Favorable Outcomes of Preterm Infants With Parenteral Nutrition-associated Liver Disease Treated With Intravenous Fish Oil-based Lipid Emulsion.

OBJECTIVES: The aim of the study was to determine the acute and long-term outcomes of preterm infants treated with an intravenous fish oil-based lipid emulsion (FishLE) for parenteral nutrition-associated liver disease (PNALD). METHODS: Preterm infants 14 days to 24 months of age with anatomic short gut or severe intestinal dysmotility, serum direct bilirubin ≥4 mg/dL, and requiring >60% calories from parenteral nutrition were eligible. Enrolled infants received 1 g ·â€Škg ·â€Šday of FishLE until resolution of direct hyperbilirubinemia or return of enteral nutrition. Acute clinical effects and biochemical markers of liver function were monitored. Growth and developmental scores at 6 and 12 months postmenstrual age (PMA) were assessed and compared with controls matched by gestational age (GA). RESULTS: Thirteen patients with mean GA of 28 ±â€Š4 weeks were treated and compared with 119 GA-matched controls. Their mean direct bilirubin was 9.8 ±â€Š6.4 mg/dL at enrollment. All infants had resolution of cholestasis after study completion. There were no acute adverse events, deaths, or liver/intestinal transplants. Weight and head circumference were similar between FishLE-treated patients and controls at 6- and 12-month PMA. Cognitive and motor scores were decreased at 6 and 12 months PMA in FishLE-treated infants. Logistic regression analysis showed that prolonged hospitalization was detrimental to cognitive and motor development, whereas treatment was not. CONCLUSIONS: The use of intravenous FishLEs in premature infants appears to be safe and reverses PNALD despite significant liver disease and intestinal failure. This therapy should be used in preterm infants with PNALD and followed long term to evaluate development.

Texas Pulse Oximetry Project: A Multicenter Educational and Quality Improvement Project for Implementation of Critical Congenital Heart Disease Screening Using Pulse Oximetry.

Objective Critical congenital heart disease (CCHD) is a leading cause of death in infants. Newborn screening (NBS) by pulse oximetry allows early identification of CCHD in asymptomatic newborns. To improve readiness of hospital neonatal birthing facilities for mandatory screening in Texas, an educational and quality improvement (QI) project was piloted to identify an implementation strategy for CCHD NBS in a range of birthing hospitals. Study Design Thirteen Texas hospitals implemented standardized CCHD screening by pulse oximetry. An educational program was devised and a tool kit was created to facilitate education and implementation. Newborn nursery nurses' knowledge was assessed using a pre- and posttest instrument. Results The nurses' knowledge assessment improved from 71 to 92.5% (p < 0.0001). Of 11,322 asymptomatic newborns screened after 24 hours of age, 11 had a positive screen, with 1 confirmed case of CCHD. Pulse oximetry CCHD NBS had sensitivity of 100%, specificity of 99.91%, false-positive rate of 0.088%, positive predictive value of 9.09%, and negative predictive value of 100%. Conclusion Our educational program, including a tool kit, QI processes, and standardized pulse oximetry CCHD NBS, is applicable for a range of hospital birthing facilities and may facilitate wide-scale implementation, thereby improving newborn health.

A Multicenter Initiative for Critical Congenital Heart Disease Newborn Screening in Texas Neonatal Intensive Care Units.

Objective The objective of this study was to implement a strategy for critical congenital heart disease (CCHD) newborn screening in the neonatal intensive care unit (NICU). Design A NICU-specific curriculum, screening algorithm, slide presentations, and templates of orders, policies, and procedures were developed into a toolkit for training NICU personnel. Screening was conducted on first and second screen pre- and postductal oxygen saturations (SpO2) on newborns admitted or transferred to the NICU. Results We trained 347 NICU personnel in 13 Texas hospitals, representing rural, suburban, and metropolitan settings. Key hospital staff submitted deidentified, case-based screening data. Of 4,621 NICU admissions, 80% received a first screen. Second screening rates were substantially lower in all gestational age groups. Screening rates on first and second screens were lowest among infants born < 28 weeks. For the first screen, SpO2 was lowest among the youngest gestational ages. The false positive rate was 2.3%. Conclusion CCHD screening in the NICU is challenging, given the complexities of the NICU population. A modified screening protocol that recognizes special circumstances of neonatal intensive care could facilitate a more efficient system.

