Noise or sound management in the neonatal intensive care unit for preterm or very low birth weight infants.

BACKGROUND: Infants in the neonatal intensive care unit (NICU) are subjected to different types of stress, including sounds of high intensity. The sound levels in NICUs often exceed the maximum acceptable level recommended by the American Academy of Pediatrics, which is 45 decibels (dB). Hearing impairment is diagnosed in 2% to 10% of preterm infants compared to only 0.1% of the general paediatric population. Bringing sound levels under 45 dB can be achieved by lowering the sound levels in an entire unit; by treating the infant in a section of a NICU, in a 'private' room, or in incubators in which the sound levels are controlled; or by reducing sound levels at the individual level using earmuffs or earplugs. By lowering sound levels, the resulting stress can be diminished, thereby promoting growth and reducing adverse neonatal outcomes. This review is an update of one originally published in 2015 and first updated in 2020. OBJECTIVES: To determine the benefits and harms of sound reduction on the growth and long-term neurodevelopmental outcomes of neonates. SEARCH METHODS: We used standard, extensive Cochrane search methods. On 21 and 22 August 2023, a Cochrane Information Specialist searched CENTRAL, PubMed, Embase, two other databases, two trials registers, and grey literature via Google Scholar and conference abstracts from Pediatric Academic Societies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) or quasi-RCTs in preterm infants (less than 32 weeks' postmenstrual age (PMA) or less than 1500 g birth weight) cared for in the resuscitation area, during transport, or once admitted to a NICU or stepdown unit. We specified three types of intervention: 1) intervention at the unit level (i.e. the entire neonatal department), 2) at the section or room level, or 3) at the individual level (e.g. hearing protection). DATA COLLECTION AND ANALYSIS: We used the standardised review methods of Cochrane Neonatal to assess the risk of bias in the studies. We used the risk ratio (RR) and risk difference (RD), with their 95% confidence intervals (CIs), for dichotomous data. We used the mean difference (MD) for continuous data. Our primary outcome was major neurodevelopmental disability. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included one RCT, which enroled 34 newborn infants randomised to the use of silicone earplugs versus no earplugs for hearing protection. It was a single-centre study conducted at the University of Texas Medical School in Houston, Texas, USA. Earplugs were positioned at the time of randomisation and worn continuously until the infants were 35 weeks' postmenstrual age (PMA) or discharged (whichever came first). Newborns in the control group received standard care. The evidence is very uncertain about the effects of silicone earplugs on the following outcomes. • Cerebral palsy (RR 3.00, 95% CI 0.15 to 61.74)and Mental Developmental Index (MDI) (Bayley II) at 18 to 22 months' corrected age (MD 14.00, 95% CI 3.13 to 24.87); no other indicators of major neurodevelopmental disability were reported. • Normal auditory functioning at discharge (RR 1.65, 95% CI 0.93 to 2.94) • All-cause mortality during hospital stay (RR 2.07, 95% CI 0.64 to 6.70; RD 0.20, 95% CI -0.09 to 0.50) • Weight (kg) at 18 to 22 months' corrected age (MD 0.31, 95% CI -1.53 to 2.16) • Height (cm) at 18 to 22 months' corrected age (MD 2.70, 95% CI -3.13 to 8.53) • Days of assisted ventilation (MD -1.44, 95% CI -23.29 to 20.41) • Days of initial hospitalisation (MD 1.36, 95% CI -31.03 to 33.75) For all outcomes, we judged the certainty of evidence as very low. We identified one ongoing RCT that will compare the effects of reduced noise levels and cycled light on visual and neural development in preterm infants. AUTHORS' CONCLUSIONS: No studies evaluated interventions to reduce sound levels below 45 dB across the whole neonatal unit or in a room within it. We found only one study that evaluated the benefits of sound reduction in the neonatal intensive care unit for hearing protection in preterm infants. The study compared the use of silicone earplugs versus no earplugs in newborns of very low birth weight (less than 1500 g). Considering the very small sample size, imprecise results, and high risk of attrition bias, the evidence based on this research is very uncertain and no conclusions can be drawn. As there is a lack of evidence to inform healthcare or policy decisions, large, well designed, well conducted, and fully reported RCTs that analyse different aspects of noise reduction in NICUs are needed. They should report both short- and long-term outcomes.

Vestibular stimulation for promoting development and preventing morbidity in preterm infants.

