Seizures after initiation of rewarming in cooled infants with hypoxic ischaemic encephalopathy.

BACKGROUND: Seizures after initiation of rewarming from therapeutic hypothermia for neonatal encephalopathy are well recognised but not easy to predict. METHODS: A secondary analysis was performed of NEOLEV2 trial data, a multicentre randomised trial of levetiracetam versus phenobarbital for neonatal seizures. Enrolled infants underwent continuous video EEG (cEEG) monitoring. The trial data were reviewed for 42 infants with seizures during therapeutic hypothermia and 118 infants who received therapeutic hypothermia but had no seizures on cEEG. RESULTS: Overall, 112 of 160 (70%) had cEEG monitoring continued until rewarming was completed. Of the 42 infants with prior seizures, there were 30 infants with valid cEEG available and seizures occurred following the initiation of rewarming in 8 (26.6%). For the 118 seizure-naive infants, 82 (69.5%) continued cEEG until either rewarming was completed or 90 h of age and none had documented seizures. CONCLUSION: Overall, just over a quarter of infants with prior seizures had cEEG evidence of at least one seizure in the 24 h after initiation of rewarming but no seizure-naive infant had cEEG evidence of seizure(s) on rewarming. Critically, by reporting the two groups separately, the data can provide guidance on the duration of EEG monitoring. IMPACT: Infants with hypoxic ischaemic encephalopathy who have cEEG evidence of seizures during therapeutic hypothermia have a significant risk of further seizures on rewarming. For infants with hypoxic ischaemic encephalopathy but no cEEG evidence of seizures during therapeutic hypothermia, there is very little risk of de novo seizures. Ongoing work utilising large cohorts may generate EEG criteria that refine estimates of risk for rewarming seizures. Based on current experience, if seizures have occurred during therapeutic hypothermia for hypoxic ischaemic encephalopathy, the EEG monitoring should be continued during rewarming and for 12 h thereafter to minimise the risk of missing an event.

COHESION: a core outcome set for the treatment of neonatal encephalopathy.

BACKGROUND: Heterogeneity in outcomes reported in trials of interventions for the treatment of neonatal encephalopathy (NE) makes evaluating the effectiveness of treatments difficult. Developing a core outcome set for NE treatment would enable researchers to measure and report the same outcomes in future trials. This would minimise waste, ensure relevant outcomes are measured and enable evidence synthesis. Therefore, we aimed to develop a core outcome set for treating NE. METHODS: Outcomes identified from a systematic review of the literature and interviews with parents were prioritised by stakeholders (n = 99 parents/caregivers, n = 101 healthcare providers, and n = 22 researchers/ academics) in online Delphi surveys. Agreement on the outcomes was achieved at online consensus meetings attended by n = 10 parents, n = 18 healthcare providers, and n = 13 researchers/ academics. RESULTS: Seven outcomes were included in the final core outcome set: survival; brain injury on imaging; neurological status at discharge; cerebral palsy; general cognitive ability; quality of life of the child, and adverse events related to treatment. CONCLUSION: We developed a core outcome set for the treatment of NE. This will allow future trials to measure and report the same outcomes and ensure results can be compared. Future work should identify how best to measure the COS. IMPACT: We have identified seven outcomes that should be measured and reported in all studies for the treatment of neonatal encephalopathy. Previously, a core outcome set for neonatal encephalopathy treatments did not exist. This will help to reduce heterogeneity in outcomes reported in clinical trials and other studies, and help researchers identify the best treatments for neonatal encephalopathy.

Neonatal and maternal outcomes at early vs. full term following induction of labor; A secondary analysis of the OBLIGE randomized trial.