Changes in Course of Retinopathy of Prematurity from 1986 to 2013: Comparison of Three Studies in the United States.

PURPOSE: To compare infant and retinopathy of prematurity (ROP) characteristics from 3 clinical studies conducted over a 27-year period in the United States. DESIGN: Secondary analysis of results of 3 clinical studies. PARTICIPANTS: Infants with birth weight (BW) <1251 g. METHODS: Analysis of data from the Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) and Early Treatment for Retinopathy of Prematurity (ETROP) trials and the primary data from the Telemedicine Approaches for the Evaluation of Acute-Phase Retinopathy of Prematurity (e-ROP) study. MAIN OUTCOME MEASURES: Infant characteristics and onset, severity, and time course of ROP. RESULTS: Across the 3 studies, mean (standard deviation) BW and mean gestational age (GA) decreased over time from CRYO-ROP (954 g [185 g], 27.9 weeks [2.2 weeks]) to ETROP (907 g [205 g], 27.4 weeks [2.2 weeks]) to e-ROP (864 g [212 g], 27.0 weeks [2.2 weeks]), with an increase in the percentage of infants enrolled weighing <750 g (15.8% CRYO, 24.9% ETROP, 33.4% e-ROP; P<0.0001). The percentage of infants who developed ROP varied only minimally (65.8% CRYO, 68.0% ETROP, 63.7% e-ROP; P = 0.003). Moderately severe ROP (defined as prethreshold or referral warranted) varied (17.8% CRYO, 12.3% ETROP, 19.4% e-ROP; P<0.0001), whereas the time of onset of any ROP did not vary (34.3 weeks CRYO, 34.1 weeks ETROP, 34.8 weeks e-ROP). CONCLUSIONS: The BW and GA of infants enrolled in ROP studies in the United States have decreased over the past 27 years, whereas ROP prevalence and onset of disease are stable.

Safety of Retinopathy of Prematurity Examination and Imaging in Premature Infants.

OBJECTIVES: To describe adverse events (AEs) and noteworthy clinical or ocular findings associated with retinopathy of prematurity (ROP) evaluation procedures. STUDY DESIGN: Descriptive analysis of predefined AEs and noteworthy findings reported in a prospective observational cohort study of infants <1251 g birth weight who had ROP study visits consisting of both binocular indirect ophthalmoscopy (BIO) and digital retinal imaging. We compared infant characteristics during ROP visits with and without AEs. We compared respiratory support, nutrition, and number of apnea, bradycardia, or hypoxia events 12 hours before and after ROP visits. RESULTS: A total of 1257 infants, mean birth weight 802 g, had 4263 BIO and 4048 imaging sessions (total 8311 procedures). No serious AEs were related to ROP visits. Sixty-five AEs were reported among 61 infants for an AE rate of 4.9% infants (61/1257) or 0.8% total procedures (65/8311 BIO + imaging). Most AEs were due to apnea, bradycardia, and/or hypoxia (68%), tachycardia (16%), or emesis (8%). At ROP visit, infants with AEs, compared with those without, were more likely to be on mechanical ventilation (26% vs 12%, P = .04) even after adjustment for weight and postmenstrual age. Noteworthy clinical findings were reported during 8% BIO and 15% imaging examinations. Respiratory and nutrition support were not significantly different before and after ROP evaluations. CONCLUSIONS: Retinal imaging by nonphysicians combined with BIO was safe. Noteworthy clinical findings occurred during both procedures. Ventilator support was a risk factor for AEs. Monitoring rates of AEs and noteworthy findings are important to the safe implementation of ROP imaging protocols. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01264276.

Impact of early and high amino acid supplementation on ELBW infants at 2 years.

