Additional therapy for young children with spastic cerebral palsy: a randomised controlled trial.

OBJECTIVES: To investigate whether, in the short and medium term, additional support by (a) a physiotherapy assistant improved physical function in young children with spastic cerebral palsy and (b) a family support worker improved family functioning. DESIGN: This was a multi-centre randomised controlled trial (RCT) with blinded assessments and a cost-effectiveness analysis. The children studied had spastic cerebral palsy that was the consequence of perinatal adversity. All were less than 4 years old on entry to the study. SETTING: In the child development centre and in the home. PARTICIPANTS: Seventy-six families completed the intervention period. Forty-three families were reassessed 6 months after the end of the intervention and 34 of these after a further 6-month period. INTERVENTIONS: Randomisation was to: (a) a group who received extra physiotherapy from a physiotherapy assistant; (b) a group who received standard physiotherapy; and (c) a group where the child received standard physiotherapy and the family was also visited by a family support worker. Children in all groups continued to receive standard physiotherapy in addition to the study interventions. MAIN OUTCOME MEASURES: The child outcome measures were motor functioning, developmental status and adaptive functioning. The family outcome measures were self-reported maternal stress, level of family needs and parental satisfaction. RESULTS: There was no evidence that additional physical therapy for 1 hour per week for 6 months by a physiotherapy assistant improved any child outcome measure in the short or medium term. Intervention by a family support worker did not have a clinically significant effect on parental stress or family needs. Over the 6-month period the total cost of services for each child ranged from 250 pounds to 6750 pounds, with higher costs associated with children with more severe impairments. No significant relationship was found between measures of intensity of services received by the children and families and the main outcome measures. Low-functioning children, in terms of both motor and cognitive function, were more likely to receive more services in terms of range and frequency. Parents generally reported high satisfaction ratings after all interventions and some stated that the interventions had benefited the child and/or the family. There was therefore a discrepancy between the perceptions of these parents and the objective, quantitative measurements. The family support workers identified a small number of families who were experiencing considerable family problems, but who had not been referred for appropriate support by any other agency. CONCLUSIONS: The findings of this study provide support for the current literature that there was no evidence that additional intervention (in this case by a physiotherapy assistant or family support worker) helped the motor or general development of young children with spastic cerebral palsy. Nor was there any quantitative evidence that providing extra family support helped levels of parental stress and family needs. The implication was that the provision of extra physical therapy does not necessarily improve the motor function of a young child with cerebral palsy and additional family support should not automatically be assumed to be beneficial. In addition, no significant association was found between the intensity of the local services provided and any outcome measure, other than a slight association with lowered family needs. The provision of local services was related to the severity of the child's impairments and not to family difficulties. A small group of families with complex family problems needed more service input. There was a wide range in the costs of services. Research is needed to examine what 'sufficient' levels of provision or therapy might be for which children and which families. A time series of different levels of input and outcomes would provide valuable information for practitioners. It is also recommended that future assessments of therapies of this type adopt a similar multifaceted approach, which is likely to be more suitable than a simple RCT for the evaluation of clinical interventions where the effects are complex. The most appropriate measures of outcome should be used, including assessment of provision of information and emotional support for families.

Determinants of cerebral fractional oxygen extraction using near infrared spectroscopy in preterm neonates.

