Developing a model of neonatal nurse-controlled analgesia: A Delphi study.

AIM: To develop a nurse-led model of analgesia to manage post-operative pain in the surgical neonate. DESIGN: A four-round e-Delphi study was conducted from March to December 2022. METHODS: An e-Delphi method was used seeking a consensus of 70% or greater. Fifty-one experts were invited to join the panel. Members consisted of multi-disciplinary healthcare professionals who work in areas associated with neonatal care. In round 1, 49 statements relative to neonatal pain assessment and management were distributed to the panel. Panel members were asked to rate their level of agreeance on a Likert scale from 1 to 5 (1 = strongly disagree to 5 = strongly agree). Ratings equal to or greater than 4 represented agreement, 3 indicated uncertainty and 2 or less disagreement with the proposed statement. An opportunity for free-text responses after each statement was provided. This iterative process continued for three rounds. In the fourth and final round, the completed model of neonatal nurse-controlled analgesia was presented along with a further opportunity to provide feedback on the final version. RESULTS: Four rounds of statements and voting were required to reach consensus on a model of neonatal nurse-controlled analgesia. The model consists of criteria for use, over-arching guidelines and three separate pathways based on an individual baby's pain assessment scores, need for pain relieving interventions and time-lapsed post-surgical procedure. CONCLUSION: A comprehensive model of neonatal nurse-controlled analgesia, applicable to the Australasian context, was developed in collaboration with a group of neonatal experts. IMPACT: This study provides a multi-modal family-integrated model to manage neonatal post-operative pain. By providing nurses with increased autonomy to assess and manage acute pain, this model has the potential to not only provide a more responsive and individualized approach to alleviate discomfort, but highlights the integral role of parent partnerships in the neonatal intensive care. REPORTING METHOD: This study was reported in line with the Conducting and REporting of DElphi studies (CREDE) guidance on Delphi studies. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution was utilized for this study.

Higher versus lower sodium intake for preterm infants.