INTRODUCTION: Birth at early term (37+0-38+6 completed gestational weeks [GW] and additional days) is associated with adverse neonatal outcomes compared with waiting to ≥39 GW. Most studies report outcomes after elective cesarean section or a mix of all modes of births; it is unclear whether these adverse outcomes apply to early-term babies born after induction of labor (IOL). We aimed to determine, in women with a non-urgent induction indication (elective/planned >48 h in advance), if IOL at early and late term was associated with adverse neonatal and maternal outcomes compared with IOL at full term. MATERIAL AND METHODS: An observational cohort study as a secondary analysis of a multicenter randomized controlled trial of 1087 New Zealand women with a planned IOL ≥37+0 GW. Multivariable logistic regression was used to analyze neonatal and maternal outcomes in relation to gestational age; 37+0-38+6 (early term), 39+0-40+6 (full term) and ≥41+0 (late term) GW. Neonatal outcome analyses were adjusted for sex, birthweight, mode of birth and induction indication, and maternal outcome analyses for parity, age, body mass index and induction method. The primary neonatal outcome was admission to neonatal intensive care unit (NICU) for >4 hours; the primary maternal outcome was cesarean section. RESULTS: Among the 1087 participants, 266 had IOL at early term, 480 at full term, and 341 at late term. Babies born following IOL at early term had increased odds for NICU admission for >4 hours (adjusted odds ratio [aOR] 2.16, 95% confidence intervals (CI) 1.16-4.05), compared with full term. Women having IOL at early term had no difference in emergency cesarean rates but had an increased need for a second induction method (aOR 1.70, 95% CI 1.15-2.51) and spent 4 h longer from start of IOL to birth (Hodges-Lehmann estimator 4.10, 95% CI 1.33-6.95) compared with those with IOL at full term. CONCLUSIONS: IOL for a non-urgent indication at early term was associated with adverse neonatal and maternal outcomes and no benefits compared with IOL at full term. These findings support international guidelines to avoid IOL before 39 GW unless there is an evidence-based indication for earlier planned birth and will help inform women and clinicians in their decision-making about timing of IOL.

How well are we collecting umbilical cord lactate and gas samples?

AIMS: The aim of this study is to measure staff compliance with the local umbilical cord lactate (UCL) sampling guideline and investigate the quality of paired UCG samples at a tertiary maternity unit. METHODS: We performed a retrospective consecutive sampling of 100 babies delivered via emergency caesarean section and 50 babies with each of all other guideline-based indications for UCL sampling born on and before 31 December 2021. Data were extracted from physical and electronic records. Compliance with guideline-based indications for UCL at birth was measured. The proportion of valid UCG samples was calculated. Samples were considered invalid under the following cases: (i) inadvertently collecting from the same vessel, (ii) switching arterial and venous samples, (iii) collecting from only one vessel or (iv) committing errors during sample collection and handling. RESULTS: Of the samples collected at birth from 321 babies, 280 (87%) had UCL. Small for gestational age and concerns about fetal well-being in labour were indications associated with poorer compliance, 66% and 78%, respectively. About 99 (44%) babies of 226 babies with UCG performed had valid UCG samples. The most common reasons for invalid samples were collection and handling errors (22%) and inadvertent collection from the same vessel (15%). CONCLUSIONS: Generally, compliance with the guidelines is good. However, invalid UCG samples were more frequent than expected.

International Variation in the Management of Patent Ductus Arteriosus and Its Association with Infant Outcomes: A Survey and Linked Cohort Study.

OBJECTIVE: To assess whether treating patients with a presymptomatic patent ductus arteriosus (PDA), based on early routine echocardiography, performed regardless of clinical signs, improved outcomes. STUDY DESIGN: This multicenter, survey-linked retrospective cohort study used an institutional-level questionnaire and individual patient-level data and included infants of <29 weeks of gestation born in 2014-2016 and admitted to tertiary neonatal intensive care units (NICUs) of 9 population-based national or regional neonatal networks. Infants in NICUs receiving treatment of presymptomatic PDA identified by routine echocardiography and those not were compared for the primary composite outcome (early death [≤7 days after birth] or severe intraventricular hemorrhage) and secondary outcomes (any in-hospital mortality and major morbidities). RESULTS: The unit survey (response rates of 86%) revealed a wide variation among networks in the treatment of presymptomatic PDA (7%-86%). Among 246 NICUs with 17 936 infants (mean gestational age of 26 weeks), 126 NICUs (51%) with 7785 infants treated presymptomatic PDA. The primary outcome of early death or severe intraventricular hemorrhage was not significantly different between the NICUs treating presymptomatic PDA and those who did not (17% vs 21%; aOR 1.00, 95% CI 0.85-1.18). The NICUs treating presymptomatic PDA had greater odds of retinopathy of prematurity treatment (13% vs 7%; aOR 1.47, 95% CI 1.01-2.12); however, it was not significant in a sensitivity analysis excluding Japanese data. CONCLUSIONS: Treating presymptomatic PDA detected by routine echocardiography was commonplace but associated with no significant benefits. Well-designed trials are needed to assess the efficacy and safety of early targeted PDA treatment.

