Malformations In Infants Research Articles

Efficacy of digital nasoalveolar molding in reducing severity of cleft lip or palate malformation in infants: a systematic review protocol.

This review will compare the efficacy of nasoalveolar molding plates fabricated using a digital workflow to conventional fabrication methods or no intervention in infants with cleft lip or palate. Nasoalveolar molding reduces the severity of orofacial defects in infants with cleft lip or palate using a series of adaptable plates for the maxillary arch. The conventional method needs multiple patient visits at short intervals for treatment. A digital workflow can be used to fabricate multiple plates in one appointment, which eliminates human error, reduces the number of appointments, and allocates more time for patient care for the orthodontic team than appliance fabrication. This review will consider clinical studies that report the results of digital nasoalveolar molding in infants with cleft lip or palate and compare it to the conventional method or to no treatment. Outcomes of interest will be objective measures of craniofacial form, nasolabial measurements, or palatal form. This review will be conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Databases including PubMed, Embase, Cochrane Oral Health Group Trial Register, and ClinicalTrials.gov will be searched using appropriate keywords. Publications in English will be considered. Screening based on titles and abstracts will be done after de-duplication, followed by full-text reading for selection based on the inclusion criteria. Data extracted from the studies will be tabulated and assessed for risk of bias. If applicable, a meta-analysis of the pooled data will be conducted. PROSPERO CRD42020186452.

School-age structural and functional MRI and lung function in children following lung resection for congenital lung malformation in infancy

BackgroundThe management of asymptomatic congenital lung malformations is debated. Particularly, there is a lack of information regarding long-term growth and development of the remaining lung in children following lung resection for congenital lung malformations. In addition to conventional pulmonary function tests, we used novel functional magnetic resonance imaging (MRI) methods to measure perfusion and ventilation.ObjectiveTo assess functionality of the remaining lung expanded into the thoracic cavity after resection of congenital lung malformations.Materials and methodsA prospective, cross-sectional pilot study in five children who had surgery for congenital lung malformations during infancy. Participants had structural and functional MRI as well as spirometry, body plethysmography and multiple breath washout at school age.ResultsStructural MRI showed an expansion of the remaining lung in all cases. Fractional ventilation and relative perfusion of the expanded lung were locally decreased in functional MRI. In all other parts of the lungs, fractional ventilation and relative perfusion were normal in all children. There was an association between overall impairment of perfusion and elevated lung clearance index. The results of spirometry and body plethysmography varied between patients, including normal lung function, restriction and obstruction.ConclusionFractional ventilation and relative perfusion maps from functional MRI specifically locate impairment of the remaining lung after lung resection. These changes are not captured by conventional measures such as structural MRI and standard pulmonary function tests. Therefore, following lung resection for congenital lung malformation, children should be investigated more systematically with functional lung MRI.

Surgical Complications and Functional Outcomes in Children with Anorectal Malformations with Vestibular Fistula

Background: Vestibular fistula is one of the most common types of anorectal malformations in female infants. Colostomy prior to definitive anorectoplasty is still controversial. Objective: To compare the complication rates and functional outcomes of the surgical treatments of vestibular anus between colostomy prior to anorectoplasty and treatment without colostomy. Materials and Methods: The medical records of 40 patients with vestibular fistula that underwent definitive surgical treatments at Siriraj Hospital between January 2006 and December 2018 were reviewed. Demographic data, operative records, functional outcomes, and complications were analyzed. Results: In the 40 vestibular fistula patients, colostomy (C) prior to vestibular fistula repair was performed in 18 patients, while vestibular fistula was repaired without colostomy (NC) in the other 22 patients. The C group had more associated anomalies than the NC group, including GI tract anomalies at 23.5% versus 9.1%, spinal anomalies at 47.1% versus 9.1%, and KUB anomalies at 52.9% versus 9.1%. The definitive anorectoplasty for vestibular fistula were anal transposition (31, 77.5%), PSARP (5, 12.5%), and other operations (7, 10%). Anal transpositions were performed in both the NC (90.9%) and C (61.1%) groups, respectively. NC had higher complications than C at 36.4% versus 22.2%. The recurrence of fistula occurred in 9.1% of NC cases versus 0% in C. Anal stricture was found in 18.2% of NC cases versus 5.6% in C. The wound infection rates of these two groups were the same. The complication rate with colostomy was 22.2% with prolapsed colostomy in 11.1% of cases and wound infection in 5.6%. The NC group had higher complication rates of anorectoplasty than the C group, but the overall complications, including colostomy complications, of these two groups were comparable. The Krickenbeck scoring system was used to evaluate the functional outcomes. In the median follow-up period of 1,336 days and 23 patients were evaluated. Even though the NC group had higher complication rates of anorectoplasty than the C group, the functional outcomes of these two groups were the same. Conclusion: Vestibular fistula repair with prior colostomy had lower complication rates of anorectoplasty than primary vestibular fistula repair, but the functional outcomes of these two groups were the same. Keywords: Vestibular; Rectovestibular; Anovestibular

