Watch me grow integrated (WMG-I): protocol for a cluster randomised controlled trial of a web-based surveillance approach for developmental screening in primary care settings.

INTRODUCTION: The increasing prevalence of developmental disorders in early childhood poses a significant global health burden. Early detection of developmental problems is vital to ensure timely access to early intervention, and universal developmental surveillance is recommended best practice for identifying issues. Despite this, there is currently considerable variation in developmental surveillance and screening between Australian states and territories and low rates of developmental screening uptake by parents. This study aims to evaluate an innovative web-based developmental surveillance programme and a sustainable approach to referral and care pathways, linking primary care general practice (GP) services that fall under federal policy responsibility and state government-funded child health services. METHODS AND ANALYSIS: The proposed study describes a longitudinal cluster randomised controlled trial (c-RCT) comparing a 'Watch Me Grow Integrated' (WMG-I) approach for developmental screening, to Surveillance as Usual (SaU) in GPs. Forty practices will be recruited across New South Wales and Queensland, and randomly allocated into either the (1) WMG-I or (2) SaU group. A cohort of 2000 children will be recruited during their 18-month vaccination visit or opportunistic visit to GP. At the end of the c-RCT, a qualitative study using focus groups/interviews will evaluate parent and practitioner views of the WMG-I programme and inform national and state policy recommendations. ETHICS AND DISSEMINATION: The South Western Sydney Local Health District (2020/ETH01625), UNSW Sydney (2020/ETH01625) and University of Queensland (2021/HE000667) Human Research Ethics Committees independently reviewed and approved this study. Findings will be reported to the funding bodies, study institutes and partners; families and peer-reviewed conferences/publications. TRIAL REGISTRATION NUMBER: ANZCTR12621000680864.

Consumer and health professional perceptions of Watch Me Grow - Electronic (WMG-E) platform for developmental surveillance in early childhood: A qualitative study.

BACKGROUND AND OBJECTIVES: Watch Me Grow - Electronic (WMG-E) platform is an online resource to enhance the capacity of general practitioners (GPs) to involve parents in developmental surveillance. The aim of this study was to evaluate the acceptability and perceived utility of WMG-E. METHOD: Semi-structured interviews were conducted with GPs/paediatricians (n = 6) and parents (n = 6). Focus groups were conducted with child and family health nurses (n = 25). Transcripts were analysed thematically. RESULTS: Participants indicated that WMG-E could empower clinicians and parents by enhancing health literacy about child developmental issues, but that it could also be disempowering if not used carefully. Clinicians mentioned being strategic at health service and public policy levels. A final theme was that of the need to balance widespread promotion with its targeted use. DISCUSSION: This study established the face validity of WMG-E, and reveals key lessons to inform the ways in which it is promoted and used.

The effect of lactoferrin supplementation on death or major morbidity in very low birthweight infants (LIFT): a multicentre, double-blind, randomised controlled trial.

