Francesca Orsini

Incidence and Outcome of CPAP Failure in Preterm Infants

BACKGROUND AND OBJECTIVES: Data from clinical trials support the use of continuous positive airway pressure (CPAP) for initial respiratory management in preterm infants, but there is concern regarding the potential failure of CPAP support. We aimed to examine the incidence and explore the outcomes of CPAP failure in Australian and New Zealand Neonatal Network data from 2007 to 2013. METHODS: Data from inborn preterm infants managed on CPAP from the outset were analyzed in 2 gestational age ranges (25–28 and 29–32 completed weeks). Outcomes after CPAP failure (need for intubation <72 hours) were compared with those succeeding on CPAP using adjusted odds ratios (AORs). RESULTS: Within the cohort of 19 103 infants, 11 684 were initially managed on CPAP. Failure of CPAP occurred in 863 (43%) of 1989 infants commencing on CPAP at 25–28 weeks’ gestation and 2061 (21%) of 9695 at 29–32 weeks. CPAP failure was associated with a substantially higher rate of pneumothorax, and a heightened risk of death, bronchopulmonary dysplasia (BPD) and other morbidities compared with those managed successfully on CPAP. The incidence of death or BPD was also increased: (25–28 weeks: 39% vs 20%, AOR 2.30, 99% confidence interval 1.71–3.10; 29–32 weeks: 12% vs 3.1%, AOR 3.62 [2.76–4.74]). The CPAP failure group had longer durations of respiratory support and hospitalization. CONCLUSIONS: CPAP failure in preterm infants is associated with increased risk of mortality and major morbidities, including BPD. Strategies to promote successful CPAP application should be pursued vigorously.

Appetite Control and Glycaemia Reduction in Overweight Subjects treated with a Combination of Two Highly Standardized Extracts from Phaseolus vulgaris and Cynara scolymus

The management of overweight may include the use of dietary supplements targeted to favour the increase of the satiation associated with a decrease in blood glucose and lipid levels. The aim of this study was to evaluate the efficacy of a dietary supplementation with an extract from Phaseolus vulgaris and Cynara scolymus, on satiation, the glucose and lipid pattern. A randomized, double‐blind, placebo‐controlled clinical trial was performed in 39 overweight subjects (20 supplemented group, 19 placebo group) for 2 months. The modification of satiation, by Habers scale, was the primary end‐point, and the variation of the glucose and lipid pattern, of the anthropometric parameters and of the psychodynamic tests score were the secondary end‐points. At the end of treatment, the net change of the Habers mean score increased significantly in the intervention group. The net change of the glycaemia and of the dietary restriction score of the three factor eating questionnaire (TFEQ), were reduced significantly only in the intervention group. Moreover, in the supplemented group, the homeostasis model assessment, the body mass index and the susceptibility‐to‐hunger score of the TFEQ, decreased significantly after intervention; these parameters did not change in the controls. This treatment appears potentially useful in the management of overweight and dysglycaemia. Copyright

Semen controlled-release capsules allow a single artificial insemination in sows

Controlled-release capsules containing boar spermatozoa were developed to extend the preservation time of spermatozoa and maximize the efficiency of a single artificial insemination. A large trial (4245 sows) was performed with these capsules using double/triple conventional artificial insemination as a control. The effect of treatment on pregnancy diagnosis, delivery, and born piglets was investigated, with allowance being made for considering season, spermatozoa amount, and the weaning-to-estrus interval as confounding variables. The same pregnancy rate and prolificacy were obtained by two insemination techniques, and a higher parturition frequency was reached with capsules. The reproductive performance in pigs has therefore been optimized by a single instrumental insemination with controlled-release capsules.