Oral dextrose gel for the treatment of hypoglycaemia in newborn infants.

BACKGROUND: Neonatal hypoglycaemia, a common condition, can be associated with brain injury. It is frequently managed by providing infants with an alternative source of glucose, often given enterally with milk-feeding or intravenously with dextrose solution, which may decrease breastfeeding success. Intravenous dextrose also often requires that mother and baby are cared for in separate environments. Oral dextrose gel is simple and inexpensive, and can be administered directly to the buccal mucosa for rapid correction of hypoglycaemia, in association with continued breastfeeding and maternal care. This is an update of a previous review published in 2016. OBJECTIVES: To assess the effectiveness of oral dextrose gel in correcting hypoglycaemia in newborn infants from birth to discharge home and reducing long-term neurodevelopmental impairment. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase from database inception to October 2021.  We also searched international clinical trials networks, the reference lists of included trials, and relevant systematic reviews identified in the search.  SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs comparing oral dextrose gel versus placebo, no treatment, or other therapies for the treatment of neonatal hypoglycaemia in newborn infants from birth to discharge home. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study quality and extracted data; they did not assess publications for which they were study authors. We contacted investigators to obtain additional information. We used fixed-effect models and the GRADE approach to assess the certainty of evidence. MAIN RESULTS: We included two studies conducted in high-income countries, involving 312 late preterm and at-risk term infants and comparing oral dextrose gel (40% concentration) to placebo gel. One study was at low risk of bias, and the other (an abstract) was at unclear to high risk of bias. Oral dextrose gel compared with placebo gel probably increases correction of hypoglycaemic events (rate ratio 1.08, 95% confidence interval (CI) 0.98 to 1.20; rate difference 66 more per 1000, 95% CI 17 fewer to 166 more; 1 study; 237 infants; moderate-certainty evidence), and may result in a slight reduction in the risk of major neurological disability at age two years or older, but the evidence is uncertain (risk ratio (RR) 0.46, 95% CI 0.09 to 2.47; risk difference (RD) 24 fewer per 1000, 95% CI 41 fewer to 66 more; 1 study, 185 children; low-certainty evidence). The evidence is very uncertain about the effect of oral dextrose gel compared with placebo gel or no gel on the need for intravenous treatment for hypoglycaemia (RR 0.78, 95% CI 0.46 to 1.32; RD 37 fewer per 1000, 95% CI 91 fewer to 54 more; 2 studies, 312 infants; very low-certainty evidence). Investigators in one study of 237 infants reported no adverse events (e.g. choking or vomiting at the time of administration) in the oral dextrose gel or placebo gel group (low-certainty evidence).  Oral dextrose gel compared with placebo gel probably reduces the incidence of separation from the mother for treatment of hypoglycaemia (RR 0.54, 95% CI 0.31 to 0.93; RD 116 fewer per 1000, 95% CI 174 fewer to 18 fewer; 1 study, 237 infants; moderate-certainty evidence), and increases the likelihood of exclusive breastfeeding after discharge (RR 1.10, 95% CI 1.01 to 1.18; RD 87 more per 1000, 95% CI 9 more to 157 more; 1 study, 237 infants; moderate-certainty evidence).   AUTHORS' CONCLUSIONS: Oral dextrose gel (specifically 40% dextrose concentration) used to treat hypoglycaemia in newborn infants (specifically at-risk late preterm and term infants) probably increases correction of hypoglycaemic events, and may result in a slight reduction in the risk of major neurological disability at age two years or older. Oral dextrose gel treatment probably reduces the incidence of separation from the mother for treatment and increases the likelihood of exclusive breastfeeding after discharge. No adverse events have been reported. Oral dextrose gel is probably an effective and safe first-line treatment for infants with neonatal hypoglycaemia in high-income settings.  More evidence is needed about the effects of oral dextrose gel treatment on later neurological disability and the need for other treatments for hypoglycaemia. Future studies should be conducted in low-and middle-income settings, in extremely and moderately preterm infants, and compare oral dextrose gel with other therapies such as intravenous dextrose. There are two ongoing studies that may alter the conclusions of this review when published.