New Challenges with Treatment Advances in Newborn Infants with Genetic Disorders and Severe Congenital Malformations.

Advances in the prognosis of relevant syndromes and severe congenital malformations in infants during the last few decades have enabled the treatment and survival of an ever-increasing number of infants, whose prospects were previously judged futile by professional health care teams. This required detailed counselling for families, which frequently started before birth when a diagnosis was made using genetic testing or ultrasound. Predictions of the estimated prognosis, and frequently the more-or-less broad range of prospects, needed to include the chances of survival and data on acute and long-term morbidities. However, in the interest of a having an informed basis for parental decision-making with a professional interdisciplinary team, this process needs to acknowledge the rights of the parents for a comprehensive presentation of the expected quality of life of their child, the potential consequences for family life, and the couple’s own relationship. Besides expert advice, professional psychological and familial support is needed as a basis for a well-founded decision regarding the best treatment options for the child. It needs to be acknowledged by the professional team that the parental estimate of a “good outcome” or quality of life does not necessarily reflect the attitudes and recommendations of the professional team. Building a mutually trusting relationship is essential to avoid decision conflicts.

Challenges in the Management of Congenital Malformations in Infants: A Single Centre Experience

Background: Congenital malformations are structural anomalies that occur during intra-uterine life that may be identified before or at birth or later in life. Materials and Methods: This was a retrospective evaluation of the challenges encountered during the management of children with congenital anomalies at the pediatric surgery unit of Enugu State University Teaching Hospital (ESUTH), Enugu, Nigeria. Diagnosis of congenital anomalies was made based on clinical and radiological findings. Results: A total of 104 infants with congenital anomalies were evaluated during the study period. There was male predominance and majority of the patients were neonates. Seven days and 3 days were the mean age at diagnosis and median interval before presentation respectively. Hypospadias was the most common congenital anomaly and surgical site infection was the most common post-operative complication. Mortality occurred in about one-third of the patients. The general challenges encountered in the management of these patients could categorized as patient related, surgeon related or facility related. Conclusion:In developing countries, management of congenital anomalies is challenging and is fraught with difficulties. Modifiable factors such as late presentation and provision of facilities will improve outcome.

Teratogenic effect of alcohol on the myocardium of laboratory animals at the stages of prenatal ontogenesis (literature review)

Background. To date, close attention is paid to the problems of formation and development of the myocardium in general and in particular its structural components. This phenomenon is associated with an increase in cardiovascular malformations in both adults and infants. These defects can be caused by genetic factors, as well as various teratogenic substances. One such substance is alcohol. Despite the risks, many women still drink alcohol during pregnancy. The main problem is that almost half of pregnancies are unplanned, so a woman may continue to consume alcohol for several weeks before learning about her condition. Especially in young women, fertilization can occur in a state of intoxication. In addition, under the influence of ethanol, cardiac function may be impaired in the absence of structural abnormalities. Chronic alcohol intoxication causes changes in the myocardium at all levels of its structural organization. First of all, teratogenic changes caused by the action of ethanol affect the development of cardiomyocytes in the process of embryogenesis, which contributes to the underdevelopment of the structure or function of heart cells. Although the effect of maternal alcohol consumption on the fetus has been studied for decades, there are still conflicting conclusions about the severity of myocardial morphological changes depending on the time, frequency and duration of alcohol consumption. Objective: to conduct a retrospective analysis of literature sources devoted to the study of adverse effects on the fetus caused by alcohol. Methods. The paper conducted a retrospective analysis of literature references and formed an understanding of the changes in the structure of the myocardium caused by teratogenic effects of alcohol. Results and conclusion. Analysis of literature sources showed a high level of adverse effects observed in offspring born to alcoholic mothers. Detrimental effects of alcohol cause changes in the myocardium at all levels of structural organization, including its ultrastructure. It was studied that prenatal exposure to ethanol induces significant changes in relative heart weight, left ventricular wall thickness and cardiomyocyte size. Exposure to high concentrations of alcohol in experimental animals during gestation can lead to congenital heart defects, such as atrial, ventricular, and septal defects. The main manifestation of the prenatal effect of alcohol after birth is the fetal alcohol syndrome, which combines various degrees of deviation in the development of the child.

