Two-Year Outcomes After Minimally Invasive Surfactant Therapy in Preterm Infants: Follow-Up of the OPTIMIST-A Randomized Clinical Trial.

Importance: The long-term effects of surfactant administration via a thin catheter (minimally invasive surfactant therapy [MIST]) in preterm infants with respiratory distress syndrome remain to be definitively clarified. Objective: To examine the effect of MIST on death or neurodevelopmental disability (NDD) at 2 years' corrected age. Design, Setting, and Participants: Follow-up study of a randomized clinical trial with blinding of clinicians and outcome assessors conducted in 33 tertiary-level neonatal intensive care units in 11 countries. The trial included 486 infants with a gestational age of 25 to 28 weeks supported with continuous positive airway pressure (CPAP). Collection of follow-up data at 2 years' corrected age was completed on December 9, 2022. Interventions: Infants assigned to MIST (n = 242) received exogenous surfactant (200 mg/kg poractant alfa) via a thin catheter; those assigned to the control group (n = 244) received sham treatment. Main Outcomes and Measures: The key secondary outcome of death or moderate to severe NDD was assessed at 2 years' corrected age. Other secondary outcomes included components of this composite outcome, as well as hospitalizations for respiratory illness and parent-reported wheezing or breathing difficulty in the first 2 years. Results: Among the 486 infants randomized, 453 had follow-up data available (median gestation, 27.3 weeks; 228 females [50.3%]); data on the key secondary outcome were available in 434 infants. Death or NDD occurred in 78 infants (36.3%) in the MIST group and 79 (36.1%) in the control group (risk difference, 0% [95% CI, -7.6% to 7.7%]; relative risk [RR], 1.0 [95% CI, 0.81-1.24]); components of this outcome did not differ significantly between groups. Secondary respiratory outcomes favored the MIST group. Hospitalization with respiratory illness occurred in 49 infants (25.1%) in the MIST group vs 78 (38.2%) in the control group (RR, 0.66 [95% CI, 0.54-0.81]) and parent-reported wheezing or breathing difficulty in 73 (40.6%) vs 104 (53.6%), respectively (RR, 0.76 [95% CI, 0.63-0.90]). Conclusions and Relevance: In this follow-up study of a randomized clinical trial of preterm infants with respiratory distress syndrome supported with CPAP, MIST compared with sham treatment did not reduce the incidence of death or NDD by 2 years of age. However, infants who received MIST had lower rates of adverse respiratory outcomes during their first 2 years of life. Trial Registration: anzctr.org.au Identifier: ACTRN12611000916943.

Effect of Minimally Invasive Surfactant Therapy vs Sham Treatment on Death or Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome: The OPTIMIST-A Randomized Clinical Trial.