Lower insulin sensitivity remains a feature of children born very preterm.

BACKGROUND: The first report of children born very preterm (<32 weeks of gestation) having insulin resistance was made 16 years ago. However, neonatal care has improved since. Thus, we aimed to assess whether children born very preterm still have lower insulin sensitivity than term controls. METHODS: Participants were prepubertal children aged 5 to 11 years born very preterm (<32 weeks of gestation; n = 51; 61% boys) or at term (37-41 weeks; n = 50; 62% boys). Frequently sampled intravenous glucose tolerance tests were performed, and insulin sensitivity was calculated using Bergman's minimal model. Additional clinical assessments included anthropometry, body composition using whole-body dual-energy X-ray absorptiometry scans, clinic blood pressure, and 24-hour ambulatory blood pressure monitoring. RESULTS: Children born very preterm were 0.69 standard deviation score (SDS) lighter (P < .001), 0.53 SDS shorter (P = .003), and had body mass index 0.57 SDS lower (P = .003) than children born at term. Notably, children born very preterm had insulin sensitivity that was 25% lower than term controls (9.4 vs 12.6 × 10-4 minutes-1 ·[mU/L]; P = .001). Other parameters of glucose metabolism, including fasting insulin levels, were similar in the two groups. The awake systolic blood pressure (from 24-hour monitoring) tended to be 3.1 mm Hg higher on average in children born very preterm (P = .054), while the clinic systolic blood pressure was 5.4 mm Hg higher (P = .002). CONCLUSIONS: Lower insulin sensitivity remains a feature of children born very preterm, despite improvements in neonatal intensive care. As reported in our original study, our findings suggest the defect in insulin action in prepubertal children born very pretermis primarily peripheral and not hepatic.

Clinical practice of health professionals working in early detection for infants with or at risk of cerebral palsy across New Zealand.

AIM: A diagnosis of cerebral palsy (CP) can, and should, be made as early as possible. This work describes current clinical practice around the awareness and use of diagnostic tools for the detection of CP in New Zealand (NZ). METHODS: A purpose-developed survey distributed electronically to NZ clinicians working with young children with or at risk of CP. RESULTS: A total of 159 clinicians (including paediatricians, physiotherapists and occupational therapists) participated in this cross-sectional study. Ninety-six percent were aware that a diagnosis of CP can be made by 12 months of age, with high levels of awareness of the use of magnetic resonance imaging (94%), Prechtl's qualitative assessment of general movements (GMs) (70%) and Hammersmith Infant Neurological Examination (HINE) (77%). Only 40% were aware of the HINE optimality scoring. Fifty-four clinicians provided a diagnosis of CP as part of their role: 48% never used the GMs or HINE to assess children <1 year, and 57% never used the HINE for children between 1 and 2 years. Clinicians not providing a diagnosis within their professional role (n = 104) also indicated infrequent use of assessment tools with 74% and 54% never using the GM's or HINE (respectively) in their assessment of children at risk of CP. Barriers to use included lack of time and funding, lack of clear pathways and management support. CONCLUSION: Despite high awareness, current use of international best practice tools in NZ clinical practice appears low. Multiple barriers are reported to the use of these tools, which need to be addressed to improve the timeliness of diagnosis.

Shoulder dystocia, umbilical cord blood gases and neonatal encephalopathy.

