Pilot Study In Infants Research Articles

A novel quantitative approach to evaluate femoral head perfusion by contrast-enhanced ultrasound: A pilot study in infants with developmental dysplasia of the hip.

Avascular necrosis (AVN) is a major morbidity that can occur after surgical reduction of a hip with developmental dysplasia. Early detection of changes in femoral head perfusion during surgery may help detect a hip at risk for AVN and guide intraoperative management. Contrast-enhanced ultrasound (CEUS) can be employed for visualization of femoral head perfusion. In this study we evaluate a quantitative CEUS technique to assess femoral head perfusion pre- and post-surgical reduction. CEUS images were obtained following a bolus injection of an ultrasound contrast agent, prior to and again following surgical reduction and casting. An image processing technique called delta projection was used to quantify hip perfusion, measuring peak enhancement (PE) and perfusion index (PI). We analyzed CEUS images of the hips of eight patients, including seven females, whose ages ranged from 4 months to 1 year. In five hips, perfusion increased following surgery, with a mean pre-surgery PE of 6.7 ±2.5(± SE) and PI of 10.5 ±6.3; and a post-reduction PE of 13.1±6.1 (p=0.07) and PI of 14.2 ±6.2 (p=0.008). The change in contrast visualization was observed to be greater within the central aspect of the cartilaginous femoral epiphysis. The proposed technique can quantify pre- and post-surgical perfusion changes on CEUS images in patients with developmental dysplasia. This quantitative technique may provide a more objective and accurate assessment of changes in femoral head perfusion that may have the potential to be indicative of the risk of developing AVN.

Infant behavioral state and stool microbiome in infants receiving Lactocaseibacillus rhamnosus GG in formula: randomized controlled trial

BackgroundOur aim was to evaluate infant behavioral state, stool microbiome profile and calprotectin in infants with infantile colic receiving a partially hydrolyzed protein formula with or without added Lacticaseibacillus (formerly Lactobacillus) rhamnosus GG (LGG).MethodsIn this single-center, double-blind, controlled, parallel, prospective study, term infants (14–28 days of age) identified with colic (using modified Wessel’s criteria: cried and/or fussed ≥ 3 h/day for ≥ 3 days/week, in a one-week period) were randomized to receive one of two formulas over a three-week feeding period: marketed partially hydrolyzed cow’s milk-based infant formula (PHF, n = 35) or a similar formula with added LGG (PHF-LGG, n = 36). Parent-reported infant behavior was recorded at three time points (Study Days 2–4, 10–12, and 18–20). Duration (hours/day) of crying/fussing (averaged over each three-day period) was the primary outcome. Stool samples were collected at Baseline and Study End (Days 19–21) to determine stool LGG colonization (by qPCR) and microbial abundance (using 16S rRNA gene sequencing) and calprotectin (μg/g).ResultsDuration of crying/fussing (mean ± SE) decreased and awake/content behavior increased over time with no significant group differences over the course of the study. There were no group differences in the percentage of infants who experienced colic by study end. Colic decreased by Study End vs Baseline in both groups. Change in fecal calprotectin also was similar between groups. Comparing Study End vs Baseline, LGG abundance was greater in the PHF-LGG group (P < 0.001) whereas alpha diversity was greater in the PHF group (P = 0.022). Beta diversity was significantly different between PHF and PHF-LGG at Study End (P = 0.05). By study end, relative abundance of L. rhamnosus was higher in the PHF-LGG vs PHF group and vs Baseline.ConclusionsIn this pilot study of infants with colic, both study formulas were well tolerated. Crying/fussing decreased and awake/content behavior increased in both study groups over the course of the study. Study results demonstrate a successful introduction of the probiotic to the microbiome. The partially hydrolyzed protein formula with added LGG was associated with significant changes in the gut microbiome.Trial registrationClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT02340143. Registered 16/01/2015.

Diaphragm Ultrasonography to Predict Noninvasive Respiratory Treatment Failure in Infants With Severe Bronchiolitis.

