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1.
JAMA Netw Open ; 7(5): e2411140, 2024 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-38758557

RESUMEN

Importance: Providing assisted ventilation during delayed umbilical cord clamping may improve outcomes for extremely preterm infants. Objective: To determine whether assisted ventilation in extremely preterm infants (23 0/7 to 28 6/7 weeks' gestational age [GA]) followed by cord clamping reduces intraventricular hemorrhage (IVH) or early death. Design, Setting, and Participants: This phase 3, 1:1, parallel-stratified randomized clinical trial conducted at 12 perinatal centers across the US and Canada from September 2, 2016, through February 21, 2023, assessed IVH and early death outcomes of extremely preterm infants randomized to receive 120 seconds of assisted ventilation followed by cord clamping vs delayed cord clamping for 30 to 60 seconds with ventilatory assistance afterward. Two analysis cohorts, not breathing well and breathing well, were specified a priori based on assessment of breathing 30 seconds after birth. Intervention: After birth, all infants received stimulation and suctioning if needed. From 30 to 120 seconds, infants randomized to the intervention received continuous positive airway pressure if breathing well or positive-pressure ventilation if not, with cord clamping at 120 seconds. Control infants received 30 to 60 seconds of delayed cord clamping followed by standard resuscitation. Main Outcomes and Measures: The primary outcome was any grade IVH on head ultrasonography or death before day 7. Interpretation by site radiologists was confirmed by independent radiologists, all masked to study group. To estimate the association between study group and outcome, data were analyzed using the stratified Cochran-Mantel-Haenszel test for relative risk (RR), with associations summarized by point estimates and 95% CIs. Results: Of 1110 women who consented to participate, 548 were randomized and delivered infants at GA less than 29 weeks. A total of 570 eligible infants were enrolled (median [IQR] GA, 26.6 [24.9-27.7] weeks; 297 male [52.1%]). Intraventricular hemorrhage or death occurred in 34.9% (97 of 278) of infants in the intervention group and 32.5% (95 of 292) in the control group (adjusted RR, 1.02; 95% CI, 0.81-1.27). In the prespecified not-breathing-well cohort (47.5% [271 of 570]; median [IQR] GA, 26.0 [24.7-27.4] weeks; 152 male [56.1%]), IVH or death occurred in 38.7% (58 of 150) of infants in the intervention group and 43.0% (52 of 121) in the control group (RR, 0.91; 95% CI, 0.68-1.21). There was no evidence of differences in death, severe brain injury, or major morbidities between the intervention and control groups in either breathing cohort. Conclusions and Relevance: This study did not show that providing assisted ventilation before cord clamping in extremely preterm infants reduces IVH or early death. Additional study around the feasibility, safety, and efficacy of assisted ventilation before cord clamping may provide additional insight. Trial Registration: ClinicalTrials.gov Identifier: NCT02742454.


Asunto(s)
Recien Nacido Extremadamente Prematuro , Clampeo del Cordón Umbilical , Humanos , Recién Nacido , Femenino , Masculino , Clampeo del Cordón Umbilical/métodos , Canadá , Respiración Artificial/métodos , Hemorragia Cerebral Intraventricular/prevención & control , Cordón Umbilical , Presión de las Vías Aéreas Positiva Contínua/métodos , Edad Gestacional , Factores de Tiempo , Estados Unidos
2.
Nutrients ; 16(10)2024 May 13.
Artículo en Inglés | MEDLINE | ID: mdl-38794701

RESUMEN

Preterm infants have increased body adiposity at term-equivalent age and risk of adverse metabolic outcomes. The aim of the study was to define how nutrient intake may impact body composition (BC) of very low-birth weight infants fed with early progressive enteral feeding and standard fortification. Eighty-six infants with <1500 g birth weight were included in the BC study and stratified into extremely preterm (EP) and very preterm (VP) groups. Nutrient intake was calculated during the first 28 days and BC assessed by dual X-ray absorptiometry at discharge and by skinfold thickness at 12 months of corrected age (CA). Total nutrient intake did not differ between the groups. EP infants had a higher fat mass percentage at discharge than VP infants (24.8% vs. 19.4%, p < 0.001); lean mass did not differ. None of the nutrients had any impact on BC of EP infants. Protein intake did not result in a higher lean mass in either group; fat intake was a significant predictor of increased fat mass percentage in VP infants at discharge (p = 0.007) and body adiposity at 12 months of CA (p = 0.021). Nutritional needs may depend on gestational age and routine fortification should be used with caution in more mature infants.