OBJECTIVES: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of vestibular stimulation compared to standard care or non-vestibular stimulation for physical and neurological development in preterm infants. To assess whether the effects of vestibular stimulation differ according to gestational age at birth; the type, frequency, and duration of the intervention; and settings, such as the country where the study is conducted.

Multisensory stimulation for promoting development and preventing morbidity in preterm infants.

OBJECTIVES: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To assess the benefits and harms of multisensory stimulation compared to any single sensory intervention or standard care for physical and neurological development in preterm infants.

Olfactory stimulation for promoting development and preventing morbidity in preterm infants.

OBJECTIVES: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the benefits and harms of olfactory stimulation with different odorants in the NICU for promoting development and preventing morbidity in preterm infants.

Prenatal and Neonatal Pulmonary Thrombosis as a Potential Complication of SARS-CoV-2 Infection in Late Pregnancy.

Neonatal venous thrombosis is a rare condition that can be iatrogenic or occur due to viral infections or genetic mutations. Thromboembolic complications are also commonly observed as a result of SARS-CoV-2 infections. They can affect pediatric patients, especially the ones suffering from multisystem inflammatory syndrome in children (MIS-C) or multisystem inflammatory syndrome in neonates (MIS-N). The question remains whether the maternal SARS-CoV-2 infection during pregnancy can lead to thromboembolic complications in fetuses and neonates. We report on a patient born with an embolism in the arterial duct, left pulmonary artery, and pulmonary trunk, who presented several characteristic features of MIS-N, suspecting that the cause might have been the maternal SARS-CoV2 infection in late pregnancy. Multiple genetic and laboratory tests were performed. The neonate presented only with a positive result of IgG antibodies against SARS-CoV-2. He was treated with low molecular weight heparin. Subsequent echocardiographic tests showed that the embolism dissolved. More research is necessary to evaluate the possible neonatal complications of maternal SARS-CoV-2 infection.

Universal newborn hearing screening: methods and results, obstacles, and benefits.

The incidence of sensorineural hearing loss ranges from 1 to 3 per 1,000 live births in term healthy neonates, and 2-4 per 100 in high-risk infants, a 10-fold increase. Early identification and intervention with hearing augmentation within 6 mo yields optimal effect. If undetected and without treatment, significant hearing impairment may negatively impact speech development and lead to disorders in psychological and mental behaviors. Hearing screening programs in newborns enable detection of hearing impairment in the first days after birth. Programs to identify hearing deficit have significantly improved over the two decades, and their implementation continues to grow throughout the world. Initially based on risk factors, these programs identified only 50-75% of infants with hearing loss. Current recommendations are to conduct universal hearing screening in all infants. Techniques used primarily include automated auditory brainstem responses and otoacoustic emissions that provide noninvasive recordings of physiologic auditory activity and are easily performed in neonates and infants. The aim of this review is to present the objectives, benefits, and results of newborn hearing screening programs including the pros and cons of universal vs. selective screening. A brief history and the anticipated future development of these programs will also be discussed.

It's time to shed some light on the importance of fungi in neonatal intensive care units: what do we know about the neonatal mycobiome?

The 21st century, thanks to the development of molecular methods, including DNA barcoding, using Sanger sequencing, and DNA metabarcoding, based on next-generation sequencing (NGS), is characterized by flourishing research on the human microbiome. Microbial dysbiosis is perceived as a new pathogenetic factor for neonatal diseases. Fungi are crucial, but neglected, components of the neonatal microbiome, which, despite their low abundance, significantly impact morbidity and mortality rates of premature infants hospitalized in Neonatal Intensive Care Units (NICUs). The neonatal mycobiome's composition and effect on health remain poorly studied research areas. Our knowledge about neonatal mycobiome, composed of limited genera, is mainly based on research on the bacterial microbiome. We presume it is influenced by clinical factors, including prematurity, antibiotic therapy, and type of delivery. Understanding these risk factors may be useful in prevention strategies against dysbiosis and invasive fungal infections. Despite the methodological challenges resulting from the biology of the fungal cell, this topic is an attractive area of research that may contribute to more effective treatment, especially of newborns from risk groups. In this mini review, we discuss the current state of knowledge, research gaps, study difficulties, and future research directions on the neonatal mycobiome, concerning potential future clinical applications.

Performance and safety of volume guarantee ventilation in neonates using the fabian ventilator, a multicenter study.

