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Newborns who do not reach a weight appropriate for their gestational age and sex can be classified in different ways. This article defines the concepts of small for gestational age (SGA) and intrauterine growth restriction, as well as the underlying causes of these conditions, with the goal of establishing consensus definitions for these patients, in whom treatment with growth hormone throughout childhood may be indicated and who may be at risk of developing endocrine or metabolic disorders in puberty and adulthood. Most SGA children experience spontaneous catch-up growth that is usually completed by age 2 years. In SGA children who remain short, treatment with recombinant human growth hormone is effective, increasing adult height. Small for gestational age infants with rapid catch-up growth and marked weight gain are at increased risk of premature adrenarche, early puberty, polycystic ovary syndrome (girls), insulin resistance and obesity, all of which are risk factors for type 2 diabetes and metabolic syndrome in adulthood. The SGA status can affect different areas of neurodevelopment and manifest at different stages in life; neurodevelopmental outcomes are better in SGA infants with spontaneous catch-up growth. Due to the potential risks associated with SGA, adequate characterization of these patients at birth is imperative, as it allows initiation of appropriate follow-up and early detection of abnormalities.
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Recém-Nascido Pequeno para a Idade Gestacional , Feminino , Humanos , Recém-Nascido , Masculino , Retardo do Crescimento Fetal/diagnóstico , Seguimentos , Fatores de RiscoRESUMO
BACKGROUND: Immediately after birth, the oxygen saturation is between 30 and 50%, which then increases to 85-95% within the first 10 min. Over the last 10 years, recommendations regarding the ideal level of the initial fraction of inspired oxygen (FiO2) for resuscitation in preterm infants have changed from 1.0, to room air to low levels of oxygen (< 0.3), up to moderate concentrations (0.3-0.65). This leaves clinicians in a challenging position, and a large multi-center international trial of sufficient sample size that is powered to look at safety outcomes such as mortality and adverse neurodevelopmental outcomes is required to provide the necessary evidence to guide clinical practice with confidence. METHODS: An international cluster, cross-over randomized trial of initial FiO2 of 0.3 or 0.6 during neonatal resuscitation in preterm infants at birth to increase survival free of major neurodevelopmental outcomes at 18 and 24 months corrected age will be conducted. Preterm infants born between 230/7 and 286/7 weeks' gestation will be eligible. Each participating hospital will be randomized to either an initial FiO2 concentration of either 0.3 or 0.6 to recruit for up to 12 months' and then crossed over to the other concentration for up to 12 months. The intervention will be initial FiO2 of 0.6, and the comparator will be initial FiO2 of 0.3 during respiratory support in the delivery room. The sample size will be 1200 preterm infants. This will yield 80% power, assuming a type 1 error of 5% to detect a 25% reduction in relative risk of the primary outcome from 35 to 26.5%. The primary outcome will be a composite of all-cause mortality or the presence of a major neurodevelopmental outcome between 18 and 24 months corrected age. Secondary outcomes will include the components of the primary outcome (death, cerebral palsy, major developmental delay involving cognition, speech, visual, or hearing impairment) in addition to neonatal morbidities (severe brain injury, bronchopulmonary dysplasia; and severe retinopathy of prematurity). DISCUSSION: The use of supplementary oxygen may be crucial but also potentially detrimental to preterm infants at birth. The HiLo trial is powered for the primary outcome and will address gaps in the evidence due to its pragmatic and inclusive design, targeting all extremely preterm infants. Should 60% initial oxygen concertation increase survival free of major neurodevelopmental outcomes at 18-24 months corrected age, without severe adverse effects, this readily available intervention could be introduced immediately into clinical practice. TRIAL REGISTRATION: The trial was registered on January 31, 2019, at ClinicalTrials.gov with the Identifier: NCT03825835.
