A trial comparing continuous positive airway pressure (CPAP) devices in preterm infants.

OBJECTIVE: To test the hypothesis that infants born <30 weeks' gestation supported by Seattle-PAP will have lower rates of continuous positive airway pressure (CPAP) failure than infants supported with conventional, Fisher&Paykel-CPAP (FP-CPAP). STUDY DESIGN: Randomized trial (3/2017-01/2019) at 5 NICUs. The primary outcome was CPAP failure; subgroup analyses (gestational age, receipt antenatal corticosteroids) were performed. RESULTS: A total of 232 infants were randomized. Infants in the Seattle-PAP and FP-CPAP groups had mean gestational ages of 27.0 and 27.2 weeks, respectively. We observed no differences in rates of treatment failure between Seattle-PAP (40/112, 35.7%) and FP-CPAP (38/120, 31.7%; risk difference, 4.1%; 95% CI, -8.1-16.2; P = 0.51). Subgroup analysis indicated no differences in rates of CPAP failure. We observed no differences between the two groups in frequencies of adverse events or duration of respiratory support. CONCLUSIONS: Among infants born <30 weeks' gestation, rates of CPAP failure did not differ between Seattle-PAP and FP-CPAP.

Evaluating the efficacy of Seattle-PAP for the respiratory support of premature neonates: study protocol for a randomized controlled trial.

BACKGROUND: At birth, the majority of neonates born at <30 weeks of gestation require respiratory support to facilitate transition and ensure adequate gas exchange. Although the optimal approach to the initial respiratory management is uncertain, the American Academy of Pediatrics endorses noninvasive respiratory support with nasal continuous positive airway pressure (nCPAP) for premature neonates with respiratory insufficiency. Despite evidence for its use, nCPAP failure, requiring intubation and mechanical ventilation, is common. Recently, investigators have described a novel method to deliver bubble nCPAP, termed Seattle-PAP. While preclinical and pilot studies are encouraging regarding the potential value of Seattle-PAP, a large trial is needed to compare Seattle-PAP directly with the current standard of care for bubble nCPAP (Fisher & Paykel CPAP or FP-CPAP). METHODS/DESIGN: We designed a multicenter, non-blinded, randomized controlled trial that will enroll 230 premature infants (220/7 to 296/7 weeks of gestation). Infants will be randomized to receive Seattle-PAP or FP-CPAP. The primary outcome is respiratory failure requiring intubation and mechanical ventilation. Secondary outcomes include measures of short- and long-term respiratory morbidity and cost-effectiveness. DISCUSSION: This trial will assess whether Seattle-PAP is more efficacious and cost-effective than FP-CPAP in real-world practice among premature neonates. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03085329 . Registered on 21 March 2017.

"Trying to Figure Out If You're Doing Things Right, and Where to Get the Info": Parents Recall Information and Support Needed During the First 6 weeks Postpartum.

Objectives The first 6 weeks postpartum represent a time of significant adjustment and learning for parents. Healthcare providers accurately understanding parents' needs and preferences regarding support, education, and services during this critical time is essential for optimizing maternal and infant health. The first objective of this study was to explore parents' experiences adjusting to the parenting role during the first 6 weeks postpartum. The second objective was to elicit from parents where and how they sought support and information during the early postpartum period, and what hindered this process. Methods Five focus groups were conducted with 33 mothers and fathers of young children, stratified by ethnicity, education, and income. An interdisciplinary team thematically coded verbatim transcripts and identified emergent themes. Results Main themes included low confidence in parenting and sifting through parenting information. Additional themes included communicating with partner about changing roles, breastfeeding, maternal mental health, and maternal postpartum recovery. Low parenting confidence was closely linked with information seeking, yet participants expressed being overwhelmed by the task of managing conflicting parenting information. Women reported that providers focused on infant needs, leaving them feeling unprepared for their own mental and physical health needs. Conclusions for Practice Parents report extensive needs for education and support in the early postpartum period, yet also report feeling overwhelmed by the quantity of parenting information available. These findings suggest parents need and desire reliable healthcare education after discharge that includes parent health and adjustment.

Differences in inflammatory markers between nulliparous women admitted to hospitals in preactive vs active labor.