BACKGROUND: Very low birthweight or preterm infants are at increased risk of adverse outcomes including sepsis, necrotising enterocolitis, and death. We assessed whether supplementing the enteral diet of very low-birthweight infants with lactoferrin, an antimicrobial protein, reduces all-cause mortality or major morbidity. METHODS: We did a multicentre, double-blind, pragmatic, randomised superiority trial in 14 Australian and two New Zealand neonatal intensive care units. Infants born weighing less than 1500 g and aged less than 8 days, were eligible and randomly assigned (1:1) using minimising web-based randomisation to receive once daily 200 mg/kg pasteurised bovine lactoferrin supplements or no lactoferrin supplement added to breast or formula milk until 34 weeks' post-menstrual age (or for 2 weeks, if longer), or until discharge from the study hospital if that occurred first. Designated nurses preparing the daily feeds were not masked to group assignment, but other nurses, doctors, parents, caregivers, and investigators were unaware. The primary outcome was survival to hospital discharge or major morbidity (defined as brain injury, necrotising enterocolitis, late-onset sepsis at 36 weeks' post-menstrual age, or retinopathy treated before discharge) assessed in the intention-to-treat population. Safety analyses were by treatment received. We also did a prespecified, PRISMA-compliant meta-analysis, which included this study and other relevant randomised controlled trials, to estimate more precisely the effects of lactoferrin supplementation on late-onset sepsis, necrotising enterocolitis, and survival. This trial is registered with the Australian and New Zealand Clinical Trials Registry, ACTRN12611000247976. FINDINGS: Between June 27, 2014, and Sept 1, 2017, we recruited 1542 infants; 771 were assigned to the intervention group and 771 to the control group. One infant who had consent withdrawn before beginning lactoferrin treatment was excluded from analysis. In-hospital death or major morbidity occurred in 162 (21%) of 770 infants in the intervention group and in 170 (22%) of 771 infants in the control group (relative risk [RR] 0·95, 95% CI 0·79-1·14; p=0·60). Three suspected unexpected serious adverse reactions occurred; two in the lactoferrin group, namely unexplained late jaundice and inspissated milk syndrome, but were not attributed to the intervention and one in the control group had fatal inspissated milk syndrome. Our meta-analysis identified 13 trials completed before Feb 18, 2020, including this Article, in 5609 preterm infants. Lactoferrin supplements significantly reduced late-onset sepsis (RR 0·79, 95% CI 0·71-0·88; p<0·0001; I2=58%), but not necrotising enterocolitis or all-cause mortality. INTERPRETATION: Lactoferrin supplementation did not improve death or major morbidity in this trial, but might reduce late-onset sepsis, as found in our meta-analysis of over 5000 infants. Future collaborative studies should use products with demonstrated biological activity, be large enough to detect moderate and clinically important effects reliably, and assess greater doses of lactoferrin in infants at increased risk, such as those not exclusively receiving breastmilk or infants of extremely low birthweight. FUNDING: Australian National Health and Medical Research Council.

A Randomized Trial of Baby Triple P for Preterm Infants: Child Outcomes at 2 Years of Corrected Age.

OBJECTIVE: To determine the efficacy of a hospital-based intervention that transitions into existing community support, in enhancing developmental outcomes at 2 years of corrected age in infants born at less than 32 weeks. STUDY DESIGN: In total, 323 families of 384 infants born <32 weeks were randomized to receive intervention or care-as-usual. The intervention teaches parents coping skills, partner support, and effective parenting strategies over 4 hospital-based and 4 home-phone sessions. At 2 years of corrected age maternally reported child behavior was assessed by the Infant and Toddler Social Emotional Adjustment Scale. Observed child behavior was coded with the Revised Family Observation Schedule. Cognitive, language, and motor skills were assessed with the Bayley Scales of Infant and Toddler Development III. RESULTS: Mean gestational age of infants was 28.5 weeks (SD = 2.1), and mothers' mean age was 30.6 years (SD = 5.8). A total of 162 families (n = 196 infants) were allocated to intervention and 161 families (n = 188 infants) received care-as-usual. There was no significant adjusted difference between treatment groups on dysregulation (0.2; 95% CI -2.5 to 3.0, P = .9) externalizing (0.3; 95% CI -1.6 to 2.2, P = .8), internalizing (-1.5; 95% CI -4.3 to 1.3, P = .3), observed aversive (0.00; -0.04 to 0.04, P = .9), or nonaversive behavior (-0.01; 95% CI -0.05 to 0.03, P = .7). Intervention children scored significantly higher on cognition (3.5; 95% CI 0.2-6.8, P = .04) and motor skill (5.5; 95% CI 2.5-8.4, P < .001), and approached significance on language (3.8; 95% CI -0.3 to 7.9, P = .07). CONCLUSIONS: Baby Triple P for Preterm Infants increases cognitive and motor skills but does not impact behavior. The results are evidence that hospital-based interventions can improve some developmental outcomes for infants <32 weeks. TRIAL REGISTRATION: ACTRN 12612000194864.

PREDICTING ATTENDANCE OF A PREVENTIVE PARENTING INTERVENTION FOR VERY PRETERM INFANTS.