The interpretation of umbilical cord gases may not be straightforward following shoulder dystocia. We reviewed Perinatal and Maternal Mortality Review Committee data from New Zealand infants with moderate and severe neonatal encephalopathy (NE) for 2010-2017 inclusive. If one or more of: pH of ≤7.1; base excess of ≤-12 mmol/L; or lactate of ≥6 mmol/L were present it was considered an abnormal result. One-third (12/36) of infants born following shoulder dystocia had documented umbilical cord gases within the normal range. It is important for clinicians to be aware of this possibility when assessing newborn infants with NE.

How do neonatal units within the Australian and New Zealand Neonatal Network manage ex-preterm infants with severe chronic lung disease still requiring major respiratory support at term?

AIM: The aim was to survey the Australian and New Zealand Neonatal Network (ANZNN) member units regarding current services and management guidelines for the ex-premature infant with severe chronic lung disease (CLD) still requiring significant respiratory support at term. METHODS: A 16-question survey was sent to clinical directors of all Level 3 units in Australia and New Zealand via the network. Reminder emails were sent, as required, to prompt a satisfactory response rate. RESULTS: Survey responses were received from 26 of the 29 (90%) ANZNN Level 3 units. At 37 weeks' corrected gestation, over 90% of the units provide ongoing respiratory support in the neonatal intensive care unit (NICU). However, by 50 weeks, ongoing care is provided in several settings, including NICU, high dependency unit (HDU)/paediatric intensive care unit or respiratory wards. The majority (76%) of units arrange transfer on an ad hoc basis, but six units (24%) have set criteria for transfer based on gestation, workload and respiratory requirement. Three units declared a maximum age in NICU (44, 46 or 48 weeks). A variety of approaches were used to identify infants who were likely to require transfer, and 78% of units had a staff member assigned to assist transition. Three units stated that they had a home ventilation programme suitable for these infants. No unit supplied a guideline on tracheostomy or specific respiratory management post-term. CONCLUSION: Despite a significant number of babies requiring ongoing support for severe CLD, the location of the service appears very variable, and there is a lack of specific written guidelines.

Anterior abdominal wall defects managed at a tertiary maternal-fetal medicine service in New Zealand: What counselling advice can we offer parents?

BACKGROUND: Anterior abdominal wall defects, including gastroschisis and omphalocoele, are common fetal anomalies. The management remains complicated, and their diagnosis may lead to significant parental distress. Effective parental counselling may impact on parental perceptions of the defect and help guide pregnancy management. AIMS: Using contemporary data, we aimed to describe clinical outcomes of patients with gastroschisis or omphalocoele in order to provide information for clinicians to assist in parental counselling. MATERIALS AND METHODS: We followed a case-series of patients with anterior abdominal wall defects referred to our regional Maternal Fetal Medicine services from 2011 to 2016. Outcomes of interest antenatally included details of diagnosis, associated anomalies and outcomes of pregnancy and postnatally included the nature of surgical repair, hospital stay and secondary complications until initial discharge. RESULTS: Eighty babies with gastroschisis were referred antenatally, and 72 were liveborn. Forty-nine babies with omphalocoele were referred antenatally, and 24 were liveborn. One further neonate with omphalocoele was postnatally diagnosed. Seventy-one neonates with gastroschisis progressed to operation, 30 developed complications post-surgery, and 68 survived until initial discharge. Twenty-two neonates with omphalocoele progressed to surgery, only two developed complications, and 21 survived until initial discharge. Eight of the surviving neonates with omphalocoele had associated structural abnormalities. The median hospital stay was 27 and eight days for gastroschisis and omphalocoele, respectively. CONCLUSION: Neonates with gastroschisis can have complex postnatal periods. Omphalocoele is associated with high antenatal mortality, especially in the presence of associated abnormalities; however, surviving neonates may have uneventful postnatal periods.

Contributory factors and potentially avoidable neonatal encephalopathy associated with acute peripartum events: An observational study.