Large cavernous malformations in infant

Cavernous malformations are rare vascular malformations in the central nervous system. We present the case of a 2-month-old female patient who presented tonic-clonic seizures, with no previous history of seizures. Magnetic resonance imaging showed a 5.6 cm tumor in the left parieto-occipital region. The radiological aspect of the tumor initially suggested an anaplastic meningioma. After surgical treatment and anatomopathological analysis, it was found to be a cavernous malformation. Cavernous malformations, or cavernomas, are rare lesions and even more rare is the occurrence of large cavernomas. In the pediatric population, although still quite rare, they usually are presented as larger cavernomas. Surgical resection is considered the most effective treatment.

Refractory Head and Neck Lymphatic Malformation in Infants Treated With Sirolimus: A Case Series.

BackgroundExtensive and complex head and neck lymphatic malformations (LMs) are challenging to manage through traditional therapy. The purpose of this retrospective study was to assess the efficacy and safety of sirolimus in infants with refractory head and neck LMs.MethodsSirolimus was administered orally on a continuous dosing schedule. Patients were seen every month for the first three months and then subsequently every three months. The primary endpoints were safety and efficacy based on clinical and radiological evaluations.ResultsEight patients, refractory to standard care, were enrolled and received sirolimus continuously. After 12 months of follow-up, the response and safety to medication was evaluated: all patients experienced reductions in LMs bulk, ranging from modest to significant. Some minor adverse effects were reported: mouth sores, eczema, gastrointestinal reaction, dyslipidemia, and neutropenia.ConclusionSirolimus was efficient in children with refractory head and neck LMs and was well tolerated.

Study of relationships between maternal HLA-G gene polymorphism and intrauterine infection with risk of congenital malformations

This study aims for assessing relationships between maternal HLA-G gene polymorphisms (rs41551813, rs12722477, rs41557518) and intrauterine infection with the risk of congenital malformations (CM) in infants. We studied 331 women who had offspring with CMs, and 408 women with one or more healthy children. Influence of the intrauterine infection was analyzed on the basis of laboratory tests. Diagnostics of bacterial vaginosis and vulvovaginal candidiasis by microscopic examination were conducted. Viral infections (herpes simplex virus type 2, cytomegalovirus, human papilloma virus type 16/18) as well as Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum, Gardnerella vaginalis; Trichomonas vaginalis and Toxoplasma gondii were detected by enzyme-linked immunoassay or polymerase chain reaction (PCR) techniques. The data were obtained from the medical cards of the surveyed women. The gene polymorphisms were typed for Thr31Ser (rs41551813, HLA-G*01:03) in exon 2, Leu110Ile (rs12722477, HLA-G*01:04) and 1597 delС (rs41557518, HLA-G*01:05N) in exon 3 HLA-G using real-time PCR followed by melting analysis. The study showed that maternal age was not a significant risk factor for CMs in the fetus/newborns. Meanwhile, the maternal intrauterine infections were shown to be a significant risk factor for CMs in their infants (OR = 1.57 (1.08-2.29); p = 0.002). It was found that the 110 Ile allele (HLA-G *01:04) was a risk factor for CMs incidence in the fetus/newborns (OR = 1.57 (1.08-2.29), p = 0.01). No association was found between the maternal rs41551813 and rs41557518 HLA-G genetic polymorphisms and CMs in the infants. Hence, intrauterine infections and maternal 110 Ile allele (HLA-G *01:04) may be suggested as risk factors for birth defects in the children. Our results will be useful in understanding the molecular mechanisms of immune disorders in feto-maternal interface.

Cerebral Oxygenation by Near-Infrared Spectroscopy in Infants Undergoing Thoracoscopic Lung Resection.