BACKGROUND: Infants born preterm are at increased risk of early hypernatraemia (above-normal blood sodium levels) and late hyponatraemia (below-normal blood sodium levels). There are concerns that imbalances of sodium intake may impact neonatal morbidities, growth and developmental outcomes. OBJECTIVES: To determine the effects of higher versus lower sodium supplementation in preterm infants. SEARCH METHODS: We searched CENTRAL in February 2023; and MEDLINE, Embase and trials registries in March and April 2022. We checked reference lists of included studies and systematic reviews where subject matter related to the intervention or population examined in this review. We compared early (< 7 days following birth), late (≥ 7 days following birth), and early and late sodium supplementation, separately. SELECTION CRITERIA: We included randomised, quasi-randomised or cluster-randomised controlled trials that compared nutritional supplementation that included higher versus lower sodium supplementation in parenteral or enteral intake, or both. Eligible participants were preterm infants born before 37 weeks' gestational age or with a birth weight less than 2500 grams, or both. We excluded studies that had prespecified differential water intakes between groups. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed eligibility and risk of bias, and extracted data. We used the GRADE approach to assess the certainty of evidence. MAIN RESULTS: We included nine studies in total. However, we were unable to extract data from one study (20 infants); some studies contributed to more than one comparison. Eight studies (241 infants) were available for quantitative meta-analysis. Four studies (103 infants) compared early higher versus lower sodium intake, and four studies (138 infants) compared late higher versus lower sodium intake. Two studies (103 infants) compared intermediate sodium supplementation (≥ 3 mmol/kg/day to < 5 mmol/kg/day) versus no supplementation, and two studies (52 infants) compared higher sodium supplementation (≥ 5 mmol/kg/day) versus no supplementation. We assessed only two studies (63 infants) as low risk of bias. Early (less than seven days following birth) higher versus lower sodium intake Early higher versus lower sodium intake may not affect mortality (risk ratio (RR) 1.02, 95% confidence interval (CI) 0.38 to 2.72; I2 = 0%; 3 studies, 83 infants; low-certainty evidence). Neurodevelopmental follow-up was not reported. Early higher versus lower sodium intake may lead to a similar incidence of hyponatraemia < 130 mmol/L (RR 0.68, 95% CI 0.40 to 1.13; I2 = 0%; 3 studies, 83 infants; low-certainty evidence) but an increased incidence of hypernatraemia ≥ 150 mmol/L (RR 1.62, 95% CI 1.00 to 2.65; I2 = 0%; 4 studies, 103 infants; risk difference (RD) 0.17, 95% CI 0.01 to 0.34; number needed to treat for an additional harmful outcome 6, 95% CI 3 to 100; low-certainty evidence). Postnatal growth failure was not reported. The evidence is uncertain for an effect on necrotising enterocolitis (RR 4.60, 95% CI 0.23 to 90.84; 1 study, 46 infants; very low-certainty evidence). Chronic lung disease at 36 weeks was not reported. Late (seven days or more following birth) higher versus lower sodium intake Late higher versus lower sodium intake may not affect mortality (RR 0.13, 95% CI 0.01 to 2.20; 1 study, 49 infants; very low-certainty evidence). Neurodevelopmental follow-up was not reported. Late higher versus lower sodium intake may reduce the incidence of hyponatraemia < 130 mmol/L (RR 0.13, 95% CI 0.03 to 0.50; I2 = 0%; 2 studies, 69 infants; RD -0.42, 95% CI -0.59 to -0.24; number needed to treat for an additional beneficial outcome 2, 95% CI 2 to 4; low-certainty evidence). The evidence is uncertain for an effect on hypernatraemia ≥ 150 mmol/L (RR 7.88, 95% CI 0.43 to 144.81; I2 = 0%; 2 studies, 69 infants; very low-certainty evidence). A single small study reported that later higher versus lower sodium intake may reduce the incidence of postnatal growth failure (RR 0.25, 95% CI 0.09 to 0.69; 1 study; 29 infants; low-certainty evidence). The evidence is uncertain for an effect on necrotising enterocolitis (RR 0.07, 95% CI 0.00 to 1.25; 1 study, 49 infants; very low-certainty evidence) and chronic lung disease (RR 2.03, 95% CI 0.80 to 5.20; 1 study, 49 infants; very low-certainty evidence). Early and late (day 1 to 28 after birth) higher versus lower sodium intake for preterm infants Early and late higher versus lower sodium intake may not have an effect on hypernatraemia ≥ 150 mmol/L (RR 2.50, 95% CI 0.63 to 10.00; 1 study, 20 infants; very low-certainty evidence). No other outcomes were reported. AUTHORS' CONCLUSIONS: Early (< 7 days following birth) higher sodium supplementation may result in an increased incidence of hypernatraemia and may result in a similar incidence of hyponatraemia compared to lower supplementation. We are uncertain if there are any effects on mortality or neonatal morbidity. Growth and longer-term development outcomes were largely unreported in trials of early sodium supplementation. Late (≥ 7 days following birth) higher sodium supplementation may reduce the incidence of hyponatraemia. We are uncertain if late higher intake affects the incidence of hypernatraemia compared to lower supplementation. Late higher sodium intake may reduce postnatal growth failure. We are uncertain if late higher sodium intake affects mortality, other neonatal morbidities or longer-term development. We are uncertain if early and late higher versus lower sodium supplementation affects outcomes.

Intratracheal budesonide mixed with surfactant to increase survival free of bronchopulmonary dysplasia in extremely preterm infants: study protocol for the international, multicenter, randomized PLUSS trial.

