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Biomedical subjects

P B Colditz

Publications and source records attributed to P B Colditz.

At least 19 recordsLinked to original sources

A cost-effectiveness analysis of the intrapartum fetal pulse oximetry multicentre randomised controlled trial (the FOREMOST trial).

OBJECTIVE: To report an economic analysis of the Australian intrapartum fetal pulse oximetry (FPO) multicentre randomised controlled trial (the FOREMOST trial), which examined whether adding FPO to conventional cardiotocographic (CTG) monitoring (intervention group) was cost-effective in reducing operative delivery rates for non-reassuring fetal status compared with the use of CTG alone (control group). DESIGN: Cost-effectiveness analysis of the FOREMOST trial. SETTING: Four Australian maternity hospitals, each with more than 4000 births/year. POPULATION: Women in labour at > or =36 weeks of gestation, with a non-reassuring CTG. METHODS: Costs were for treatment-related expenses, incorporating diagnosis-related grouping costs and direct costs (including fetal monitoring). Incremental cost-effectiveness ratio (ICER) and cost-effectiveness plane were calculated, and sensitivity analysis was conducted. The primary outcome was that of the clinical trial: operative delivery for non-reassuring fetal status avoided in the intervention group relative to that in the control group. MAIN OUTCOME MEASURES: The ICER. RESULTS: The ICER demonstrated a saving of $A813 for each operative birth for non-reassuring fetal status averted by the addition of FPO to CTG monitoring compared with the use of CTG monitoring alone. CONCLUSION: The addition of FPO to CTG monitoring represented a less costly and more effective use of resources to reduce operative delivery rates for non-reassuring fetal status than the use of conventional CTG monitoring alone.

Adult↗

Vibroacoustic stimulation for fetal assessment in labour in the presence of a nonreassuring fetal heart rate trace.

BACKGROUND: Fetal vibroacoustic stimulation is a simple, non-invasive technique where a device is placed on the maternal abdomen over the region of the fetal head and sound is emitted at a predetermined level for several seconds. It is hypothesized that the resultant startle reflex in the fetus and subsequent fetal heart rate acceleration or transient tachycardia following vibroacoustic stimulation provide reassurance of fetal well-being. This technique has been proposed as a tool to assess fetal well-being in the presence of a non-reassuring cardiotocographic trace during the first and second stages of labour. OBJECTIVES: To evaluate the clinical effectiveness and safety of vibroacoustic stimulation in the assessment of fetal well-being during labour, compared with mock or no stimulation for women with a singleton pregnancy exhibiting a non-reassuring fetal heart rate pattern. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 September 2004), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2004), MEDLINE (January 1966 to January 2005), EMBASE (January 1966 to January 2005) and reference lists of all retrieved articles. We sought unpublished trials and abstracts submitted to major international congresses and contacted expert informants. SELECTION CRITERIA: All published and unpublished randomised trials that compared maternal and fetal/neonatal/infant outcomes when vibroacoustic stimulation was used to evaluate fetal status in the presence of a non-reassuring cardiotocographic trace during labour, compared with mock or no stimulation. DATA COLLECTION AND ANALYSIS: Two independent review authors identified potential studies from the literature search and assessed them for methodological quality and appropriateness of inclusion, using a data extraction form. Attempts to contact study authors for additional information were unsuccessful. MAIN RESULTS: The search strategies yielded six studies for consideration of inclusion. However, none of these studies fulfilled the requirements for inclusion in this review. AUTHORS' CONCLUSIONS: There are currently no randomised controlled trials that address the safety and efficacy of vibroacoustic stimulation used to assess fetal well-being in labour in the presence of a non-reassuring cardiotocographic trace. Although vibroacoustic stimulation has been proposed as a simple, non-invasive tool for assessment of fetal well-being, there is insufficient evidence from randomised trials on which to base recommendations for use of vibroacoustic stimulation in the evaluation of fetal well-being in labour in the presence of a non-reassuring cardiotocographic trace.

Acoustic Stimulation↗

Fetal pulse oximetry for fetal assessment in labour.

