Improving knowledge of outcomes in neonatology

Background: An outcome is a measured effect a treatment has on an individual, but in other fields problems have been identified with how outcomes are selected, collected, reported and interpreted. Core outcomes sets (a minimum set of essential outcomes reported by all related research) have been developed using consensus methods to address these problems. There has been no systematic evaluation of the importance of outcomes in neonatal research. Aims: Improve understanding of the importance of outcomes to neonatal research. Methods: Two systematic reviews identifying outcomes from neonatal trials and qualitative research were completed. The results of these reviews informed a consensus process, which included a Delphi survey, to identify a core outcomes set. The Delphi results were also used to analyse how groups prioritise outcomes and how methodological approaches affect core outcomes set development. Finally, the core outcomes set and population-level data were used to explore how early parenteral nutrition use affects outcomes in very preterm neonates in a retrospective cohort study using propensity score matching. Results: In 76 neonatal trials, 216 outcomes were reported using 889 measures; 146 outcomes were identified in 62 qualitative studies. These outcomes were scored by importance by 414 former patients, parents, healthcare professionals and researchers: the final core outcomes set included 12 outcomes. Delphi results showed stakeholder groups prioritise different outcomes. Data from 16, 292 matched very premature neonates showed that those given PN in the first postnatal week had higher rates of survival (absolute increase 0.91%; confidence interval 0.53, 1.30), but increased morbidity. Conclusions: Outcomes are inconsistently reported in neonatal trials: different outcomes are discussed in qualitative research. The core outcomes set will ensure research outcomes meet the priorities of different groups: I have demonstrated its utility in observational research. Keywords: Outcomes, systematic review, Delphi survey, core outcomes setOpen Acces

Early neonatal outcome in late preterms compared with term neonates

Introduction: Neonates born between 34 weeks and 36 weeks 6 days of gestational age (GA) are known as late preterm neonates. These late preterm neonates are the largest subgroup of preterm neonates. There have been few studies regarding the early morbidity in this cohort of neonates when compared to neonates born at term. Objectives: The objectives of the study were to study the incidence and various causes of early morbidities and mortality in late preterm neonates and to compare with term neonates. Materials and Methods: This prospective cohort study was conducted at a tertiary care teaching institution of Bengaluru. All late preterm and term neonates born between December 2016 and July 2018 were enrolled in the study. Data regarding parity, mode of delivery, sex, GA, birth weight, predefined neonatal morbidities, and maternal risk factors were all entered in the pre-designed pro forma. The morbidities and mortality of these late preterm neonates were compared with the term neonates. Results: A total of 408 late preterms and 1660 term neonates were enrolled in this study. These late preterm neonates were at significantly higher risk of overall morbidity due to any cause (85.3%, p<0.001, adjusted odds ratio [OR]: 1.4, 95% confident interval [CI]=0.8–2.4). They were also at higher risk of developing respiratory distress (23.5%, p<0.001, adjusted OR: 1.5, 95% CI: 1.1–2.2), need for ventilation ([Nasal continuous positive airway pressure – 8.6%] [synchronized intermittent mandatory ventilation [SIMV] – 3.7%], p<0.001), and neonatal sepsis (9.1%, p=0.003, adjusted OR: 1.3, 95% CI=0.3–3.3) when compared with term neonates. Conclusion: Gestational maturity is the most important determinant of the outcome in newborns. Late preterm neonates are not the same as term neonates as evidenced by the high incidence of complications in late preterm compared to term infants

The Special Care Nursery

Providing services to high-risk infants and their families in the neonatal intensive care unit is a complex subspecialty of pediatric physical therapy requiring knowledge and skills beyond the competencies for entry into practice. The newborns in the neonatal intensive care unit (NICU) are among the most fragile patients that physical therapists will treat, and detrimental effects can occur as the result of routine caregiving procedures. Pediatric physical therapists (PTs) need advanced education in areas such as early fetal and infant development; infant neurobehavior; family responses to having a sick newborn; the environment of the NICU, physiologic assessment and monitoring; newborn pathologies, treatments, and outcomes; optimal discharge planning; and collaboration with the members of the health care team.256 This chapter describes the neonatal intensive care unit and the role of the physical therapist within this setting. Practice in this setting requires knowledge of neonatal physiology, development, and health complications including prematurity, pulmonary conditions, neurologic conditions, fetal alcohol syndrome, fetal abstinence syndrome, and pain. A framework for physical therapy examination, evaluation, prognosis, and interventions for infants in the special care nursery is presented. The follow-up of infants after discharge from the intensive care nursery is addressed. Two case studies are presented to apply knowledge to practice

