Haresh Kirpalani

Hypothermia Therapy after Traumatic Brain Injury in Children

BACKGROUNDnHypothermia therapy improves survival and the neurologic outcome in animal models of traumatic brain injury. However, the effect of hypothermia therapy on the neurologic outcome and mortality among children who have severe traumatic brain injury is unknown.nnnMETHODSnIn a multicenter, international trial, we randomly assigned children with severe traumatic brain injury to either hypothermia therapy (32.5 degrees C for 24 hours) initiated within 8 hours after injury or to normothermia (37.0 degrees C). The primary outcome was the proportion of children who had an unfavorable outcome (i.e., severe disability, persistent vegetative state, or death), as assessed on the basis of the Pediatric Cerebral Performance Category score at 6 months.nnnRESULTSnA total of 225 children were randomly assigned to the hypothermia group or the normothermia group; the mean temperatures achieved in the two groups were 33.1+/-1.2 degrees C and 36.9+/-0.5 degrees C, respectively. At 6 months, 31% of the patients in the hypothermia group, as compared with 22% of the patients in the normothermia group, had an unfavorable outcome (relative risk, 1.41; 95% confidence interval [CI], 0.89 to 2.22; P=0.14). There were 23 deaths (21%) in the hypothermia group and 14 deaths (12%) in the normothermia group (relative risk, 1.40; 95% CI, 0.90 to 2.27; P=0.06). There was more hypotension (P=0.047) and more vasoactive agents were administered (P<0.001) in the hypothermia group during the rewarming period than in the normothermia group. Lengths of stay in the intensive care unit and in the hospital and other adverse events were similar in the two groups.nnnCONCLUSIONSnIn children with severe traumatic brain injury, hypothermia therapy that is initiated within 8 hours after injury and continued for 24 hours does not improve the neurologic outcome and may increase mortality. (Current Controlled Trials number, ISRCTN77393684 [controlled-trials.com].).

Efficiency of aerosol medication delivery from a metered dose inhaler versus jet nebulizer in infants with bronchopulmonary dysplasia

The best means for optimal delivery of drugs into lungs of infants with bronchopulmonary dysplasia (BPD) is uncertain. We aimed to measure radio‐aerosol deposition of salbutamol by jet nebulizer and metered dose inhalers (MDI) in ventilated and non‐ventilated BPD infants. In a randomized, crossover sequence, salbutamol lung deposition was measured using an MDI (2 puffs or 200 μg) or sidestream jet nebulizer (5 minutes of nebulization with 100 μg/kg) in 10 ventilated (mean birthweight, 1.101 g) and 13 non‐ventilated (mean birthweight, 1,093 g) prematurely born infants. Non‐ventilated infants inhaled aerosol through a face mask, connected to a nebulizer or an MDI and spacer (Aerochamber®). Ventilated infants received aerosol from an MDI + MV15 Aerochamber® or a nebulizer inserted in the ventilator circuit. Lung deposition by both methods was low: mean (SEM) from the MDI was 0.67 (0.17)% of the actuated dose, and from the nebulizer it was 1.74 (0.21)% and 0.28 (0.04)% of the nebulized and initial reservoir doses, respectively. Corresponding figures for the ventilated infants were 0.98 (0.19)% from the MDI and 0.95 (0.23)% and 0.22 (0.08)% from the nebulizer. In both groups, and for both methods of delivery, there was marked inter‐subject variability in lung deposition and a tendency for the aerosol to be distributed to the central lung regions. Pediatr Pulmonol. 1996; 2:301–309.

A Trial Comparing Noninvasive Ventilation Strategies in Preterm Infants

BACKGROUNDnTo reduce the risk of bronchopulmonary dysplasia in extremely-low-birth-weight infants, clinicians attempt to minimize the use of endotracheal intubation by the early introduction of less invasive forms of positive airway pressure.nnnMETHODSnWe randomly assigned 1009 infants with a birth weight of less than 1000 g and a gestational age of less than 30 weeks to one of two forms of noninvasive respiratory support--nasal intermittent positive-pressure ventilation (IPPV) or nasal continuous positive airway pressure (CPAP)--at the time of the first use of noninvasive respiratory support during the first 28 days of life. The primary outcome was death before 36 weeks of postmenstrual age or survival with bronchopulmonary dysplasia.nnnRESULTSnOf the 497 infants assigned to nasal IPPV for whom adequate data were available, 191 died or survived with bronchopulmonary dysplasia (38.4%), as compared with 180 of 490 infants assigned to nasal CPAP (36.7%) (adjusted odds ratio, 1.09; 95% confidence interval, 0.83 to 1.43; P=0.56). The frequencies of air leaks and necrotizing enterocolitis, the duration of respiratory support, and the time to full feedings did not differ significantly between treatment groups.nnnCONCLUSIONSnAmong extremely-low-birth-weight infants, the rate of survival to 36 weeks of postmenstrual age without bronchopulmonary dysplasia did not differ significantly after noninvasive respiratory support with nasal IPPV as compared with nasal CPAP. (Funded by the Canadian Institutes of Health Research; NIPPV ClinicalTrials.gov number, NCT00433212; Controlled-Trials.com number, ISRCTN15233270.).