BACKGROUND: Bronchopulmonary dysplasia (BPD), an inflammatory-mediated chronic lung disease, is common in extremely preterm infants born before 28 weeks' gestation and is associated with an increased risk of adverse neurodevelopmental and respiratory outcomes in childhood. Effective and safe prophylactic therapies for BPD are urgently required. Systemic corticosteroids reduce rates of BPD in the short-term but are associated with poorer neurodevelopmental outcomes if given to ventilated infants in the first week after birth. Intratracheal administration of corticosteroid admixed with exogenous surfactant could overcome these concerns by minimizing systemic sequelae. Several small, randomized trials have found intratracheal budesonide in a surfactant vehicle to be a promising therapy to increase survival free of BPD. METHODS: An international, multicenter, double-blinded, randomized trial of intratracheal budesonide (a corticosteroid) mixed with surfactant for extremely preterm infants to increase survival free of BPD at 36 weeks' postmenstrual age (PMA; primary outcome). Extremely preterm infants aged < 48 h after birth are eligible if: (1) they are mechanically ventilated, or (2) they are receiving non-invasive respiratory support and there is a clinical decision to treat with surfactant. The intervention is budesonide (0.25 mg/kg) mixed with poractant alfa (200 mg/kg first intervention, 100 mg/kg if second intervention), administered intratracheally via an endotracheal tube or thin catheter. The comparator is poractant alfa alone (at the same doses). Secondary outcomes include the components of the primary outcome (death, BPD prior to or at 36 weeks' PMA), potential systemic side effects of corticosteroids, cost-effectiveness, early childhood health until 2 years of age, and neurodevelopmental outcomes at 2 years of age (corrected for prematurity). DISCUSSION: Combining budesonide with surfactant for intratracheal administration is a simple intervention that may reduce BPD in extremely preterm infants and translate into health benefits in later childhood. The PLUSS trial is powered for the primary outcome and will address gaps in the evidence due to its pragmatic and inclusive design, targeting all extremely preterm infants regardless of their initial mode of respiratory support. Should intratracheal budesonide mixed with surfactant increase survival free of BPD, without severe adverse effects, this readily available intervention could be introduced immediately into clinical practice. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ( https://www.anzctr.org.au ), ACTRN12617000322336. First registered on 28th February 2017.

'Propped and prone' positioning reduces respiratory events in spontaneously breathing preterm infants: A randomised triple crossover study.

AIM: We compared effects of infant positioning and feed-rate interventions on respiratory events and oximetry parameters in spontaneously breathing preterm infants born <32 weeks gestation managed in a neonatal unit. METHODS: A randomised triple crossover design was employed. n = 68 infants underwent three test conditions A: control (supine/flat, gravity bolus feeds), B: position intervention (propped/prone) and C: feed-rate intervention (continuous pump feeds) in randomised sequence over three consecutive days. Primary outcomes were number of events (apnoea, bradycardia and desaturation) and percentage time SpO2 < 80% over 24 h. The secondary outcome was percentage time SpO2 ≥ 88%. Treatment effects were estimated using linear mixed-effects models. RESULTS: Propped/prone positioning significantly reduced events and improved percentage time SpO2 < 80% and ≥88% compared to both other conditions (all P < 0.001). Outcomes for the feed-rate intervention were not significantly different to control. CONCLUSIONS: Alternative infant positioning should be considered in preterm infants managed in the neonatal unit.

Decreasing delivery room intubations: A quality improvement project.

AIM: The delivery room intubation rate for babies born less than 32 weeks postmenstrual age (PMA) at the Mater Mothers' Hospital in 2017 was 51%. Delivery room intubation of preterm infants may be associated with an increased risk of developing bronchopulmonary dysplasia. This quality improvement project aimed to decrease the rate of delivery room intubation for infants born less than 32 weeks PMA. METHODS: A quality improvement process using the evidence-based practice for improving quality framework and Plan-Do-Study-Act cycles was undertaken from October 2018 to December 2019. Commencing bubble continuous positive airway pressure for initial resuscitation in the delivery room was the principal change idea. RESULTS: The delivery room intubation rate for infants born less than 32 weeks PMA before the commencement of this project was 48% (cohort 1, n = 221). There was a significant decrease in the rate to 37.2% while the project was being conducted (cohort 2, n = 277) and a further significant reduction to 28.2% after introducing bubble continuous positive airway pressure in the delivery room (cohort 3, n = 202). There was a significant improvement in admission temperatures and a significant decrease in mortality rate between cohort 1 and cohort 2 but not between cohort 2 and cohort 3. There was no change in the rate of discharge home on oxygen between cohorts. CONCLUSIONS: This quality improvement project led to a significantly decreased delivery room intubation rate in infants born less than 32 weeks PMA. There was no evidence of any adverse outcomes with this approach.

Standardised neonatal parenteral nutrition formulations - Australasian neonatal parenteral nutrition consensus update 2017.