Respiratory Management of Newborns

In this book, you'll learn multiple new aspects of respiratory management of the newborn. For example, ventilator management of infants with unusually severe bronchopulmonary dysplasia and infants with omphalocele is discussed, as well as positioning of endotracheal tube in extremely low birth weight infants, noninvasive respiratory support, utilization of a protocol-driven respiratory management, and more. This book includes a chapter on noninvasive respiratory function monitoring during chest compression, analyzing the efficacy and quality of chest compression and exhaled carbon dioxide. It also provides an overview on new trends in the management of fetal and transitioning lungs in infants delivered prematurely. Lastly, the book includes a chapter on neonatal encephalopathy treated with hypothermia along with mechanical ventilation. The interaction of cooling with respiration and the strategies to optimize oxygenation and ventilation in asphyxiated newborns are discussed

Psychological Case Record

DIAGNOSTIC CLARIFICATION: Master V was noticed to have persistent, intractable hiccough for the past one year. It was present throughout the day and was absent during sleep. He could voluntarily control the hiccough for only a while by holding his breath. The hiccough was exacerbated by anxiety-provoking situations. There was no history suggestive of organic pathology for hiccough. Several physicians were consulted for the same but without any improvement. For the past six months, Master V was observed to be preoccupied. He was found to be in tearful most often. He expressed that he felt sad but could not explain the reason. He was found to be disinterested in mingling with his peers. He was occasionally expressing feelings of helplessness. He also expressed guilt feelings. He reported that he had poor appetite. There was no change in his sleep pattern. He was able to maintain his basic activities of daily living. There was no history of expressing hopelessness or worthlessness or suicidal ideas. There were no melancholic features. There was no history suggestive of hypomania or mania. There was no history of psychosis. There was no history suggestive of an organic involvement. CONCLUSION: The diagnosis of depression was confirmed. He was started on antidepressant. A diagnosis of Somatoform autonomic dysfunction (upper gastrointestinal) was also made. Principles of cutting down secondary gains and differential reinforcement were discussed. He was found to be anxious, timid and less assertive. He had low average intelligence. There was pressure to excel in academics. Moreover there was comparison to a well-performing elder sister. This conflict resulted in strong resentment towards his sister. There was also a conflict due to low socioeconomic status. The boy was deeply distressed regarding the marital problems between parents and the substance use pattern of his father. The implication of low intelligence on academic performance was discussed. A step down in curriculam with reduced pressure in academics was encouraged. Coping skill training, assertiveness training, academic skill building, role plays, group activities, and relaxation technique training were practiced. The need to avoid direct confrontation between parents in presence of children was stressed. The option of father getting treated for alcohol consumption in adult psychiatry too was discussed. At the time of discharge, Master V was euthymic. There was marked improvement in hiccough. PERSONALITY ASSESSMENT: The complaints started while he was doing his intermediate. He started experiencing repeatitive and recurrent thoughts of dead body whenever he came across his close relatives, of throwing chappal at idol while worshipping and of faecal matter while taking food. He acknowledged those thoughts as his own. He also considered those thoughts were absurd and senseless. But the thoughts were occurring without his will. They were so intrusive that his attempts to resist them most often failed. These thoughts were reportedly occurring in clear consciousness and, was dominating and persisting without any cause. Hence he was in deep distress. He could manage his studies and passed intermediate. While doing BCom the intensity and severity of unusual thoughts increased. Moreover, he started having a repetitive and recurrent urge to keep things in order, check lock and zip. This also he considered as own action not being imposed by others, as absurd and senseless, but intrusive occurring in clear consciousness. These were dominating and persisting without any cause. There was release of tension after the act. The thoughts and acts were so intense that he sometimes used to feel death wish. His sleep too was disturbed. There were no active suicidal plans or suicidal attempts so far. There was no pervasive sad mood or lack of interest in pleasurable activities or easy fatiguability. There was no pervasive feeling of worthlessness or hopelessness or helplessness. There was no loss of libido or loss of weight. There was no early morning awakening. The thoughts and acts were so impairing that he stopped his studies. He could not make steady progress in business so that he was expelled by his business partners. Though his personal care