Headache after lumbar puncture: randomised crossover trial of 22-gauge versus 25-gauge needles

Objectives To compare the frequency of headache and the procedure time following lumbar puncture (LP) using a 25-gauge needle compared to a 22-gauge needle. Design 4-period crossover blinded randomised controlled trial. Setting Oncology unit, Royal Childrens Hospital, Melbourne. Patients Children aged 4–15 years at enrolment having LPs as part of their treatment for leukaemia. Interventions Each child was allocated a random sequence of four LPs, two with a 22-gauge and two with a 25-gauge needle. Outcome measures The presence of post-LP headache. Secondary outcomes included the presence of any headache, procedure time and impact of headache on the family. Results Data on 341 procedures in 93 randomised children were analysed. There was little difference in the incidence of post-LP headache between the two needle sizes (22-gauge 7.2%, 95% CI 3.8 to 12.2; 25-gauge 4.6%, 95% CI 2.0 to 8.9, p=0.3) or in the incidence of any headache (22-gauge 18% 95% CI 12.5 to 24.6; 25-gauge 15%, 95% CI 10.0 to 21.1, p=0.4). Use of the 25-gauge needle was associated with longer procedure times. The incidence of post-LP headache showed little evidence of an age effect (OR =1.1, 95% CI 0.98 to 1.3) and was higher in girls than in boys (11% vs 3%, respectively, OR=3.3, 95% CI 1.3 to 8.4, p=0.014). Fifty-five per cent of families with a child with a post-LP headache assessed the overall functional impact as moderate or severe. Conclusions There was little difference in the occurrence of post-LP headache or any headache between procedures carried out using the 22-gauge or 25-gauge needles. Depending on the circumstances of the procedure and the experience of the operator, either gauge may be appropriate for an LP in a child.

Children with cerebral palsy and periventricular white matter injury: Does gestational age affect functional outcome?

This study aimed to determine differences in functional profiles and movement disorder patterns in children aged 4-12 years with cerebral palsy (CP) and periventricular white matter injury (PWMI) born >34 weeks gestation compared with those born earlier. Eligible children born between 1999 and 2006 were recruited through the Victorian CP register. Functional profiles were determined using the Gross Motor Function Classification System (GMFCS), Manual Abilities Classification System (MACS), Communication Function Classification System (CFCS), Functional Mobility Scale (FMS) and Bimanual Fine Motor Function (BFMF). Movement disorder and topography were classified using the Surveillance of Cerebral Palsy in Europe (SCPE) classification. 49 children born >34 weeks (65% males, mean age 8 y 9 mo [standard deviation (SD) 2 y 2 mo]) and 60 children born ≤ 34 weeks (62% males, mean age 8 y 2 mo [SD 2 y 2 mo]) were recruited. There was evidence of differences between the groups for the GMFCS (p=0.003), FMS 5, 50 and 500 (p=0.003, 0.002 and 0.012), MACS (p=0.04) and CFCS (p=0.035), with a greater number of children born ≤ 34 weeks more severely impaired compared with children born later. Children with CP and PWMI born >34 weeks gestation had milder limitations in gross motor function, mobility, manual ability and communication compared with those born earlier.

Rotavirus Specific Maternal Antibodies and Immune Response to RV3-BB Neonatal Rotavirus Vaccine in New Zealand.

ABSTRACT Background: Maternal antibodies, acquired passively via placenta and/or breast milk, may contribute to the reduced efficacy of oral rotavirus vaccines observed in children in developing countries. This study aimed to investigate the effect of rotavirus specific maternal antibodies on the serum IgA response or stool excretion of vaccine virus after any dose of an oral rotavirus vaccine, RV3-BB, in parallel to a Phase IIa clinical trial conducted at Dunedin Hospital, New Zealand. At the time of the study rotavirus vaccines had not been introduced in New Zealand and the burden of rotavirus disease was evident. Methods: Rotavirus specific IgG and serum neutralizing antibody (SNA) levels in cord blood and IgA levels in colostrum and breast milk samples collected ∼4 weeks, ∼20 weeks and ∼28 weeks after birth were measured. Infants were randomized to receive the first dose of vaccine at 0–5 d (neonatal schedule) or 8 weeks (infant schedule). Breast feeding was with-held for 30 minutes before and after vaccine administration. The relationship between rotavirus specific IgG and SNA levels in cord blood and IgA in colostrum and breast milk at the time of first active dose of RV3-BB vaccine and level of IgA response and stool excretion after 3 doses of vaccine was assessed using linear and logistic regression. Results: Forty infants received 3 doses of RV3-BB rotavirus vaccine and were included in the analysis of the neonatal and infant groups. Rotavirus specific IgA in colostrum (neonatal schedule group) and breast milk at 4 weeks (infant schedule group) was identified in 14/21 (67%) and 14/17 (82%) of infants respectively. There was little evidence of an association between IgA in colostrum or breast milk IgA at 4 weeks, or between cord IgG or SNA level, and IgA response or stool excretion after 3 doses of RV3-BB, or after one dose (neonatal schedule) (all p>0.05). Conclusions: The level of IgA in colostrum or breast milk and level of placental IgG and SNA did not impact on the serum IgA response or stool excretion following 3 doses of RV3-BB Rotavirus Vaccine administered using either a neonatal or infant schedule in New Zealand infants.