Importance: The benefits of surfactant administration via a thin catheter (minimally invasive surfactant therapy [MIST]) in preterm infants with respiratory distress syndrome are uncertain. Objective: To examine the effect of selective application of MIST at a low fraction of inspired oxygen threshold on survival without bronchopulmonary dysplasia (BPD). Design, Setting, and Participants: Randomized clinical trial including 485 preterm infants with a gestational age of 25 to 28 weeks who were supported with continuous positive airway pressure (CPAP) and required a fraction of inspired oxygen of 0.30 or greater within 6 hours of birth. The trial was conducted at 33 tertiary-level neonatal intensive care units around the world, with blinding of the clinicians and outcome assessors. Enrollment took place between December 16, 2011, and March 26, 2020; follow-up was completed on December 2, 2020. Interventions: Infants were randomized to the MIST group (n = 241) and received exogenous surfactant (200 mg/kg of poractant alfa) via a thin catheter or to the control group (n = 244) and received a sham (control) treatment; CPAP was continued thereafter in both groups unless specified intubation criteria were met. Main Outcomes and Measures: The primary outcome was the composite of death or physiological BPD assessed at 36 weeks' postmenstrual age. The components of the primary outcome (death prior to 36 weeks' postmenstrual age and BPD at 36 weeks' postmenstrual age) also were considered separately. Results: Among the 485 infants randomized (median gestational age, 27.3 weeks; 241 [49.7%] female), all completed follow-up. Death or BPD occurred in 105 infants (43.6%) in the MIST group and 121 (49.6%) in the control group (risk difference [RD], -6.3% [95% CI, -14.2% to 1.6%]; relative risk [RR], 0.87 [95% CI, 0.74 to 1.03]; P = .10). Incidence of death before 36 weeks' postmenstrual age did not differ significantly between groups (24 [10.0%] in MIST vs 19 [7.8%] in control; RD, 2.1% [95% CI, -3.6% to 7.8%]; RR, 1.27 [95% CI, 0.63 to 2.57]; P = .51), but incidence of BPD in survivors to 36 weeks' postmenstrual age was lower in the MIST group (81/217 [37.3%] vs 102/225 [45.3%] in the control group; RD, -7.8% [95% CI, -14.9% to -0.7%]; RR, 0.83 [95% CI, 0.70 to 0.98]; P = .03). Serious adverse events occurred in 10.3% of infants in the MIST group and 11.1% in the control group. Conclusions and Relevance: Among preterm infants with respiratory distress syndrome supported with CPAP, minimally invasive surfactant therapy compared with sham (control) treatment did not significantly reduce the incidence of the composite outcome of death or bronchopulmonary dysplasia at 36 weeks' postmenstrual age. However, given the statistical uncertainty reflected in the 95% CI, a clinically important effect cannot be excluded. Trial Registration: anzctr.org.au Identifier: ACTRN12611000916943.

The prevalence of vitamin D deficiency in children in the Northern Territory.

AIMS: The primary aim of this study was to determine the frequency of vitD deficiency/insufficiency in an opportunistic sample of Northern Territory (NT) children. The secondary aim was to evaluate whether: (i) 25(OH)vitD (25(OH)D) levels differ between Indigenous/non-Indigenous children; and (ii) VitD insufficiency is associated with increased acute/infective hospitalisations. METHODS: Twenty-five (OH)D levels were measured in 98 children <16 years between August 2011 and January 2012 (children hospitalised acutely/non-acutely and well children from other studies based in Darwin). VitD deficiency was defined as 25(OH)D < 50 nmol/L, and insufficiency was postulated to be <75 nmol/L. Demographic data were collected, and computer records were reviewed. RESULTS: Median age was 59 months (range 2-161); 3.1% were vitD deficient, 19.4% insufficient. There was no significant difference in mean 25(OH)D level between Indigenous (93.2, standard deviation (SD) 21.9, n = 42) and non-Indigenous (97.3, SD 27.9, n = 56) children (P = 0.32). Median number of hospitalisations/year were similar (P = 0.319) between vitD sufficient (0.34, range 0-12, n = 76) and insufficient (0.22, 0-6, n = 22) children. There was no significant difference between number of infective admissions per year between vitD sufficient/insufficient groups (P = 0.119). CONCLUSIONS: Compared with US data (19% deficient, 65% insufficient) fewer NT children are vitD deficient/insufficient. In our limited sample, being vitD insufficient was not associated with increased acute/infective hospitalisations, but a larger unbiased sample of NT children is needed. More information is needed about the optimum level of vitD for non-bone-related health in children.

How domestically violent Fathers impact children's social-emotional development: Fathers' psychological functioning, parenting, and coparenting.

BACKGROUND: Most children exposed to father-perpetrated domestic violence (DV) continue to have contact or live with fathers, yet there is little research on the impact of fathering in the context of domestic violence. OBJECTIVE: This paper aimed to identify pathways from children's exposure to father-perpetrated DV to compromised social-emotional outcomes. Based on extant literature on fathering and domestic violence, psychological, parenting, and coparenting features in DV fathers were identified as potential mediators of the relationship between child exposure to DV and their social-emotional outcomes. PARTICIPANTS AND SETTING: Participants were 123 fathers with confirmed histories of DV perpetration and 101 comparison fathers without such histories. METHODS: Fathers completed self-report measures during two assessment sessions held at the university. Simple mediation analyses were used to examine pathways between fathers' DV perpetration and child internalizing and externalizing difficulties through potential mediators. RESULTS: Paternal depression, hostility, and coparenting difficulties significantly mediated the relationship between child exposure to DV and child internalizing and externalizing difficulties. Low paternal warmth was associated with child externalizing difficulties but did not function as a mediator. Paternal over-reactivity and laxness, in contrast, were not significantly correlated with DV perpetration or with child internalizing or externalizing outcomes. CONCLUSIONS: This study suggests that fathers' emotion regulation and coparenting difficulties are important correlates of his DV perpetration and of their children's psychological symptoms and should be considered as potential foci for parenting intervention with this population.