Background: Thoracoscopic resection is the standard of care for congenital lung malformations (CLMs) in infants. However, there is rising concern that capnothorax may affect cerebral perfusion and oxygenation, carrying potential long-term effects on neurodevelopmental behavior. The aim of our study was to investigate, using near-infrared spectroscopy (NIRS), the regional cerebral oxygenation (CrSO2) in infants undergoing thoracoscopic lung resection; the secondary aim was to assess the relationship between rSO2 and standard monitoring. Methods: In this retrospective study, we reviewed all infants (<1 year old, ASA II) who underwent thoracoscopic CLM resection in double-lung ventilation under fixed capnothorax parameters (5 mmHg of pressure, 1 L/minute flow), standardized anesthetic protocol, standard monitoring, and multisite NIRS in our center. We focused our attention on 8 anesthetic and surgical maneuvers, potentially affecting tissue oxygen saturation. Results: Ten infants met the inclusion criteria. At surgery, median age was 5.5 (4-7) months, median weight 7.2 (6.6-8) kg, median operative time 110 (55-180) minutes, and median capnothorax duration 79 (34-168) minutes. No conversion to open surgery occurred. CrSO2 values remained within clinically accepted values during thoracoscopy, beside a CrSO2 drop >20% of basal value in 1 patient, during capnothorax induction. Renal NIRS added very little to standard monitoring, which appeared generally inadequate to consistently appraise end-organ perfusion. ETCO2 best correlated with CrSO2 variations, suggesting to be able to realistically predict them. Conclusions: The thoracoscopic treatment of CLMs under the given conditions appears well tolerated in infants, pending the continuous adjustment of ventilator settings by an experienced anesthetist, confident with NIRS technology.

Dye Laser Treatment for Capillary Malformations (Port-wine Stains) of Infants

Dye Laser Treatment for Capillary Malformations (Port-wine Stains) of Infants

Reproductive safety of aripiprazole: data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics.

Aripiprazole has become one of the most commonly prescribed psychotropics, making a more comprehensive understanding of its reproductive safety profile a priority. The goal of the current analysis was to determine the risk of major malformations in infants exposed during the first trimester of pregnancy to aripiprazole compared to infants whose mothers had psychiatric diagnoses but did not use an atypical antipsychotic during pregnancy. The National Pregnancy Registry for Atypical Antipsychotics is a prospective pharmacovigilance program in which pregnant women are enrolled and interviewed during pregnancy and the postpartum period. Medical records are assessed to confirm presence or absence of major malformations. Pregnant women ages 18-45 with psychiatric diagnoses are enrolled. As of April 2020, N = 848 women who had delivered infants were eligible for analyses. A total of 158 women with first trimester exposure to aripiprazole were compared to 690 controls. For 163 infants born to women in the exposed group, seven major malformations were confirmed (4.29%), compared to fourteen of the 690 unexposed infants (1.99%). The unadjusted odds ratio for major malformations between aripiprazole-exposed and unexposed infants was 2.21 (95% confidence interval [CI] = (0.88, 5.57) The adjusted odds ratio for major malformations was 1.35 (95% confidence interval [CI] = (0.43, 4.20). After adjustment for confounding variables, the risk of major malformations after first trimester exposure to aripiprazole was not significant compared to controls. While these results are reassuring, they are limited by relatively small numbers of participants. Future analyses with larger numbers are expected to provide more of a complete and precise reproductive safety profile regarding aripiprazole use during pregnancy. Trial registration: clinicaltrials.gov NCT01246765.

Pregnancy outcome after first trimester exposure to domperidone-An observational cohort study.

AimTo assess the teratogenic risk of domperidone by comparing the incidence of major malformation with domperidone to a control.MethodsPregnancy outcome data were obtained for women at two Japanese facilities that provide counseling on drug use during pregnancy between April 1988 and December 2017. The incidence of major malformation was calculated among infants born to women taking domperidone (n = 519), nonteratogenic drugs (control, n = 1673), or metoclopramide (reference, n = 241) during the first trimester of pregnancy. Using the control group as reference, the crude odds ratio (OR) of the incidence of major malformation in the domperidone and metoclopramide groups was calculated using univariable logistic regression analysis. Adjusted OR was also calculated using multivariable logistic regression analysis adjusted for various other factors.ResultsThe incidence of major malformation was 2.9% (14/485, 95% confidence interval [CI]: 1.6–4.8) in the domperidone group, 1.7% (27/1554, 95%CI: 1.1–2.5) in the control group, and 3.6% (8/224, 95%CI: 1.6–6.9) in the metoclopramide group. The adjusted multivariable logistic regression analysis showed no significant difference in incidence between the control and domperidone groups (adjusted OR: 1.86 [95%CI: 0.73–4.70], p = 0.191) or between the control and metoclopramide groups (adjusted OR: 2.20 [95%CI: 0.69–6.98], p = 0.183).ConclusionsThis observational cohort study showed that domperidone exposure during the first trimester was not associated with increased risk of major malformation in infants. These results may help alleviate the anxiety of patients who took domperidone during pregnancy.