OBJECTIVE: To determine whether labor-associated inflammatory markers differ between low-risk, nulliparous women in preactive vs active labor at hospital admission and over time. STUDY DESIGN: Prospective comparative study of low-risk, nulliparous women with spontaneous labor onset at term (n = 118) sampled from 2 large Midwestern hospitals. Circulating concentrations of inflammatory markers were measured at admission and again 2 and 4 hours later: namely, neutrophil, and monocyte counts; and serum inflammatory cytokines (interleukin -1ß, interleukin-6, tumor necrosis factor-α, interleukin-10) and chemokines (interleukin-8). Biomarker concentrations and their patterns of change over time were compared between preactive (n = 63) and active (n = 55) labor admission groups using Mann-Whitney U tests. RESULTS: Concentrations of interleukin-6 and interleukin-10 in the active labor admission group were significantly higher than concentrations in the preactive labor admission group at all 3 time points. Neutrophil levels were significantly higher in the active group at 2 and 4 hours after admission. The rate of increase in neutrophils and interleukin-10 between admission and 2 hours later was faster in the active group (P < .001 and P = .003, respectively). CONCLUSION: Circulating concentrations of several inflammatory biomarkers are higher and their rate of change over time since admission is faster among low-risk, nulliparous women admitted to hospitals in active labor, as compared with those admitted in preactive labor. More research is needed to determine if progressive changes in inflammatory biomarkers might be a useful adjunct to improving the assessment of labor progression and determining the optimal timing of labor admission.

Outcomes of nulliparous women with spontaneous labor onset admitted to hospitals in preactive versus active labor.

INTRODUCTION: The timing of when a woman is admitted to the hospital for labor care following spontaneous contraction onset may be among the most important decisions that labor attendants make because it can influence care patterns and birth outcomes. The aims of this study were to estimate the percentage of low-risk, nulliparous women at term who are admitted to labor units prior to active labor and to evaluate the effects of the timing of admission (ie, preactive vs active labor) on labor interventions and mode of birth. METHODS: Data from low-risk, nulliparous women with spontaneous labor onset at term gestation were merged from 2 prospective studies conducted at 3 large Midwestern hospitals. Baseline characteristics, labor interventions, and outcomes were compared between groups using Fisher's exact and Mann-Whitney U tests, as appropriate. Likelihoods for oxytocin augmentation, amniotomy, and cesarean birth were assessed by logistic regression. RESULTS: Of the sample of 216 low-risk nulliparous women, 114 (52.8%) were admitted in preactive labor and 102 (47.2%) were admitted in active labor. Women who were admitted in preactive labor were more likely to undergo oxytocin augmentation (84.2% and 45.1%, respectively; odds ratio [OR], 6.5; 95% confidence interval [CI], 3.43-12.27) but not amniotomy (55.3% and 61.8%, respectively; OR, 0.8; 95% CI, 0.44-1.32) when compared to women admitted in active labor. The likelihood of cesarean birth was higher for women admitted before active labor onset (15.8% and 6.9%, respectively; OR, 2.6; 95% CI, 1.02-6.37). DISCUSSION: Many low-risk nulliparous women with regular, spontaneous uterine contractions are admitted to labor units before active labor onset, which increases their likelihood of receiving oxytocin and giving birth via cesarean. An evidence-based, standardized approach for labor admission decision making is recommended to decrease inadvertent admissions of women in preactive labor. When active labor cannot be diagnosed with relative certainty, observation before admission to the birthing unit is warranted.

Relationships among intrapartum maternal fluid intake, birth type, neonatal output, and neonatal weight loss during the first 48 hours after birth.

OBJECTIVE: To examine predictive relationships among intrapartum maternal fluid intake, birth type, neonatal output, and neonatal weight loss during the first 48 hours after birth. DESIGN: Prospective descriptive design. SETTING: Women's center of a 900-bed regional acute care facility with 6,700 births per year. PARTICIPANTS: A convenience sample of 200 mother/neonate dyads. The Optimality Index of Murphy and Fullerton guided the inclusion and exclusion criteria to ensure healthy dyads. METHODS: Data collection began in the intrapartum period and concluded with maternal/neonatal discharge. Measures included maternal intrapartum fluid intake from admission to birth, daily neonatal weight, output, and feedings. Data were analyzed via descriptive statistics, tests of significance and multiple regression. RESULTS: Neonatal weight loss was not significantly related to intrapartum maternal fluid intake. Strong predictors of neonatal weight loss and significant weight loss within the first 48 hours were type of feeding (p=.000) and average number of wet diapers (p=.003). CONCLUSIONS: Variables predictive of neonatal weight loss can facilitate identification of at-risk neonates to prevent significant weight loss. Close monitoring of the number of wet diapers in the first 48 hours and accurate daily weights at birth time can lead to early detection and preventive interventions.