Project description:Administration of oropharyngeal colostrum (OPC) is safe, feasible, and potentially beneficial in preterm infants. We aimed to assess the effects of OPC in preterm infants. A systematic review of randomized controlled trials (RCTs) and non-RCTs of OPC administration in preterm infants was conducted. We searched MEDLINE via PubMed and Ovid, EMBASE, the Cochrane Central Register of Controlled Trials, Emcare databases, abstracts of Pediatric Academic Societies meetings, and gray literature in April 2018. Six RCTs (n = 269) and 4 non-RCTs (n = 737) were included. One RCT (n = 40) focused on enteral bovine colostrum and hence was excluded from our review. Five of the 6 RCTs had unclear risk of bias in many domains of assessment. Meta-analysis (random effects model) of RCT data showed no significant difference in ≥stage 2 necrotizing enterocolitis (RR: 0.83; 95% CI: 0.39, 1.75; P = 0.62), late-onset sepsis (RR: 0.78; 95% CI: 0.50, 1.22; P = 0.28), all-cause mortality (RR: 0.74; 95% CI: 0.27, 2.06; P = 0.56); duration of hospital stay (mean difference [MD]: -1.65 d; 95% CI: -10.09, 6.80; P = 0.70), and time to full feeds (MD: -2.86 d; 95% CI: -6.49, 0.77; P = 0.12). Meta-analysis of data from non-RCTs also showed no benefit for any of these outcomes. OPC increased secretory IgA and lactoferrin concentrations (4 RCTs), and had only a transient effect on the oral microbiome (1 RCT). There were no adverse effects (e.g., aspiration) of OPC. The overall quality of evidence (Grades of Recommendation, Assessment, Development, and Evaluation analysis) was very low. Adequately powered RCTs are needed to confirm the nutritional and immunomodulatory benefits of OPC in preterm infants.
Project description:BACKGROUND:Glutamine is a conditionally essential amino acid. Endogenous biosynthesis may be insufficient for tissue needs in states of metabolic stress. Evidence exists that glutamine supplementation improves clinical outcomes in critically ill adults. It has been suggested that glutamine supplementation may also benefit preterm infants. OBJECTIVES:To determine the effects of glutamine supplementation on mortality and morbidity in preterm infants. SEARCH METHODS:We used the standard search strategy of the Cochrane Neonatal Review Group. This included searches of the Cochrane Central Register of Controlled Trials (CENTRAL, 2015, Issue 12), MEDLINE, EMBASE and Maternity and Infant Care (to December 2015), conference proceedings and previous reviews. SELECTION CRITERIA:Randomised or quasi-randomised controlled trials that compared glutamine supplementation versus no glutamine supplementation in preterm infants at any time from birth to discharge from hospital. DATA COLLECTION AND ANALYSIS:We extracted data using the standard methods of the Cochrane Neonatal Review Group, with separate evaluation of trial quality and data extraction by two review authors. We synthesised data using a fixed-effect model and reported typical relative risk, typical risk difference and weighted mean difference. MAIN RESULTS:We identified 12 randomised controlled trials in which a total of 2877 preterm infants participated. Six trials assessed enteral glutamine supplementation and six trials assessed parenteral glutamine supplementation. The trials were generally of good methodological quality. Meta-analysis did not find an effect of glutamine supplementation on mortality (typical relative risk 0.97, 95% confidence interval 0.80 to 1.17; risk difference 0.00, 95% confidence interval -0.03 to 0.02) or major neonatal morbidities including the incidence of invasive infection or necrotising enterocolitis. Three trials that assessed neurodevelopmental outcomes in children aged 18 to 24 months and beyond did not find any effects. AUTHORS' CONCLUSIONS:The available trial data do not provide evidence that glutamine supplementation confers important benefits for preterm infants.