BACKGROUND: In 25% of affected babies, neonatal encephalopathy results from acute peripartum events, but rigorous review of these cases for quality improvement is seldom reported. New Zealand has maintained a national database of all babies diagnosed with Sarnat moderate and severe neonatal encephalopathy since 2010 under the Perinatal and Maternal Mortality Review Committee. AIMS: To determine the rate of contributory factors, potentially avoidable mortality or morbidity, and to identify key areas for improvements to maternity and neonatal care among cases of neonatal encephalopathy following an acute peripartum event. MATERIALS AND METHODS: Sarnat moderate and severe cases identified from the national collection of neonatal encephalopathy with a history of an acute peripartum event were reviewed using a standardised independent multidisciplinary methodology and a tool for assessing contributory factors and potential avoidability, with the addition of a human factors lens. RESULTS: Forty-seven cases from 2013 to 2015 were reviewed. The most common acute peripartum events were placental abruption (12) and shoulder dystocia (11). Contributory factors were identified in 89%, and the severity of outcome was potentially avoidable in 66%. Key modifiable areas included dynamic risk assessment, preparedness for obstetric and neonatal emergencies, best practice for maternal and fetal surveillance in labour, and documentation. CONCLUSIONS: There is significant potential to improve quality and safety in acute peripartum care to reduce the risk of neonatal encephalopathy. Human factors were not well captured by the clinical notes or review tool. Attention to human factors by improved methodology can enhance review of neonatal encephalopathy.

Community-based screening to detect school readiness problems in very preterm children.

AIM: Very preterm (VPT) children (≤32 weeks) have school readiness difficulties across multiple domains, but routine follow-up is often limited. We assessed the performance of VPT children on the Before School Check (B4SC), a community-based screening programme of school readiness at 4 years of age. METHODS: VPT children discharged from Wellington and Auckland Neonatal Intensive Care Units (2005-2009) were compared to a national control cohort born during the same period. Outcome measures included Parental Evaluation of Developmental Status (PEDS), parent and teacher versions of the Strengths and Difficulties Questionnaire (SDQ-P and SDQ-T) and vision and hearing screening, and were related to perinatal and demographic characteristics obtained from the Australia and New Zealand Neonatal Network database. RESULTS: Of 1105 VPT children, 920 were matched to the B4SC database, of whom 814 (88%) had one or more B4SC screening outcomes recorded. Compared with controls, VPT children were more likely to have abnormal PEDS (odds ratio (OR) = 1.79, 1.53-2.10), SDQ-P (OR = 1.82, 1.49-2.23), SDQ-T (OR = 1.51, 1.10-2.06), vision (OR = 2.00, 1.54-2.60) and hearing (OR = 1.95, 1.65-2.31) screen outcomes. While VPT children with an abnormal screen were more likely to be referred for further assessment, only 34%, 22%, 94% and 51% with abnormal PEDS, SDQ or vision and hearing screen, respectively, had evidence of appropriate referral. School readiness difficulties were significantly associated with birthweight z-score ≤ -1, vaginal delivery, significant cranial ultrasound abnormalities, younger maternal age, higher deprivation neighbourhood and ventilation ≥72 h. CONCLUSION: Community-based screening may be useful for identifying VPT children with school readiness difficulties, but low referral rates may limit the effectiveness of such programmes.

Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration.