Asunto(s)
Composición Corporal , Nutrición Enteral , Fenómenos Fisiológicos Nutricionales del Lactante , Recién Nacido de muy Bajo Peso , Humanos , Nutrición Enteral/métodos , Recién Nacido de muy Bajo Peso/crecimiento & desarrollo , Femenino , Masculino , Recién Nacido , Edad Gestacional , Adiposidad , Recien Nacido Prematuro/crecimiento & desarrollo , Lactante , Nutrientes , Absorciometría de Fotón , Recien Nacido Extremadamente Prematuro , Ingestión de Energía , Alimentos Fortificados , Grosor de los Pliegues Cutáneos
3.
Andes Pediatr ; 95(2): 165-173, 2024 Apr.
Artículo en Español | MEDLINE | ID: mdl-38801364

RESUMEN

Extensive intraventricular hemorrhage (IVH) in very preterm newborns (VPNB) is associated with mortality and severe long-term neurological sequelae. OBJECTIVES: To know the most frequent neurological pathologies associated with extensive IVH, to determine the functional outcomes of mobility in the motor area and intellectual capacity in the cognitive area, to analyze the association between both areas and to know the schooling achieved. PATIENTS AND METHOD: Descriptive and longitudinal study in VPNB with extensive IVH born between 2001 and 2014. They underwent protocolized neurological follow-up until school age. The functional outcomes in mobility and intellectual capacity were categorized into 4 levels: level 1 corresponds to good functionality and autonomy; level 2, functionality that allows independence, with support in some tasks; level 3 requires constant external support; and level 4 where there is total dependence. The association was analyzed using Chi-square and Cramer's V coefficient. RESULTS: 74 children completed the follow-up; the most frequent associated neurological pathologies were neurodevelopmental disorders, hypertensive hydrocephalus, and epilepsy. Independent mobility (normal or with limitations) reached 74.4% while 24.3% used wheelchairs. 51.3% was categorized as normal to borderline intellectual range, 12.2% as mild intellectual disability (ID), 17.6% as moderate ID, and 19.9% as severe to profound ID. There was a strong statistical association between functional levels of mobility and intellectual capacity (p < 0.000 and V = 0.62). Schooling was proportional to intellectual capacity: 56.8% attended regular schools, 27.0% attended special schools, and 16.2% had no schooling. CONCLUSIONS: 2/3 VPNB with extensive IVH showed positive functional outcomes, from normal to mild limitations that allow an almost autonomous life; in 1/3 the outcomes were unfavorable in mobility and cognitive performance, and there was a strong statistical correlation between both areas studied. Schooling was consistent with the intellectual level.


Asunto(s)
Escolaridad , Recien Nacido Extremadamente Prematuro , Humanos , Masculino , Recién Nacido , Estudios Longitudinales , Femenino , Niño , Preescolar , Enfermedades del Prematuro/diagnóstico , Enfermedades del Prematuro/mortalidad , Discapacidad Intelectual/diagnóstico , Estudios de Seguimiento , Lactante , Trastornos del Neurodesarrollo/diagnóstico , Trastornos del Neurodesarrollo/etiología , Hemorragia Cerebral Intraventricular/diagnóstico , Hemorragia Cerebral/complicaciones , Hemorragia Cerebral/diagnóstico , Índice de Severidad de la Enfermedad
4.
BMC Pediatr ; 24(1): 369, 2024 May 29.
Artículo en Inglés | MEDLINE | ID: mdl-38807056

RESUMEN

BACKGROUND: Early childhood education offers opportunities for stimulation in multiple developmental domains and its positive impact on long-term outcomes and wellbeing for children is well documented. Few studies have explored early education in children born very preterm (VPT; <32 weeks of gestation) who are at higher risk of neurodevelopmental disorders and poor educational outcomes than their term-born peers. The purpose of the study is to describe and compare the educational environment of children born VPT in European countries at 5 years of age according to the degree of perinatal risk. METHODS: Data originated from the population-based Screening to Improve Health In very Preterm infants (SHIPS) cohort of children born VPT in 2011/2012 in 19 regions from 11 European countries. Perinatal data were collected from medical records and the 5-year follow-up was conducted using parental questionnaires. Outcomes at 5 years were participation in early education (any, type, intensity of participation) and receipt of special educational support, which were harmonized across countries. RESULTS: Out of 6,759 eligible children, 3,687 (54.6%) were followed up at 5 years (mean gestational age 29.3 weeks). At 5 years, almost all children (98.6%) were in an educational program, but type (preschool/primary), attendance (full-time/part-time) and use and type of school support/services differed by country. In some countries, children with high perinatal risk were more likely to be in full-time education than those with low risk (e.g. Estonia: 97.9% vs. 87.1%), while the inverse pattern was observed elsewhere (e.g. Poland: 78.5% vs. 92.8%). Overall, 22.8% of children received special educational support (country range: 12.4-34.4%) with more support received by children with higher perinatal risk. Large variations between countries remained after adjustment for socio-demographic characteristics. CONCLUSIONS: There are marked variations in approaches to early education for children born VPT in Europe, raising opportunities to explore its impact on their neurodevelopment and well-being.