Noninvasive respiratory support is commonly used in treatment of bronchiolitis. Determinants of failure are needed to prevent delayed intubation. We conducted a prospective observational pilot study in infants admitted to a pediatric ICU. Diaphragmatic excursion (dExc), diaphragmatic inspiratory/expiratory time, and diaphragmatic thickening fraction (dTF) were recorded at admission, 24 h, and 48 h in both hemidiaphragms. Twenty-six subjects were included (14 on HFNC and 12 on NIV) with a total of 56 ultrasonographic evaluations. Three subjects required invasive ventilation. Sixty-four percent of the subjects on HFNC required NIV as rescue therapy and 2/14 invasive ventilation (14.2%). In the HFNC group there were no differences in dExc between those who required escalation to NIV or invasive ventilation and those who didn't. Left dTF was higher in subjects on HFNC requiring invasive ventilation versus those needing NIV (left dTF 47% vs 22% [13-30]; P = .046, r = 0.7). Diaphragmatic I:E ratios were higher in infants on HFNC requiring invasive ventilation and diaphragmatic expiratory time was shorter (left P = .038; right P = .02). In the NIV group there were no differences in dExc, I:E ratios, or dTF between subjects needing escalation to invasive ventilation and those who didn't. We found no correlation between a clinical work of breathing score and echographic dTF. In infants with moderate or severe bronchiolitis receiving HFNC, the use of ultrasonographic left dTF could help predict respiratory treatment failure and need for invasive ventilation. The use of ultrasonographic dExc is of little help to predict both.

Head circumference in infants undergoing Foker process for long-gap esophageal atresia repair: Call for attention

IntroductionWe extended our pilot study in infants following long-gap esophageal atresia (LGEA) repair to report head circumference, an easily obtainable indirect measure of brain size. Data are presented in the context of previously reported body weight and T2-weighted MRI measures of intracranial and brain volumes. MethodsClinical information and head circumference were obtained for term-born (n = 13) and premature (n = 13) infants following LGEA repair with Foker process, as well as healthy term-born controls (n = 20) <1-year corrected age who underwent non-sedated research MRI. General Linear Model univariate analysis with corrected age at scan as a covariate and Bonferroni adjusted p values assessed group differences. ResultsWe report no difference in head circumference between the three groups. Such findings paralleled trends in body weight and total intracranial volume but not in brain volume as previously reported for the same pilot cohort. DiscussionResults suggest uncompromised somatic and head growth after repair of LGEA. In contrast, a novel finding of discrepancy between head circumference (novel data) and brain size (previously published data) in the same cohort suggests that head circumference might not be the best indirect measure of brain size in selected group of patients.

" All-Nasal " Approach for 25-Gauge Lens Sparing Vitrectomy in Stage 4B Retinopathy of Prematurity.

To describe a novel "all-nasal" approach for lens sparing vitrectomy in stage 4B retinopathy of prematurity. This is a pilot study in infants with Stage 4B retinopathy of prematurity. Eyes included had tractional retinal detachment approaching the retrolental space temporally. The surgeon sat nasal to the eye being operated. Infusion was placed in the center between the superonasal and inferonasal ports. The surgical technique and anatomical outcomes of eyes undergoing "all-nasal" lens sparing vitrectomy are reported. Eight eyes with Stage 4B retinopathy of prematurity were operated with this approach. All surgical objectives could be achieved with this technique. Lensectomy could be avoided in seven of the eight eyes (87.5%). At 6 months of follow-up, retinal reattachment could be achieved in 6 eyes (75%). All-nasal approach for lens sparing vitrectomy appears safe and effective in Stage 4B retinopathy of prematurity.

High-Flow Nasal Cannula versus Continuous Positive Airway Pressure in Critical Bronchiolitis: A Randomized Controlled Pilot.

We conducted a randomized controlled pilot study in infants with critical bronchiolitis ( n = 63) comparing high-flow nasal cannula (HFNC, n = 35) to continuous positive airway pressure (CPAP, n = 28). The primary outcome was treatment failure, defined as the need for bilevel positive pressure ventilation or endotracheal intubation. Treatment failure occurred in 10 patients (35.7%) in the CPAP group and 13 patients (37.1%) in the HFNC group ( p = 0.88). Pediatric intensive care unit length of stay was similar between the CPAP and HFNC groups (5 [4-7] days and 5 [4-8] days, p = 0.46, respectively). In this pilot study, treatment with HFNC resulted in a rate of treatment failure similar to CPAP.