BACKGROUND: The first consensus standardised neonatal parenteral nutrition formulations were implemented in many neonatal units in Australia in 2012. The current update involving 49 units from Australia, New Zealand, Singapore, Malaysia and India was conducted between September 2015 and December 2017 with the aim to review and update the 2012 formulations and guidelines. METHODS: A systematic review of available evidence for each parenteral nutrient was undertaken and new standardised formulations and guidelines were developed. RESULTS: Five existing preterm Amino acid-Dextrose formulations have been modified and two new concentrated Amino acid-Dextrose formulations added to optimise amino acid and nutrient intake according to gestation. Organic phosphate has replaced inorganic phosphate allowing for an increase in calcium and phosphate content, and acetate reduced. Lipid emulsions are unchanged, with both SMOFlipid (Fresenius Kabi, Australia) and ClinOleic (Baxter Healthcare, Australia) preparations included. The physicochemical compatibility and stability of all formulations have been tested and confirmed. Guidelines to standardise the parenteral nutrition clinical practice across facilities have also been developed. CONCLUSIONS: The 2017 PN formulations and guidelines developed by the 2017 Neonatal Parenteral Nutrition Consensus Group offer concise and practical instructions to clinicians on how to implement current and up-to-date evidence based PN to the NICU population.

Evaluation of the Kejian KJ-8000 bilirubinometer in an Australian setting.

AIM: To evaluate the accuracy of the Kejian 8000 (KJ-8000) transcutaneous bilirubinometer in infants of differing ethnicity and gestational age. METHODS: This was a prospective study of infants in the Newborn Care Unit at Gold Coast University Hospital. Transcutaneous bilirubin (TcB) and serum bilirubin (SBR) results were compared using linear regression and a Bland-Altman plot. Predicted indices were calculated to assess the KJ-8000 as a screening tool using local jaundice management guidelines. RESULTS: A total of 416 paired samples were collected from 201 infants. There was a strong correlation between TcB and SBR with a Pearson correlation coefficient of 0.8 (<0.00001). The bias was -5.9 µmol/L (95% confidence interval: -101, 89). The bias was not evenly spread, with the KJ-8000 tending to underestimate at higher SBR levels. Infants <32 weeks' gestation had a poor correlation of 0.48. Non-Caucasian infants were more likely to have TcB overestimation, and measurements were less precise. As a screening tool using local guidelines, the KJ-8000 had a sensitivity, specificity, positive predictive value and negative predictive value of 83, 53, 20 and 96%, respectively, and is predicted to avoid blood tests in 48% of infants screened. CONCLUSIONS: In this study, the correlation and agreement of TcB measurements using the KJ-8000 were not as good as has been reported with other more studied devices but may still have value as a screening tool. The poor correlation in preterm infants suggests that use should be restricted to term infants. The overall results of this study are affected by an underrepresentation of term infants, and so, further clinical assessment of this device should be undertaken before it can be recommended for widespread use.

A randomised, controlled trial of heparin in total parenteral nutrition to prevent sepsis associated with neonatal long lines: the Heparin in Long Line Total Parenteral Nutrition (HILLTOP) trial.

BACKGROUND: Infections are common complications of neonatal long lines. Heparin has been shown to prolong the effective duration of neonatal long lines and to reduce the ability of bacteria to adhere to foreign surfaces, but the effect of heparin on rates of infection is uncertain. OBJECTIVE: The goal of this study was to evaluate the effect of heparin on the frequency of episodes of catheter-related sepsis (CRS) in infants receiving total parenteral nutrition (TPN) through a neonatal long line. DESIGN/METHODS: This randomised, controlled, double blind, single-centre clinical trial compared heparin at 0.5 IU/ml with no heparin in TPN infused through a neonatal long line, with episodes of CRS as the primary outcome. RESULTS: 210 infants were enrolled (TPN with heparin n=102, TPN without heparin n=108). There was a statistically significant reduction in all episodes of culture-positive CRS in those infants with heparin added to the TPN compared with those without heparin (p=0.04; RR 0.57, 95% CI 0.32 to 0.98; number needed to treat 9, 95% CI 4.6 to 212.4). CONCLUSIONS: The addition of heparin at 0.5 IU/ml to TPN infused through a neonatal long line reduces the incidence of culture-positive CRS.