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Randomized control trial comparing physiologic effects in preterm infants during treatment with nasal continuous positive airway pressure (NCPAP) generated by Bubble NCPAP and Ventilator NCPAP: a pilot study

Guerin, Craig; Bailey, Sean M; Mally, Pradeep V; Rojas, Mary; Bhutada, Alok; Rastogi, Shantanu
OBJECTIVES: Nasal continuous positive airway pressure (NCPAP) is an accepted form of non-invasive ventilation in preterm infants. Few, if any, studies have shown an advantage of one type of NCPAP over another. It has been theorized that bubble-generated NCPAP may be advantageous for the preterm neonate versus traditionally used ventilator-generated NCPAP. The aim of this study was to examine for any short-term differences in physiologic parameters in preterm subjects receiving these two different methods of NCPAP. METHODS: We conducted a randomized, prospective, cross-over pilot study of preterm infants being treated with NCPAP in the neonatal intensive care unit. Subjects were continuously monitored for several physiologic parameters including heart rate, respiratory rate, oxygen saturation, cerebral tissue oxygen saturation and cerebral fractional oxygen extraction using routine neonatal monitors and near-infrared spectroscopy (NIRS) while on 2 h of bubble NCPAP and 2 h of ventilator NCPAP. Subjects were randomized to be monitored while either starting on bubble NCPAP and then switching to ventilator NCPAP or starting on ventilator NCPAP and switching to bubble NCPAP. RESULTS: Eighteen subjects were included. We found no statistically significant difference in any of the physiologic parameters while subjects were receiving bubble NCPAP versus ventilator NCPAP during the monitoring time periods. While on bubble NCPAP, subjects showed a trend toward decreasing respiratory rate and decreasing cerebral fractional oxygen extraction over time, but this did not reach statistical significance. CONCLUSION: There appears to be no difference in immediate physiologic effects between bubble NCPAP and ventilator NCPAP. This does not preclude the possibility of potential long-term differences, but any differences seen would likely be based on mechanisms that take more time to develop. A larger prospective trial is warranted to confirm our findings.
PMID: 26352079
ISSN: 1619-3997
CID: 2239552

Impact of Respiratory Morbidities on Neurodevelopmental Outcome of Late Preterm Infants

Wachtel, Elena V; Zaccario, Michele; Mally, Pradeep
Objective This study aims to evaluate impact of respiratory and other neonatal comorbidities on neurodevelopmental outcome in late preterm infants (LPT). Method Retrospective study of LPT infants (34 (0/7)-36 (6/7) weeks' gestation) discharged from the New York University Langone Medical Center neonatal intensive care unit, during January 2006 to December 2010 and received follow-up care up to 2 years of age. Neonatal morbidities were correlated with neurodevelopmental outcomes and assessed by performance on the Mullen Scales of Early Learning during three developmental follow-up visits. Results A total of 99 LPT completed neurodevelopmental assessment up to 2 years of age. Infants with diagnosis of moderate-to-severe respiratory distress syndrome showed a significantly lower performance in the visual reception on the second (p < 0.01) and third visit (p = 0.02), as well as lower performance in the receptive language (visit 2, p = 0.02; visit 3, p < 0.01). A diagnosis of persistent pulmonary hypertension was found to be associated with significantly lower performance in the visual reception at all visits (p < 0.01; p = 0.02; p = 0.02) and in the receptive language on the second and third visit (p = 0.03; p = 0.02). Combined respiratory morbidities were also associated with lower developmental scores in fine motor (visit 2, p < 0.01; visit 3, p = 0.04) as well as expressive language (visit 3, p = 0.02). Conclusion LPT with significant respiratory morbidities are at higher risk for long-term developmental delays, mainly affecting cognitive developmental domains.
PMID: 25978842
ISSN: 1098-8785
CID: 1792902

Variability in splanchnic tissue oxygenation during preterm red blood cell transfusion given for symptomatic anaemia may reveal a potential mechanism of transfusion-related acute gut injury