General Criminality as a Marker of Heterogeneity in Domestically Violent Men: Differences in Trauma History, Psychopathology, Neurocognitive Functioning, and Psychophysiology.

This study examined whether involvement in general criminal behavior was a useful marker of critical historic, psychological, and cognitive aspects of heterogeneity in domestically violent men. Two subgroups of domestically violent men, those with (n = 56) and without (n = 54) a history of criminal involvement, were compared with a group of nonviolent men (n = 82) on internalizing psychopathology, substance abuse, maltreatment in the family of origin, cognitive and executive functioning, and psychophysiological factors. Results found that domestically violent criminal men scored higher than the other two groups on a number of measures including history of childhood violence exposure, childhood externalizing behavior, and adult internalizing psychopathology. No differences were found on their psychophysiological reactivity and cognitive performance. The domestically violent noncriminal group and the comparison group were largely similar on study variables with the exception of education and substance use. Results suggest that general theories of antisocial behavior may be relevant and helpful for understanding domestically violent and criminally involved batterers, whereas social and family violence theories may be of greater relevance to noncriminally involved batterers. Implications of these results for intervention are considered.

The Effect of Preterm Birth on Renal Development and Renal Health Outcome.

Preterm birth is associated with adverse renal health outcomes including hypertension, chronic kidney disease, and an increased rate of progression to end-stage renal failure. This review explores the antenatal, perinatal, and postnatal factors that affect the functional nephron mass of an individual and contribute to long-term kidney outcome. Health-care professionals have opportunities to increase their awareness of the risks to kidney health in this population. Optimizing maternal health around the time of conception and during pregnancy, providing kidney-focused supportive care in the NICU during postnatal nephrogenesis, and avoiding accelerating nephron loss throughout life may all contribute to improved long-term outcomes. There is a need for ongoing research into the long-term kidney outcomes of preterm survivors in mid-to-late adulthood as well as a need for further research into interventions that may improve ex utero nephrogenesis.

Measurement of neonatal heart rate using handheld Doppler ultrasound.

OBJECTIVE: This pilot study aimed to determine whether handheld Doppler ultrasound is feasible and reliable for measuring neonatal heart rate (HR) when compared with ECG. SETTING: Stable newborns were recruited from the neonatal intensive care unit and postnatal ward between July 2014 and January 2015 at Royal North Shore Hospital, Sydney, Australia. INTERVENTIONS: Each newborn had their HR recorded every 15 s over 145 s using four different modalities: ECG, counted audible Doppler (AD) over 10 s, pulse oximetry (PO) and the Doppler display (DD). OUTCOME MEASURES: The correlation and variation between each modality and ECG. RESULTS: 51 newborns with a median gestational age of 38 weeks (27-41) and a mean weight of 2.78 kg (0.82 to 4.76) with a median postnatal age of 3 days (0-87) were studied. There was a mean difference of 0.69 bpm (95% CI -2.9 to +1.5) between AD-HR and ECG-HR with good correlation between modalities (r=0.94, p<0.01). The median time to achieve AD-HR was 3 s (1-45). The mean difference between DD-HR and ECG-HR was 5.37 bpm (95% CI -12.8 to +2.1) with moderate correlation (r=0.37, p=0.04). The mean difference between PO-HR and ECG-HR was 0.49 bpm (95% CI -1.5 to +0.51) with good correlation (r=0.99, p<0.01). The variability between AD-HR and ECG-HR decreased with decreasing weight. CONCLUSIONS: AD-HR correlates well with ECG-HR. Further research in the delivery room is recommended before using AD-HR in this area.