OBJECTIVE: To evaluate the performance (i.e., agreement between set and measured parameters) and safety (adverse events, device malfunctions, and ventilator alarms) of the fabian HFOi neonatal ventilator in volume guaranteed (VG) mode during conventional ventilation. To analyze the impact of leakage around the endotracheal tube and the set maximum allowed inflating pressure (Pmax). DESIGN: Prospective multicenter observational study. METHODS: Clinical and ventilator data were collected from 71 infants receiving VG ventilation for ≥12 h in four neonatal intensive care units (NICUs). Ventilator settings, parameters, and alarms were downloaded with 0.5 Hz sampling rate. RESULTS: Data from 4,341 h of ventilation were analyzed. The median (interquartile range, IQR) of the absolute difference between the target and measured expired tidal volume was 0.76 (0.51-1.16) mL/kg. It was less when leak was <50% (median 0.36, IQR: 0.25-0.64 mL/kg, p < .001) and even less when the required peak inflating pressure (PIP) was also below Pmax (median: 0.09 mL/kg, IQR: 0.00-0.16 mL/kg, p < .001). On NICUs setting Pmax higher, tidal volume was maintained significantly closer to target. In 56 patients VG was continued until extubation. Two ventilator malfunctions were reported, none of them resulting in patient harm. "Tidal volume not reached" alarm occurred 32 times hourly, usually lasting for <10 s. CONCLUSION: The fabian HFOi ventilator maintains tidal volume close to its target, particularly when leak is <50% and when PIP is below Pmax. In most patients VG can be continued until extubation. Despite frequent ventilator alarms, ventilator malfunctions occur very rarely.

Performance and safety of the PRICO closed-loop oxygen saturation targeting system in neonates: pragmatic multicentre cross-over study (TarOx Study).

OBJECTIVE: This study aims to evaluate the performance of the fabian-Predictive-Intelligent-Control-of-Oxygenation (PRICO) system for automated control of the fraction of inspired oxygen (FiO2). DESIGN: Multicentre randomised cross-over study. SETTING: Five neonatal intensive care units experienced with automated control of FiO2 and the fabian ventilator. PATIENTS: 39 infants: median gestational age of 27 weeks (IQR: 26-30), postnatal age 7 days (IQR: 2-17), weight 1120 g (IQR: 915-1588), FiO2 0.32 (IQR: 0.22-0.43) receiving both non-invasive (27) and invasive (12) respiratory support. INTERVENTION: Randomised sequential 24-hour periods of automated and manual FiO2 control. MAIN OUTCOME MEASURES: Proportion (%) of time in normoxaemia (90%-95% with FiO2>0.21 and 90%-100% when FiO2=0.21) was the primary endpoint. Secondary endpoints were severe hypoxaemia (<80%) and severe hyperoxaemia (>98% with FiO2>0.21) and prevalence of episodes ≥60 s at these two SpO2 extremes. RESULTS: During automated control, subjects spent more time in normoxaemia (74%±22% vs 51%±22%, p<0.001) with less time above and below (<90% (9%±8% vs 12%±11%, p<0.001) and >95% with FiO2>0.21 (16%±19% vs 35%±24%) p<0.001). They spent less time in severe hyperoxaemia (1% (0%-3.5%) vs 5% (1%-10%), p<0.001) but exposure to severe hypoxaemia was low in both arms and not different. The differences in prolonged episodes of SpO2 were consistent with the times at extremes. CONCLUSIONS: This study demonstrates the ability of the PRICO automated oxygen control algorithm to improve the maintenance of SpO2 in normoxaemia and to avoid hyperoxaemia without increasing hypoxaemia.

Multiple daily injections of insulin versus continuous subcutaneous insulin infusion for pregnant women with type 1 diabetes.

AIMS: The aim was to evaluate the outcome of pregnancies with type 1 diabetes (T1DM) treated from the first trimester with continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI). METHODS: In a retrospective, observational study, we matched 64 CSII patients for age, age at onset and duration of diabetes and HbA1c in the first trimester with 64 MDI pregnancies. We analysed carbohydrate metabolism, insulin requirements, development of PIH, progression of retinopathy and fetal outcome. RESULTS: In CSII group, we found a significantly smaller insulin requirement both at the beginning of pregnancy and before delivery, significant decrease in HbA1c levels and significantly smaller number of hypoglycaemic episodes in the second trimester and significantly more hyperglycaemic episodes in the first trimester. In both groups, maternal, fetal and perinatal outcomes were similar and the number of hypo- and hyperglycaemic episodes decreased throughout pregnancy. CONCLUSION: Continuous subcutaneous insulin infusion (CSII) treatment in pregnant women with type 1 diabetes is associated with a reduced number of hypoglycaemia and decreased insulin requirement. We noted no difference in perinatal outcome comparing women on multiple insulin injections with those on continuous insulin infusion.