BACKGROUND: Fetal pulse oximetry (FPO) may contribute to the evaluation of fetal well-being during labour. OBJECTIVES: To compare the effectiveness and safety of FPO with conventional surveillance techniques, using the results of randomised controlled trials. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (31 July 2004) and conducted a systematic literature search of MEDLINE (1994 to July 2004), EMBASE (1994 to July 2004) and Current Contents (1994 to July 2004). SELECTION CRITERIA: All published and unpublished randomised controlled trials (RCTs) that compared maternal and fetal/neonatal/infant outcomes when FPO was used in labour, with or without concurrent use of conventional fetal surveillance, compared with using cardiotocography (CTG) alone. DATA COLLECTION AND ANALYSIS: Two independent reviewers performed data extraction. Analyses were performed on an intention-to-treat basis. We sought additional information from the investigators of the one reported trial. MAIN RESULTS: One published RCT (comparing FPO and CTG with CTG alone) was included; and two ongoing RCTs were identified. The single included RCT reported on 1010 cases. Unpublished pilot data were available for some outcomes to give a total of 1190 cases. There was no difference in the overall caesarean section rate between the two groups (relative risk (RR) 1.12, 95% confidence interval (CI) 0.91 to 1.37). There were less caesarean sections for nonreassuring fetal status in the FPO plus CTG group compared with the CTG only group (RR 0.45, 95% CI 0.28 to 0.72). The only reported neonatal seizure occurred in the CTG only group (RR 0.29 95% CI 0.01 to 7.08). Use of FPO with CTG decreased operative delivery (caesarean section, forceps, vacuum) for nonreassuring fetal status (RR 0.71, 95% CI 0.55 to 0.93) compared with CTG alone. No differences were seen for overall operative deliveries, endometritis, intrapartum or postpartum haemorrhage, uterine rupture, low Apgar scores, umbilical arterial pH or base excess, admission to the neonatal intensive care unit or fetal/neonatal death. REVIEWERS' CONCLUSIONS: The one published RCT reported that FPO decreased the caesarean section rate and operative delivery rates for nonreassuring fetal status, without adversely affecting maternal or fetal/neonatal outcomes. However, no difference was seen in the overall caesarean section (CS) or operative delivery rates because more CS were performed for dystocia in the FPO group. Further RCTs may address dystocia in labours monitored with FPO, maternal satisfaction with fetal monitoring and labour, long-term neurodevelopmental outcome of infants who exhibited nonreassuring fetal status in labour and costs of FPO.

Cardiotocography↗

Rebreathing potential of infant mattresses and bedcovers.

OBJECTIVE: To establish the CO2 dispersion and retention properties of some mattresses and bed coverings commercially available in Australia. METHODS: Five mattresses were studied in (i) an in vivo model in which an infant's head was covered by a headbox, rebreathing was allowed to occur, and the final steady state CO2 concentration was measured; and (ii) an in vitro model in which 5% CO2 in a headbox was allowed to disperse, and the time taken for the concentration to reach 1% was measured. Five types of bedcover were studied in (i) an in vivo model in which an infant's head was covered by a bedcover and the final steady state CO2 concentration was measured; and (ii) an in vitro model in which 5% CO2 under a bedcover was allowed to disperse, and the time taken for the concentration to reach 1% was measured. RESULTS: The steady state CO2 concentrations ranged from 0.6% to 3.0% for the mattresses (P < 0.05). The time for CO2 to disperse ranged from 5.5 min to 30.4 min (P < 0.05). Steady state CO2 concentrations ranged from 2.5% to 3.6% for the bedcoverings (P > 0.05). The time for CO2 to disperse ranged from 5.4 min to 7.7 min (P > 0.05). CONCLUSIONS: Some commercial cot mattresses and bedcoverings allow high concentrations of CO2 to accumulate in rebreathing environments. Some mattress types studied were more diffusive to CO2, whereas there was no difference between the bedcovers studied. This may have implications for vulnerable infants at risk of sudden infant death syndrome.