Cerebral fractional oxygen extraction (FOE) represents the balance between cerebral oxygen delivery and consumption. This study aimed to determine cerebral FOE in preterm infants during hypotension, during moderate anemia, and with changes in the PaCO2. Three groups of neonates were studied: stable control neonates (n = 43), anemic neonates (n = 46), and hypotensive neonates (n = 19). Cerebral FOE was calculated from the arterial oxygen saturation measured by pulse oximetry, and cerebral venous oxygen saturation was measured using near infrared spectroscopy with partial jugular venous occlusion. Mean +/- SD cerebral FOE was similar in control (0.292+/-0.06), anemic (0.310+/-0.08; P = 0.26), and hypotensive (0.278+/-0.06; P = 0.41) neonates. After anemic neonates were transfused, mean +/- SD cerebral FOE decreased to 0.274+/-0.05 (P = 0.02). There was a weak negative correlation with the hemoglobin concentration (n = 89, r = -0.24, P = 0.04) but not with the hemoglobin F fraction (n = 56, r = 0.24, P = 0.09). In the hypotensive neonates, there was no relationship between cerebral FOE and blood pressure (n = 19, r = 0.34, P = 0.15). There was a significant negative correlation between cerebral FOE and PaCO2 within individuals (n = 14, r = -0.63, P = 0.01), but there was no relationship between individuals (n = 14, r = 0, P = 1). Cerebral FOE was not significantly altered in neonates with either mild anemia or hypotension. There were, however, changes in cerebral FOE when physiological changes occurred over a relatively short period: Cerebral FOE decreased after blood transfusion and increased with decreasing PaCO2. As no change in cerebral FOE was seen during hypotension, it was speculated that cerebral oxygen delivery may have been maintained by cerebral blood flow autoregulation.

Peripheral fractional oxygen extraction and other measures of tissue oxygenation to guide blood transfusions in preterm infants.

The physiological effects of anemia in the preterm infant are complex and the indications for transfusions in preterm infants are controversial. A measure of the adequacy of tissue oxygenation may be a better guide to the need for transfusions than currently used criteria. This article considers 2 measures of tissue oxygenation of preterm infants: 1) The whole blood lactate concentration, and 2) Peripheral fractional oxygen extraction (FOE) by using near infrared spectroscopy. Several studies have shown falls in blood lactate concentration after blood transfusion, but it has been difficult to establish a convincing link between raised lactate concentrations and significant anemia because even anemic infants have lactate concentrations that are within or close to the normal range. Lactate concentrations may be affected by the haematocrit of the blood sample. Peripheral FOE can be measured by using near infrared spectroscopy with partial venous occlusion and has been studied in preterm infants with symptomatic and asymptomatic anaemia. Mean (SD) FOE was significantly higher in symptomatic [0.425 (0.06)] (P< .01) but not asymptomatic [0.334 (0.05)] compared to controls [0.352 (0.06)], (P = .22). After transfusion there was a significant fall in FOE in symptomatic infants to 0.367 (0.06) (P = .001) but there was no change in infants who were asymptomatic. FOE correlated with other measures known to reflect the adequacy of oxygen availability during anemia. These results suggest that peripheral FOE may be suitable as a guide to the need for blood transfusions. A pilot randomized controlled trial is currently being undertaken to test this hypothesis.

Three year visual outcome for treated stage 3 retinopathy of prematurity: cryotherapy versus laser.

BACKGROUND/AIMS: In the management of retinopathy of prematurity (ROP), several studies have demonstrated laser photocoagulation to be as effective as cryotherapy in reducing the incidence of unfavourable structural outcome. However, few data are available on the functional outcome. The 3 year visual acuity outcome of infants treated with laser or cryotherapy in a neonatal unit is presented. METHODS: The case notes of 34 infants (64 eyes) treated with cryotherapy, between 1989 and 1992, and 32 infants (59 eyes) treated with laser, between 1992 and 1995, were reviewed. RESULTS: In the cryotherapy group 69% of eyes had a favourable structural outcome. Of these structurally successful eyes 62.5%, 35.0%, and 33.3% of eyes had visual acuities within normal limits at the 12 month, 24 month, and 36 month corrected age milestones respectively. In the laser group 93% of eyes had a favourable structural outcome. Of these structurally successful eyes 96.4%, 66.7%, and 59.5% of eyes had visual acuities within normal limits at the 12 month, 24 month, and 36 month corrected age milestones respectively. CONCLUSION: In the management of ROP, when laser photocoagulation induces a structurally successful result, the potential for normal visual acuity development at 3 years is high. Whether the poorer functional outcome of the eyes treated with cryotherapy is an artefact of the historical nature of the study or as a result of an adverse effect of the destructive transcleral application is unknown.