Importance: There are potential benefits and harms of hyperoxemia and hypoxemia for extremely preterm infants receiving more vs less supplemental oxygen. Objective: To compare the effects of different target ranges for oxygen saturation as measured by pulse oximetry (Spo2) on death or major morbidity. Design, Setting, and Participants: Prospectively planned meta-analysis of individual participant data from 5 randomized clinical trials (conducted from 2005-2014) enrolling infants born before 28 weeks' gestation. Exposures: Spo2 target range that was lower (85%-89%) vs higher (91%-95%). Main Outcomes and Measures: The primary outcome was a composite of death or major disability (bilateral blindness, deafness, cerebral palsy diagnosed as ≥2 level on the Gross Motor Function Classification System, or Bayley-III cognitive or language score <85) at a corrected age of 18 to 24 months. There were 16 secondary outcomes including the components of the primary outcome and other major morbidities. Results: A total of 4965 infants were randomized (2480 to the lower Spo2 target range and 2485 to the higher Spo2 range) and had a median gestational age of 26 weeks (interquartile range, 25-27 weeks) and a mean birth weight of 832 g (SD, 190 g). The primary outcome occurred in 1191 of 2228 infants (53.5%) in the lower Spo2 target group and 1150 of 2229 infants (51.6%) in the higher Spo2 target group (risk difference, 1.7% [95% CI, -1.3% to 4.6%]; relative risk [RR], 1.04 [95% CI, 0.98 to 1.09], P = .21). Of the 16 secondary outcomes, 11 were null, 2 significantly favored the lower Spo2 target group, and 3 significantly favored the higher Spo2 target group. Death occurred in 484 of 2433 infants (19.9%) in the lower Spo2 target group and 418 of 2440 infants (17.1%) in the higher Spo2 target group (risk difference, 2.8% [95% CI, 0.6% to 5.0%]; RR, 1.17 [95% CI, 1.04 to 1.31], P = .01). Treatment for retinopathy of prematurity was administered to 220 of 2020 infants (10.9%) in the lower Spo2 target group and 308 of 2065 infants (14.9%) in the higher Spo2 target group (risk difference, -4.0% [95% CI, -6.1% to -2.0%]; RR, 0.74 [95% CI, 0.63 to 0.86], P < .001). Severe necrotizing enterocolitis occurred in 227 of 2464 infants (9.2%) in the lower Spo2 target group and 170 of 2465 infants (6.9%) in the higher Spo2 target group (risk difference, 2.3% [95% CI, 0.8% to 3.8%]; RR, 1.33 [95% CI, 1.10 to 1.61], P = .003). Conclusions and Relevance: In this prospectively planned meta-analysis of individual participant data from extremely preterm infants, there was no significant difference between a lower Spo2 target range compared with a higher Spo2 target range on the primary composite outcome of death or major disability at a corrected age of 18 to 24 months. The lower Spo2 target range was associated with a higher risk of death and necrotizing enterocolitis, but a lower risk of retinopathy of prematurity treatment.

The use of dextrose/insulin infusions during labour and delivery in women with gestational diabetes mellitus: Is there any point?

We compared, in 733 women with gestational diabetes mellitus treated with metformin and/or insulin, rates of neonatal hypoglycaemia in those who had received a dextrose/insulin infusion during labour and prior to delivery (n = 132) with those who did not (n = 601). Women who had infusions were more likely to have been treated with insulin (87.1% vs 70.4%, P < 0.01) and have higher mean capillary glucose values (measured four times daily) in the two weeks prior to delivery (P < 0.01). They had lower mean (SD) glucose values in the 12 h prior to delivery (5.1 (1.1) mmol/L vs 5.4 (0.9) mmol/L, P < 0.01). There was no difference between the groups in rates of neonatal hypoglycaemia (glucose <2.6 mmol/L on two or more occasions), 15.9% versus 17.8%, P = 0.78, or of severe neonatal hypoglycaemia (one or more glucose <1.6 mmol/L), 8.3% versus 5.2%, P = 0.15. In the absence of randomised data comparing use of infusions with no infusions, these data are reassuring for clinicians who do not routinely use infusions.

Oxygen saturation and outcomes in preterm infants.