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Recém-Nascido de muito Baixo Peso , Ressuscitação , Humanos , Lactente , Recém-Nascido , Idade Gestacional , Lactente Extremamente Prematuro , Oxigênio , Ressuscitação/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Introduction: Despite advances in respiratory distress syndrome (RDS) management over the past decade, non-invasive ventilation (NIV) failure is frequent and associated with adverse outcomes. There are insufficient data on the failure of different NIV strategies currently used in clinical practice in preterm infants. Methods: This was a prospective, multicenter, observational study of very preterm infants [gestational age (GA) <32 weeks] admitted to the neonatal intensive care unit for RDS that required NIV from the first 30â min after birth. The primary outcome was the incidence of NIV failure, defined as the need for mechanical ventilation for <72â h of life. Secondary outcomes were risk factors associated with NIV failure and complication rates. Results: The study included 173 preterm infants with a median GA of 28 (IQR 27-30) weeks and a median birth weight of 1,100 (IQR 800-1,333) g. The incidence of NIV failure was 15.6%. In the multivariate analysis, lower GA (OR, 0.728; 95% CI, 0.576-0.920) independently increased the risk of NIV failure. Compared to NIV success, NIV failure was associated with higher rates of unfavorable outcomes, including pneumothorax, intraventricular hemorrhage, periventricular leukomalacia, pulmonary hemorrhage, and a combined outcome of moderate-to-severe bronchopulmonary dysplasia or death. Conclusion: NIV failure occurred in 15.6% of the preterm neonates and was associated with adverse outcomes. The use of LISA and newer NIV modalities most likely accounts for the reduced failure rate. Gestational age remains the best predictor of NIV failure and is more reliable than the fraction of inspired oxygen during the first hour of life.
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The Spanish Society of Neonatology established the care levels of the Neonatal Units in Spain in 2013. Since then, the birth rate in our country, as well as the universalization of knowledge, techniques and patient treatment devices, has evolved significantly. This situation forces a redefinition of the current levels of care based on quality criteria that allow better comparability between the Units and represents a challenge to improve the care of our newborns.
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Neonatologia , Recém-Nascido , Humanos , EspanhaRESUMO
The scant evidence on the use of transfusions in neonatal care explains the limitations of current clinical guidelines. Despite this, in this document we explore the most recent evidence to make recommendations for the clinical practice. The prevention of anaemia of prematurity, the use of protocols and restrictive transfusion strategies constitute the best approach for clinicians in this field. In the case of platelet transfusions, the risk of bleeding must be assessed, combining clinical and laboratory features. Lastly, fresh frozen plasma is recommended in neonates with coagulopathy and active bleeding, with congenital factor deficiencies for which there is no specific treatment or with disseminated intravascular coagulation. All blood products have adverse effects that warrant a personalised and thorough assessment of the need for transfusion.
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Neonatologia , Transfusão de Sangue , Hemorragia/etiologia , Hemorragia/terapia , Humanos , Recém-Nascido , Plasma , Transfusão de Plaquetas/efeitos adversos , Transfusão de Plaquetas/métodosRESUMO
Perinatal Palliative Care is a model of care designed to prevent and treat the physical, spiritual, emotional, and social needs of fetuses and newborn infants with life-threatening or life-limiting conditions. The care extends to the infant's family. It is delivered by an interdisciplinary team to improve the quality of life from the time of diagnosis (possibly in utero) into death and bereavement (days, months or years later). To guarantee the access of this vulnerable population to high quality palliative care, structured programs and protocols need to be further developed in tertiary hospitals that treat highly complex obstetric and neonatal pathologies. Basic training is required for all the professionals involved.
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Luto , Cuidados Paliativos , Criança , Feminino , Humanos , Lactente , Recém-Nascido , Assistência Perinatal , Gravidez , Qualidade de VidaRESUMO
Pain recognition and management continues to be a challenge for health professionals in Neonatal Intensive Care Units. Many of the patients are routinely exposed to repeated painful experiences with demonstrated short- and long-term consequences. Preterm babies are a vulnerable high-risk population. Despite international recommendations, pain remains poorly assessed and managed in many Neonatal Intensive Care Units. Due to there being no general protocol, there is significant variability as regards the guidelines for the approach and treatment of pain between the different Neonatal Intensive Care Units. The objective of this article is to review and assess the general principles of pain in the initial stages of development, its recognition through the use of standardised scales. It also includes its prevention and management with the combination of pharmacological and non-pharmacological measures, as well as to establish recommendations that help alleviate pain in daily clinical practice by optimising pain and stress control in the Neonatal Intensive Care Units.