Characterising doctor-parent communication in counselling for impending preterm delivery

Objective: To examine the counselling of women admitted to hospital in preterm labour. Such women and their partners are often asked to participate in difficult decisions including mode of delivery, fetal monitoring, and resuscitation. Study design: Questionnaire based descriptive study. Study setting: A tertiary level perinatal referral centre. Patients: Forty nine women in preterm labour at 22–30 weeks gestation, admitted in two separate periods between March 1997 and May 1999. Intervention and outcome measure: Within 24 hours of counselling, parents were asked to complete a questionnaire assessing recall of the management plan, desire for involvement in decision making, anxiety, and feelings of control over their health. A parallel questionnaire was completed by the clinicians. Results: Parents and clinicians on recall agreed well about obstetric issues but poorly about neonatal issues. Overall 27% of parents felt: “I would prefer to have the doctors advise me, rather than asking me to decide”. In 79% of cases, clinicians believed parents preferred advice rather than to make decisions, but in 45% of these, they misidentified those who wished to make their decisions. Anxiety levels for one third of the mothers were high, and associated with poorer concordance of recall between parents and clinicians. Conclusions: Serious deficiencies exist in parent-clinician encounters during extremely preterm labour. Concordance between parents and clinicians is poor and anxiety very high. A quarter of parents appear to prefer to relinquish decision making autonomy, but clinicians cannot correctly identify this subgroup. Standardised counselling in the perinatal period, using formal decision aids, should be investigated.

Supporting bereaved parents: practical steps in providing compassionate perinatal and neonatal end-of-life care – A North American perspective☆

Providing compassionate bereavement support challenges care-givers in perinatal medicine. A practical and consistent approach tailored to individual families may increase the care-givers ability to relieve parental grief. This approach includes: (1) clear and consistent communication compassionately delivered; (2) shared decision-making; (3) physical and emotional support; and (4) follow-up medical, psychological and social care. Challenges to providing comprehensive end-of-life care include care-giver comfort, consistency of care, cultural and legal barriers, and lack of adequate training.

Development and pretesting of a decision-aid to use when counseling parents facing imminent extreme premature delivery.

OBJECTIVEnTo develop and pretest a decision-aid to help parents facing extreme premature delivery during antenatal counseling regarding delivery room resuscitation.nnnSTUDY DESIGNnSemistructured interviews with 31 clinicians and with 30 parents of children born <26 weeks gestation were conducted following standard methods of qualitative research. These characterized perceptions of prenatal counseling to identify information that parents value when making decisions regarding delivery room resuscitation. These parental needs were formatted into a decision-aid. We assessed the primary outcome of how effectively the decision-aid improved knowledge during a simulated counseling session. Two groups of women were studied: parents with a history of prematurity (experienced) and healthy women without prior knowledge of prematurity (naïve).nnnRESULTSnInterviewees thought that visual formats to present survival and short- and long-term outcome information facilitated their own preparation, recall, and understanding. Accordingly, we designed a decision-aid as a set of cards with pictures and pictographs to show survival rates and complications. There was significant improvement in knowledge in 13 experienced parents (P = .04) and 11 naïve women (P < .0001). Participants found the cards useful and easy to understand.nnnCONCLUSIONSnA decision-aid for parents facing extreme premature delivery may improve their understanding of complicated information during antenatal counseling.

A new measure of parent satisfaction with medical care provided in the neonatal intensive care unit.