OBJECTIVE: The aim of the present study was to examine the effects of early and high intravenous (IV) amino acid (AA) supplementation on growth, health, and neurodevelopment of extremely-low-birth-weight (ELBW) infants throughout their first 2 years of life. METHODS: Infants were prospectively randomized in a double-masked fashion and treated for 7 days with either IV AA starting at 0.5 g · kg (-1) · day(-1) and increased by 0.5 g · kg(-1) every day to 3 g · kg(-1)· day(-) or starting at 2 g · kg (-1) · day(-1) of IV AA and advanced by 1 g · kg(-1) every day to 4 g · kg (-1) · day(-1). Plasma AA concentrations were determined by reverse-phase high-performance liquid chromatography. Survivors were longitudinally assessed with Bayley II Scales of Infant Development and physical, social, and global health. RESULTS: Forty-three of 51 survivors were studied. Mental Developmental Index (MDI) and Psychomotor Developmental Index were similar between groups; however, the early and high AA group had a lower MDI at 18 months. This difference disappeared at 2 years of age. The early and high AA group z score means for weight, length, and head circumferences were significantly lower than the standard AA group at most visits. Cumulative and single plasma AA concentrations correlated negatively with MDI and postnatal growth. CONCLUSIONS: ELBW infants who received early and high IV AA during the first week of life were associated with poor overall growth at 2 years.

Family nurture intervention increases term age forebrain EEG activity: A multicenter replication trial.

OBJECTIVE: This trial (RCT-2) sought to replicate the EEG findings of a randomized controlled trial of Family Nurture Intervention in the NICU (FNI-NICU) (RCT-1) comparing infants receiving standard care (SC) with infants receiving SC plus FNI . METHODS: RCT-2 (NCT02710474) was conducted at two NICUs. Subjects were randomly assigned to receive SC or FNI during their NICU stay. The primary outcome was EEG power in the frontal polar region at 39-41 weeks gestational age (GA). Sixty preterm infants (26-34 weeks GA; 33 SC, 27 FNI) were assessed. FNI-NICU consisted of repeated calming sessions (∼4 times/week) facilitated by Nurture Specialists during which mothers engaged in emotional expression during clothed or skin-to-skin holding, vocal soothing, and eye contact. EEGs were collected from 128 leads. EEG power was computed using Fast Fourier Transforms. RESULTS: RCT-2 replicated RCT-1 results; FNI-NICU led to significantly increased frontal polar power at frequencies > 12 Hz. Effects were spatially more widespread than in RCT-1, with substantial effect sizes (∼0.50) in frontal and parietal regions. CONCLUSIONS: RCT-2 results provide further evidence that FNI-NICU increases term age brain activity. SIGNIFICANCE: FNI-NICU is designed to facilitate autonomic emotional connection and coregulation between mothers and infants in the NICU resulting in profound effects on early brain development.

Early changes in plasma amino acid concentrations during aggressive nutritional therapy in extremely low birth weight infants.

OBJECTIVE: To examine the changes in plasma amino acid (AA) concentrations over time when extremely low birth weight infants are provided either a standard intravenous AA supplementation (standard AA) or an early and high supplementation regimen (early and high AA). STUDY DESIGN: Sixty-two infants were enrolled at birth in a randomized, double-masked, prospective fashion and treated for 7 days. The infants with standard AA concentrations received intravenous AA starting at 0.5 g/kg/d and increased by 0.5 g/kg every day to a maximum of 3 g/kg/d. Infants in the early and high AA group received 2 g/kg/d of intravenous AA soon after birth and advanced by 1 g/kg every day to 4 g/kg/d. Plasma AA concentrations were determined by high-pressure liquid chromatography on days 1, 3, and 7. RESULTS: Total AA concentrations, total essential AA concentrations, and total nonessential AA concentrations were significantly higher in the infants in the early and high AA group; essential AA concentrations and total AA concentrations were higher at 1 and 3 days, and nonessential AA concentrations were different only on day 3. There were significant differences between standard AA and early and high AA groups for all AA concentrations except the nonessential AAs Glu, Asn, Gly, Gln, Ala, and Tyr and the conditionally essential AA Cys. CONCLUSION: Infants who received early and higher parenteral AA had higher plasma AA concentrations.

Factors in Premature Infants Associated With Low Risk of Developing Retinopathy of Prematurity.