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Unidades de Terapia Intensiva Neonatal , Manejo da Dor , Humanos , Recém-Nascido , DorRESUMO
The first hours of life of a sick or premature newborn are crucial for its prognosis and therefore delivery should take place in a center prepared for that degree of complexity. When this condition is not met, the newborn must be transferred in an optimal and safe way to the center that can offer the necessary care. The training, staffing, organization and coordination of the neonatal transport team are essential to guarantee a safe transfer. Being aware of the interest and the advances that are currently taking place in this area of ââpediatrics, the Standards Commission and the Neonatal Transport Commission of the Spanish Society of Neonatology have prepared this document. In it, both the provision of human and material resources necessary as well as the bases of clinical stabilization in transport to carry out the neonatal transfer in a safe way and proportionate to the needs of the critical newborn have been exhaustively reviewed and detailed.
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Neonatologia , Criança , Humanos , Recém-Nascido , Espanha , Recursos HumanosRESUMO
Home birth is a controversial issue that raises safety concerns for paediatricians and obstetricians. Hospital birth was the cornerstone to reduce maternal and neonatal mortality. This reduction in mortality has resulted in considering pregnancy and childbirth as a safe procedure, which, together with a greater social awareness of the need for the humanisation of these processes, have led to an increase in the demand for home birth. Studies from countries such as Australia, the Netherlands, and United Kingdom show that home birth can provide advantages to the mother and the newborn. It needs to be provided with sufficient material means, and should be attended by trained and accredited professionals, and needs to be perfectly coordinated with the hospital obstetrics and neonatology units, in order to guarantee its safety. Therefore, in our environment, there are no safety data or sufficient scientific evidence to support home births at present.
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Parto Domiciliar/normas , Segurança do Paciente/normas , Países Desenvolvidos , Feminino , Saúde Global , Parto Domiciliar/efeitos adversos , Parto Domiciliar/métodos , Hospitalização , Humanos , Tocologia/normas , Guias de Prática Clínica como Assunto , Gravidez , Risco , EspanhaRESUMO
Home birth is a controversial issue that raises safety concerns for paediatricians and obstetricians. Hospital birth was the cornerstone to reduce maternal and neonatal mortality. This reduction in mortality has resulted in considering pregnancy and childbirth as a safe procedure, which, together with a greater social awareness of the need for the humanisation of these processes, have led to an increase in the demand for home birth. Studies from countries such as Australia, the Netherlands, and United Kingdom show that home birth can provide advantages to the mother and the newborn. It needs to be provided with sufficient material means, and should be attended by trained and accredited professionals, and needs to be perfectly coordinated with the hospital obstetrics and neonatology units, in order to guarantee its safety. Therefore, in our environment, there are no safety data or sufficient scientific evidence to support home births at present.
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Parto Domiciliar , Obstetrícia , Parto Obstétrico , Feminino , Parto Domiciliar/efeitos adversos , Parto Domiciliar/tendências , Humanos , Lactente , Mortalidade Infantil , Recém-Nascido , Mortalidade Materna , GravidezRESUMO
OBJECTIVE: Scientific evidence supports the use of less invasive surfactant administration (LISA) techniques, but certain issues may be limiting its generalized incorporation in clinical practice. The objectives were to determine the level of acceptance of LISA techniques in Spanish hospitals, the types of methods used, the target population, and the premedication administered. STUDY DESIGN: An online survey was designed and sent to various secondary/tertiary hospitals in Spain. RESULTS: Among 67 neonatal units contacted, 44 (65.7%) participated. LISA was used in 89%, and those that did not perform the technique were contemplating its use in the future. In total, 77% of hospitals used some type of pharmacologic sedation/analgesia before the procedure: 28% always and 49% sometimes. In all cases, the reason for premedication was concerned about pain and discomfort. The types of drugs and doses varied. CONCLUSION: LISA has been incorporated in clinical practice of the hospitals surveyed, with a utilization rate higher than what has been reported to date. Sedation and analgesia are commonly administered. LISA is viewed as potentially involving some degree of pain and discomfort. Further studies are needed to determine the safest and most effective pharmacologic and nonpharmacologic measures to apply in these procedures.