was reportedly adequate, there was severe interference due to the complaints. There was impairment in instrumental activities of daily living. There was no history suggestive of first rank symptoms. There was no history of expressing false belief with conviction. There was no history of any abnormal perception. There was no history of mania or hypomania. There was no history of phobia or panic attacks. There was no history suggestive of organicity or seizures. CONCLUSION: The defense mechanisms were mostly mature and neurotic. There were major conflicts in areas of sexuality and autonomy. Obsessive compulsive personality with ego strength was confirmed. He was found to be vulnerable to social rejection. There was also tendency to loss self-sufficiency. Both finally may culminate in somatisation with secondary gain. There were significant conflicts in family relations especially with parents. Hatred towards mother has to be explored. Conflicts in sexuality warrants further probing. It was decided to give an adequate trial of Fluoxetine and augment it with Clonazepam. Non-pharmacologically, cognitive behaviour therapy too was started. It primarily involved exposure-response prevention strategy, where he was repeatedly exposed himself to provocative stimuli and refrained from compulsions. For this, a complete list of obsessions, compulsions, and things that he avoided was first made. This list was then arranged in a hierarchy from least anxiety-provoking to most anxiety-provoking. He then started with a moderately anxiety-provoking stimulus and repeatedly exposed himself to it until the situation produces minimal anxiety (i.e., habituation). The next (more anxiety-provoking) stimulus in the hierarchy was then tackled. This was combined with cognitive therapy, in which faulty beliefs were challenged to help reduce the feeling of impending catastrophe. Social skills training with focus on helping him to deal with heavy responsibilities and stress was also undertaken. Specific techniques as instruction, feedback, and reinforcement of positive interactions were used. DIAGNOSTIC CLARIFICATION: From early childhood onwards, Mr SKA was reported to be adamant. He had poor frustration tolerance that even for trivial incidents at school or at home he will be angry and sometimes agitated. But significant changes were noticed since he was studying in 12th standard. Then he was found preoccupied with his physical appearance. He started complaining that there was more hair growth in him. He expressed concern that he was losing vitamins due to this. Hence he used to apply costly cosmetics, for which he always quarreled with his father. Once he found that cosmetics were not reducing his hair growth he started demanding consultations at various cosmetologists. He was also concerned about asymmetry of his jaw bone. Since there was no improvement with expert consultation he started demanding LASER therapy for the same. Almost during the same period, he used to get angry even for other reasons like not serving him tea on time. It was also reported that he would not persist with a task that yielded no immediate reward. He insisted on that he would do things on his own way and would not agree to others’ suggestion. At the same time he will deeply be moved by criticism. He tends to blame others when criticised. He used to blame parents for all his failures. He was always found complaining to others that he was not brought up well; he was not guided properly by parents; he was not made to excel in his academics. He used to be abusive and assaultive towards parents. He was also found blaming his friends for inappropriate behaviour toward him. He also pointed fingers at school authorities for lack of infrastructure at school, one of the reasons he considered for his poor scholastic performance. His sleep too was disturbed. There was difficulty in sleep initiation. He used to get up late in the morning. His personal care was reportedly adequate, but there was no routine. Since all these complaints started simultaneously while studying in 12th standard, he did not complete the academic year. Then he worked in a stationary shop. Gradually he stopped going for work. Thereafter he spent all his time at house mostly sleeping or relaxing. There was gross impairment of instrumental activities of daily living. There was no history suggestive of first rank symptoms. There was no history of expressing false belief with conviction. There was no history of any abnormal perception. There was no history of depressive syndrome or mania or hypomania. There was no history of phobia or panic attacks. There was no history suggestive of organicity or seizures. His index visit to us was on 25/4/2007 with multiple somatic symptoms, anxiety and agitation. Initially, possibilities of anxious personality disorder and somatoform disorder were considered. Later on, he was described to have repeated behaviour of checking and washing. Hence, diagnoses of Obsessive compulsive disorder and Somatisation disorder were made. CONCLUSION: The tests revealed his personality traits viz. avoidant, emotional dysregulation, sensitivity to stressors, and obsessions. He was prone to exhibit maladaptive behaviour under stressful situation. His disregard to social norms was also evident. The