Raised pulmonary artery pressure in very low birthweight infants requiring supplemental oxygen at 36 weeks after conception.

This study aimed to investigate the changes in pulmonary artery pressure in infants with chronic lung disease who then developed prolonged oxygen dependency. The time to peak velocity: right ventricular ejection time (TPV:RVET) ratio calculated from the Doppler waveform, which correlates negatively with pulmonary artery pressure, was used. Thirty four infants with chronic lung disease were studied. At 36 weeks after conception 19 infants still required supplemental oxygen (POD group) and 16 infants were in air (controls). Over the first three weeks, there was a significant rise in the ratio in both groups, indicating a fall in pulmonary arterial pressure. From the third week onwards the ratio was significantly lower in the POD group. There was a significant rise in the ratio from four to 36 weeks after conception in the control group; the POD group showed a tendency towards a fall over the same time period. The requirement for supplemental oxygen almost mirrored the changes in the ratio in both groups but was not significantly different until the fifth week after birth. These data suggest that pulmonary arterial pressure has a significant role in the pathophysiology of prolonged oxygen dependency and may be important in the subsequent morbidity associated with this group of very low birthweight infants.

A pilot randomised controlled trial of peripheral fractional oxygen extraction to guide blood transfusions in preterm infants.

BACKGROUND: Peripheral fractional oxygen extraction (FOE) may be a better indicator of the need for transfusion than the haemoglobin concentration (Hb) because it is a measure of the adequacy of oxygen delivery to meet demand. A randomised controlled trial of the use of peripheral FOE to guide the need for blood transfusions in preterm infants was carried out to test this hypothesis. METHOD: Infants less than 1500 g birth weight who were stable and less than 2 weeks old were randomised to receive transfusions guided by either a conventional protocol based on Hb (conventional group) or a protocol based on measurements of peripheral FOE made by near infrared spectroscopy (NIRS group). Measurements of Hb and FOE were made on all infants from randomisation until discharge. The primary outcome measures were number of transfusions received, rate of weight gain, and postmenstrual age at discharge. RESULTS: Thirty seven infants were randomised to each group. Birth weight (median, range) (1200, 1004-1373 v 1136, 1009-1285 g) and Hb (median, range) at randomisation (160, 149-179 v 155, 145-181 g/l) did not differ between the two groups. The total number of transfusions given to the NIRS group was 56 and to the conventional group 84. The median number of transfusions per infant, the median volume of blood transfused to each group, and the total number of donors to which infants were exposed were similar in the two groups. Infants transfused according to the conventional protocol were more likely to be transfused earlier and at a higher Hb than those transfused in the NIRS group. Infants in the conventional group spent a significantly shorter period than those in the NIRS group with Hb < 100 g/l. Of the 56 transfusions given to the NIRS group, 33 (59%) were given because of clinical concerns rather than because of high FOE. There was no difference in the rate of weight gain, rate of linear growth, postmenstrual age at discharge, or the incidence of chronic lung disease or retinopathy of prematurity. CONCLUSIONS: FOE measurements failed to identify many infants felt by clinicians to require blood transfusion. This may have been because clinicians relied on conventional indicators of transfusion that are vague and non-specific, or a peripheral FOE of 0.47 alone may not be a sensitive enough predictor of the need for transfusion. This requires further study.

Effect of blood transfusion on lipid peroxidation in preterm infants.