Preventive parenting interventions can experience challenges in maximizing dosage, or the amount of intervention received by parents. This study examined the associations of baseline mother, father, and very preterm infant (VPT; <32 weeks) characteristics with satisfactory intervention attendance of the family within a randomized controlled trial of Baby Triple P for Preterm Infants (Colditz et al., 2015). Mothers (n = 160) and fathers (n = 115) completed questionnaires prior to the randomization of family units (n = 160) to receive the intervention. Satisfactory session attendance (seven or eight sessions of eight in total) was achieved by 114 families (71.25%). In the logistic model for mothers, satisfactory attendance of the family was more likely when infants were extremely low birth weight (ELBW), odds ratio (OR) = 2.81, 95% confidence interval (CI) [1.16, 6.80], when the mother had a university, OR = 11.38, 95% CI [4.03, 32.19], or trade-certificate-level education, OR = 4.97, 95% CI [1.93, 12.84], or when she was not under financial stress, OR = 3.53, 95% CI [1.34, 9.28]. A similar pattern of results was found in the model for fathers. Session attendance of preventive parenting interventions for VPT infants may be improved by increasing the engagement of parents with infants not born ELBW, who have lower education, or are experiencing financial stress.

Depression, posttraumatic stress and relationship distress in parents of very preterm infants.

To determine the prevalence, associated factors, and relationships between symptoms of depression, symptoms of posttraumatic stress (PTS), and relationship distress in mothers and fathers of very preterm (VPT) infants (< 32 weeks). Mothers (n = 323) and fathers (n = 237) completed self-report measures on demographic and outcome variables at 38 days (SD = 23.1, range 9-116) postpartum while their infants were still hospitalised. Of mothers, 46.7% had a moderate to high likelihood of depression, 38.1% had moderate to severe symptoms of PTS, and 25.1% were in higher than average relationship distress. The corresponding percentages in fathers were 16.9, 23.7, and 27%. Depression was positively associated with having previous children (p = 0.01), speaking little or no English at home (p = 0.01), financial stress (p = 0.03), and recently accessing mental health services (p = 0.003) for mothers, and financial stress (p = 0.005) and not being the primary income earner (p = 0.04) for fathers. Similar associations were found for symptoms of PTS and relationship distress. Being in higher relationship distress increased the risk of depression in both mothers (p < .001) and fathers (p = 0.03), and PTS symptoms in mothers (p = 0.001). For both mothers and fathers, depression was associated with more severe PTS symptoms (p < .001). Fathers of VPT infants should be screened for mental health problems alongside mothers, and postpartum parent support programs for VPT infants should include strategies to improve the couple relationship.

Delayed versus Immediate Cord Clamping in Preterm Infants.

BACKGROUND: The preferred timing of umbilical-cord clamping in preterm infants is unclear. METHODS: We randomly assigned fetuses from women who were expected to deliver before 30 weeks of gestation to either immediate clamping of the umbilical cord (≤10 seconds after delivery) or delayed clamping (≥60 seconds after delivery). The primary composite outcome was death or major morbidity (defined as severe brain injury on postnatal ultrasonography, severe retinopathy of prematurity, necrotizing enterocolitis, or late-onset sepsis) by 36 weeks of postmenstrual age. Analyses were performed on an intention-to-treat basis, accounting for multiple births. RESULTS: Of 1634 fetuses that underwent randomization, 1566 were born alive before 30 weeks of gestation; of these, 782 were assigned to immediate cord clamping and 784 to delayed cord clamping. The median time between delivery and cord clamping was 5 seconds and 60 seconds in the respective groups. Complete data on the primary outcome were available for 1497 infants (95.6%). There was no significant difference in the incidence of the primary outcome between infants assigned to delayed clamping (37.0%) and those assigned to immediate clamping (37.2%) (relative risk, 1.00; 95% confidence interval, 0.88 to 1.13; P=0.96). The mortality was 6.4% in the delayed-clamping group and 9.0% in the immediate-clamping group (P=0.03 in unadjusted analyses; P=0.39 after post hoc adjustment for multiple secondary outcomes). There were no significant differences between the two groups in the incidences of chronic lung disease or other major morbidities. CONCLUSIONS: Among preterm infants, delayed cord clamping did not result in a lower incidence of the combined outcome of death or major morbidity at 36 weeks of gestation than immediate cord clamping. (Funded by the Australian National Health and Medical Research Council [NHMRC] and the NHMRC Clinical Trials Centre; APTS Australian and New Zealand Clinical Trials Registry number, ACTRN12610000633088 .).

Nasal High-Flow Therapy for Primary Respiratory Support in Preterm Infants.