Asunto(s)
Recien Nacido Extremadamente Prematuro , Humanos , Europa (Continente)/epidemiología , Femenino , Preescolar , Masculino , Recién Nacido , Educación Especial , Estudios de Seguimiento , Estudios de Cohortes , Desarrollo Infantil , Intervención Educativa Precoz
5.
Crit Care Nurs Clin North Am ; 36(2): 167-184, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38705686

RESUMEN

Caring for extremely preterm infants in the neonatal intensive care unit (NICU) is a multidisciplinary team effort. A clear understanding of roles for each member of the delivery team, anticipation of challenges, and standardized checklists support improved outcomes for this population. Physicians and nursing leaders are responsible for being role models and holding staff accountable for creating a unit culture of Neuroprotective Infant and Family-Centered Developmental Care. It is essential for parents to be included as part of the care team and babies to be acknowledged for their efforts in coping with the developmentally unexpected NICU environment.


Asunto(s)
Unidades de Cuidado Intensivo Neonatal , Humanos , Unidades de Cuidado Intensivo Neonatal/organización & administración , Recién Nacido , Recien Nacido Extremadamente Prematuro , Grupo de Atención al Paciente , Padres/psicología , Padres/educación , Neuroprotección , Desarrollo Infantil/fisiología , Cuidado Intensivo Neonatal/organización & administración
6.
Respir Res ; 25(1): 199, 2024 May 08.
Artículo en Inglés | MEDLINE | ID: mdl-38720331

RESUMEN

BACKGROUND: Bronchopulmonary dysplasia-associated pulmonary hypertension (BPD-PH) remains a devastating clinical complication seriously affecting the therapeutic outcome of preterm infants. Hence, early prevention and timely diagnosis prior to pathological change is the key to reducing morbidity and improving prognosis. Our primary objective is to utilize machine learning techniques to build predictive models that could accurately identify BPD infants at risk of developing PH. METHODS: The data utilized in this study were collected from neonatology departments of four tertiary-level hospitals in China. To address the issue of imbalanced data, oversampling algorithms synthetic minority over-sampling technique (SMOTE) was applied to improve the model. RESULTS: Seven hundred sixty one clinical records were collected in our study. Following data pre-processing and feature selection, 5 of the 46 features were used to build models, including duration of invasive respiratory support (day), the severity of BPD, ventilator-associated pneumonia, pulmonary hemorrhage, and early-onset PH. Four machine learning models were applied to predictive learning, and after comprehensive selection a model was ultimately selected. The model achieved 93.8% sensitivity, 85.0% accuracy, and 0.933 AUC. A score of the logistic regression formula greater than 0 was identified as a warning sign of BPD-PH. CONCLUSIONS: We comprehensively compared different machine learning models and ultimately obtained a good prognosis model which was sufficient to support pediatric clinicians to make early diagnosis and formulate a better treatment plan for pediatric patients with BPD-PH.


Asunto(s)
Displasia Broncopulmonar , Hipertensión Pulmonar , Aprendizaje Automático , Humanos , Displasia Broncopulmonar/diagnóstico , Recién Nacido , Hipertensión Pulmonar/diagnóstico , Masculino , Femenino , Estudios Retrospectivos , Recien Nacido Extremadamente Prematuro , Recien Nacido Prematuro
7.
JAMA Netw Open ; 7(5): e2413550, 2024 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-38709738