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Recém-Nascido Prematuro , Surfactantes Pulmonares/administração & dosagem , Síndrome do Desconforto Respiratório do Recém-Nascido/tratamento farmacológico , Idade Gestacional , Pesquisas sobre Atenção à Saúde , Humanos , Recém-Nascido , Instilação de Medicamentos , Unidades de Terapia Intensiva Neonatal , Ventilação não Invasiva , Berçários Hospitalares , Pré-Medicação , EspanhaAssuntos
Pessoal de Saúde , Qualidade da Assistência à Saúde , Recessão Econômica , Humanos , Recém-Nascido , Percepção , Portugal , EspanhaRESUMO
BACKGROUND AND OBJECTIVES: Therapeutic interventions to improve the efficacy of whole-body cooling for hypoxic-ischemic encephalopathy (HIE) are desirable. Topiramate has been effective in reducing brain damage in experimental studies. However, in the clinical setting information is limited to a small number of feasibility trials. We launched a randomized controlled double-blinded topiramate/placebo multicenter trial with the primary objective being to reduce the antiepileptic activity in cooled neonates with HIE and assess if brain damage would be reduced as a consequence. STUDY DESIGN: Neonates were randomly assigned to topiramate or placebo at the initiation of hypothermia. Topiramate was administered via a nasogastric tube. Brain electric activity was continuously monitored. Topiramate pharmacokinetics, energy-related and Krebs' cycle intermediates, and lipid peroxidation biomarkers were determined using liquid chromatography-mass spectrometry and MRI for assessing brain damage. RESULTS: Out of 180 eligible patients 110 were randomized, 57 (51.8%) to topiramate and 53 (48.2%) to placebo. No differences in the perinatal or postnatal variables were found. The topiramate group exhibited less seizure burden in the first 24 h of hypothermia (topiramate, n = 14 [25.9%] vs. placebo, n = 22 [42%]); needed less additional medication, and had lower mortality (topiramate, n = 5 [9.2%] vs. placebo, n = 10 [19.2%]); however, these results did not achieve statistical significance. Topiramate achieved a therapeutic range in 37.5 and 75.5% of the patients at 24 and 48 h, respectively. A significant association between serum topiramate levels and seizure activity (p < 0.016) was established. No differences for oxidative stress, energy-related metabolites, or MRI were found. CONCLUSIONS: Topiramate reduced seizures in patients achieving therapeutic levels in the first hours after treatment initiation; however, they represented only a part of the study population. Our results warrant further studies with higher loading and maintenance dosing of topiramate.
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Hipotermia Induzida , Hipóxia-Isquemia Encefálica/terapia , Fármacos Neuroprotetores/uso terapêutico , Topiramato/uso terapêutico , Terapia Combinada , Método Duplo-Cego , Feminino , Humanos , Hipóxia-Isquemia Encefálica/diagnóstico por imagem , Recém-Nascido , Modelos Logísticos , Imageamento por Ressonância Magnética , Masculino , Fármacos Neuroprotetores/efeitos adversos , Topiramato/efeitos adversosRESUMO
OBJECTIVE: To evaluate the initial doses of surfactant administered to preterm infants with respiratory distress syndrome. STUDY DESIGN: This is a retrospective cohort study of 206 preterm infants admitted in four level III neonatal intensive care units of acute tertiary care hospitals in Spain between 2013 and 2015. RESULTS: The mean initial dose of surfactant was 173.9 (37.3) mg/kg, and 47.5% of infants received a dose of 200 mg/kg ± 10% (180-220 mg/kg), 47% less than 180 mg/kg (-10%), and 5.4% more than 220 mg/kg (+10%). Very preterm infants (<28 weeks) received higher initial doses than more mature infants, but in all cases, the mean doses were below the recommended 200 mg/kg (by 9.2% in gestational age 23-28 weeks, by 15.9% in 29-32 weeks, and by 24.3% in >32 weeks). CONCLUSION: Administration of surfactant below the prescribed dose is a frequent error in clinical practice. Inadvertently rounding down doses seems a plausible explanation.