BACKGROUND: The clinically appropriate range for oxygen saturation in preterm infants is unknown. Previous studies have shown that infants had reduced rates of retinopathy of prematurity when lower targets of oxygen saturation were used. METHODS: In three international randomized, controlled trials, we evaluated the effects of targeting an oxygen saturation of 85 to 89%, as compared with a range of 91 to 95%, on disability-free survival at 2 years in infants born before 28 weeks' gestation. Halfway through the trials, the oximeter-calibration algorithm was revised. Recruitment was stopped early when an interim analysis showed an increased rate of death at 36 weeks in the group with a lower oxygen saturation. We analyzed pooled data from patients and now report hospital-discharge outcomes. RESULTS: A total of 2448 infants were recruited. Among the 1187 infants whose treatment used the revised oximeter-calibration algorithm, the rate of death was significantly higher in the lower-target group than in the higher-target group (23.1% vs. 15.9%; relative risk in the lower-target group, 1.45; 95% confidence interval [CI], 1.15 to 1.84; P=0.002). There was heterogeneity for mortality between the original algorithm and the revised algorithm (P=0.006) but not for other outcomes. In all 2448 infants, those in the lower-target group for oxygen saturation had a reduced rate of retinopathy of prematurity (10.6% vs. 13.5%; relative risk, 0.79; 95% CI, 0.63 to 1.00; P=0.045) and an increased rate of necrotizing enterocolitis (10.4% vs. 8.0%; relative risk, 1.31; 95% CI, 1.02 to 1.68; P=0.04). There were no significant between-group differences in rates of other outcomes or adverse events. CONCLUSIONS: Targeting an oxygen saturation below 90% with the use of current oximeters in extremely preterm infants was associated with an increased risk of death. (Funded by the Australian National Health and Medical Research Council and others; BOOST II Current Controlled Trials number, ISRCTN00842661, and Australian New Zealand Clinical Trials Registry numbers, ACTRN12605000055606 and ACTRN12605000253606.).

Contributory factors and potentially avoidable neonatal encephalopathy associated with perinatal asphyxia.

BACKGROUND: The recently published monograph, Neonatal encephalopathy and neurologic outcome, from the American College of Obstetricians and Gynecologists calls for a root cause analysis to identify components of care that contributed to cases of neonatal encephalopathy to design better practices, surveillance mechanisms, and systems. All cases of infants born in New Zealand with moderate and severe neonatal encephalopathy were reported to the New Zealand Perinatal and Maternal Mortality Review Committee from 2010. A national clinical review of these individual cases has not previously been undertaken. OBJECTIVES: The objective of the study was to undertake a multidisciplinary structured review of all cases of neonatal encephalopathy that arose following the onset of labor in the absence of acute peripartum events in 2010-2011 to determine the frequency of contributory factors, the proportion of potentially avoidable morbidity and mortality and to identify themes for quality improvement. STUDY DESIGN: National identification of, and collection of clinical records on, cases of moderate or severe neonatal encephalopathy occurring after the onset of labor in the absence of an acute peripartum event, excluding those with normal gases and Apgar scores at 1 minute, among all cases of moderate and severe neonatal encephalopathy at term in New Zealand in 2010-2011 was undertaken. Cases were included if they had abnormal gases as defined by any of pH of ≤ 7.2, base excess of ≤ -10, or lactate of ≥ 6 or if there were no cord gases, an Apgar score at 1 minute of ≤ 7. A clinical case review was undertaken by a multidisciplinary team using a structured tool to record contributory factors (organization and/or management, personnel, and barriers to access and/or engagement with care), potentially avoidable morbidity and mortality and to identify themes to guide quality improvement. RESULTS: Eighty-three babies fulfilled the inclusion criteria for the review, 56 moderate (67%) and 27 severe (33%), 21 (25%) of whom were deceased prior to hospital discharge. Eighty-four percent of 64 babies with cord gas results had one of pH of ≤ 7.0, base excess of ≤ -12, or lactate of ≥ 6; and 42% (8 of 19) without cord gases had 5 minute Apgar scores < 5. Excluding 5 babies who died within a day of birth, all but 1 baby were admitted to a neonatal unit within 1 day of birth. Contributory factors were identified in 84% of 83 cases, most commonly personnel factors (76%). Fifty-five percent of cases with morbidity or mortality were considered to be potentially avoidable, and 52% of cases were considered potentially avoidable because of personnel factors. The most frequently identified theme related to the use and interpretation of cardiotocography in labor. CONCLUSION: A multidisciplinary case review of neonatal encephalopathy following apparently uncomplicated labor identified a high rate of potentially avoidable morbidity and mortality and issues amenable to quality improvement such as multidisciplinary training of staff in fetal surveillance in labor.