OBJECTIVE: To see whether there was a link between blood transfusion and lipid peroxidation as measured by urinary malondialdehyde (MDA) concentration in preterm infants. METHODS: Urine samples were collected before and after blood transfusions in preterm infants. Twenty blood transfusion episodes were studied in 12 infants (some infants were studied on more than one occasion). Twenty two infants who had not received a transfusion were used as controls. All infants were preterm and less than 1500 g birth weight. Urinary MDA was measured using a thiobarbituric acid assay and expressed as nmol/mg creatinine. RESULTS: The median (interquartile range) urinary MDA concentration before transfusion was 9.1 (6.4-12.6) nmol/mg, and was not significantly different from that in the 22 non-transfused infants (11.3 (7.3-15.6) nmol/mg). There was a significant increase 24 hours after transfusion to 14.6 (7.3-23.7) nmol/mg, but it decreased to 10.1 (6.6-15.4) nmol/mg when measured a median (range) of 6 (3-9) days later. CONCLUSIONS: Blood transfusions were associated with evidence of increased lipid peroxidation. If lipid peroxidation contributes to the pathogenesis of retinopathy of prematurity and chronic lung disease, these results suggest an explanatory mechanism.

Dependency level of babies on the neonatal unit: a comparison of two different classification systems.

BACKGROUND: Monitoring activity on the neonatal unit is important for planning service provision and as part of monitoring quality of care. The dependency level of the patients cared for must be taken into account as well as the number of patients. Two different systems for determining dependency level are in common use. AIM: To develop a system that would allow the accurate determination of dependency level for babies in our care using both the British Association for Perinatal Medicine and Neonatal Nurses Association definitions and the Northern Neonatal Network definitions and to perform a comparison between these two systems. METHOD: Forty details relating to current clinical status and treatment being given were recorded daily for every patient on two neonatal units over a 17 month period. These details were recorded in a computer database, and dependency levels were calculated for each patient day using both systems. RESULTS: A total of 21 905 patient days were recorded for 1555 patients. There was good agreement between the two systems on what constituted the highest level of dependency, but overall comparability was poor, with the two systems assigning comparable dependency levels to only 76% of patient days. CONCLUSIONS: There is limited comparability in dependency levels between these two widely used systems. There is a need for a standardisation of definitions to allow meaningful comparisons to be made between units.

Congenital brachial palsy: incidence, causes, and outcome in the United Kingdom and Republic of Ireland.

OBJECTIVES: To determine the incidence and study the causes and outcome of congenital brachial palsy (CBP). DESIGN: Active surveillance of newborn infants using the British Paediatric Surveillance Unit notification system and follow up study of outcome at 6 months of age. SETTING: The United Kingdom and Republic of Ireland. PARTICIPANTS: Newborn infants presenting with a flaccid paresis of the arm (usually one, rarely both) born between April 1998 and March 1999. MAIN OUTCOME MEASURES: Extent of the lesion at birth and degree of recovery at 6 months of age. FINDINGS: There were 323 confirmed cases giving an incidence of 0.42 per 1000 live births (1 in 2300). Significant associated risk factors in comparison with the normal population were shoulder dystocia (60% v 0.3%), high birth weight with 53% infants weighing more than the 90th centile, and assisted delivery (relative risk (RR) 3.4, 95% confidence interval (CI) 2.9 to 3.9, p = 0.0001). There was a considerably lower risk of CBP in infants delivered by caesarean section (RR 7, 95% CI 2 to 56, p = 0.002). At about 6 months of age, about half of the infants had recovered fully, but the remainder showed incomplete recovery including 2% with no recovery. The relative risk of partial or no recovery in infants with extensive lesions soon after birth compared with those with less extensive lesions was 11.28 (95% CI 2.38 to 63.66, p = 0.000005). CONCLUSIONS: The incidence of CBP in the United Kingdom and Republic of Ireland is strikingly similar to that previously reported nearly 40 years ago. Most cases are due to trauma at delivery, which is not necessarily excessive or inappropriate. Given the uncertainty about the appropriate management of these infants, serious consideration should be given to a formal clinical trial of microsurgical nerve repair.

An improved morphological approach to background normalization of ECG signals.