The objective of this study was to develop a valid and reliable discriminative index that measures parent satisfaction with the medical care of their infant in the NICU. We developed an initial questionnaire (Item Reduction Questionnaire) by reviewing the literature, surveying 63 NICU clinicians, and interviewing 125 parents of infants in 2 tertiary level NICUs regarding what they liked and disliked about the medical care of their infants. We administered the Item Reduction Questionnaire, which included 154 items, to 60 parents, who rated the frequency and importance of these items. We included the items identified most frequently as sources of dissatisfaction and rated most important in a second, briefer instrument, the Neonatal Index of Parent Satisfaction (NIPS). To measure reliability we administered the NIPS to 47 parents twice, separated by a 1-week interval. We assessed validity by comparing actual to predicted correlations between NIPS scores and other measures: parents global rating of satisfaction, medical caregiver ratings of mothers satisfaction, medical caregiver ratings of fathers satisfaction, and parents perception of their infants health status. We also compared mean NIPS scores for parents who did and who did not report incidents when errors occurred in the medical care of the infant. Of 154 items generated, we included 27 in the NIPS. The intraclass correlation between two administrations of the NIPS to the same 47 parents was 0.71. As predicted, there was a high correlation (0.61) between the NIPS score and parent global rating of satisfaction, and much lower correlations with other variables. Mean NIPS scores for parents who did and who did not report errors differed significantly (difference, 14.6; 95% CI around difference, 5.8-23.5; p < 0.001). The NIPS is likely to be a useful measure for discriminating between parents who differ in terms of their satisfaction with the medical care of their infant in the NICU.

Pulmonary Deposition of Salbutamol Aerosol Delivered by Metered Dose Inhaler, Jet Nebulizer, and Ultrasonic Nebulizer in Mechanically Ventilated Rabbits

The deposition efficiency of three methods of aerosol delivery of salbutamol into lungs of ventilated rabbits was compared: 1) metered dose inhaler (MDI) with holding chamber (HC), 2) jet nebulizer (JN), and 3) ultrasonic (US) nebulizer. The latter system was tested using two different sized medication reservoirs, a large (20 mL) cup (US20) and a small (10 mL) cup (US10). After delivery of technetium-99m-labeled sulbutamol aerosol, deposition in the lungs, trachea, and ventilator circuit were estimated by a γ counter. Total pulmonary deposition [mean(SEM)] as a percentage of the prescribed drug was: MDI + HC 0.22(0.05)%; JN 0.48(0.05)%; US20 0.90(0.13)%; US10 3.05(0.49%)%. Only the deposition from the US10 was statistically significantly higher than the other modes (p < 0.05). Dynamic scintigraphy showed that, among the nebulizers, the US10 continued to deliver medication for longer than either the JN or the US20. We conclude that the US10 appears to be more efficient in delivering aerosol to the lung in this rabbit model and merits further evaluation for clinical efficiency.

Nebulisation of surfactants in an animal model of neonatal respiratory distress

AIMS To evaluate pulmonary deposition and gas exchange following nebulisation of two surfactants by either a jet or an ultrasonic nebuliser. METHOD After bronchoalveolar lavage (BAL), 19 rabbits were ventilated in four groups. Group A1 (n=5) and A2 (n=6) received Technetium-99m labelled Exosurf, and groups B1 (n=4) and B2 (n=4) received radiolabelled Survanta. Groups A1 and B1 received jet nebuliser therapy, whereas groups A2 and B2 received ultrasonic nebuliser. Pulmonary deposition, distribution, and blood gases were determined. RESULTS Pulmonary deposition as per cent of initial dose and mg lipid) was 0.28(0.10)% or 0.59(0.21) mg in group A1, 1.05(0.23)% or 2.21(0.48) mg in group A2, 0.08(0.02)% or 0.30(0.08) mg in group B1, and 0.09(0.02)% or 0.34(0.08) mg in group B2. Deposition in group A2 was greater than in other groups (p= 0.001). Group A2 showed a small improvement in blood gases. CONCLUSIONS Even the highest deposition—ultrasonic nebuliser witosurf—achieved limited clinical effect. The aerosol route is currently not effective for surfactant treatment.

Do Transfusions Cause Necrotizing Enterocolitis? The Complementary Role of Randomized Trials and Observational Studies

A systematic review and a meta-analysis of the published literature on the association between transfusions in newborns and the occurrence of transfusion-associated necrotizing enterocolitis were performed. We discuss the differences between findings in randomized trials, and the results of observational studies that first explored this putative link. We suggest the following framework: where observational studies play a hypothesis generating- role for therapies and harm, and randomized studies allow an acid test of that hypothesis. It is acknowledged that not all questions can be subject to a randomized evaluation, but argued that this particular association is amenable to such a test.