RESUMEN

Importance: Studies suggest that early neurodevelopmental assessments are beneficial for identifying cerebral palsy, yet their effectiveness in practical scenarios and their ability to detect cognitive impairment are limited. Objective: To assess the effectiveness of early neurodevelopmental assessments in identifying cerebral palsy and cognitive and other neurodevelopmental impairments, including their severity, within a multidisciplinary clinic. Design, Setting, and Participants: This diagnostic study was conducted at Monash Children's Hospital, Melbourne, Australia. Participants were extremely preterm infants born at less than 28 weeks' gestation or extremely low birth weight infants less than 1000 g and term encephalopathic infants who received therapeutic hypothermia, attending the early neurodevelopmental clinic between January 2019 and July 2021. Data were analyzed from December 2023 to January 2024. Exposures: Early cerebral palsy or high risk of cerebral palsy, the absence of fidgety movements, and Hammersmith Infant Neurological Examination (HINE) scores at corrected age (CA) 3 to 4 months. Early cerebral palsy or high risk of cerebral palsy diagnosis was based on absent fidgety movements, a low HINE score (<57), and medical neurological examination. Main Outcome and Measures: The outcomes of interest were cerebral palsy, cognitive and neurodevelopmental impairments and their severity, diagnosed at 24 to 36 months' CA. Results: A total of 116 infants (median [IQR] gestational age, 27 [25-29] weeks; 65 [56%] male) were included. Diagnosis of early cerebral palsy or high risk of cerebral palsy demonstrated a sensitivity of 92% (95% CI, 63%-99%) and specificity of 84% (95% CI, 76%-90%) for predicting cerebral palsy and 100% (95% CI, 59%-100%) sensitivity and 80% (95% CI, 72%-87%) specificity for predicting moderate to severe cerebral palsy. Additionally, the accuracy of diagnosis of early cerebral palsy or high risk of cerebral palsy was 85% (95% CI, 77%-91%) for predicting cerebral palsy and 81% (95% CI, 73%-88%) for predicting moderate to severe cerebral palsy. Similarly, the absence of fidgety movements had an 81% (95% CI, 73%-88%) accuracy in predicting cerebral palsy, and HINE scores exhibited good discriminatory power with an area under the curve of 0.88 (95% CI, 0.79-0.97) for cerebral palsy prediction. However, for cognitive impairment, the predictive accuracy was 44% (95% CI, 35%-54%) for an early cerebral palsy or high risk of cerebral palsy diagnosis and 45% (95% CI, 36%-55%) for the absence of fidgety movements. Similarly, HINE scores showed poor discriminatory power for predicting cognitive impairment, with an area under the curve of 0.62 (95% CI, 0.51-0.73). Conclusions and Relevance: In this diagnostic study of infants at high risk for cerebral palsy or other cognitive or neurodevelopmental impairment, early neurodevelopmental assessments at 3 to 4 months' CA reliably predicted cerebral palsy and its severity at 24 to 36 months' CA, signifying its crucial role in facilitating early intervention. However, for cognitive impairment, longer-term assessments are necessary for accurate identification.


Asunto(s)
Parálisis Cerebral , Humanos , Parálisis Cerebral/epidemiología , Parálisis Cerebral/diagnóstico , Femenino , Masculino , Recién Nacido , Lactante , Examen Neurológico/métodos , Recien Nacido Extremadamente Prematuro , Trastornos del Neurodesarrollo/diagnóstico , Trastornos del Neurodesarrollo/epidemiología , Trastornos del Neurodesarrollo/etiología , Preescolar , Australia/epidemiología
8.
BMJ Paediatr Open ; 8(1)2024 May 15.
Artículo en Inglés | MEDLINE | ID: mdl-38754896

RESUMEN

OBJECTIVE: This study aims to examine the perspectives of neonatologists in Israel regarding resuscitation of preterm infants born at 22-24 weeks gestation and their consideration of parental preferences. The factors that influence physicians' decisions on the verge of viability were investigated, and the extent to which their decisions align with the national clinical guidelines were determined. STUDY DESIGN: Descriptive and correlative study using a 47-questions online questionnaire. RESULTS: 90 (71%) of 127 active neonatologists in Israel responded. 74%, 50% and 16% of the respondents believed that resuscitation and full treatment at birth are against the best interests of infants born at 22, 23 and 24 weeks gestation, respectively. Respondents' decisions regarding resuscitation of extremely preterm infants showed significant variation and were consistently in disagreement with either the national clinical guidelines or the perception of what is in the best interest of these newborns. Gender, experience, country of birth and the level of religiosity were all associated with respondents' preferences regarding treatment decisions. Personal values and concerns about legal issues were also believed to affect decision-making. CONCLUSION: Significant variation was observed among Israeli neonatologists regarding delivery room management of extremely premature infants born at 22-24 weeks gestation, usually with a notable emphasis on respecting parents' wishes. The current national guidelines do not fully encompass the wide range of approaches. The country's guidelines should reflect the existing range of opinions, possibly through a broad survey of caregivers before setting the guidelines and recommendations.