The addition of tramadol to the standard of IV acetaminophen and morphine infusion for postoperative analgesia in neonates offers no clinical benefit: a randomized placebo‐controlled trial

Tramadol is used following neonatal cardiac and general surgery. However, its ability to opioid‐spare or facilitate earlier extubation in postoperative neonates is unquantified.

Classroom promotion of oral language (CPOL): protocol for a cluster randomised controlled trial of a school-based intervention to improve children's literacy outcomes at grade 3, oral language and mental health

Introduction Oral language and literacy competence are major influences on children’s developmental pathways and life success. Children who do not develop the necessary language and literacy skills in the early years of school then go on to face long-term difficulties. Improving teacher effectiveness may be a critical step in lifting oral language and literacy outcomes. The Classroom Promotion of Oral Language trial aims to determine whether a specifically designed teacher professional learning programme focusing on promoting oral language can lead to improved teacher knowledge and practice, and advance outcomes in oral language and literacy for early years school children, compared with usual practice. Methods and analysis This is a two-arm cluster multisite randomised controlled trial conducted within Catholic and Government primary schools across Victoria, Australia. The intervention comprises 4 days of face-to-face professional learning for teachers and ongoing implementation support via a specific worker. The primary outcome is reading ability of the students at grade 3, and the secondary outcomes are teacher knowledge and practice, student mental health, reading comprehension and language ability at grade 1; and literacy, writing and numeracy at grade 3. Economic evaluation will compare the incremental costs of the intervention to the measured primary and secondary outcomes. Ethics and dissemination This trial was approved by the Monash University Human Research Ethics Committee #CF13/2634-2013001403 and later transferred to the University of Melbourne #1545540. The investigators (including Government and Catholic partners) will communicate trial results to stakeholders, collaborators and participating schools and teachers via appropriate presentations and publications. Trial registration number ISRCTN77681972; Pre-results.

What do Clinicians Perceive as a Successful "Trial of Fluids"?: A Secondary Assessment of a Randomized Controlled Trial.

Objective The aim of the study was to explore physician perceptions of the amount of fluid that demonstrates a successful “trial of fluids” (adequate fluid intake) in the emergency department in children who have had insufficient fluid intake at home. Methods This is a secondary analysis of a randomized placebo-controlled trial of viscous lidocaine versus placebo in children aged 6 months to 8 years with acute infectious ulcerative mouth conditions (gingivostomatitis, ulcerative pharyngitis, or hand foot and mouth disease) and poor oral fluid intake. We measured the amount of fluid ingested in 60 minutes after administration of the intervention and related physician perception of adequate intake to measured intake. Given that there was little difference in oral intake between the treatment groups, the 2 arms were pooled for this analysis. Results One hundred participants were recruited (50 per treatment group), all of whom completed the 60-minute trial period. At baseline, 72% were mildly dehydrated, 21% were not dehydrated, and 5% were moderately dehydrated. The participants drank a median of 8.6 mL/kg (interquartile range [IQR], 3.7-14). Clinicians perceived 58% of the participants to have an adequate intake within the first hour after intervention. The median consumption of those whose oral intake was deemed as adequate was 12.6 mL/kg (IQR, 9.4–18.4); for those whose oral intake was not deemed adequate, the median consumption was 2.7 mL/kg (IQR, 0.7–5.3) (rank sum, P < 0.001). Conclusions In children undergoing trial of fluids, we found that most clinicians perceived a fluid intake greater than 9 mL/kg as adequate and lower than 5 mL/kg as inadequate.