This paper describes an improved morphological approach to remove baseline wander from neonatal electrocardiogram (ECG) signals, with particular emphasis on preserving the ST segment of the original signal. The algorithm consists of two stages of morphological processing. First, the QRS complex and impulsive noise component due to skeletal muscle contractions etc., are detected and removed from the input signal. Second, the corrected QT interval (QTc) and RR interval are used to determine a structuring element. With this structuring element, the same morphological operation as in the first stage is then applied to the QRS-removed signal to obtain and remove the baseline wander. The performance of the algorithm is evaluated with simulated and real ECGs. Compared with an existing morphological method, there is a substantial improvement, especially in reducing distortion of the baseline waveform within the PR and QT intervals.

Interventions for the treatment of twin-twin transfusion syndrome.

BACKGROUND: Twin-twin transfusion syndrome, a condition affecting monochorionic twin pregnancies, is associated with a high risk of perinatal mortality and morbidity. A number of treatments have been introduced to treat the condition but it is unclear which intervention improves maternal and fetal outcome. OBJECTIVES: The objective of this review was to evaluate the impact of treatment modalities in twin-twin transfusion syndrome. SEARCH STRATEGY: We searched The Cochrane Pregnancy and Childbirth Trials Register and Cochrane Controlled Trials Register. We also searched conference proceedings and made personal contact with experts active in the area of the review. Date of last search: August 2000. SELECTION CRITERIA: Randomised and quasi-randomised studies of amnioreduction versus laser coagulation, septostomy versus laser coagulation or septostomy versus amnioreduction. DATA COLLECTION AND ANALYSIS: Eligibility was assessed by one reviewer. Study authors were contacted for additional information. MAIN RESULTS: No studies were included. REVIEWER'S CONCLUSIONS: There is no current evidence from randomised trials to influence practice. Three ongoing randomised studies have been identified.

Peripheral oxygenation in preterm infants.

When tissue oxygenation is impaired, compensatory mechanisms occur, including a redistribution of blood flow in order to maintain oxygen delivery to vital organs, resulting in a fall in peripheral blood flow. Monitoring peripheral oxygenation therefore has potential benefits as it may provide an early warning of changes in the state of tissue oxygenation. Clinical assessments of the state of peripheral perfusion are common, and several physiological measurements have been described or used which are able to monitor peripheral oxygenation. Some of the available methods and their clinical implications will be reviewed. Near infrared spectroscopy is a particularly promising technique that has only recently been used in the preterm neonate to quantify peripheral oxygenation. It may be of potential value in understanding pathophysiological changes that occur in certain situations and needs further assessment to determine whether it may be useful to guiding clinical interventions.

Measurement of venous oxyhaemoglobin saturation in the adult human forearm by near infrared spectroscopy with venous occlusion.

Measurement of the oxygenation of the peripheral tissues provides useful information about tissue perfusion. A method is described for the measurement of peripheral venous oxyhaemaglobin saturation (SvO2) in the adult forearm by a noninvasive technique, near infrared spectroscopy (NIRS) with venous occlusion. A series of studies is performed on healthy adults to compare measurements of forearm SvO2 made by NIRS with measurements of superficial venous SvO2 made by co-oximetry, and to study the effect of different optode spacings. There is a significant correlation between forearm SvO2 measured by NIRS and SvO2 of superficial venous blood measured by co-oximetry (n = 19, r = 0.7, p < 0.0001). Higher values for SvO2 were obtained using a 2.5 cm spacing than with a 4 cm spacing (mean difference = 4.1% (95% CI 1.4%-6.8%) n = 16). This difference is likely to have been due to a more superficial volume of tissue being studied with the closer optode spacing. Peripheral SvO2 can be measured non-invasively using NIRS with venous occlusion. It may prove to be a useful method to study circulatory disturbances.

How has research in the last 5 years changed my clinical practice?

This paper considers some of the changes in practice that have occurred in the last 5 years. There have been significant improvements in parental involvement in care. Not all changes have been based on evidence from research: practice has also been affected by changing technology and pressure by industry and other groups. Among the research-based changes were: an awareness of confidentiality, individualised developmental care, increased use of inhaled nitric oxide, therapeutic hypothermia, less postnatal steroids (although the dosage used is not evidence-based), sucrose as analgesia and permissive hypotension.