Asunto(s)
Actitud del Personal de Salud , Recien Nacido Extremadamente Prematuro , Neonatólogos , Órdenes de Resucitación , Humanos , Israel , Recién Nacido , Femenino , Masculino , Órdenes de Resucitación/ética , Encuestas y Cuestionarios , Adulto , Viabilidad Fetal , Toma de Decisiones , Padres/psicología , Resucitación , Neonatología , Edad Gestacional
9.
J Neonatal Perinatal Med ; 17(2): 275-284, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38728205

RESUMEN

BACKGROUND: Pulmonary vascular disease (PVD) is a major determinant of both morbidity and mortality in extremely low birth weight infants. It is biologically plausible that postnatal cytomegalovirus (pCMV) infection may lead to PVD in premature infants secondary to pneumonitis or via derangement of pulmonary vascular development directly through endothelial dysfunction. Uncertainty remains, however, regarding thresholds for intervention in premature infants with cardiorespiratory instability and presumed CMV infection likely secondary to the limited understanding of the natural history of the disease. METHODS/RESULTS: We describe four cases of premature infants with clinical and echocardiography features of PVD, in the setting of postnatally acquired CMV. All patients had atypical PVD trajectories, refractory to vasodilator treatment, which improved after initiation of CMV treatment. CONCLUSION: We highlight the need to consider postnatally acquired CMV infection in patients with PVD non-responsive to standard pulmonary vasodilator therapies or disease severity which is out of proportion of the usual clinical trajectory. Treatment of extremely premature infants with CMV-associated PVD may have positive impact on cardiorespiratory health, although duration of therapy remains uncertain.


Asunto(s)
Infecciones por Citomegalovirus , Recien Nacido Extremadamente Prematuro , Humanos , Infecciones por Citomegalovirus/complicaciones , Infecciones por Citomegalovirus/diagnóstico , Infecciones por Citomegalovirus/tratamiento farmacológico , Recién Nacido , Femenino , Masculino , Antivirales/uso terapéutico , Vasodilatadores/uso terapéutico , Enfermedades del Prematuro/virología , Ecocardiografía/métodos
10.
J Clin Invest ; 134(9)2024 May 01.
Artículo en Inglés | MEDLINE | ID: mdl-38690742

RESUMEN

The discovery and replacement of lung surfactant have helped increase survival rates for neonatal respiratory distress syndrome in extremely premature infants.


Asunto(s)
Recien Nacido Prematuro , Surfactantes Pulmonares , Síndrome de Dificultad Respiratoria del Recién Nacido , Humanos , Recién Nacido , Recien Nacido Extremadamente Prematuro , Surfactantes Pulmonares/metabolismo , Historia del Siglo XX
11.
Soins Pediatr Pueric ; 45(338): 14-17, 2024.
Artículo en Francés | MEDLINE | ID: mdl-38697719

RESUMEN

Despite its high prevalence, moderate prematurity has been little studied in comparison with great or very great prematurity. In order to better understand the causes of this under-representation in the literature and in post-hospital care, this article proposes to analyze the historical and medical issues surrounding prematurity, and to investigate the different representations, by caregivers and parents, of the subject of intermediate prematurity. A necessary step in the evolution of practices.


Asunto(s)
Recien Nacido Prematuro , Humanos , Recién Nacido , Recien Nacido Extremadamente Prematuro
12.
Catheter Cardiovasc Interv ; 103(6): 934-942, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38584522

RESUMEN

BACKGROUND: Transcatheter closure of the patent ductus arteriosus (PDA) in premature infants is currently dependent on fluoroscopic guidance and transportation to the catheterization laboratory. AIM: We describe a new echocardiographically guided technique to allow our team to move to the bedside at the neonatal intensive care unit (NICU) of the referring center for percutaneous treatment of PDA in premature infants. METHODS: This is a single-center, retrospective, primarily descriptive analysis. Clinical details about the procedure, its outcomes, and complications were collected. RESULTS: Fifty-eight neonates with a median weight of 1110 g (range 730-2800) and postnatal age of 28 days (range 9-95) underwent percutaneous PDA closure. Five of them were treated in our center with ultrasound guidance only and the other 53 in 18 different neonatology units in 12 towns. The median duration of the procedure was 40 min (range 20-195 min). There were no procedural deaths. There was one residual shunt for 3 weeks, in all other patients the duct closed completely in the first few hours after the intervention. In one patient the procedure had to be interrupted because of a pericardial effusion which had to be drained, the PDA was closed successfully interventionally 5 days later. One device-related aortic coarctation had to be stented. One embolization and one late migration occurred and required treatment. CONCLUSIONS: Echocardiographically guided transcatheter closure of the PDA in prematures was repeatedly possible and allowed that the procedure is performed at the bedside at the NICU with an acceptable rate of complications.