Bailey, Sean M; Hendricks-Munoz, Karen D; Mally, Pradeep V
BACKGROUND: There is increasing evidence indicating an association between red blood cell (RBC) transfusions and necrotising enterocolitis (NEC) in preterm infants, especially late-onset NEC. This phenomenon is referred to as transfusion-related acute gut injury (TRAGI). One theory as to a pathophysiological mechanism is that transfusion may result in an ischemia-reperfusion injury to intestinal tissue. We tested the hypothesis that there is significantly greater variability during transfusion in splanchnic tissue oxygen saturation (SrSO2) than in cerebral tissue oxygen saturation (CrSO2). MATERIALS AND METHODS: This was a prospective, observational study using near-infrared spectroscopy to monitor SrSO2 and CrSO2 in preterm neonates undergoing RBC transfusion for symptomatic anaemia. Mean, standard deviation, highest and lowest SrSO2 and CrSO2 values during each transfusion were determined. The greatest difference in SrSO2 and CrSO2 during each transfusion was calculated, along with the coefficient of variation. RESULTS: We studied 37 subjects. Throughout all transfusions, the mean SrSO2 was 45.6% +/-13.8 and the mean CrSO2 was 65.4% +/-6.9 (p<0.001). The variability of SrSO2 was significantly greater than that of CrSO2. Averaging data from all subjects, the greatest difference in SrSO2 was 43.8% +/-13.4 compared with 23.3% +/-7.6 for CrSO2 (p<0.001). The mean coefficient of variation in all transfusions was 20.5% for SrSO2 and 6.0% for CrSO2 (p<0.001). Increasing post-conceptional age did not affect SrSO2 variability (R2=0.022; p=0.379), whereas CrSO2 variability during transfusion decreased with increasing post-conceptional age (R2=0.209; p=0.004). DISCUSSION: In preterm infants, there is a large degree of tissue oxygenation variability in splanchnic tissue during RBC transfusion and this does not change with increasing maturity. We speculate that these findings, combined with lower average tissue oxygenation, may demonstrate susceptibility of the preterm gut to TRAGI.
PMCID:4614295
PMID: 25761320
ISSN: 1723-2007
CID: 1495022

Evacuation of a neonatal intensive care unit in a disaster: lessons from hurricane sandy

Espiritu, Michael; Patil, Uday; Cruz, Hannaise; Gupta, Arpit; Matterson, Heideh; Kim, Yang; Caprio, Martha; Mally, Pradeep
NICU patients are among those potentially most vulnerable to the effects of natural or man-made disaster on a medical center. The published data on evacuations of NICU patients in the setting of disaster are sparse. In October of 2012, New York University Langone Medical Center was evacuated during Hurricane Sandy in the setting of a power outage secondary to a coastal surge. In this setting, 21 neonates were safely evacuated from the medical center's NICU to receiving hospitals within New York City in a span of 4.5 hours. Using data recorded during the evacuation and from staff debriefings, we describe the challenges faced and lessons learned during both the power outage and vertical evacuation. From our experience, we identify several elements that are important to the functioning of an NICU in a disaster or to an evacuation that may be incorporated into future NICU-focused disaster planning. These include a clear command structure, backups (personnel, communication, medical information, and equipment), establishing situational awareness, regional coordination, and flexibility as well as special attention to families and to the availability of neonatal transport resources.
PMID: 25384488
ISSN: 0031-4005
CID: 1368982

Measurement of novel biomarkers of neuronal injury and cerebral oxygenation after routine vaginal delivery versus cesarean section in term infants

