodynamic side effects resolved spontaneously. High-dose dexmedetomidine did not result in respiratory depression.