Bedding and Linens↗

An improved survival model of hypoxia/ischaemia in the piglet suitable for neuroprotection studies.

The purpose of this study was to develop a newborn piglet model of hypoxia/ischaemia which would better emulate the clinical situation in the asphyxiated human neonate and produce a consistent degree of histopathological injury following the insult. One-day-old piglets (n=18) were anaesthetised with a mixture of propofol (10 mg/kg/h) and alfentinal (55.5 microg/kg/h) i.v. The piglets were intubated and ventilated. Physiological variables were monitored continuously. Hypoxia was induced by decreasing the inspired oxygen (FiO(2)) to 3-4% and adjusting FiO(2) to maintain the cerebral function monitor peak amplitude at < or =5 microV. The duration of the mild insult was 20 min while the severe insult was 30 min which included 10 min where the blood pressure was allowed to fall below 70% of baseline. Control piglets (n=4 of 18) were subjected to the same protocol except for the hypoxic/ischaemic insult. The piglets were allowed to recover from anaesthesia then euthanased 72 h after the insult. The brains were perfusion-fixed, removed and embedded in paraffin. Coronal sections were stained by haematoxylin/eosin. A blinded observer examined the frontal and parietal cortex, hippocampus, basal ganglia, thalamus and cerebellum for the degree of damage. The total mean histology score for the five areas of the brain for the severe insult was 15.6+/-4.4 (mean +/-S.D., n=7), whereas no damage was seen in either the mild insult (n=4) or control groups. This 'severe damage' model produces a consistent level of damage and will prove useful for examining potential neuroprotective therapies in the neonatal brain.

Animals↗

Infant autonomic function is altered by maternal smoking during pregnancy.

Sudden infant death syndrome (SIDS) is more prevalent in infants of smokers and may involve subtle alterations in autonomic control mechanisms. Autonomic function can be assessed using blood pressure responses to a passive head-up tilt and power spectral analysis of heart rate variability. This study aimed to determine if maternal smoking altered infants' responses to head-up tilt. Blood pressure and heart rate responses to a passive 70 degrees head-up tilt were compared in infants of smokers and non-smokers at 2-3 days and 3 months of age. There were no significant differences between groups in power spectral indices. At 2-3 days, the systolic pressure response to tilt was significantly different between groups (P<0.01). In infants of smokers, systolic pressure decreased by a mean (S.E.) of 7.7(1.1) mmHg, whereas in control infants it remained unchanged. At 3 months, systolic pressure in infants of smokers remained unchanged but increased in control infants by 6.2(2.1) mmHg (P<0.05). These results indicate that maternal smoking alters autonomically mediated cardiovascular responses in the infant.

Autonomic Nervous System↗

Cardiac responses to mild hypoxic hypercapnia in newborn babies: no effect of sleep position.

OBJECTIVE: To evaluate whether cardiac responses to a level of hypoxic hypercapnia that may be observed in rebreathing studies are altered with infant sleep position. METHODOLOGY: Eighteen healthy term infants (< 5-days-old) were studied. Heart rate (HR) and HR variability were monitored during air breathing and during 3 min exposure to a mixture of 15% O2/3% CO2 in both the prone and supine positions. Power spectral analysis of HR was performed. RESULTS: Heart rate was the only measured variable to be significantly changed in response to 15% O2/3% CO2. Hypoxic hypercapnia elicited no significant responses in power spectral HR variables. There was no effect of sleeping position on any of the measured variables. CONCLUSIONS: There are no significant differences in cardiac responses to mild hypoxic hypercapnia between sleep positions and power spectral indices of the autonomic control of HR are not altered by sleep position in newborn babies.

Female↗

Clinicians' perceptions of placing a fetal oximetry sensor.