difficulty in decision-making and problem-solving justify his dissatisfaction with life. The environment was perceived threatening and insecure. Poor interpersonal relations can be due to both the cause and the effect of his psychopathology. The test results also point towards his significant difficulty in reality testing indicating a psychotic psychopathology. The use of narcissistic and neurotic defenses further strengthens the possibility of psychosis and personality disorder respectively. A current working diagnosis of mixed personality disorder with high index of suspicion of prodrome of schizophrenia was concluded. NEUROPSYCHOLOGICAL ASSESSMENT: The episodes started when Mr ARS was twelve years of age. Mr ARS’s mother first noticed that, Mr ARS had a vacant stare while having his lunch. She also observed that he was spreading the food in plate with his right hand. Suddenly she called him but he was found unresponsive. After twenty to thirty seconds, he became responsive. There was no major confused state after the episode. When his mother tried to clarify what was happening, he could not recollect whether any such episode has happened. There was no involvement of any other limbs. There was no lip smacking or any other complex motor activity. There was no aura. There were no tonic-clonic movements or incontinence or frothing or loss of consciousness with postural fall suggestive of generalised tonic-clonic seizure. There was no fever prior to the episode. Afterwards, he was normal to his studies with no residual effect. Hence he was not consulted then. Four months later he had second episode of similar semiology. Then he was taken to a local physician who started him on Carbamazepine. While on medication, he again had similar episode four months later. Then he was consulted by a Neurologist. After imaging, the dose of Carbamazepine was titrated. But he continued to experience at least one episode every four months mostly while having food. The episodes were not interfering with his daily activities and the episodes were of short duration that they did not seek any change in medication. He was compliant with medication but no drug levels were done. From the age of twenty nine, he started experiencing aura – an abnormal sensation in abdomen that ascends upto his neck and a sense of arrested speech. This will last a few seconds. It will be followed by the episode as described before. It was reported that not all aura was followed by seizure. During the same period, while driving a motorbike he probably had an episode; he fell down; he sustained left clavicular fracture. A few other episodes occurred at work place. While he was soldering he developed a seizure episode. Then he unknowingly moved the soldering iron to his face and burned his face. Similarly he burned his hand once. Since the episodes started affecting his daily activities some of which were life threatening, he consulted another Neurologist. He was started on Phenytoin in addition to Carbamazepine. The dose was titrated. There was no significant change in frequency or severity of episodes. In view of poor response to two antiepileptic medications, Sodium valproate was added as third antiepileptic. Even then he continued to have seizure in the same frequency. Hence he was brought to CMC for expert opinion. Drug levels were found to be within normal range indication good drug compliance. In view of poor control of seizure with three antiepileptics with good compliance, option of surgery was discussed. Meantime it was decided to try fourth antipepileptic Clobazam and, to taper off Carbamazepine and Sodium valproate. But he continued to develop seizure. Moreover, he could not tolerate the dose of Phenytoin that was prescribed. He had severe side effects and hence he stopped the medicine. There was no history of apathy or emotional lability or sexual disinhibition. There was no history of forgetfulness or difficulty in speech. There was no history of apraxia or difficulty in calculation. There was no history suggestive of psychosis or syndromal depression or mania. There was no history of deviant personality traits or obsessions or compulsions or phobia or panic attacks. There was no history of head injury. His biological functions were reportedly normal. He still continued to maintain his basic and instrumental activities of daily living independently. INTELLIGENCE QUOTIENT ASSESSMENT: Master T A was brought with history of disobedience, abusing parents, demanding immediate ratification of his demands, behaving opposite to what elders ask him to and deliberately annoying others, since he joined 5th standard. Simultaneously there was gradual deterioration in his scholastic performance. He was reportedly inattentive in class and was disturbing his classmates during sessions. Back at home, he was spending little time for his studies, often making excuses during study time. He could independently carry out age-appropriate basic and instrumental activities of daily living. There was no history suggestive of attention deficit hyperactivity disorder or conduct disorder. There was no history suggestive of psychotic syndrome, mood syndrome, obsessive-compulsive disorder, anxiety disorder or phobia. There was no history suggestive of organicity or substance us