Catheter-related venous thrombosis in NICU: A case-control retrospective study.

INTRODUCTION: Newborns treated in a neonatal intensive care unit (NICU) are susceptible to several complications one of them being vein thrombosis. AIM: The study aims to evaluate risk factors of catheter-related venous thrombosis, clinical manifestations, treatment, and the outcomes of thrombotic events (TE) during the neonatal period. METHODS: This work is a case-control retrospective study performed on patients in the tertiary NICU between January 2013 and June 2016. The analysis includes data from infants with CVC diagnosed with thrombosis and infants with CVC, not being diagnosed with thrombosis (control group). Statistica 10 software was used for statistical analysis. RESULTS: Vein thrombosis was diagnosed in 19 NICU infants including 16 cases of catheter-related vein thrombosis (84% of complicated cases). Other statistically significant risk factors were asphyxia, infection, and the duration of CVC use. The incidence of thrombosis in our population increased during the study which may result from a statistically significant increase in the number of inserted CVC (294 vs 435), and more frequent diagnosis of incidental thrombosis (1 vs 9). CONCLUSION: Vein catheterization, asphyxia, infection, and prolonged CVC use are critical risk factors for thrombosis in the neonatal period. Given the hereinbefore mentioned increased number of central line catheterizations in the NICU, it would be useful to conduct a prospective study with a scheduled routine ultrasound protocol applied not only as a tool to diagnose thrombosis but also to prevent it by determining a proper catheter for a particular vein.

Diagnostic Challenges in Neonatal Respiratory Distress-Congenital Surfactant Metabolism Dysfunction Caused by ABCA3 Mutation.

Surfactant is a complex of phospholipids and proteins produced in type II pneumocytes. Its deficiency frequently occurs in preterm infants and causes respiratory distress syndrome. In full-term newborns, its absence results from mutations in the SFTPC, SFTPB, NKX2-1, or ABCA3 genes involved in the surfactant metabolism. ABCA3 encodes ATP-binding cassette, which is responsible for transporting phospholipids in type II pneumocytes. We present a case of a male late preterm newborn with inherited surfactant deficiency in whom we identified the likely pathogenic c.604G>A variant in one allele and splice region/intron variant c.4036-3C>G of uncertain significance in the second allele of ABCA3. These variants were observed in trans configuration. We discuss the diagnostic challenges and the management options. Although invasive treatment was introduced, only temporary improvement was observed. We want to raise awareness about congenital surfactant deficiency as a rare cause of respiratory failure in term newborns.

Markers of Maternal Insulin Resistance and Lipid Ratios Measured in Early Pregnancy Are Related to Adverse Fetomaternal Outcomes in Women Treated for Hyperglycemia Detected in Early Pregnancy-Data from a Retrospective Cohort Study.

Background: Hyperglycemia detected in early pregnancy is still inadequately studied as a risk factor for adverse maternal and neonatal outcomes. Methods: a retrospective study of a cohort of N = 193 women in singleton pregnancies with hyperglycemia diagnosed before the 20th gestational week (GW). Results: characteristics of the study group: GW at the diagnosis: 12.0 (9.0; 15.0), diabetes diagnosed in early pregnancy (eDiP): 21%, insulin-therapy required: 61.8%, gestational hypertension/preeclampsia: 7.7%, premature delivery: 9.2%, composite adverse neonatal outcome: 59.2%, high (LGA) birth weight/low (SGA) birth weight according to the WHO growth charts: 24.2%/9.2%, respectively. Women with eDiP have lower eGDR, a higher TAG/HDL ratio, and a higher atherogenic index of plasma (AIP) compared to women with gestational diabetes diagnosed in early pregnancy­eGDM (9.33 ± 1.56 vs. 7.92 ± 2.54, p = 0.007, 1.06 ± 0.78, vs. 1.25 ± 0.68, p = 0.020, and −0.06 ± 0.25 vs. 0.04 ± 0.23 p = 0.021, respectively). NonHDL/HDL cholesterol ratio > 2.6, and AIP > 0.24 total/HDL cholesterol ratio > 4.5 significantly predicted metabolic adverse neonatal outcome (hypoglycemia and/or hyperbilirubinemia)­OR (95% CI): 4.62 (1.35; 15.79), 3.60 (1.04; 12.48), 8.75 (1.02; 74.83), respectively. Conclusions: 1, Hyperglycemia diagnosed in early pregnancy coexists with a lipid profile suggestive of insulin resistance. 2, Lipid-related markers of cardiometabolic risk measured in early pregnancy can be useful tools in assessment of fetomaternal risk in high-risk populations. 3, Women with eDiP present a more severe insulin resistance phenotype than those with eGDM.