BACKGROUND: Treatment with nasal high-flow therapy has efficacy similar to that of nasal continuous positive airway pressure (CPAP) when used as postextubation support in neonates. The efficacy of high-flow therapy as the primary means of respiratory support for preterm infants with respiratory distress has not been proved. METHODS: In this international, multicenter, randomized, noninferiority trial, we assigned 564 preterm infants (gestational age, ≥28 weeks 0 days) with early respiratory distress who had not received surfactant replacement to treatment with either nasal high-flow therapy or nasal CPAP. The primary outcome was treatment failure within 72 hours after randomization. Noninferiority was determined by calculating the absolute difference in the risk of the primary outcome; the chosen margin of noninferiority was 10 percentage points. Infants in whom high-flow therapy failed could receive rescue CPAP; infants in whom CPAP failed were intubated and mechanically ventilated. RESULTS: Trial recruitment stopped early at the recommendation of the independent data and safety monitoring committee because of a significant difference in the primary outcome between treatment groups. Treatment failure occurred in 71 of 278 infants (25.5%) in the high-flow group and in 38 of 286 infants (13.3%) in the CPAP group (risk difference, 12.3 percentage points; 95% confidence interval [CI], 5.8 to 18.7; P<0.001). The rate of intubation within 72 hours did not differ significantly between the high-flow and CPAP groups (15.5% and 11.5%, respectively; risk difference, 3.9 percentage points; 95% CI, -1.7 to 9.6; P=0.17), nor did the rate of adverse events. CONCLUSIONS: When used as primary support for preterm infants with respiratory distress, high-flow therapy resulted in a significantly higher rate of treatment failure than did CPAP. (Funded by the National Health and Medical Research Council and others; Australian New Zealand Clinical Trials Registry number, ACTRN12613000303741 .).

Outcomes of Two Trials of Oxygen-Saturation Targets in Preterm Infants.

BACKGROUND: The safest ranges of oxygen saturation in preterm infants have been the subject of debate. METHODS: In two trials, conducted in Australia and the United Kingdom, infants born before 28 weeks' gestation were randomly assigned to either a lower (85 to 89%) or a higher (91 to 95%) oxygen-saturation range. During enrollment, the oximeters were revised to correct a calibration-algorithm artifact. The primary outcome was death or disability at a corrected gestational age of 2 years; this outcome was evaluated among infants whose oxygen saturation was measured with any study oximeter in the Australian trial and those whose oxygen saturation was measured with a revised oximeter in the U.K. trial. RESULTS: After 1135 infants in Australia and 973 infants in the United Kingdom had been enrolled in the trial, an interim analysis showed increased mortality at a corrected gestational age of 36 weeks, and enrollment was stopped. Death or disability in the Australian trial (with all oximeters included) occurred in 247 of 549 infants (45.0%) in the lower-target group versus 217 of 545 infants (39.8%) in the higher-target group (adjusted relative risk, 1.12; 95% confidence interval [CI], 0.98 to 1.27; P=0.10); death or disability in the U.K. trial (with only revised oximeters included) occurred in 185 of 366 infants (50.5%) in the lower-target group versus 164 of 357 infants (45.9%) in the higher-target group (adjusted relative risk, 1.10; 95% CI, 0.97 to 1.24; P=0.15). In post hoc combined, unadjusted analyses that included all oximeters, death or disability occurred in 492 of 1022 infants (48.1%) in the lower-target group versus 437 of 1013 infants (43.1%) in the higher-target group (relative risk, 1.11; 95% CI, 1.01 to 1.23; P=0.02), and death occurred in 222 of 1045 infants (21.2%) in the lower-target group versus 185 of 1045 infants (17.7%) in the higher-target group (relative risk, 1.20; 95% CI, 1.01 to 1.43; P=0.04). In the group in which revised oximeters were used, death or disability occurred in 287 of 580 infants (49.5%) in the lower-target group versus 248 of 563 infants (44.0%) in the higher-target group (relative risk, 1.12; 95% CI, 0.99 to 1.27; P=0.07), and death occurred in 144 of 587 infants (24.5%) versus 99 of 586 infants (16.9%) (relative risk, 1.45; 95% CI, 1.16 to 1.82; P=0.001). CONCLUSIONS: Use of an oxygen-saturation target range of 85 to 89% versus 91 to 95% resulted in nonsignificantly higher rates of death or disability at 2 years in each trial but in significantly increased risks of this combined outcome and of death alone in post hoc combined analyses. (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 number, ACTRN12605000055606.).