Importance: Most premature infants will not develop retinopathy of prematurity (ROP) of clinical relevance, yet screening evaluations often continue beyond hospital discharge, even for those infants without ROP. Objectives: To identify the characteristics of infants at low risk for ROP, for whom further postdischarge screening may be of limited value. Design, Setting, and Participants: This study took place in North American neonatal intensive care units where clinicians had expertise in ROP. Infants with birth weight less than 1251 g who were born at or transferred into an Telemedicine Approaches to Evaluating Acute-Phase ROP (e-ROP) study center were enrolled. The study included post hoc analysis of prospectively collected in-hospital ROP examination results among infants enrolled in the e-ROP study. We characterized infants without ROP and performed logistic regression on the subset of infants who were 27 to 33 weeks' gestational age to determine characteristics associated with the absence of ROP during all in-hospital examinations. Main Outcomes and Measures: The main measure was the absence of ROP prior to hospital discharge; the main outcome was treatment for ROP. Results: A total of 1257 infants born at 22 to 35 weeks' gestation (median [interquartile range (IQR)], 26 [25-28] weeks) with birth weights less than 1251 g (median [IQR], 860 [690-1040] g) underwent 4113 ROP examinations between 31 and 47 weeks' postmenstrual age. Overall, 1153 examinations (38%) showed no ROP, and 456 infants (36%) did not have ROP prior to study center discharge or study end point. Among infants without ROP during examinations at 32 and 33 weeks' postmenstrual age, 16 (9.4%) and 14 (5.3%) subsequently underwent ROP treatment, respectively. At hospital discharge, there was no ROP in 59% of infants of 27 to 33 weeks' gestational age, compared with 15% of those who were less than 27 weeks' gestational age (difference, 44% [95% CI, 38.5%-48.1%]; P ≤ .001). With more than 85% follow-up among infants without ROP by 37 weeks' postmenstrual age, none (95% CI, 0%-0.98%) were treated for ROP. In multivariate analysis of infants born at 27 to 33 weeks' gestation, larger birth weight (OR, 4.1 [95% CI, 1.6-10.3]) and higher gestational age (OR, 4.0 [95% CI, 1.5-10.8]) were significantly associated with absence of ROP. Conclusions and Relevance: These findings suggest that, for infants of 27 weeks' gestational age or greater and birth weights larger than 750 g, if no ROP has been detected by discharge at near-term postmenstrual age, then further ROP surveillance has limited value. Studies of all infants at risk are needed to develop more specific, objective criteria for termination of ROP surveillance and focus resources on infants at higher risk of ROP. Trial Registration: ClinicalTrials.gov Identifier: NCT01264276.

Metabolic responses to early and high protein supplementation in a randomized trial evaluating the prevention of hyperkalemia in extremely low birth weight infants.

OBJECTIVE: To determine whether early and higher intravenous amino acid (EHAA) supplementation decreases hyperkalemia in extremely low birth weight (ELBW) infants (<1000 g). STUDY DESIGN: Infants were enrolled at birth in a randomized, double-masked, prospective fashion and treated for 7 days. The standard group (SAA) infants received intravenous amino acid (AA) starting at 0.5 g x kg(-1) x d(-1) and increased by 0.5 g x kg(-1) every day to a maximum of 3 g x kg(-1) x d(-1). EHAA group infants received 2 g x kg(-1) x d(-1) of AA soon after birth and advanced by 1 g x kg(-1) every day to 4 g x kg(-1) x d(-1). Data analysis was by SPSS 11.5, with statistical significance at alpha = 0.05 and 90% power to determine a difference in mean K(+) level of 2. RESULTS: Sixty-two patients, mean gestational age of 26.0 +/- 2.0 weeks and birth weight of 775 +/- 136 g, were enrolled. Hyperkalemia (K(+) > or =6.5 mEq/L) occurred in 13% of the studied population; no difference in incidence of hyperkalemia was found between the SAA and EHAA groups (16% vs 10%, respectively, P = .70). Serum blood urea nitrogen was higher in the EHAA group. AA infusion was stopped early in 6 patients for high blood urea nitrogen or elevated ammonia level. CONCLUSIONS: During the study period, hyperkalemia decreased significantly and was not affected by EHAA supplementation in the first week of life.

Newborn intensive care survivors: a review and a plan for collaboration in Texas.