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Produtos Biológicos/administração & dosagem , Recém-Nascido Prematuro , Erros de Medicação , Fosfolipídeos/administração & dosagem , Surfactantes Pulmonares/administração & dosagem , Síndrome do Desconforto Respiratório do Recém-Nascido/tratamento farmacológico , Produtos Biológicos/efeitos adversos , Cálculos da Dosagem de Medicamento , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Unidades de Terapia Intensiva Neonatal , Masculino , Fosfolipídeos/efeitos adversos , Surfactantes Pulmonares/efeitos adversos , Estudos RetrospectivosRESUMO
Birth asphyxia is one of the principal causes of early neonatal death. In survivors it may evolve to hypoxic-ischaemic encephalopathy and major long-term neurological morbidity. Prolonged and intense asphyxia will lead to energy exhaustion in tissues exclusively dependent on aerobic metabolism, such as the central nervous system. Energy deficit leads to ATP-dependent pumps blockage, with the subsequent loss of neuronal transmembrane potential. The most sensitive areas of the brain will die due to necrosis. In more resistant areas, neuronal hyper-excitability, massive entrance of ionic calcium, activation of NO-synthase, free radical generation, and alteration in mitochondrial metabolism will lead to a secondary energy failure and programmed neuronal death by means of the activation of the caspase pathways. A third phase has recently been described that includes persistent inflammation and epigenetic changes that would lead to a blockage of oligodendrocyte maturation, alteration of neurogenesis, axonal maturation, and synaptogenesis. In this scenario, oxidative stress plays a critical role causing direct damage to the central nervous system and activating metabolic cascades leading to apoptosis and inflammation. Moderate whole body hypothermia to preserve energy stores and to reduce the formation of oxygen reactive species attenuates the mechanisms that lead to the amplification of cerebral damage upon resuscitation. The combination of hypothermia with coadjuvant therapies may contribute to improve the prognosis.
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Asfixia Neonatal/metabolismo , Hipóxia-Isquemia Encefálica/metabolismo , Estresse Oxidativo , Asfixia Neonatal/diagnóstico , Asfixia Neonatal/terapia , Humanos , Hipóxia-Isquemia Encefálica/diagnóstico , Hipóxia-Isquemia Encefálica/terapia , Recém-NascidoRESUMO
Therapeutic hypothermia (TH) initiated within 6 h from birth is the most effective therapeutic approach for moderate to severe hypoxic-ischemic encephalopathy (HIE). However, underlying mechanisms and effects on the human metabolism are not yet fully understood. This work aims at studying the evolution of several energy related key metabolites in newborns with HIE undergoing TH employing gas chromatography - mass spectrometry. The method was validated following stringent FDA requirements and applied to 194 samples from a subgroup of newborns with HIE (N = 61) enrolled in a multicenter clinical trial (HYPOTOP) for the determination of lactate, pyruvate, ketone bodies and several Krebs cycle metabolites at different sampling time points. The analysis of plasma samples from newborns with HIE revealed a decrease of lactate, pyruvate and ß-hydroxybutyrate concentrations, whereas rising malate concentrations were observed. In healthy control newborns (N = 19) significantly lower levels of pyruvate and lactate were found in comparison to age-matched newborns with HIE undergoing TH, whereas acetoacetate and ß-hydroxybutyrate levels were clearly increased. Access to a validated analytical method and a controlled cohort of newborns with HIE undergoing hypothermia treatment for the first time allowed the in-depth study of the evolution of key metabolites of metabolic junctions in this special population.
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Hipotermia Induzida/métodos , Hipóxia-Isquemia Encefálica/terapia , Ácido 3-Hidroxibutírico/sangue , Acetoacetatos/sangue , Biomarcadores/sangue , Estudos de Casos e Controles , Feminino , Cromatografia Gasosa-Espectrometria de Massas , Humanos , Recém-Nascido , Corpos Cetônicos/sangue , Ácido Láctico/sangue , Limite de Detecção , Masculino , Ácido Pirúvico/sangueRESUMO
Aim To investigate whether increased brain natriuretic propeptide (NT-proBNP) levels at 48 to 72 h of life are associated with the development of bronchopulmonary dysplasia (BPD) or death in premature neonates. Methods A retrospective study was performed in neonates born before 32 weeks' gestation or with birth weight below 1500 grams, in whom NT-proBNP determination and echocardiography were performed at 48 to 72 h of life. Associations between NT-proBNP levels and the combined outcome BPD or death were analyzed using multivariate logistic regression analysis. Results 117 neonates with mean gestational age 27.8±2.1 weeks and birth weight 949.7±267.5 grams were included. Forty (34.2%) had an outcome of BPD or death. The risk of this combined outcome was found to be 3.95-fold higher (OR 3.95; 95% CI 1.1-14.6) in neonates with NT-proBNP levels above 17800 pg/mL. Conclusion Increased NT-proBNP levels may be associated with a significant decrease in BPD-free survival in very immature newborns.