Early Maternal Reflective Functioning and Infant Emotional Regulation in a Preterm Infant Sample at 6 Months Corrected Age.

OBJECTIVE: This study investigated the influence of maternal reflective functioning (RF) on 6-month-old infants' emotional self-regulating abilities in preterm infant-mother dyads. METHODS: 25 preterm (gestational age 28-34.5 weeks) infants' affect, gaze toward mother, and self-soothing behaviors (thumb-sucking and playing with clothing) were measured during the still-face procedure at 6 months corrected age. Maternal RF was measured at 7-15 days post-delivery using the Parent Development Interview. RESULTS: Infants with high RF mothers showed the most negative affect during the still-face episode (M = 21.33s, SE = 5.44), whereas infants with low RF mothers showed the most negative affect in the reunion episode (M = 18.14s, SE = 3.69). Infants with high RF mothers showed significantly more self-soothing behaviors when distressed (Ms > 14.5s) than infants with low RF mothers (Ms < 1s), p's < .01. CONCLUSION: Maternal RF was associated with infants' self-regulating behavior, providing preliminary evidence for the regulatory role of maternal RF in preterm infants' emotion regulation capacity.

Autism in Toddlers Born Very Preterm.

OBJECTIVE: This study aimed to determine the prevalence of autism spectrum disorder (ASD) by using the Autism Diagnostic Observation Schedule-Generic (ADOS-G) classifications in children born very preterm during their toddler years. METHODS: Two birth cohorts of toddlers (2 and 4 years old) each recruited over 12 months and born at <29 weeks' gestation were administered the Modified Checklist of Autism in Toddlers-Follow-up Interview (M-CHAT-FI) screen, the ADOS-G, and developmental assessments. The ADOS-G was conducted on toddlers with M-CHAT-FI-positive screens. RESULTS: Data were available on 88% (169/192) of children. In total, 22 (13%) toddlers screened positive and 3 (1.8%) were confirmed diagnostically with ASD. These 3 cases reached the highest ADOS-G threshold classification of autism. All but 1 child who scored below the ADOS-G thresholds (11/12) demonstrated some difficulty with social communication. Risk was significantly increased for co-occurring neurodevelopmental problems in 21 of the 22 positive-screen ASD cases. Adaptive behavior (P < .001) was the only co-occurring factor independently predictive of ASD in toddlers. CONCLUSIONS: Children born very preterm are at increased risk of ASD. By using the ADOS-G, we found a lower incidence of ASD in children born at <29 weeks' gestation compared with previous studies. Children who screened positive for ASD on the M-CHAT-FI had developmental delays consistent with subthreshold communication impairment.

Prem Baby Triple P: a randomised controlled trial of enhanced parenting capacity to improve developmental outcomes in preterm infants.

BACKGROUND: Very preterm birth (<32 weeks gestation) is associated with motor, cognitive, behavioural and educational problems in children and maternal depression and withdrawal. Early interventions that target parenting have the greatest potential to create sustained effects on child development and parental psychopathology. Triple P (Positive Parenting Program) has shown positive effects on child behaviour and adjustment, parenting practices and family functioning. Baby Triple P for Preterm infants, has been developed to target parents of very preterm infants. This study tests the effectiveness of Baby Triple P for Preterm infants in improving child and parent/couple outcomes at 24 months corrected age (CA). METHODS/DESIGN: Families will be randomised to receive either Baby Triple P for Preterm infants or Care as Usual (CAU). Baby Triple P for Preterm infants involves 4 × 2 hr group sessions at the hospital plus 4 × 30 min telephone consultations soon after transfer (42 weeks C.A.). After discharge participants will be linked to community based Triple P and intervention maintenance up to 24 months C.A. Assessments will be: baseline, post-intervention (6 weeks C.A.), at 12 and 24 months C.A. The primary outcome measure is the Infant Toddler Social & Emotional Assessment (ITSEA) at 24 months C.A. Child behavioural and emotional problems will be coded using the mother-toddler version of the Family Observation Schedule at 24 months C.A. Secondary outcome will be the Bayley Scales of Infant and Toddler Development (BSID III) cognitive development, language and motor abilities. Proximal targets of parenting style, parental self-efficacy, parental mental health, parental adjustment, parent-infant attachment, couple relationship satisfaction and couple communication will also be assessed. Our sample size based on the ITSEA, has 80% power, predicted effect size of 0.33 and an 85% retention rate, requires 165 families are required in each group (total sample of 330 families). DISCUSSION: This protocol presents the study design, methods and intervention to be analysed in a randomised trial of Baby Triple P for Preterm infants compared to Care as Usual (CAU) for families of very preterm infants. Publications of all outcomes will be published in peer reviewed journals according to CONSORT guidelines. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12612000194864.