Analysis of Infant Congenital Malformation Data using the Bayesian Count Regression

Background: Congenital malformations are one of the most important and common types of anomalies in infants, which are one of the main causes of disability and mortality in children. Objectives: This study aimed to investigate the risk factors affecting the incidence of congenital malformations, as well as the number of different infant anomalies recorded in neonatal health data in Khoy, Iran, during 2017. Methods: In this study, all neonates born in the maternity wards of hospitals in Khoy, Iran, during 2017 were evaluated in terms of gender, weight, and parental consanguinity. Hurdle and Zero-inflation approaches were utilized for the double Poisson model. Moreover, the data were collected using some checklists, and the analyses were performed in R-3-6-1 software. Result: According to the results of the present study, the Hurdle approach was better than Zero-inflation. The birth weight and parental consanguinity affected the incidence of congenital malformations in infants. Conclusion: Given that a significant proportion of infants are born without any congenital malformations, it is important to use count regression models based on excess zero approaches to assess congenital malformations. It is also necessary to take steps to reduce consanguineous marriages and the number of infants with low-birth-weight to prevent congenital malformations.

PREDICTION MODEL OF PROBABILITY ESTIMATE OF FATAL CASES IN INFANTS WITH CONGENITAL MALFORMATIONS IN SURGICAL INTERVENTIONS

Aim: To evaluate different types of combined anesthesia in surgical correction of congenital malformations in infants and to develop a prediction model of the association of risk factors and fatal cases in chosen methods of anesthesia care. Material and methods: The retrospective study included newborns and infants with congenital malformations, who received and continued phased surgical treatment. Determination of risk factors was performed by the method of simple logistic regression with the calculation of the odds ratio (OR), 95% confidence interval (95% CI). Results: A total of 150 children were included in the study. The risk factors for deaths in the surgical correction of congenital malformations in children have been established, a prognostic model has been created. Conclusions: To prevent fatal cases in various types of surgery and options for anesthesia care of newborns and infants with CM, it is advisable to more closely monitor the cerebral, peripheral oximetry at all stages of treatment and timely correct the impaired condition of the child.

Enzymatic Changes in Red Blood Cells of Diamond-Blackfan Anemia

Diamond-Blackfan anemia is a congenital bone marrow failure syndrome characterized by red blood cell (RBC) aplasia with varied malformations in infants. Elevated activity of adenosine deaminase (ADA) has been considered as a useful biomarker of Diamond-Blackfan anemia, and ADA assay has been shown to be more sensitive than genetic diagnosis. Approximately, 80% of the examined patients showed elevated ADA activity, whereas genetic tests of ribosome subunit genes identified mutations in approximately 60% of the patients. We previously reported that reduced glutathione (GSH) levels in RBCs may serve as a biomarker of Diamond-Blackfan anemia. In this study, to confirm the universality of our data, we extended the analysis to seven RBC enzymes and GSH of 14 patients with Diamond-Blackfan anemia and performed a cross-analysis study using enzyme activity assay and recently reported proteome data. Statistical analysis revealed that both data exhibited high similarity, upregulation in the hexokinase and pentose-phosphate pathway, and downregulation in glycolytic enzymes such as phosphofructokinase and pyruvate kinase, in the RBCs obtained from the subjects with Diamond-Blackfan anemia. The only discrepancy between enzyme activity and proteome data was observed in glucose-6-phosphate dehydrogenase (G6PD), as increased G6PD activity showed no relation with the significant elevation in protein levels. These results suggest that our enzymatic activity data of Diamond-Blackfan anemia are universal and that the enzymatic activation of G6PD via a hitherto-unveiled mechanism is another metabolic feature of RBCs of Diamond-Blackfan anemia.