Asunto(s)
Cateterismo Cardíaco , Conducto Arterioso Permeable , Ultrasonografía Intervencional , Humanos , Conducto Arterioso Permeable/terapia , Conducto Arterioso Permeable/diagnóstico por imagen , Conducto Arterioso Permeable/fisiopatología , Recién Nacido , Estudios Retrospectivos , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Resultado del Tratamiento , Edad Gestacional , Valor Predictivo de las Pruebas , Masculino , Femenino , Factores de Tiempo , Índice de Severidad de la Enfermedad , Recien Nacido Prematuro , Recien Nacido Extremadamente Prematuro , Unidades de Cuidado Intensivo Neonatal , Sistemas de Atención de Punto , Pruebas en el Punto de Atención , Dispositivo Oclusor Septal , Lactante
13.
Trials ; 25(1): 236, 2024 Apr 04.
Artículo en Inglés | MEDLINE | ID: mdl-38575977

RESUMEN

BACKGROUND: The process of obtaining prior informed consent for experimental treatment does not fit well into the clinical reality of acute and intensive care. The therapeutic window of interventions is often short, which may reduce the validity of the consent and the rate of enrolled participants, to delay trial completion and reduce the external validity of the results. Deferred consent and 'opt-out' are alternative consent methods. The SafeBoosC-III trial was a randomised clinical trial investigating the benefits and harms of cerebral oximetry monitoring in extremely preterm infants during the first 3 days after birth, starting within the first 6 h after birth. Prior, deferred and opt-out consent were all allowed by protocol. This study aimed to evaluate the use of different consent methods in the SafeBoosC-III trial, Furthermore, we aimed to describe and analyse concerns or complaints that arose during the first 6 months of trial conduct. METHODS: All 70 principal investigators were invited to join this descriptive ancillary study. Each principal investigator received a questionnaire on the use of consent methods in their centre during the SafeBoosC-III trial, including the possibility to describe any concerns related to the consent methods used during the first 6 months of the trial, as raised by the parents or the clinical staff. RESULTS: Data from 61 centres were available. In 43 centres, only prior informed consent was used: in seven, only deferred consent. No centres used the opt-out method only, but five centres used prior and deferred, five used prior, deferred and opt-out (all possibilities) and one used both deferred and opt-out. Six centres applied to use the opt-out method by their local research ethics committee but were denied using it. One centre applied to use deferred consent but was denied. There were only 23 registered concerns during the execution of the trial. CONCLUSIONS: Consent by opt-out was allowed by the protocol in this multinational trial but only a few investigators opted for it and some research ethics boards did not accept its use. It is likely to need promotion by the clinical research community to unfold its potential.


Asunto(s)
Circulación Cerebrovascular , Oximetría , Lactante , Recién Nacido , Humanos , Recien Nacido Extremadamente Prematuro , Padres , Encuestas y Cuestionarios , Consentimiento Informado
14.
Trials ; 25(1): 237, 2024 Apr 04.
Artículo en Inglés | MEDLINE | ID: mdl-38576007

RESUMEN

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.


Asunto(s)
Recién Nacido de muy Bajo Peso , Resucitación , Lactante , Recién Nacido , Humanos , Resucitación/efectos adversos , Recien Nacido Extremadamente Prematuro , Oxígeno , Edad Gestacional
15.
Clin Nutr ; 43(5): 1162-1170, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38603973

RESUMEN

BACKGROUND & AIM: Clinical trials supplementing the long-chain polyunsaturated fatty acids (LCPUFAs) docosahexaenoic acid (DHA) and arachidonic acid (AA) to preterm infants have shown positive effects on inflammation-related morbidities, but the molecular mechanisms underlying these effects are not fully elucidated. This study aimed to determine associations between DHA, AA, and inflammation-related proteins during the neonatal period in extremely preterm infants. METHODS: A retrospective exploratory study of infants (n = 183) born below 28 weeks gestation from the Mega Donna Mega trial, a randomized multicenter trial designed to study the effect of DHA and AA on retinopathy of prematurity. Serial serum samples were collected after birth until postnatal day 100 (median 7 samples per infant) and analyzed for phospholipid fatty acids and proteins using targeted proteomics covering 538 proteins. Associations over time between LCPUFAs and proteins were explored using mixed effect modeling with splines, including an interaction term for time, and adjusted for gestational age, sex, and center. RESULTS: On postnatal day one, 55 proteins correlated with DHA levels and 10 proteins with AA levels. Five proteins were related to both fatty acids, all with a positive correlation. Over the first 100 days after birth, we identified 57 proteins to be associated with DHA and/or AA. Of these proteins, 41 (72%) related to inflammation. Thirty-eight proteins were associated with both fatty acids and the overall direction of association did not differ between DHA and AA, indicating that both LCPUFAs similarly contribute to up- and down-regulation of the preterm neonate inflammatory proteome. Primary examples of this were the inflammation-modulating cytokines IL-6 and CCL7, both being negatively related to levels of DHA and AA in the postnatal period. CONCLUSIONS: This study supports postnatal non-antagonistic and potentially synergistic effects of DHA and AA on the inflammation proteome in preterm infants, indicating that supplementation with both fatty acids may contribute to limiting the disease burden in this vulnerable population. CLINICAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT03201588).