Multispecialty Approach to a Very Large Congenital Head and Neck Cystic Lymphatic Malformation in an Infant Born by SARS-CoV-2 Positive Mother-A Case Report.

Masses of the head and neck are often diagnosed prenatally and require special care due to the risk of airway obstruction. The EXIT procedure is a preferable mode of delivery. A congenital cystic lymphatic malformation is one of the most common lesions of the cervical region described in neonates. The treatment consists of different strategies and involves the cooperation of multiple specialists. Up to now, no guidelines or protocols are available. We report a case of a congenital cystic lymphatic malformation of the head and neck delivered during the EXIT procedure by a mother who was SARS-CoV-2 positive. We analyzed clinical characteristics, radiologic features, and treatment with injections of sclerotic agents and orally administrated sirolimus. Sirolimus seems a valuable and safe therapeutic option for treating lymphatic malformations, especially with adjunct therapies.

Hearing Impairment in Infants with Hypoxic Ischemic Encephalopathy Treated with Hypothermia.

Therapeutic hypothermia acts as the standard of care for infants with moderate to severe hypoxic ischemic encephalopathy (HIE). A proportion of neonates who undergo hypothermia due to HIE have shown to develop various degrees of hearing impairment. Analyzing and identifying infants at high risk of developing hearing difficulties is fundamental for early intervention of such auditory complications. The aim was to assess clinical factors in the development of hearing impairment following therapeutic hypothermia in HIE infants. A retrospective analysis was performed on infants hospitalized in our neonatology department in Poznan University of Medical Sciences, Poland. All infants experienced moderate to severe HIE, and were treated with therapeutic hypothermia. Risk factors for hearing impairment were identified in all infants included in the study. Clinical data during hospital stay and follow-up hearing status were analyzed. A total of 87 HIE infants were included in the study. Seventy-six infants (40 male and 36 female) had otoacoustic emission (OAE) examination following birth, of which 14 (18.4%) demonstrated abnormal (positive) results. Infants with abnormal OAE results had significantly lower blood pH (6.86 ± 0.16, p = 0.001) and base excess (BE) (-22.46 ± 2.59, p = 0.006). Of the 49 infants who returned for follow-up assessment, 4 (8.2%) were diagnosed with sensorineural bilateral hearing impairment (1 infant, mild [<40 dB], 2 moderate [41-70 dB], and 1 profound [>90 dB]). The biochemical analysis following birth revealed significantly lower umbilical BE levels (-23.90 ± 4.99, p = 0.041) and higher lactate levels (160.67 ± 4.93, p = 0.019) in the infants with eventual sensorineural hearing deficit. Infants with moderate or severe HIE are at risk of delayed onset hearing loss. Diligent efforts to monitor auditory status are required, even if early screening results for hearing are insignificant. Exploring biochemical parameters, such as lactate, BE, and blood pH, can prove beneficial in identifying HIE infants at risk of developing a hearing impairment.

Maternal/fetal mortality and fetal growth restriction: role of nitric oxide and virulence factors in intrauterine infection in rats.

OBJECTIVE: The mechanism of infection-related deaths of pregnant rats and intrauterine growth restriction are not understood. We assessed whether nitric oxide (NO) has differential effects on infection with Escherichia coli Dr/Afa mutants that lack either AfaE or AfaD invasins. STUDY DESIGN: Sprague-Dawley rats were infected intrauterinally with the clinical strain of E coli AfaE(+)D(+) or 1 of its isogenic mutants in the presence or absence of the NO synthesis inhibitor N(G)-nitro-L-arginine methyl ester (L-NAME). Maternal/fetal mortality rates, fetoplacental weight, and infection rates were evaluated. RESULTS: Maternal and/or fetal death was associated with the presence of at least 1 virulence factor (AfaE(+)D(+)>AfaE(+)D(-)>AfaE(-)D(+)) and was increased by L-NAME treatment. The fetal and placental weights were lower than controls and were further reduced by L-NAME treatment. CONCLUSION: These results demonstrate that NO enhanced AfaE- and AfaD-mediated virulence and plays an important role in Dr/Afa(+)E coli gestational tropism.