Non-invasive ventilation during paediatric retrieval: a systematised review

Background: In hospital critical-care and emergency settings, non-Invasive ventilation (NIV) is increasingly used in neonatal and paediatric patients as an alternative to invasive positive pressure ventilation (IPPV). Critically ill children and babies may need transfer to higher levels of care, but the emergency transport setting is lagging behind the hospital sector in terms of availability of NIV. Aim and objectives: The goal of this study was to assess the evidence on the safety and effectiveness of NIV in children during transportation. Safety outcome measures were intubation or escalation of ventilation mode (during and soon after transport) and adverse event (AE) occurrence during transport. Effectiveness outcome measures related to improvement in clinical parameters during transfer. Methods: A systematised review of the literature was conducted, based on searches of MEDLINE via PubMed, EMBASE (via Scopus), Cochrane Central Register of Controlled Trials (CENTRAL), African Index Medicus, Web of Science Citation Index and the World Health Organisation Trials Registry (ICTRP). Two reviewers independently reviewed all identified studies for eligibility, with an initial screening round followed by a full-text review of potentially relevant articles. The quality of studies meeting inclusion criteria was evaluated using an adapted quality assessment tool developed for this study. Results: A total of 1287 records were identified; of these, 12 studies met inclusion criteria. Following quality assessment, eight studies were included and four studies were excluded. There were no randomised controlled trials, quasi-randomised controlled trials or non-randomised studies of intervention, to answer the research question. The included studies were all observational in design: seven studies (n= 708) evaluated in-transport use of continuous positive airway pressure (CPAP) and one study (n=150) reported on use of high-flow nasal cannula (HFNC) in children during transport. During transport on NIV, 3/858 (0.4%) patients required either intubation (1/708; 0.1%; CPAP studies) or escalation of mode of ventilation (2/150; 1%; HFNC study). In the 24 hours following transfer, 63/650 (13%) of children transferred on NIV, were intubated. The odds of intubation within 24 hours were significantly higher for CPAP transfer 60/500 (12%) compared with HFNC 3/150(2%): OR (95% CI) 6.68 (2.40 - 18.63), p=0.00003. Adverse events, where reported, were found to occur in 2-4% of NIV transports, with use of BVM in 8/334 (2%), desaturation episodes in 9/290 (3%), apnoea in 11/290(4%) and administration of CPR in 0/290 (0%) cases being described. There was insufficient reporting of change in vital signs or clinical condition during transport for meaningful analysis. Conclusion: This study is the first systematised review indicating that NIV use in children during transport is likely to be safe. From the low-reliability evidence available, it was calculated that NIV use in children during transport would result in a 0.4% rate of intubation or escalation during transport and an in-transport adverse event rate of 2-4%. There was insufficient evidence to comment on clinical effectiveness of NIV during transfer. Following NIV transfer, 13% of patients were intubated within 24 hours, with significantly higher odds of intubation in children transported on CPAP compared with HFNC. Recommendations: Further research is needed in order to make firm recommendations regarding the safety and effectiveness of NIV during transport of children. A recommended minimum data set, for the standardised reporting of observational studies of paediatric NIV use during transport, is suggested. It is recommended that transport databases and registries are expanded to include NIV details as well as information regarding the presence or absence of pre-specified adverse events during transport