Asunto(s)
Ácido Araquidónico , Ácidos Docosahexaenoicos , Recien Nacido Extremadamente Prematuro , Inflamación , Proteoma , Humanos , Ácidos Docosahexaenoicos/sangre , Ácido Araquidónico/sangre , Recien Nacido Extremadamente Prematuro/sangre , Recién Nacido , Femenino , Estudios Retrospectivos , Masculino , Inflamación/sangre , Proteoma/análisis
16.
Early Hum Dev ; 193: 106015, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38688106

RESUMEN

BACKGROUND: It is unknown how accurately the current Japanese classification system for neurodevelopmental delay based on the assessment with the Kyoto Scale of Psychological Development (KSPD) at toddlerhood and pre-school periods predicts cognitive impairment at school age. METHODS: This single-center retrospective cohort study enrolled infants born at 22-29 weeks of gestational age. At 18-24 months of corrected age and 3 years of age, the patients were categorized according to the current Japanese criteria for neurodevelopmental delay based on their overall developmental quotient calculated using the KSPD-2001. Cognitive impairment at 6 years of age was classified according to the calculated or estimated full-scale intelligence quotient. The predictability of the current Japanese classification of neurodevelopmental delay for cognitive impairment at 6 years of age was investigated. RESULTS: Of 566 eligible patients, 364 (64 %) completed the protocol. The current classification for the neurodevelopmental delay showed significant agreement with the severity of cognitive impairment at 6 years of age. The sensitivity and specificity of the KSPD-2001-based assessment for any cognitive impairment at 6 years of age were 0.64 and 0.74 at 18-24 months of corrected age and 0.83 and 0.70 at 3 years of age. The corresponding sensitivity and specificity for moderate/severe cognitive impairment were 0.51 and 0.96 at 18-24 months of corrected age and 0.68 and 0.95 at 3 years of age. CONCLUSION: The KSPD-2001 is a useful tool to predict the severity of cognitive impairment at school age.


Asunto(s)
Disfunción Cognitiva , Humanos , Masculino , Femenino , Preescolar , Recién Nacido , Disfunción Cognitiva/diagnóstico , Disfunción Cognitiva/epidemiología , Lactante , Japón , Estudios Retrospectivos , Recien Nacido Extremadamente Prematuro/crecimiento & desarrollo , Discapacidades del Desarrollo/diagnóstico , Discapacidades del Desarrollo/epidemiología , Niño , Desarrollo Infantil
17.
Zhongguo Dang Dai Er Ke Za Zhi ; 26(3): 250-257, 2024 Mar 15.
Artículo en Chino | MEDLINE | ID: mdl-38557376

RESUMEN

OBJECTIVES: To investigate the current status of delivery room transitional care management for very/extremely preterm infants in Shenzhen City. METHODS: A cross-sectional survey was conducted in November 2022, involving 24 tertiary hospitals participating in the Shenzhen Neonatal Data Network. The survey assessed the implementation of transitional care management in the delivery room, including prenatal preparation, delivery room resuscitation, and post-resuscitation management in the neonatal intensive care unit. Very/extremely preterm infants were divided into four groups based on gestational age: <26 weeks, 26-28+6 weeks, 29-30+6 weeks, and 31-31+6 weeks. Descriptive analysis was performed on the results. RESULTS: A total of 140 very/extremely preterm infants were included, with 10 cases in the <26 weeks group, 45 cases in the 26-28+6 weeks group, 49 cases in the 29-30+6 weeks group, and 36 cases in the 31-31+6 weeks group. Among these infants, 99 (70.7%) received prenatal counseling, predominantly provided by obstetricians (79.8%). The main personnel involved in resuscitation during delivery were midwives (96.4%) and neonatal resident physicians (62.1%). Delayed cord clamping was performed in 52 cases (37.1%), with an average delay time of (45±17) seconds. Postnatal radiant warmer was used in 137 cases (97.9%) for thermoregulation. Positive pressure ventilation was required in 110 cases (78.6%), with 67 cases (60.9%) using T-piece resuscitators and 42 cases (38.2%) using a blended oxygen device. Blood oxygen saturation was monitored during resuscitation in 119 cases (85.0%). The median time from initiating transitional care measures to closing the incubator door was 87 minutes. CONCLUSIONS: The implementation of delivery room transitional care management for very/extremely preterm infants in the hospitals participating in the Shenzhen Neonatal Data Network shows varying degrees of deviation from the corresponding expert consensus in China. It is necessary to bridge the gap through continuous quality improvement and multicenter collaboration to improve the quality of the transitional care management and outcomes in very/extremely preterm infants.


