Securing peripheral intravenous catheters in babies without applying adhesive dressings to the skin: a proof-of-concept study.

BACKGROUND: Most babies admitted to a Neonatal Intensive Care Unit (NICU) require a peripheral intravenous catheter (PIVC). PIVCs are secured using splints and adhesive dressings applied to the skin. Removing the dressings causes skin injury, pain, and risks infection. We designed the Pepi Splint, which supports PIVCs without the application of adhesive dressings to the skin. We sought to determine the effectiveness and acceptability of the Pepi Splint using a proof-of-concept design. METHODS: Eligible babies were > 1000 g and > 30 weeks' corrected gestation admitted to Wellington Regional NICU and who required a PIVC. All babies received the same care as those not in the study, with the addition of the Pepi Splint. Primary outcomes were the proportion of babies in which the Pepi Splint secured the PIVC for the required time and proportion of babies who experience an adverse event. Secondary outcomes were the acceptability of the Pepi Splint as reported by the parents. RESULTS: Thirty-eight babies, median (range) birth weight 2625 g (396-4970) and gestation 37wk (22-41). When the Pepi was applied the postnatal weight was 2969 g (1145 - 4970) and gestation 37wk (29 - 41). The Pepi Splint held the PIVC secure for 34/38 babies (89%), for a duration of 37 h (6 to 97). There were no adverse events. Of the four babies reported to have unsecure PIVCs, two were due to the securement two were displaced during feeding. Fifty-eight parents responded to a questionnaire (32 mothers, 26 fathers). Of these parents 52 (90%) would participate again and 52 (90%) would recommend participating to others. Overall, clinicians reported the Pepi Splint was easy to use 33/38 (87%). CONCLUSION: The Pepi Splint safely secures PIVCs without adhesive dressings being applied to the skin and is acceptable to both parents and clinicians. Our findings provide support for a larger multicentred randomised controlled trial. TRIAL REGISTRATION: Registered with the Australian and New Zealand Clinical Trials Registry Reference ACTRN12620001335987 .

UNICORN Babies: Understanding Circulating and Cerebral Creatine Levels of the Preterm Infant. An Observational Study Protocol.

Creatine is an essential metabolite for brain function, with a fundamental role in cellular (ATP) energy homeostasis. It is hypothesized that preterm infants will become creatine deplete in the early postnatal period, due to premature delivery from a maternal source of creatine and a limited supply of creatine in newborn nutrition. This potential alteration to brain metabolism may contribute to, or compound, poor neurological outcomes in this high-risk population. Understanding Creatine for Neurological Health in Babies (UNICORN) is an observational study of circulating and cerebral creatine levels in preterm infants. We will recruit preterm infants at gestational ages 23+0-26+6, 27+0-29+6, 30+0-32+6, 33+0-36+6, and a term reference group at 39+0-40+6 weeks of gestation, with 20 infants in each gestational age group. At birth, a maternal capillary blood sample, as well as a venous cord blood sample, will be collected. For preterm infants, serial infant plasma (heel prick), urine, and nutrition samples [total parenteral nutrition (TPN), breast milk, or formula] will be collected between birth and term "due date." Key fetomaternal information, including demographics, smoking status, and maternal diet, will also be collected. At term corrected postnatal age (CPA), each infant will undergo an MRI/1H-MRS scan to evaluate brain structure and measure cerebral creatine content. A general movements assessment (GMA) will also be conducted. At 3 months of CPA, infants will undergo a second GMA as well as further neurodevelopmental evaluation using the Developmental Assessment of Young Children - Second Edition (DAYC-2) assessment tool. The primary outcome measures for this study are cerebral creatine content at CPA and plasma and urine creatine and guanidinoacetate (creatine precursor) concentrations in the early postnatal period. We will also determine associations between (1) creatine levels at term CPA and neurodevelopmental outcomes (MRI, GMA, and DAY-C); (2) dietary creatine intake and circulating and cerebral creatine content; and (3) creatine levels and maternal characteristics. Novel approaches are needed to try and improve preterm-associated brain injury. Inclusion of creatine in preterm nutrition may better support ex utero brain development through improved cerebral cellular energy availability during a period of significant brain growth and development. Ethics Ref: HDEC 18/CEN/7 New Zealand. ACTRN: ACTRN12618000871246.