Morel, Alexandra Almanzar; Bailey, Sean M; Shaw, Gerry; Mally, Pradeep; Malhotra, Sunil P
Abstract Aims: It remains unclear if mode of delivery can have any impact on the neonatal brain. Our aim was to determine in term newborns any differences based on mode of delivery in either neuronal injury biomarkers, phosphorylated axonal neurofilament heavy chain (pNF-H) and ubiquitin C-terminal hydrolase (UCHL1), or brain oxygenation values, regional cerebral tissue oxygen saturation (CrSO2) and cerebral fractional tissue oxygen extraction (CFOE). Methods: An Institutional Review Board approved prospective observational pilot study of well newborns. Serum pNF-H and UCHL1 levels were measured on the day following delivery. CrSO2 values along with CFOE values were also measured using near-infrared spectroscopy (NIRS) and pulse oximetry. Results: There were 22 subjects, 15 born vaginally and seven born by cesarean section. No difference was found in mean pNF-H (107.9+/-54.3 pg/mL vs. 120.2+/-43.3 pg/mL, P=0.66) or mean UCHL1 (4.0+/-3.5 pg/mL vs. 3.0+/-2.2 pg/mL, P=0.68). No difference was found in mean CrSO2 (80.8+/-5.3% vs. 80.8+/-5.6%, P=0.99) or mean CFOE (0.17+/-0.06 vs. 0.15+/-0.08, P=0.51). Conclusions: We found no difference in neuronal injury markers between term neonates born vaginally compared to those born by cesarean section. From a neurologic standpoint, this supports current obstetric practice guidelines that emphasize vaginal birth as the preferred delivery method whenever possible.
PMID: 25222594
ISSN: 0300-5577
CID: 1258682

Cerebral, Renal, and Splanchnic Tissue Oxygen Saturation Values in Healthy Term Newborns

Bailey, Sean M; Hendricks-Munoz, Karen D; Mally, Pradeep
Objective To determine cerebral regional tissue oxygen saturation (CrSO2), renal regional tissue oxygen saturation (RrSO2), and splanchnic regional tissue oxygen saturation (SrSO2) values in healthy term infants.Study Design Near-infrared spectroscopy was used to simultaneously measure CrSO2, RrSO2, and SrSO2 continuously for a 1-hour period on the first and second days of life.Results A total of 41 subjects were monitored out of which complete data were available for 38 subjects. Mean CrSO2 was 78.2 +/- 7.9% on first day; 78.3 +/- 6.1% on second day (p = 0.95). Mean RrSO2 was 92.1 +/- 5.3% on first day; 88.9 +/- 5.9% on second day (p < 0.01). Mean SrSO2 was 69.9 +/- 12.1% on first day and 75.3 +/- 12.4% on second day (p = 0.02).Conclusion There appears to be consistency in rSO2 values in healthy newborns. CrSO2 was similar on both days. Differences observed in RrSO2 and SrSO2 between days may represent a shift in somatic blood flow distribution taking place during the first day of life.
PMID: 23873114
ISSN: 0735-1631
CID: 703652

Parental influence on clinical management during neonatal intensive care: a survey of US neonatologists

Bailey, Sean M; Hendricks-Munoz, Karen D; Mally, Pradeep
Abstract Objective: Family-centered care (FCC), which includes involving parents in conversations about medical management, is increasingly employed in the neonatal intensive care unit (NICU). Our aim was to determine which care decisions are discussed by neonatologists with families most frequently and the percentage of clinicians influenced by such conversations. Methods: Anonymous web-based survey provided to 2137 neonatologists assessing information sharing and parental involvement. Results: Thousand and two neonatologists responded in which 893 fully completed the surveys. 88% practice FCC. Topics most frequently discussed with parents were blood transfusion, steroids for lung disease and patent ductus arteriosus (PDA) surgery, each being reported and discussed by more than 90% of respondents. Many therapies, including aminoglycoisdes, total parenteral nutrition, and phototherapy, were discussed with parents by far fewer clinicians. Additionally, parents had most influence on clinicians in two categories, blood transfusion and steroids, with more than 70% reporting that their practice was influenced by parental opinion if communicated. For some topics, such as PDA surgery and central line placement, conversations impacted few clinicians. Conclusions: FCC appears to have an impact on NICU clinical decision-making processes, some more than others. Further investigation in this area may provide information on how to best communicate with families and run effective, efficient FCC rounds.
PMID: 23414460
ISSN: 1476-4954
CID: 438762

Splanchnic-cerebral oxygenation ratio (SCOR) values in healthy term infants as measured by near-infrared spectroscopy (NIRS)