Retinopathy of Prematurity in a cohort of neonates at Groote Schuur Hospital

Background: Screening for Retinopathy of Prematurity (ROP) is recommended to prevent possible blindness. Prior to 2016, resource limitations precluded routine ROP screening at Groote Schuur Hospital (GSH). Previous pilot studies at GSH did not detect ROP requiring treatment. However, improved survival of very low birth weight infants may affect the prevalence of ROP. Objectives: The study objectives were to: i) Determine the prevalence and severity of ROP in a prospective cohort of premature infants; ii) Describe the association with pre-specified potential risk factors; iii) Assess the feasibility of screening for ROP in our resource-limited setting. Methods Infants with a birth weight of < 1251 g or gestational age < 31 weeks admitted to the GSH neonatal unit from November 2012 to May 2013 were screened. A paediatric ophthalmologist examined the infants at 4 weeks chronological age or 32 weeks corrected gestational age, with follow-up examinations as indicated. Results: Screening was performed in 135 of 191 eligible infants. A total of 313 ROP examinations were performed; 38.5% of infants required a single examination and 16.3% required more than four. The mean gestational age and weight at birth were 30.1 ± 1.9 weeks and 1056 ± 172 g respectively. Seventy-four infants were female (54.8%). Only black (57.0%) and coloured (42.9%) infants were represented. ROP was diagnosed in 40 (29.6%) infants: Eight (5.9%) infants had clinically significant ROP. No infants had stage 4 or 5 ROP. No infants weighing more than 1250 g required treatment. Two infants received laser treatment. Infants with ROP had a lower mean gestational age and lower mean birth weight than those without ROP: 29.2 ± 1.6 vs. 30.5 ± 1.9 weeks (P < 0.002) and 988 ± 181 g vs. 1085 ± 160 g (P = 0.001) respectively. Infants with ROP were more likely to have received a blood transfusion (P < 0.002); to have late onset sepsis (P = 0.024); and to have receive d exclusive breast milk feeds (P = 0.005). There were no significant differences in the level of respiratory support, the need for oxygen therapy, the occurrence of apnoea, early sepsis or severe intraventricular haemorrhage in infants with ROP compared to no ROP. On multivariate analysis, only gestational age was independently associated with ROP was gestational age (RR 0.85; 95% CI 95% 0.740 - 0.988; p=0.03). When gestational age was excluded in post-hoc analysis, birth weight (RR 0.99; 95% CI 0.997 - 0.999; P=0.03) and blood transfusions (RR 1.71; 95% CI 1.0 27 - 2.859; P=0.03) were independently associated with ROP. Infants <1000 g had a 2.5 times higher risk of having ROP than their larger counterparts (95% CI 1.05 - 5.90, P=0.03). ROP screening was completed in 91.1% (123/135) of infants. Conclusion Clinically significant ROP was found in this study. In contrast to previous studies conducted in this setting, two patients received laser treatment. Extensive resources were required for successful screening. The strong association with birth weight and gestational age suggests that infants with lower birth weights and gestational ages should be prioritized for screening in our resource-limited setting

Early prediction of hypoxic ischaemic encephalopathy in newborn infants in a resource-limited setting

Includes bibliographical references.Hypoxic ischaemic encephalopathy (HIE) after birth is an important cause of neonatal morbidity and mortality, particularly in resource-limited regions. Therapeutic hypothermia initiated within the first 6 hours of life, in settings that can offer neonatal intensive care, is a therapy that can reduce death or severe disability in newborn infants with moderate or severe HIE. Therapeutic hypothermia has not been shown to be safe or effective in low-resource settings where neonatal intensive care is not available; however, there are situations such as in some centres in South Africa, where limited neonatal intensive care (NICU) is available against a background of moderate neonatal mortality rates, relatively low socio-economic conditions and limited capacity for long-term follow-up. In such settings, accurate case definition and early prediction of HIE and outcome may assist with the appropriate allocation of resources. The amplitude-integrated electro-encephalogram (aEEG) is an ideal tool to use for prediction of outcome and the need for cooling, but it’s availability is limited, particularly at primary and secondary hospitals