Gastric-Esophageal Stenting for Malignant Dysphagia: Results of Prospective Clinical Trial Evaluation of Long-Term Gastroesophageal Reflux and Quality of Life-Related Symptoms.

BACKGROUND: Stenting across the gastroesophageal (GE) junction for adenocarcinoma has historically been contraindicated secondary to the concerns for severe GE reflux (GER) symptoms. The aim of this study was to assess reflux symptoms and quality of life (QOL) effects in patients undergoing esophageal stenting across the GE junction. STUDY DESIGN: We performed a prospective single arm QOL clinical trial evaluating patients with stage 2/3 GE junction adenocarcinoma, undergoing neoadjuvant therapy (from baseline to 10 weeks post-stenting) after stenting across the GE junction, for GER symptoms and QOL-GER assessments (EORTC-QLQ-O25 and Functional Assessment of Cancer Therapy-Esophageal [FACT-E]). RESULTS: Forty consecutive patients were enrolled in this clinical trial. The median age was 62 years (range 47 to 83 years); 84% were male and 19% were female patients. Median dysphagia score of 3 (only liquids tolerated) pre-stent was significantly improved to a score of 0 (ability to eat all foods) post-stent (p = 0.01). There was a significantly improved and sustained swallowing QOL from 2 weeks up to 10 weeks post-stent. The GER-QOL scores were similar 2 weeks post-stent, but were significantly improved throughout the rest of the study. Proton pump inhibitors were being used in 58% of patients pre-stent and in 85% of patients at 2- to 10-week follow-up. Planned chemotherapy and/or chemo-radiation therapy was completed in 95% of all patients. Stent migration (radiologic and/or complete) was seen in 63% of patients at some time during their therapy and corresponded to pathologic response in 85% of those patients. CONCLUSIONS: Esophageal stenting across the GE junction remains the optimal therapy for dysphagia relief in esophageal malignancies and does not adversely affect a patient's GER-QOL. Esophageal stenting across the GE junction is not contraindicated and should be the initial therapy in patient management.

Gastroesophageal reflux disease-related symptom assessment in subjects with malignant dysphagia receiving esophageal stents.

Concerns remain over the ability to stent across of the lower esophageal sphincter (LES) for esophageal adenocarcinoma and the effects of gastroesophageal (GE) reflux. Thus, the aim of this study was to demonstrate minimal quality-of-life (QOL) side effects in patients undergoing esophageal stenting across the LES. An Institutional Review Board-approved prospective clinical trial evaluated the results of the Gastrointestinal Symptom questionnaire that includes a validated GE reflux disease (GERD) assessment (GERD-HRQL) and a dysphagia assessment. Consecutive patients were enrolled in this clinical trial, with 81 per cent male, 19 per cent female, median age of 62 years, with adenocarcinoma of the GE junction as their diagnosis. The median dysphagia score was 3 (only liquids can be tolerated) prestent and was improved to a median score of 0 (ability to eat all foods) poststent (P = 0.01). The median GERD score was 0 (none) prestent and did not change with a median score of 0 (none) poststent (P = 0.2). All GERD-related questions were unchanged prestent and poststent in all categories, specifically: frequency of GERD, time of day of reflux, pain behind breastbone, and pain medications. There was also no difference in regurgitation frequency (median prestent 1 vs poststent 0, P = 0.08), texture (prestent 2 [semisolid] vs poststent 1 [liquid]). There was only a statistical change in the ability to belch (prestent 0 [no ability] to poststent 1 [ability]), P = 0.02) and the ability to vomit. Esophageal stenting across the GE junction for dysphagia relief in esophageal malignancies does not adversely effect a patient's QOL in regard to reflux-related symptoms.