The effects of maternal depression, anxiety, and perceived stress during pregnancy on preterm birth: A systematic review.

BACKGROUND: Experiencing psychological distress such as depression, anxiety, and/or perceived stress during pregnancy may increase the risk for adverse birth outcomes, including preterm birth. Clarifying the association between exposure and outcome may improve the understanding of risk factors for prematurity and guide future clinical and research practices. AIM: The aims of the present review were to outline the evidence on the risk of preterm associated with antenatal depression, anxiety, and stress. METHODS: Four electronic database searches were conducted to identify quantitative population-based, multi-centre, cohort studies and randomised-controlled trial studies focusing on the association between antenatal depression, anxiety, and stress, and preterm birth published in English between 1980 and 2013. FINDINGS: Of 1469 electronically retrieved articles, 39 peer-reviewed studies met the final selection criteria and were included in this review following the PRISMA and MOOSE review guidelines. Information was extracted on study characteristics; depression, anxiety and perceived stress were examined as separate and combined exposures. There is strong evidence that antenatal distress during the pregnancy increases the likelihood of preterm birth. CONCLUSION: Complex paths of significant interactions between depression, anxiety and stress, risk factors and preterm birth were indicated in both direct and indirect ways. The effects of pregnancy distress were associated with spontaneous but not with medically indicated preterm birth. Health practitioners engaged in providing perinatal care to women, such as obstetricians, midwives, nurses, and mental health specialists need to provide appropriate support to women experiencing psychological distress in order to improve outcomes for both mothers and infants.

Risk determinants in early intervention use during the first postnatal year in children born very preterm.

BACKGROUND: Early interventions (EI) are recognised for their potential risk-reduction capacity. Although developmental delay is common in children born very preterm reports continue to suggest poor uptake of EI services. This study examined the risk determinants of EI in Australian children born less than 32 weeks gestation during the first year of life. METHODS: As part of a multi-centre-randomised-trial, 195 children were prospectively studied during their first year of life and EI use, type of follow-up, perinatal, social and parental psychosocial risk factors were collected using questionnaires. Child neurodevelopmental disability-status was assessed at 12-months (cerebral palsy, blind, deaf, developmental quotient 1 standard deviation (SD) below mean). The associations between EI and variables were examined using Pearson's chi-squared test (χ2) and regression techniques. RESULTS: A total of 55% of children received EI, 51% attended post discharge neonatal intensive care unit (NICU) and the remainder attended exclusive primary health care. Risk factors included, 50% perinatal, 19% social and 34% psychosocial and at 12-months 23% were categorised as disabled. Low social risk and NICU follow-up attendance were significantly associated with EI use but only perinatal risk (OR 3.1, 95% CI 1.7, 5.6, p = <0.01) and disability (OR 2.2, 95% CI 1.1, 4.7, p = 0.04) independently predicted EI use. CONCLUSIONS: It is reassuring that children with perinatal risk receive EI, opportunity remains to improve EI uptake in families with social and parental psychosocial risk during the first year of life.

High-flow nasal cannulae in very preterm infants after extubation.

