Neonatal Resuscitation with an Intact Cord: A Randomized Clinical Trial.

OBJECTIVE: To assess whether providing ventilation during delayed cord clamping (V-DCC) increases placental transfusion compared with delayed cord clamping alone (DCC only). STUDY DESIGN: Inborn premature infants (230/7-316/7 weeks' gestational age) were randomized to receive at least 60 seconds of V-DCC (initial continuous positive airway pressure) with addition of positive pressure ventilation if needed) or without assisted ventilation (DCC only). For the DCC-only group, infants were dried and stimulated by gently rubbing the back if apneic. The primary outcome was the peak hematocrit in the first 24 hours of life. Delivery room outcomes were analyzed from video recordings and a data acquisition system. Hemodynamic measurements were performed with the use of functional echocardiography, near-infrared spectroscopy, and electrical cardiometry. RESULTS: There was no difference in the primary outcome of peak hematocrit in the first 24 hours of life. The onset of breathing was similar between both groups (25 ± 20 and 27 ± 28 seconds, P = .627); however, infants receiving DCC received a greater duration of stimulation than V-DCC (41 ± 19 and 20 ± 21 seconds P = .002). There were no differences in delivery room interventions, early hemodynamics (cerebral oxygenation by near-infrared spectroscopy, cardiac output and stroke volume by electrical cardiometry, or superior vena cava flow by of functional echocardiography), or neonatal outcomes. CONCLUSIONS: V-DCC was feasible but did not lead to any measurable clinical improvements immediately after delivery or reduce subsequent neonatal morbidity. Caretakers should consider providing adequate stimulation before cord clamping. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02231411.

Relationship Between Near-Infrared Spectroscopy and Transabdominal Ultrasonography: Noninvasive Monitoring of Intestinal Function in Neonates.

BACKGROUND: Near-infrared spectroscopy (NIRS) has the potential to continuously and noninvasively monitor intestinal function. This technology may be valuable because among neonates, intestinal maturity is highly variable and difficult to assess based solely on clinical signs. The aim of this study was to determine if there is an association between NIRS-based StO2 measurements and peristaltic activity assessed by transabdominal ultrasonography (US). MATERIAL/METHODS: Nineteen neonates of gestational age >32 weeks were categorized according to "no/low" versus "normal/hyperactive" motility levels, based on blinded US scan results. StO2 was recorded every 2 s for 24 h, following the ultrasound recording. Differences between the resulting estimates of average StO2 (bias of fits) and goodness-of-fit (residuals) were evaluated. RESULTS: Newborns with normal/hyperactive motility had higher mean StO2 than newborns with no/low motility (72.3±4.4 vs. 65.5±7.9, p<0.05, F=5.65). Residual errors were not significantly different between the 2 groups (p=0.213, F=0.213). A multivariate linear regression model using the means, residuals, and pairwise products of both, demonstrated more significant separation (0.47±0.26 vs. -0.24±0.33, p<0.01, F=27.4). A non-linear variant of the multivariate linear regression model demonstrated greatest separation (0.68±0.24 vs. -0.49±0.53, p<0.01, F=41.9). CONCLUSIONS: This is the first study to demonstrate an association between NIRS-based StO2 measurements and peristaltic activity visualized by ultrasound imaging. NIRS may offer a continuous, noninvasive method to assess motility. This may have significant implications in premature infants at risk for feeding intolerance or necrotizing enterocolitis.

A Pilot Randomized Controlled Trial of Early versus Routine Caffeine in Extremely Premature Infants.

OBJECTIVE: This study aims to compare the effects of early and late (routine) initiation of caffeine in nonintubated preterm neonates. STUDY DESIGN: A total of 21 neonates < 29 weeks gestational age were randomized to receive intravenous caffeine citrate (20 mg/kg) or placebo either before 2 hours of age (early) or at 12 hours of age (routine). This was an observational trial to determine the power needed to reduce the need for endotracheal intubation by 12 hours of age. Other outcomes included comparisons of cerebral oxygenation, systemic and pulmonary blood flow, hemodynamics, hypotension treatment, oxygen requirement, and head ultrasound findings. RESULTS: There was no difference in the need for intubation (p = 0.08), or vasopressors (p = 0.21) by 12 hours of age. Early caffeine was associated with improved blood pressure (p = 0.03) and systemic blood flow (superior vena cava flow, p = 0.04 and right ventricular output, p = 0.03). Heart rate, left ventricular output, and stroke volume were not significantly affected. Cerebral oxygenation transiently decreased 1 hour after caffeine administration. There were no differences in other outcomes. CONCLUSION: This pilot study demonstrated the feasibility of conducting such a trial in extremely preterm neonates. We found that early caffeine administration was associated with improved hemodynamics. Larger studies are needed to determine whether early caffeine reduces intubation, intraventricular hemorrhage, and related long-term outcomes.

Motor learning of a gait pattern to reduce forefoot plantar pressures in individuals with diabetic peripheral neuropathy.

OBJECTIVE: To examine the role of visual feedback in the reduction of plantar pressures through teaching a "new" gait pattern to diabetic peripheral neuropathy subjects. Immediate, next day, and 1-week retention were studied to determine if motor pattern changes could occur. DESIGN: Randomized controlled trial. SETTING: VA Urban Healthcare System. PARTICIPANTS: Twenty-nine community-dwelling older adults with diabetic peripheral neuropathy volunteered. INTERVENTIONS: Subjects were randomized into feedback and no-feedback groups. All subjects received instruction and 2 days of practice and returned for a 1-week retention test. Instruction to pull the leg forward from the hip to initiate swing rather than push off the ground with the foot while walking was given to all subjects. The feedback group received visual feedback regarding peak plantar pressures after each practice trial. The no-feedback group received no feedback. MAIN OUTCOME MEASURES: Peak plantar pressures in the forefoot region for immediate retention (retention 1), next day retention (retention 2), and long-term retention (1-week retention). RESULTS: Peak plantar pressures were significantly (P < .01) reduced from baseline to retention 2 testing at the first metatarsal area in the feedback group. The feedback group walked significantly (P < .01) slower at retention 1 and 1-week testing compared with baseline. CONCLUSIONS: Individuals with diabetic peripheral neuropathy were unable to use a "new" strategy gait pattern to reduce peak plantar pressures long term (1 week). The use of visual feedback following the trial did not assist in the learning of a new walking pattern.