The Distribution of Congenital Malformations in Adolescent Pregnancies: A Single Tertiary Center Experience in Turkey

Objective: Adolescent pregnancies are more severe and dangerous for both mother and baby than adult pregnancies. Low birth weight, infections, intrauterine growth restriction, sudden infant death syndrome, and death risk are higher in neonates of adolescent pregnant women. Besides, anomalies of central nervous, gastrointestinal, and musculoskeletal systems are also seen frequently. The purpose of this study is to investigate congenital malformations of infants born from adolescent mothers. In this study, malformations were grouped according to the systems.&#x0D; Material and Methods: In this retrospective study, 166 pregnant women aged 18 and under who had fetal anomaly were included in the study and their charts reviewed. Descriptive information about the adolescents and information about the fetuses and anomalies were recorded. Maternal and neonatal characteristics were calculated as frequency and percentage.&#x0D; Results: The most common anomalies were the central nervous (40.5%), cardiovascular (15.8%), and urinary (10.8%) system. The anomalies related to the skin and phalanges, including the face, accounted for 8.1% of the cases. Ventricular dilatation (10,4%), neural tube defect (7,2%), and hydrocephalus (7,2%) were the most common abnormalities of the central nervous system. Ventricular septal defect (5,9%), pulmonary artery anomaly (2,7%), and tricuspid valve anomaly (2,3%) were the most common cardiovascular system anomalies. Intrauterine growth restriction (3,6%), pleural effusion/hydrothorax (3,2%), pes equinovarus (2,7%), diaphragmatic hernia (2,3%), cystic hygroma (2,3%), oligohydramnios (2,3%), polyhydramnios (2,3%), and cleft palate/lip (2,3%) were the most common anomalies among the other system and organ anomalies.&#x0D; Conclusion: Adolescent pregnancy was partially associated with an increased risk of severe neonatal anomalies especially in the central nervous, cardiovascular, and urinary systems. Pediatric health care providers should have a low threshold for suspecting pregnancy in adolescents.

Thoracoscopic Lingulectomy for Congenital Pulmonary Airway Malformation: Video Comparison Between Two Different Timing and Ventilation Strategies

Abstract Introduction: Thoracoscopy is generally considered the approach of choice for the treatment of uncomplicated congenital pulmonary airway malformation (CPAM) in infants and children.1–3 The...

Anesthetic management of pulmonary surgery in newborns and infants.

The main congenital pulmonary airways malformations in newborns and infants requiring surgery are cystic adenoid malformation, congenital lobar emphysema and bronchogenic cyst. The surgical treatment preferably via thoracoscopy is recommended within the first year of life to avoid the risk of pneumopathy. A monopulmonary ventilation is then required by the surgeon to operate the diseased lung. The anesthetic management of intraoperative mono-pulmonary ventilation in newborns and infants is always challenging for the anesthesiologist. The main objective of this study was to describe anesthetic protocol for thoracoscopy and variations of monitored parameters during a mono-pulmonary ventilation procedure in newborns and infants.

Seasonal Influenza Vaccination During Pregnancy and the Risk of Major Congenital Malformations in Live-born Infants: A 2010-2016 Historical Cohort Study.

BackgroundAvailable evidence indicates that seasonal inactivated influenza vaccination during pregnancy protects both the mother and her newborn and is safe. Nevertheless, ongoing safety assessments are important in sustaining vaccine uptake. Few studies have explored safety in relation to major congenital malformations (MCMs), particularly in the first trimester when most organogenesis occurs.MethodsAnonymized UK primary care data (the Clinical Practice Research Datalink), including a recently developed Pregnancy Register, were used to identify live-born singletons delivered between 2010 and 2016. Maternal influenza vaccination was determined using primary care records and stratified by trimester. Ascertainment of MCMs from infant primary care records was maximized by linkage to hospitalization data and death certificates. The relationship between vaccination and MCMs recorded in the year after delivery and in early childhood was then assessed using multivariable Cox regression.ResultsA total of 78 150 live-birth pregnancies were identified: 6872 (8.8%) were vaccinated in the first trimester, 11 678 (14.9%) in the second, and 12 931 (16.5%) in the third. Overall, 5707 live births resulted in an infant with an MCM recorded in the year after delivery and the adjusted hazard ratio when comparing first-trimester vaccination to no vaccination was 1.06 (99% CI, .94–1.19; P = .2). Results were similar for second- and third-trimester vaccination and for analyses considering MCMs recorded beyond the first birthday.ConclusionsIn this large, population-based historical cohort study there was no evidence to suggest that seasonal influenza vaccine was associated with MCMs when given in the first trimester or subsequently in pregnancy.