Pulmonary exacerbations and clinical outcomes in a longitudinal cohort of infants and preschool children with cystic fibrosis

BackgroundPulmonary exacerbations (PEx) in school aged children and adults with cystic fibrosis (CF) lead to increased morbidity and lung function decline. However, the effect of exacerbations in young children with CF is not fully understood. We sought to characterize the frequency and clinical impact of PEx in a pilot study of infants and pre-school aged children with CF.MethodsThirty young children with CF [median (range) 1.5 years (0.2–4.9)] were prospectively followed for 2 years. Exacerbation frequency (hospitalizations and outpatient antibiotic use) was determined. Chest radiographs were performed at enrollment and study completion and assigned a Brasfield score. Lung function at age 7 years was assessed in a subset of children. The association between PEx frequency, chest radiograph score, and lung function was determined using Spearman correlation coefficients and corresponding 95% confidence intervals. Correlations with an absolute magnitude of 0.3 or greater were considered clinically significant.ResultsOver 2 years, participants experienced a median of two PEx (range 0–13). Chest radiograph scores at enrollment and study completion were inversely associated with PEx frequency (R = −0.48 and R = −0.44, respectively). The association between frequency of PEx and lung function [forced expiratory volume in 1 s (FEV1)] at age 7 years was small (R = 0.20). Higher forced vital capacity (FVC) at 7 years was associated with more frequent PEx during the study (R = 0.44).ConclusionsChildren with worse chest radiograph scores had more frequent PEx over the subsequent 2 years, suggesting a group of patients at higher risk for PEx. Frequent PEx in infants and young children with CF were not associated with lower FEV1 and FVC at 7 years, although spirometry in this age group may not be a sensitive marker of mild lung disease and disease progression.

Ethanol lock therapy: a pilot infusion study in infants.

Ethanol lock therapy (ELT) has emerged as an effective method for the prevention and treatment of central line-associated bloodstream infections (CLABSIs), but the safety of ELT in infants has not been established. The objective of this study was to determine blood alcohol concentration (BAC) and evidence of hepatic injury in infants after infusing a small one-time dose of ethanol, equivalent to the volume that would be flushed through the central venous catheter (CVC) after ELT is completed. This was a prospective pilot study in infants weighing ≤6 kg with and without liver dysfunction who had a CVC. The primary end points were 5-minute and 1-hour BACs after a 0.4-mL dose of 70% ethanol was flushed through the CVC. Acceptable BACs were defined as <0.025% at 5 minutes and <0.01% at 1 hour. The secondary end point was evidence of hepatic injury, defined as a change of greater than 2 times the upper limit of normal of any component in the hepatic panel in patients with a normal baseline panel or doubling of any component in the hepatic panel in patients with an abnormal baseline panel (aspartate aminotransferase, alanine transaminase, total or direct bilirubin, gamma-glutamyl transferase, or alkaline phosphatase). A total of 10 patients were included for analysis, with a mean age and weight of 3.5 ± 2.4 months and 4.5 ± 0.9 kg, respectively. All patients had acceptable BACs and no evidence of hepatic injury. In 8 patients, 5-minute BACs were undetectable; BACs of the other 2 patients were 0.011%. One-hour BACs in all patients were undetectable. Flushing ELT resulted in acceptable BACs and no evidence of hepatic injury in this patient cohort. Further studies are needed to investigate the long-term safety and efficacy of ethanol infusion after ELT in this patient population for the prevention and treatment of CLABSIs.

Effect of Dietary Fiber on Endogenous Cholesterol Synthesis in Infants† 1521

Cholesterol (chol) content of infant diet varies with human milk providing≈150 mg/dl vs 11 mg/dl in commercial (Similac) infant formula. Endogenous chol fractional synthesis rate (FSR) is significantly lower in human milk vs formula fed infants (Pediatr Res 1994;35:135). Dietary fiber decreases chol absorption in adults. Parents often begin solids before the AAP- recommended 4-6 months (mon) of age, but metabolic effects of infant feeding practices are unknown. We conducted a pilot study to test the hypothesis that addition of dietary fiber to infant diet would result in higher chol FSR.Methods: 12 male term infants were fed SMA formula (chol 33mg/dl) to 1 yr of age. Subjects were randomized to begin barley cereal 8 Tbs/d (1.5g fiber/d) at the start of the 4th or 6th mon. Growth, dietary intake by 4-day records, serum chol and lipoproteins, & FSR were measured after 4 & 12 mon of age. FSR was measured using deuterium enrichment of erythrocyte membrane chol over a 4-day period (J Lipid Res 1991;32:1049). Nonparametric statistics were used. Results: There were no significant differences between groups for weight, intake, lipid, or FSR analyses. Median chol intake& synthesis rates are shown in the Table. Conclusion: In this pilot study of infants with moderate chol intake, earlier addition of dietary fiber resulted in a trend toward higher endogenous chol FSR that persisted beyond the dietary intervention.Speculation: Chol FSR during infancy may be responsive to early diet, which may have life-long implications for chol metabolism and cardiovascular disease risk. These pilot data may be used to design definitive studies of infant diet & cholesterol metabolism.