The aim of this study was to determine clinicians' perceptions of placing a fetal oximetry sensor. A survey was developed seeking details of staff category, birth suite experience, previous sensor placement, ease of application and use of epidural analgesia. Following staff feedback, the survey was revised from asking clinicians to rate women's comfort during sensor placement, to a visual analogue scale (VAS) of the clinician's assessment of the women's pain during sensor placement. Survey validity was sought from experts during development and for specific questions using item-total correlation in this analysis. Ease of sensor placement (n = 131) was rated as good or excellent 71% of the time. Clinicians rated women's comfort during sensor placement as good or excellent in 90% of cases. Median pain VAS was 0 (range 0-7.5). Item-total correlations of survey questions were all significant. Fetal oximetry sensor placement was rated well by clinicians in this purpose-designed survey.

Analgesia, Epidural↗

Measurement of extracellular fluid volume in the neonate using multiple frequency bio-impedance analysis.

Bioelectrical impedance analysis may be useful for cot-side monitoring of fluid balance in the neonatal intensive care unit (NICU). However the presence of cardio-respiratory monitoring equipment, non-ideal electrode placement and inability to obtain accurate crown-heel measurements may interfere with the ability to obtain reliable impedance data in this setting. This study aimed to investigate the effects of these factors on impedance analysis and to develop a prediction equation for extracellular fluid volume in the neonate. The study found that cardio respiratory monitoring had no significant effect on multi-frequency impedance measurements. Placement of current delivering electrodes on the ventral rather than dorsal surfaces improved separation of current and voltage electrodes but did not alter impedance results. Contralateral measurements were not significantly different to ipsilateral measurements. In 24 infants, extracellular fluid volume was measured using corrected bromide space (CBS) and simultaneous impedance analysis was performed. There was good correlation between CBS and the impedance quotient FF2/Ro where F is foot length and R0 is resistance at zero frequency. The study concludes that despite many potential difficulties associated with impedance analysis in the NICU, reliable measurements of impedance can be obtained and further work to validate prediction equations for ECF is warranted.

Electric Impedance↗

Prediction of aminoglycoside distribution space in neonates by multiple frequency bioelectrical impedance analysis.

OBJECTIVE: Aminoglycoside antibiotics have a narrow margin of safety between therapeutic and toxic levels. The current study used multiple frequency bioelectrical impedance analysis to develop prediction equations for gentamicin distribution space in neonates. METHODS: Gentamicin pharmacokinetic parameters and bioimpedance were measured in 14 infants in the neonatal intensive care unit. Stepwise regression analysis was used to develop predictive models, using impedance quotients (F2/R), weight and gestational age as variables, whose predictive performance was then tested in a second group of ten infants. RESULTS: The prediction model with the smallest bias and highest concordance correlation was that which included F2/R0 and weight. This bias of 50 ml or 6.7% was less than half of that found using a model including weight alone. CONCLUSION: A bioelectrical impedance-based prediction equation for prediction of gentamicin distribution space in neonates was produced. Although this prediction equation represents only a small improvement over that using weight alone, this is of clinical significance due to the narrow margin between therapeutic and toxic levels for gentamicin. A clinical trial to confirm the value of this methodology is now warranted.

Anti-Bacterial Agents↗

Anetoderma of prematurity in association with electrocardiographic electrodes.

Anetoderma in premature infants is an uncommon lesion that may be associated with the use of various types of monitoring leads. In 2 infants multiple papules of anetoderma occurred on the forehead in association with the use of gel electrocardiographic electrodes. It is postulated that the cause of these papules was a local hypoxemia caused by pressure from the electrodes. Growth-restricted infants may be particularly predisposed to iatrogenic anetoderma.

Biopsy, Needle↗

Alarm settings for the Marquette 8000 pulse oximeter to prevent hyperoxic and hypoxic episodes.