Bailey, Sean M; Hendricks-Munoz, Karen D; Mally, Pradeep
PURPOSE: The splanchnic-cerebral oxygenation ratio (SCOR) is a measurement comparing regional tissue oxygen saturation of splanchnic organs and brain tissue. SCOR has been previously proposed as a marker of clinical conditions associated with gut ischemia. Our goal was to determine SCOR values in healthy neonates in their first and second days of life. METHODS: Prospective observational study measuring SCOR in term neonates in the nursery using near-infrared spectroscopy (NIRS). RESULTS: Forty-five subjects with a mean gestational age of 39.4 +/- 1.3 weeks were included. Mean SCOR on the first day was 0.90 +/- 0.16 and 0.97 +/- 0.16 on the second day, p = 0.02 (n = 45). No correlation was found between SCOR and gestational age; however, we did find a positive correlation between hour of life and SCOR values (r = 0.28, r (2) = 0.08, p < 0.01, two tails); SCOR appears to stabilize by 36 h. CONCLUSIONS: Our findings demonstrate SCOR values in healthy neonates consistent with those previously theorized and help to validate it as a diagnostic measure. In addition, we have demonstrated that SCOR values may normally be lower in infants during their first days of life, and this information may be helpful to clinicians using NIRS as a diagnostic tool.
PMID: 23456284
ISSN: 0179-0358
CID: 353222

Usefulness of urinary immune biomarkers in the evaluation of neonatal sepsis: a pilot project

Suguna Narasimhulu, Sukumar; Hendricks-Munoz, Karen D; Borkowsky, William; Mally, Pradeep
OBJECTIVE: Our hypothesis is that specific proinflammatory and anti-inflammatory urinary cytokines are useful in the diagnostic evaluation of risk for sepsis in term neonates. We conducted a pilot, prospective hospital-based longitudinal observational study to test the urine of term neonates with a 13 biomarker panel of cytokines. METHODS: Infants were divided into 2 groups: The control group (n = 15) consisted of infants admitted to newborn nursery, and the test group (n = 15) consisted of infants admitted to the neonatal intensive care unit for presumed sepsis. Bagged urine samples were collected from 30 term neonates for testing our hypothesis. RESULTS: Urinary interleukin (IL)-8 (P = .004*), inducible protein (IP)-10 (P = .007*), and monocyte chemoattractant protein (MCP)-1 (P = .02) were significantly increased in the test group compared with the control group. CONCLUSIONS: Urinary IL-8, IP-10, and MCP-1 are proinflammatory cytokines that are increased in the neonate during an infectious inflammatory process. These may be useful predictors as an adjunct to the current protocols to recognize neonatal sepsis.
PMID: 23539685
ISSN: 0009-9228
CID: 438982

Incidence and etiology of late preterm admissions to the neonatal intensive care unit and its associated respiratory morbidities when compared to term infants

Mally, Pradeep V; Hendricks-Munoz, Karen D; Bailey, Sean
Objective To determine etiology of neonatal intensive care unit (NICU) admission and acute morbidities in late preterm (LPT) neonates.Methods Neonates admitted at New York University Langone Medical Center's NICU were grouped as follows: period 1: all LPT neonates with gestational age between 340/7 and 366/7 weeks and born between January 2006 and June 2007; period 2: all term neonates born between January 2007 and June 2008. Neonatal and maternal data were collected from both the groups and compared.Results Thirty-three percent of LPT births were admitted to the NICU, compared with 7% of term births (p < 0.05). LPT neonates had an increased incidence of low birth weight, hypoglycemia, hypothermia, and hyperbilirubinemia as an admission diagnosis (p < 0.001). The overall incidence of respiratory distress syndrome (RDS) was 9%, 4%, 3%, 0.7%, 0.2% and 0% in 34-week, 35-week, 36-week, 37-week, 38- to 39-week, and 40-week gestational age neonates (p < 0. 001).There was an increased incidence of RDS and persistent pulmonary hypertension, along with an increased need for surfactant replacement therapy, continuous positive airway pressure, and ventilator support in the LPT group when compared with the term neonates (p < 0.001).Conclusions LPT neonates are at increased risk for hypothermia, hypoglycemia, hyperbilirubinemia, and respiratory morbidity requiring increased respiratory support when compared with term neonates.
PMID: 23096053
ISSN: 0735-1631
CID: 346362