A Multifunctional, Low Cost and Sustainable Neonatal Database System.

Continuous improvement in the clinical performance of neonatal intensive care units (NICU) depends on the use of locally relevant, reliable data. However, neonatal databases with these characteristics are typically unavailable in NICUs using paper-based records, while in those using electronic records, the inaccuracy of data and the inability to customize commercial data systems limit their usability for quality improvement or research purposes. We describe the characteristics and uses of a simple, neonatologist-centered data system that has been successfully maintained for 30 years, with minimal resources and serving multiple purposes, including quality improvement, administrative, research support and educational functions. Structurally, our system comprises customized paper and electronic components, while key functional aspects include the attending-based recording of diagnoses, integration into clinical workflows, multilevel data accuracy and validation checks, and periodic reporting on both data quality and NICU performance results. We provide examples of data validation methods and trends observed over three decades, and discuss essential elements for the successful implementation of this system. This database is reliable and easily maintained; it can be developed from simple paper-based forms or used to supplement the functionality and end-user customizability of existing electronic medical records. This system should be readily adaptable to NICUs in either high- or limited-resource environments.

Early Troponin I Levels in Newborns Undergoing Therapeutic Hypothermia for Hypoxic Ischemic Encephalopathy and Residual Encephalopathy at Discharge.

OBJECTIVE: Elevation of serum troponin I has been reported in newborns with hypoxic ischemic encephalopathy (HIE), but it is diagnostic and prognostic utility for newborn under 6 hours is not clear. Study the predictive value of early serum troponin I levels in newborns with HIE undergoing therapeutic hypothermia (TH) for persistent residual encephalopathy (RE) at discharge. STUDY DESIGN: Retrospective chart review of newborns admitted with diagnosis of HIE to neonatal intensive care unit (NICU) for TH over a period of 3 years. Troponin levels were drawn with the initial set of admission laboratories while initiating TH. Newborns were followed up during hospital course and stratified into three groups based on predischarge examination and their electrical encephalography and cranial MRI findings: Group 1: no RE, Group 2: mild-to-moderate RE, and Group 3: severe RE or needing assisted medical technology or death. Demographic and clinical characteristics including troponin I levels were compared in each group. RESULTS: Out of 104 newborns who underwent TH, 65 infants were in Group 1, 26 infants in Group 2, and 13 newborns in Group 3. All groups were comparable in demographic characteristics. There was a significant elevation of serum troponin in group 2 (mild-to-moderate RE) and group 3 (severe RE) as compared with group 1 (no RE). Receiver operator curve analysis for any RE (groups 2 and 3) compared with group 1 (no RE as control) had 0.88 (0.81-0.95) area under curve, p < 0.001. A cut-off level of troponin I ≥0.12 µg/L had a sensitivity of 77% and specificity of 78% for diagnosis of any RE, positive predictive value of 68%, and a negative predictive value of 84%. CONCLUSION: In newborns undergoing TH for HIE, the elevation of troponin within 6 hours of age predicts high risk of having RE at discharge. KEY POINTS: · Troponin I elevation is a biomarker of myocardial ischemia in adults and children.. · Myocardial ischemia may be part of multi-organ injury in neonatal HIE.. · Early elevation of troponin I level may correlate with the severity of neonatal HIE and predict residual encephalopathy in newborn at discharge from initial hospitalization..

Vitamin D insufficiency in neonatal hypoxic-ischemic encephalopathy.

BACKGROUND: Vitamin D has neuroprotective and immunomodulatory properties, and deficiency is associated with worse stroke outcomes. Little is known about effects of hypoxia-ischemia or hypothermia treatment on vitamin D status in neonates with hypoxic-ischemic encephalopathy (HIE). We hypothesized vitamin D metabolism would be dysregulated in neonatal HIE altering specific cytokines involved in Th17 activation, which might be mitigated by hypothermia. METHODS: We analyzed short-term relationships between 25(OH) and 1,25(OH)2 vitamin D, vitamin D binding protein, and cytokines related to Th17 function in serum samples from a multicenter randomized controlled trial of hypothermia 33 °C for 48 h after HIE birth vs. normothermia in 50 infants with moderate to severe HIE. RESULTS: Insufficiency of 25(OH) vitamin D was observed after birth in 70% of infants, with further decline over the first 72 h, regardless of treatment. 25(OH) vitamin D positively correlated with anti-inflammatory cytokine IL-17E in all HIE infants. However, Th17 cytokine suppressor IL-27 was significantly increased by hypothermia, negating the IL-27 correlation with vitamin D observed in normothermic HIE infants. CONCLUSION: Serum 25(OH) vitamin D insufficiency is present in the majority of term HIE neonates and is related to lower circulating anti-inflammatory IL-17E. Hypothermia does not mitigate vitamin D deficiency in HIE.

Surgical site infections in the NICU.