Asunto(s)
Enfermedades del Prematuro , Cuidado de Transición , Femenino , Humanos , Lactante , Recién Nacido , Embarazo , Estudios Transversales , Salas de Parto , Edad Gestacional , Hospitales , Recien Nacido Extremadamente Prematuro
18.
Physiol Behav ; 280: 114553, 2024 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-38615730

RESUMEN

Children born very preterm often exhibit atypical gaze behaviors, affect recognition difficulties and are at risk for cerebral white matter damage. This study explored links between these sequalae. In 24 12-year-old children born very preterm, ventricle size using Evans and posterior ventricle indices, and corpus callosum area were used to measure white matter thickness. The findings revealed a correlation between less attention towards the eyes and larger ventricle size. Ventricle and posterior corpus callosum sizes were correlated to affect-recognition proficiency. Findings suggest a link between white matter damage, gaze behavior, and affect recognition accuracy, emphasizing a relation with social perception.


Asunto(s)
Imagen por Resonancia Magnética , Humanos , Proyectos Piloto , Femenino , Niño , Masculino , Recien Nacido Extremadamente Prematuro/fisiología , Sustancia Blanca/diagnóstico por imagen , Reconocimiento en Psicología/fisiología , Cuerpo Calloso/diagnóstico por imagen , Ventrículos Cerebrales/diagnóstico por imagen , Fijación Ocular/fisiología
19.
Acta Paediatr ; 113(6): 1228-1235, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38578009

RESUMEN

AIM: Parents of children born preterm have identified outcomes to be measured for audit and research at 18-24 months of age: child well-being, quality of life/function, socio-emotional/behavioural outcomes, respiratory, feeding, sleeping, and caregiver mental health. The aim was to identify the best tools to measure these seven domains. METHODS: Seven working groups completed literature reviews and evaluated potential tools to measure these outcomes in children aged 18-24 months. A group of experts and parents voted on the preferred tools in a workshop and by questionnaire. Consensus was 80% agreement. RESULTS: Consensus was obtained for seven brief, inexpensive, parent friendly valid measures available in English or French for use in a minimum dataset and potential alternative measures for use in funded research. CONCLUSION: Valid questionnaires and tools to measure parent-identified outcomes in young preterm children exist. This study will facilitate research and collection of data important to families.


Asunto(s)
Recien Nacido Extremadamente Prematuro , Humanos , Lactante , Recién Nacido , Calidad de Vida , Padres/psicología , Encuestas y Cuestionarios , Evaluación de Resultado en la Atención de Salud
20.
Sci Rep ; 14(1): 8705, 2024 04 15.
Artículo en Inglés | MEDLINE | ID: mdl-38622180

RESUMEN

This study investigated whether late pulmonary hypertension (LPH) independently increases the risk of long-term mortality or neurodevelopmental delay (NDD) in extremely preterm infants (EPIs) with severe bronchopulmonary dysplasia (BPD). Using prospectively collected data from the Korean Neonatal Network, we included EPIs with severe BPD born at 22-27 weeks' gestation between 2013 and 2021. EPIs having severe BPD with LPH (LPH, n = 124) were matched 1:3 with those without pulmonary hypertension (PH) as controls (CON, n = 372), via propensity score matching. LPH was defined as PH with the initiation of medication after 36 weeks' corrected age (CA). Long-term mortality after 36 weeks' CA or NDD at 18-24 months' CA was analyzed. NDD was assessed using composite scores based on various neurodevelopmental assessment modalities. LPH had significantly higher long-term mortality or NDD (45.2% vs. 23.1%, P < 0.001), mortality (24.2% vs. 4.84%, P < 0.001), and NDD (68.4% vs. 37.8%, P = 0.001), respectively than CON, even after adjusting for different demographic factors. Multivariable regression demonstrated that LPH independently increased the risk of mortality or NDD (adjusted odds ratio, 1.95; 95% confidence intervals, 1.17-3.25). When LPH occurs in EPIs with severe BPD, special monitoring and meticulous care for long-term survival and neurodevelopment are continuously needed.


Asunto(s)
Displasia Broncopulmonar , Hipertensión Pulmonar , Lactante , Humanos , Recién Nacido , Displasia Broncopulmonar/complicaciones , Displasia Broncopulmonar/tratamiento farmacológico , Recien Nacido Extremadamente Prematuro , Hipertensión Pulmonar/tratamiento farmacológico , Edad Gestacional
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