Objective:To determine the effectiveness and safety of moderate whole-body hypothermia in newborns with hypoxic-ischemic encephalopathy born in hospitals with and without newborn intensive care facilities or complicated hypothermia equipment.Design: Multicenter, international, randomized controlled trial.Participants: Newborns of 35 weeks' gestation or more, with indicators of peripartum hypoxia-ischemia and moderate to severe clinical encephalopathy, randomly allocated to hypothermia (n=110) or standard care (n=111).Intervention: Whole-body hypothermia to 33.5°C for 72 hours or standard care (37°C). Infants who received hypothermia were treated at ambient environmental temperature by turning off the radiant warmer and then applying refrigerated gel packs to maintain rectal temperature at 33°C to 34°C.Main Outcome Measures: Death or major sensorineural disability at 2 years of age.Results: Therapeutic hypothermia reduced the risk of death or major sensorineural disability at 2 years of age: 55 of 107 infants (51.4%) in the hypothermia group and 67 of 101 infants (66.3%) in the control group died or had a major sensorineural disability at 2 years (risk ratio, 0.77 [95% confidence interval, 0.62-0.98]; P=.03). The mortality rate decreased, and the survival rate free of any sensorineural disability increased. Adverse effects of hypothermia were minimal.Conclusions: Whole-body hypothermia is effective and appears to be safe when commenced within 6 hours of birth at the hospital of birth in term and near-term newborns with hypoxic-ischemic encephalopathy. This simple method of hypothermia could be used within strict protocols with appropriate training on correct diagnosis and application of hypothermia in nontertiary neonatal settings while awaiting retrieval and transport to the regional neonatal intensive care unit.

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Background We aimed to determine the maturational changes in systolic ventricular strain mechanics by two-dimensional speckle tracking echocardiography in extreme preterm neonates from birth to one year of age, and discern the impact of common cardiopulmonary abnormalities on the deformation measures. Methods In a prospective multi-center study of 239 extreme preterm infants (< 29 weeks gestation at birth), left ventricle (LV) global longitudinal strain and systolic strain rate (GLS, GLSRs), interventricular septal wall (IVS) GLS and GLSRs, right ventricle free wall longitudinal S and SR (RV FWLS, FWLSRs), and segmental LS (SLS) in the RVFW, LVFW and IVS were serially measured at Days 1, 2, 5–7, 32 weeks and 36 weeks post-menstrual age (PMA), and one year corrected age (CA). Premature infants who developed bronchopulmonary dysplasia (BPD) or had echocardiographic findings of pulmonary hypertension (PH) were analyzed separately. Results In uncomplicated preterm infants (n=103, 48%), LV GLS and GLSRs remained unchanged from Day 5–7 to one year CA (p=0.60 and 0.59). RV FWLS, FWLSRs and IVS GLS and GLSR significantly increased over the same time period (p < 0.01 for all measures). A significant base-to-apex (highest to lowest) SLS gradient (p < 0.01) in the RVFW and a reverse apex-to-base gradient (p < 0.01) existed in the LVFW. In infants with BPD and/or PH (n=119, 51%), RV FWLS and IVS GLS were significantly lower (p < 0.01), LV GLS and GLSRs were similar (p=0.56), and IVS SLS persisted as an RV dominant base-to-apex gradient from 32 weeks PMA to one year CA. Conclusions This study tracks the maturational patterns of global and regional deformation by 2DSTE in extreme preterm infants from birth to one year CA. The maturational patterns are ventricular specific. BPD and PH leave a negative impact on RV and IVS strain, while LV strain remains stable.

In neonates born with a gestational age below 28 weeks the presence of a PDA on day 3 of life was associated with adverse outcome; this association was even more pronounced with a large PDA. Thus, early echocardiography may facilitate the identification of neonates suitable for a targeted approach to intervention in future randomised controlled trials.