BACKGROUND: Surgical site infections (SSI) increase morbidity and mortality. In adult and pediatric populations, the incidence ranges from 1.5-12%. Studies in neonates have shown an association between preoperative stay in an intensive care unit and development of SSI. To date, there has only been a single study looking exclusively at SSI in the Neonatal Intensive Care Unit (NICU). Additionally, there has been a suggestion that prematurity may be a risk factor for SSI, but this has come from studies looking at all neonates less than 28days, rather than only neonates hospitalized in a NICU. OBJECTIVE: Primary outcome variable was to calculate the incidence of SSI in a NICU population. Secondary outcome variables were to determine if SSI is more common in premature infants and to identify additional risk factors for the development of SSI. METHODS: An IRB-approved retrospective chart review of all patients undergoing surgical procedures in a level IIIC NICU over a 2-year period was used. We utilized the CDC's definitions of surgical procedures and SSI. An epidemiologist reviewed charts if the diagnosis of SSI was questionable. Statistical analysis was done with t test and Fisher's exact test. RESULTS: We identified 165 patients who underwent 264 surgical procedures. Incidence of SSI was 11.7%. There were 31 SSI that occurred in 29 neonates over the 2-year period, with no mortality in that group. In patients who developed an SSI, 34.5% occurred after the 1st procedure, 41.4% occurred after a 2nd procedure, and 24.1% occurred after the 3rd or later procedure. There was no difference in perioperative antibiotic usage. CONCLUSIONS: This study describes SSI in a strictly neonatal population in a large academic NICU. Prematurity does not appear to be a risk factor for SSI. SSI is more common in neonates who have undergone an abdominal procedure or multiple procedures. Perioperative antibiotics are not significantly associated with prevention of SSI.

Management of the late preterm infant: not quite ready for prime time.

Preterm births account for 12.5% of all births in the United States. The preterm birth rate has increased by 33% over the last 2 decades. Late and premature infants do not develop the serious and chronic conditions of the extreme premature infant. However, there is growing evidence that these infants are not as healthy as previously thought and do in fact have an increase in morbidity and mortality compared with term infants. This article summarizes the epidemiology of late preterm infants and the associated morbidities associated with their prematurity.

Altered circulating leukocytes and their chemokines in a clinical trial of therapeutic hypothermia for neonatal hypoxic ischemic encephalopathy*.

OBJECTIVES: To determine systemic hypothermia's effect on circulating immune cells and their corresponding chemokines after hypoxic ischemic encephalopathy in neonates. DESIGN: In our randomized, controlled, multicenter trial of systemic hypothermia in neonatal hypoxic ischemic encephalopathy, we measured total and leukocyte subset and serum chemokine levels over time in both hypothermia and normothermia groups, as primary outcomes for safety. SETTING: Neonatal ICUs participating in a Neurological Disorders and Stroke sponsored clinical trial of therapeutic hypothermia. PATIENTS: Sixty-five neonates with moderate to severe hypoxic ischemic encephalopathy within 6 hours after birth. INTERVENTIONS: Patients were randomized to normothermia of 37°C or systemic hypothermia of 33°C for 48 hours. MEASUREMENTS AND MAIN RESULTS: Complete and differential leukocyte counts and serum chemokines were measured every 12 hours for 72 hours. The hypothermia group had significantly lower median circulating total WBC and leukocyte subclasses than the normothermia group before rewarming, with a nadir at 36 hours. Only the absolute neutrophil count rebounded after rewarming in the hypothermia group. Chemokines, monocyte chemotactic protein-1 and interleukin-8, which mediate leukocyte chemotaxis as well as bone marrow suppression, were negatively correlated with their target leukocytes in the hypothermia group, suggesting active chemokine and leukocyte modulation by hypothermia. Relative leukopenia at 60-72 hours correlated with an adverse outcome in the hypothermia group. CONCLUSIONS: Our data are consistent with chemokine-associated systemic immunosuppression with hypothermia treatment. In hypothermic neonates, persistence of lower leukocyte counts after rewarming is observed in infants with more severe CNS injury.

The effectiveness of policy changes designed to increase the attendance rate for outpatient retinopathy of prematurity (ROP) screening examinations.

PURPOSE: To determine the effectiveness of a series of policy changes designed to increase the attendance rate for outpatient retinopathy of prematurity (ROP) screening examinations. METHODS: We retrospectively reviewed the records of consecutive neonatal intensive care unit patients before and after the implementation of policy changes. Policy changes included parent education forms, streamlined scheduling, and creation of a log for all patients seen. The primary outcome measure was attendance rates for the first outpatient appointment after discharge. The Fisher exact test was used to compare rates between the two groups. RESULTS: Before the policy was implemented, 22 of 52 (42%) neonates and their caregivers attended their first outpatient ROP screening examination on the recommended date. This rate improved significantly after policy implementation, when 46 of 57 (81%) neonates and their caregivers were seen on the recommended date (P < 0.01). The number of patients who ultimately met the criteria for conclusion of acute retinal screening examinations also significantly improved, from 47 of 52 (90%) of neonates in the pre-implementation group to 57 of 57 (100%) in the post-implementation group (P = 0.02). CONCLUSIONS: The attendance rates for initial outpatient ROP examinations and the number of patients who ultimately met criteria for conclusion of acute retinal screening examinations significantly improved after the implementation of new policies.