BACKGROUND: The use of high-flow nasal cannulae is an increasingly popular alternative to nasal continuous positive airway pressure (CPAP) for noninvasive respiratory support of very preterm infants (gestational age, <32 weeks) after extubation. However, data on the efficacy or safety of such cannulae in this population are lacking. METHODS: In this multicenter, randomized, noninferiority trial, we assigned 303 very preterm infants to receive treatment with either high-flow nasal cannulae (5 to 6 liters per minute) or nasal CPAP (7 cm of water) after extubation. The primary outcome was treatment failure within 7 days. Noninferiority was determined by calculating the absolute difference in the risk of the primary outcome; the margin of noninferiority was 20 percentage points. Infants in whom treatment with high-flow nasal cannulae failed could be treated with nasal CPAP; infants in whom nasal CPAP failed were reintubated. RESULTS: The use of high-flow nasal cannulae was noninferior to the use of nasal CPAP, with treatment failure occurring in 52 of 152 infants (34.2%) in the nasal-cannulae group and in 39 of 151 infants (25.8%) in the CPAP group (risk difference, 8.4 percentage points; 95% confidence interval, -1.9 to 18.7). Almost half the infants in whom treatment with high-flow nasal cannulae failed were successfully treated with CPAP without reintubation. The incidence of nasal trauma was significantly lower in the nasal-cannulae group than in the CPAP group (P=0.01), but there were no significant differences in rates of serious adverse events or other complications. CONCLUSIONS: Although the result for the primary outcome was close to the margin of noninferiority, the efficacy of high-flow nasal cannulae was similar to that of CPAP as respiratory support for very preterm infants after extubation. (Funded by the National Health and Medical Research Council; Australian New Zealand Clinical Trials Network number, ACTRN12610000166077.).

Measuring sensorineural disability in preterm children using a public health screening strategy: a randomised controlled trial.

AIM: To assess the efficacy of a preterm-targeted screening programme against the routine Australian National Health Medical Research Council (NHMRC) universal child health screening programme to detect disability in a general practice setting in children born < or =31 weeks gestation at 12-months of age. METHODS: Multi-centred trial involving 202 preterm children randomised to receive the preterm-targeted or NHMRC programme. Primary outcome, correct identification of neurosensory disability by general practitioners assessed against gold standard paediatric assessments. Sensitivity analysis estimated interrater agreement and screening accuracy. Secondary outcomes, post natal depression (PND), parental stress, health service use, screening programme helpfulness and correct identification of levels of disability severity. RESULTS: Of the 195 infants with data on the primary outcome in the preterm-targeted group, their general practitioners correctly identified the disability status of 61/93 (65.6%) children, as compared with 69/102 (67.6%) in the NHMRC group (odds ratios (OR) 0.91 95% confidence interval (CI) 0.50, 1.65). Responses where general practitioners were unsure of a child's disability status were coded as incorrect and not paired for sensitivity analysis. Sensitivity analysis for 180 diagnostic pairs showed fair interrater agreement for both groups (preterm-targeted k = 0.30 vs. NHMRC k = 0.29) with screening test results favouring the preterm-targeted group with greater sensitivity (73% vs. 33%) but lower specificity (70% vs. 92%) resulting in more over referrals (30% vs. 8%); however, these had a significantly lower mean Developmental Quotient (DQ) score compared with non-disabled children. PND scores were higher in preterm-targeted group (OR 1.33 95% CI 0.01, 2.66). CONCLUSION: The preterm-targeted programme used by general practitioners: (i) did not improve overall identification of disability status compared to the NHMRC universal programme (Australian New Zealand Clinical Trails Registry number, ACTRN 12606000472572); however (ii) it did demonstrate greater efficacy as a screening tool in accurately identifying disabled children.

Parental experiences and preferences which influence subsequent use of post-discharge health services for children born very preterm.

AIM: Parents are ultimately responsible for organising and accessing health services for their children. How parents experience those services are likely to influence subsequent use. Understanding parental preference for service provision can inform compliance strategies with recommended child health recommendations. The aim of this study was to explore parental experiences and preferences which influence subsequent use of post-discharge health services for children born preterm with a birthweight < or =1250 g. METHODS: Focus groups consisted of randomly selected families recruited from a population-based cross-sectional cohort study of 2-, 4- and 7-year-old children corrected age for prematurity. Parents were asked to consider which aspects of childhood health service delivery influenced subsequent use. Transcripts were analysed and themes constructed. SWOT analysis evaluated health service practices by systematically mapping parents' accounts of the perceived strengths (S), weaknesses (W), opportunities (O) and threats (T) of services in relation to subsequent use. RESULTS: Fifteen parents participated in three groups (by children's age). Three dominant themes emerged and included (i) assistance with accessing appropriate services; (ii) provision of consistent information and comprehensive child health records; and (iii) support of parental self-efficacy in the health care of their child. CONCLUSION: Primary health carers are ideally suited to co-ordinate and provide continuity to improve parental involvement and compliance with health promoting recommendations for their preterm children. This approach may improve interagency co-operation and access to services enabling early identification and intervention. Adopting these strategies may be effective in optimising child health follow-up strategies and improve uptake of recommended intervention and prevention programmes.