BACKGROUND: Neonatal intensive care is a remarkable success story with dramatic improvements in survival rates for preterm newborns. Significant efforts and resources are invested to improve mortality and morbidity but much remains to be learned about the short and long-term effects of neonatal intensive care unit (NICU) interventions. Published guidelines recommend that infants discharged from the NICU be in an organized follow-up program that tracks medical and neurodevelopmental outcomes. Yet, there are no standardized guidelines for provision of follow-up services for high-risk infants. The National Institute of Child Health and Human Development Neonatal Research Network and the Vermont Oxford Network have made strides toward standardizing practices and conducting outcomes research, but only include a subset of developmental follow-up programs with a focus on extremely preterm infants. Several studies have been conducted to gain a better understanding of current practices in developmental follow-up. Some of the major themes in these studies are the lack of personnel and funding to provide comprehensive follow-up care; feeding difficulties as a primary issue for NICU survivors, families, and programs; wide variability in referral and follow-up care practices; and calls for standardized, systematic developmental surveillance to improve outcomes. FINDINGS: We convened a one-day summit to discuss developmental follow-up practices in Texas involving four academic and three nonacademic centers. All seven centers described variable age and weight criteria for follow-up of NICU patients and a unique set of developmental practices, including duration of follow-up, types and timing of developmental assessments administered, education and communication with families and other health care providers, and referrals for services. Needs identified by the centers focused on two main themes: resources and comprehensive care. Participants identified key challenges for developmental follow-up, generated recommendations to address these challenges, and outlined components of a quality program. CONCLUSIONS: The long-term goal is to ensure that all children maximize their potential; a goal supported through quality, comprehensive developmental follow-up care and outcomes research to continuously improve evidence-based practices. We aim to contribute to this goal through a statewide working group collaborating on research to standardize practices and inform policies that truly benefit children and their families.

The nurse champion model for advancing newborn screening of critical congenital heart disease.

Critical congenital heart disease (CCHD) is the leading cause of death in infants younger than age one year in the United States. Early detection and timely intervention can significantly reduce newborn morbidity and mortality. In Texas, nurse champions provided leadership to develop an educational program to screen newborns for CCHD using pulse oximetry. Results demonstrated the value of nurse champions in creating an effective educational program. Nurses are positioned to educate and advocate for universal CCHD newborn screening.

A transition strategy for becoming a baby-friendly hospital: exploring the costs, benefits, and challenges.

The objectives of this study were to provide an economic assessment as well as a calculated projection of the costs that typical U.S. tertiary-care hospitals would incur through policy reconfiguration and implementation to achieve the UNICEF/World Health Organization Baby-Friendly® Hospital designation and to examine the associated challenges and benefits of becoming a Baby-Friendly Hospital. We analyzed hospital resource utilization, focusing on formula use and staffing profiles at one U.S. urban tertiary-care teaching hospital, as well as conducted an online survey and telephone interviews with a selection of Baby-Friendly Hospitals to obtain their perspective on costs, challenges, and benefits. Findings indicate that added costs for a new Baby-Friendly Hospital will approximate $148 per birth, but these costs sharply decrease over time as breastfeeding rates increase in a Baby-Friendly environment.

Cost comparison of baby friendly and non-baby friendly hospitals in the United States.

OBJECTIVES: The objectives of this study were to provide an economic assessment of the incremental costs associated with obtaining the World Health Organization and United Nations International Children's Emergency Fund designation as a Infant-Friendly hospital. We hypothesized that baby-friendly hospitals will have higher costs than similar non-baby-friendly hospitals. METHODS: Data from the 2007 American Hospital Association and the 2007 Centers for Medicare and Medicaid Cost Reports were used to compare labor and delivery costs in baby-friendly and non-baby-friendly hospitals. Operational costs per delivery were calculated using a matched-pairs analysis of a sample of baby-friendly and non-baby-friendly hospitals in the United States. Costs associated with labor-and-delivery diagnosis-related codes were analyzed for each baby-friendly hospital and compared with the mean and median costs incurred by non-baby-friendly hospitals. RESULTS: Nursery plus labor-and-delivery costs for the baby-friendly sites were $2205 per delivery, compared with $2170 for the non-baby-friendly matched pair. Baby-friendly facilities have slightly higher costs than non-baby-friendly facilities, ranging from 1.6% to 5%, but these costs were not statistically significant (P > .05). CONCLUSIONS: These results suggest that becoming baby-friendly is relatively cost-neutral for a typical acute care hospital. Although the overall expense of providing baby-friendly hospital nursery services is greater than nursery service costs of non-baby-friendly hospitals, the cost difference was not statistically significant. Additional research is needed to compare the economic impact of maternal and infant health benefits from breastfeeding versus the incremental expenses of becoming a baby-friendly hospital.