Serum cytokines in a clinical trial of hypothermia for neonatal hypoxic-ischemic encephalopathy.

Inflammatory cytokines may mediate hypoxic-ischemic (HI) injury and offer insights into the severity of injury and the timing of recovery. In our randomized, multicenter trial of hypothermia, we analyzed the temporal relationship of serum cytokine levels in neonates with hypoxic-ischemic encephalopathy (HIE) with neurodevelopmental outcome at 12 months. Serum cytokines were measured every 12 hours for 4 days in 28 hypothermic (H) and 22 normothermic (N) neonates with HIE. Monocyte chemotactic protein-1 (MCP-1) and interleukins (IL)-6, IL-8, and IL-10 were significantly higher in the H group. Elevated IL-6 and MCP-1 within 9 hours after birth and low macrophage inflammatory protein 1a (MIP-1a) at 60 to 70 hours of age were associated with death or severely abnormal neurodevelopment at 12 months of age. However, IL-6, IL-8, and MCP-1 showed a biphasic pattern in the H group, with early and delayed peaks. In H neonates with better outcomes, uniform down modulation of IL-6, IL-8, and IL-10 from their peak levels at 24 hours to their nadir at 36 hours was observed. Modulation of serum cytokines after HI injury may be another mechanism of improved outcomes in neonates treated with induced hypothermia.

Nurses' guide to early detection of umbilical arterial catheter complications in infants.

Umbilical arterial catheters (UAC) are routinely used in the care of critically ill newborns. Complications related to UACs include vascular compromise, hemorrhage, complications related to malposition, severance of the catheter itself, and infection. This article is Part II in a series dedicated to assessing infants with an umbilical catheter. Part I focused on infants with umbilical venous catheters; this article will focus on the physical assessment relevant to infants with an UAC. Complications related to UACs can occur during any phase of treatment: insertion, while indwelling, or after discontinuing the catheter. Review of clinical signs of complications along with clinical photographs, will assist caregivers in promptly recognizing UAC-related complications.

Moderate hypothermia in neonatal encephalopathy: efficacy outcomes.

Therapeutic hypothermia holds promise as a rescue neuroprotective strategy for hypoxic-ischemic injury, but the incidence of severe neurologic sequelae with hypothermia is unknown in encephalopathic neonates who present shortly after birth. This study reports a multicenter, randomized, controlled, pilot trial of moderate systemic hypothermia (33 degrees C) vs normothermia (37 degrees C) for 48 hours in neonates initiated within 6 hours of birth or hypoxic-ischemic event. The trial tested the ability to initiate systemic hypothermia in outlying hospitals and participating tertiary care centers, and determined the incidence of adverse neurologic outcomes of death and developmental scores at 12 months by Bayley II or Vineland tests between normothermic and hypothermic groups. Thirty-two hypothermic and 33 normothermic neonates were enrolled. The entry criteria selected a severely affected group of neonates, with 77% Sarnat stage III. Ten hypothermia (10/32, 31%) and 14 normothermia (14/33, 42%) patients expired. Controlling for treatment group, outborn infants were significantly more likely to die than hypoxic-ischemic infants born in participating tertiary care centers (odds ratio 10.7, 95% confidence interval 1.3-90). Severely abnormal motor scores (Psychomotor Development Index < 70) were recorded in 64% of normothermia patients and in 24% of hypothermia patients. The combined outcome of death or severe motor scores yielded fewer bad outcomes in the hypothermia group (52%) than the normothermia group (84%) (P = 0.019). Although these results need to be validated in a large clinical trial, this pilot trial provides important data for clinical trial design of hypothermia treatment in neonatal hypoxic-ischemic injury.

Moderate hypothermia in neonatal encephalopathy: safety outcomes.

Hypoxic-ischemic injury may cause multisystem organ damage with significant aberrations in clotting, renal, and cardiac functions. Systemic hypothermia may aggravate these medical conditions, such as bradycardia and increased clotting times, and very little safety data in neonatal hypoxic-ischemic injury is available. This study reports a multicenter, randomized, controlled pilot trial of moderate systemic hypothermia (33 degrees C) vs normothermia (37 degrees C) for 48 hours in infants with neonatal encephalopathy instituted within 6 hours of birth or hypoxic-ischemic event. The best outcome measures of safety were determined, comparing rates of adverse events between normothermia and hypothermia groups. A total of 32 hypothermia and 33 normothermia neonates were enrolled in seven centers. Adverse events and serious adverse effects were collected by the study team during the hospital admission, monitored by an independent study monitor, and reported to Institutional Review Boards and the Data and Safety Monitoring Committee. The following adverse events were observed significantly more commonly in the hypothermia group: more frequent bradycardia and lower heart rates during the period of hypothermia, longer dependence on pressors, higher prothrombin times, and lower platelet counts with more patients requiring plasma and platelet transfusions. Seizures as an adverse event were more common in the hypothermia group. These observed side effects of 48 hours of moderate systemic hypothermia were of mild to moderate severity and manageable with minor interventions.