Gynecological Problems in Newborns and Infants.

Pediatric-adolescent or developmental gynecology has been separated from general gynecology because of the unique issues that affect the development and anatomy of growing girls and young women. It deals with patients from the neonatal period until maturity. There are not many gynecological problems that can be diagnosed in newborns; however, some are typical of the neonatal period. This paper aims to discuss the most frequent gynecological issues in the neonatal period.

Clinical Characteristics of Newborns Born to Mothers with COVID-19.

(1) Background: According to the literature, most outcomes of neonates born to mothers infected with SARS-CoV-2 are favorable. This study aimed to assess the clinical characteristics of newborns born to infected women in a tertiary center in Poznan, Poland. (2) Methods: The study comprised 101 newborns delivered by women infected with SARS-CoV-2. The control group consisted of 101 newborns born before the pandemic. Data were collected retrospectively from the medical records. (3) Results: Most newborns of SARS-CoV-2-positive mothers were delivered by cesarean section-83.17% vs. 40.59% in the control group (p < 0.05). The groups did not differ in Apgar scores and the need for resuscitation. Newborns of SARS-CoV-2-positive mothers were more likely to present with respiratory distress and require respiratory support. The most common diagnosis was transient tachypnea of the newborn, not correlated with the mode of delivery. Newborns of the study group were never exclusively breastfed, 0% vs. 64.36% (p < 0.05). None of the patients in the study group was tested positive for the virus. (4) Conclusions: Infants born to SARS-CoV-2-positive mothers seem to be more at risk of moderate respiratory failure than other newborns. Separation of mother-baby dyads results in a dramatic fall in breastfeeding in the short-term post-partum period.

Congenital Laryngeal Stenosis and Concomitant Birth Defects in a Term Newborn: A Case Report.

Congenital laryngeal stenosis is a rare and unusual anomaly that usually presents in the first minutes after delivery as severe life-threatening respiratory distress. It may exist as an isolated entity or in association with other congenital malformations, in particular cardiac anomalies. In this paper, we present the case of an infant with prenatal suspicion of tetralogy of Fallot. Immediately after delivery, the patient required intubation, which proved difficult. He was eventually diagnosed with laryngeal stenosis requiring laryngological treatment.

Early Screening for Gestational Diabetes Using IADPSG Criteria May Be a Useful Predictor for Congenital Anomalies: Preliminary Data from a High-Risk Population.

BACKGROUND: Our aim was to investigate whether the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) glycemic thresholds used for detecting hyperglycemia in pregnancy can be predictive for malformations in women with hyperglycemia detected in early pregnancy. METHODS: a single-center, retrospective observational trial of 125 mother-infant pairs from singleton pregnancies with hyperglycemia according to the IADPSG criteria diagnosed at the gestational age below 16 weeks. Glucose values obtained from 75-g OGTT (oral glucose tolerance test) were investigated as predictors for congenital malformations in newborns. RESULTS: Characteristics of the cohort: maternal age: 31.5 ± 5.2, pre-pregnancy body mass index (BMI) ≥ 30 kg/m2: 42.0%, gestational age at diagnosis (weeks): 12.0 ± 4.0, and newborns with congenital malformations: 8.8%. Fasting blood glycemia (FBG) and HbA1c (Haemoglobin A1c) at baseline significantly predicted the outcome (expB: 1.06 (1.02-1.1), p = 0.007 and expB: 2.05 (1.24-3.38), p = 0.005, respectively). Both the fasting blood glucose (FBG) value of 5.1 mmol/dL (diagnostic for gestational diabetes mellitus (GDM)) and 5.5 mmol/dL (upper limit for normoglycemia in the general population) significantly increased the likelihood ratio (LR) for fetal malformations: 1.3 (1.1; 1.4) and 1.5 (1.0; 2.4), respectively. CONCLUSIONS: (1) Fasting glycemia diagnostic for GDM measured in early pregnancy is associated with a significantly elevated risk for congenital malformations. (2) Our data suggest that women at elevated risks of GDM/diabetes in pregnancy (DiP) should have their fasting blood glucose assessed before becoming pregnant, and the optimization of glycemic control should be considered if the FBG exceeds 5.1 mmol/dL.