Parents' evaluation of developmental status in children born with a birthweight of 1250 g or less.

OBJECTIVE: To evaluate the agreement between parental reporting of development of children born very preterm using the Parents' Evaluation of Developmental Status (PEDS) questionnaire and professional assessment by a paediatric developmental team in the detection of sensorineural disability. METHODS: A cross-sectional cohort study of 362 children born in Queensland with a birthweight < or = 1250 g, who were surviving at 2 and 4 years of age corrected for prematurity, was conducted. Parents completed the PEDS questionnaire prior to their child receiving a neurodevelopmental assessment. The level of agreement for sensorineural disability between the neurodevelopmental assessment and the parents' score on the PEDS questionnaire was measured using the kappa statistic, and screening test characteristics were calculated. Logistic regression was used to investigate factors that might affect agreement. RESULTS: Two hundred and eighty-three (78%) of the eligible children were located and contacted. Of these, 216 (76%) agreed to participate in the study (110, 2-year-olds; 106, 4-year-olds). Agreement between the two forms of rating sensorineural disability (developmental quotient > -2SD (standard deviation), cerebral palsy, bilateral blindness and deafness requiring aids) for the 4-year age group children was fair (kappa = 0.27, P = 0.001). PEDS accurately identified 69% (11 of 16) of disabled children and 72% (65 of 90) non-disabled children. The test characteristics for these children were similar to Glascoe's norming sample with a PPV 31% (95% CI: 14-48%), specificity 72% (95% CI: 62-81%), but lower sensitivity 69% (95% CI: 62-81%) and higher false-negative rate 31% (95% CI: 11, 59). Agreement for the 2-year age group was fair with poor test characteristics. Other comparisons for both age groups (PEDS A and B compared using a disability status with DQ > -1SD) showed poor agreement and test characteristics. Gestation age < 27 weeks and maternal education at or below grade 10 in the 2-year age group were the only factors independently affecting agreement. CONCLUSIONS: The agreement between parental evaluation of sensorineural disability status using PEDS and paediatrics developmental assessment in children born very preterm at 4-years corrected age for prematurity compares favourably with Glascoe's norming sample. The lower agreement seen in the 2-year age group limits the utility of PEDS to be used as a screen for disability at an age when early intervention may be useful. The PEDS questionnaire is designed and normed for the general paediatric population, and it is not clear if parents of children born very preterm may have interpreted the PEDS questionnaire in relation to their satisfaction with their child's developmental progress rather than their child's functional ability.

A simplified predictive index for the detection of women at risk for postnatal depression.

BACKGROUND: Many women who suffer from postnatal depression are never diagnosed or treated. The objective of this study was to develop an index for use in maternity settings that identifies women who may be at risk for postnatal depression. METHODS: Women (n = 1762) attending the "booking-in" clinic were screened for antenatal risk factors for postnatal depression. On the third postnatal day eligible women were screened for postnatal risk factors. The Edinburgh Postnatal Depression Scale was mailed to participants 16 weeks after the birth. A predictive index was developed, based on the mean Edinburgh Postnatal Depression Scale scores for each risk factor. The sensitivity, specificity, positive predictive value, and negative predictive value were used to assess the diagnostic value of the index. RESULTS: Seven hundred and twenty-three (50.1%) of the eligible women completed all phases of the study. Of this group, 93 (12.2%) women scored higher than 12 on the Edinburgh Postnatal Depression Scale. At a cutoff of 6, the index had positive predictive value of 39.8 percent for postnatal depression, a threefold improvement over the base rate. CONCLUSION: The Brisbane Postnatal Depression Index provides a clinically useful method for identifying women at risk for developing postnatal depression. It has applications for early intervention or to identify high-risk groups for research purposes.