OBJECTIVE: To determine safe and appropriate alarm limits for the Marquette 8000 pulse oximeter to prevent hyperoxic and hypoxic episodes in neonates. It is necessary to define these limits for each brand of oximeter because of the variance in nonuser adjustable calibration algorithms used in pulse oximeters. METHODOLOGY: Oxygen saturation values obtained from a Marquette 8000 pulse oximeter (SpO2) were compared with simultaneous arterial blood gas PaO2 values obtained from blood gas analysis, for 322 samples in 24 consecutive neonates (median 30 weeks' gestation). RESULTS: In order to prevent 95% of hyperoxic episodes (PaO2 > 90 mmHg), the upper alarm limit was 95% SpO2. Similarly, to prevent 95% of hypoxic episodes (PaO2 < 40 mmHg), the lower alarm limit was 95% SpO2. A sensitivity lower than 95% had to be accepted to develop an alarm range which prevented both hyperoxic and hypoxic episodes. To maintain PaO2 values between 40 and 90 mmHg, an appropriate alarm range of 94-97% SpO2 (90% sensitivity, 28% specificity) was established. CONCLUSIONS: The relative merits of high sensitivity versus high specificity should be considered when determining appropriate alarm limits. Alarm limits which represent a balance between sensitivity and specificity will minimise false alarms and provide a clinically practical range. It would be useful for this type of information to be available for each brand of oximeter, to assist the user in determining appropriate alarm settings.

Blood Gas Analysis↗

Fetal pulse oximetry. Instrumentation and recent clinical experience.

Despite the pressing clinical need to improve fetal intrapartum surveillance, fetal oximetry has lagged well behind its application in the neonate because of the difficulty of developing a suitable method to record data from the fetus and testing its accuracy and reproducibility. Acceptable values of oxygen saturation that indicate fetal well-being are much lower than in neonates. The development of fetal pulse oximetry instrumentation is discussed. Recent clinical data acquired using the latest instrumentation are summarized and exciting new clinical applications proposed.

Animals↗

Fetal oxygen saturation during maternal bearing down efforts in the second stage of labor.

Fetal oxygen saturation (FSpO2) was monitored with the Nellcor Puritan Bennett N400/FS14 system during 16 labors to establish whether FSpO2 was influenced by maternal bearing down efforts in the second stage of labor. Fetal SpO2 is reported for 16 fetuses where neonatal outcome was normal. One hour of continuous data was recorded: 30 min prior to the onset of maternal bearing down efforts and the first 30 min of pushing. The hour was divided into six epochs of 10-min duration. Differences between mean FSpO2 for the two 30 min of monitoring and for each epoch were sought using repeated measures analysis of variance (ANOVA). The mean FSpO2 for the total 30 min prior to the onset of pushing was 49% (95% confidence intervals 46.5-50.6%), compared to a mean of 46% (95% confidence intervals 43.6-48.7%) during the first 30 min of pushing [F (1, 2.25), p = 0.14]. There was no significant decline in mean FSpO2 for each epoch. Apgar scores at 5 min were all > 7 and umbilical arterial pH values were > or = 7.20 (n = 12). We concluded that mean FSpO2 recorded prior to the onset of maternal bearing down efforts was not significantly different to mean FSpO2 during pushing, with normal neonatal outcome.

Adult↗

Fetal oxygen saturation and uterine contractions during labor.

Oxygen availability to the fetus during uterine contractions has not been widely reported. We examined whether fetal oxygen saturation (FSpO2) values and signal quality (SQ) were affected by uterine contractions. An intrauterine pressure catheter and a Nellcor FS14 fetal oxygen saturation sensor (Nellcor Puritan Bennett Inc., Pleasanton, CA) were placed transvaginally during the first stage of 17 labors. Fetal SPO2 and SQ units were recorded on a beat-to-beat basis and 10 sec averages of the data calculated over 25 contractions per patient. Five epochs were determined: (1) 30 sec prior to a contraction; (2) during a contraction; (3) 50 sec following completion of a contraction; (4) noncontraction periods, excluding epochs 1 or 3; and (5) equivocal, that is, overlap of epochs 1-3. Mean FSpO2 was lowest during epoch 3 (45.0) and highest during epoch 2 (47.3%) (p <0.001). This small difference is unlikely to be of any clinical significance, however. Mean signal quality was lowest in epoch 1 (42.8 units) and highest in epoch 4 (48.0 units) (p <0.05), that is, in noncontraction periods. We conclude that FSpO2 and SQ were unaffected by uterine contractions.

Female↗