Project description:BACKGROUND:In Reunion Island, a French overseas department, the burden of preterm birth and perinatal mortality exceed those observed in mainland France, despite similar access to standard perinatal care. The purpose of the study was to compare the outcome of two cohorts of NICU-admitted very preterm infants born between 24 and 31 weeks of gestation (WG): the registry-based OGP (Observatoire de la Grande Prématurité, Reunion Island, 2008-2013) cohort, and the nationwide EPIPAGE-2 (mainland France, 2011) observational cohort. METHODS:The primary outcome was adverse neonatal outcomes defined as a composite indicator of in-hospital mortality or any of three following severe morbidities: bronchopulmonary dysplasia (BPD), necrotising enterocolitis, or severe neurological injury (periventricular leukomalacia or grade III-IV intraventricular haemorrhages). Logistic regression modelling adjusting for confounders was performed. RESULTS:A total of 1272 very preterm infants from the Reunionese OGP cohort and 3669 peers from the mainland EPIPAGE-2 cohort were compared. Adverse neonatal outcomes were more likely observed in the OGP cohort (32.6% versus 26.6%, p < 0.001), as result of both increased in-hospital mortality across all gestational age strata and increased BPD among the survivors of the 29-31 WG stratum. After adjusting for gestational age, gender and multiple perinatal factors, the risk of adverse neonatal outcomes was higher in the OGP cohort than in the EPIPAGE-2 cohort across all gestational age strata. CONCLUSIONS:Despite similar guidelines for standard perinatal care, very preterm infants born in Reunion Island have a higher risk for death or severe morbidity compared with those born in mainland France.
Project description:The initial colonization of the human microbiota is of paramount importance. In this context, the oropharyngeal administration of colostrum is a safe, viable, and well-tolerated practice even by the smallest preterm infants. Therefore, this study evaluated the effects of oropharyngeal administration of colostrum on the establishment of preterm infants' oral microbiota. A longitudinal observational study was carried out with 20 premature neonates, divided into two groups: one receiving the protocol (Oropharyngeal Administration of Colostrum; OAC) and the other one receiving Standard Caare (SC). Saliva samples were collected from the newborns weekly during the study period (from the day of birth until the 21st day of life) for analysis of oral microbiota through 16S rRNA gene sequencing. We observed that the colonization of the oral microbiota of preterm newborns preseanted a higher relative abundance of Staphylococcus on the 7th day of life, mainly in the OAC group. Additionally, an increased abundance of Bifidobacterium and Bacteroides was observed in the OAC group at the first week of life. Regarding alpha and beta diversity, time was a key factor in the oral modulation of both groups, showing how dynamic this environment is in early life.
Project description:BackgroundPreterm infants are susceptible to hyperglycaemia and hypoglycaemia, which may lead to adverse neurodevelopment. The use of continuous glucose monitoring (CGM) devices might help in keeping glucose levels in the normal range, and reduce the need for blood sampling. However, the use of CGM might be associated with harms in the preterm infant.ObjectivesTo assess the benefits and harms of CGM versus intermittent modalities to measure glycaemia in preterm infants 1. at risk of hypoglycaemia or hyperglycaemia; 2. with proven hypoglycaemia; or 3. with proven hyperglycaemia.Search methodsWe searched CENTRAL (2021, Issue 4); PubMed; Embase; and CINAHL in April 2021. We also searched clinical trials databases, conference proceedings, and reference lists of retrieved articles for randomized controlled trials (RCTs) and quasi-RCTs.Selection criteriaWe included RCTs and quasi-RCTs comparing the use of CGM versus intermittent modalities to measure glycaemia in preterm infants at risk of hypoglycaemia or hyperglycaemia; with proven hypoglycaemia; or with proven hyperglycaemia.Data collection and analysisWe assessed the methodological quality of included trials using Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria (assessing randomization, blinding, loss to follow-up, and handling of outcome data). We evaluated treatment effects using a fixed-effect model with risk ratio (RR) with 95% confidence intervals (CI) for categorical data and mean, standard deviation (SD), and mean difference (MD) for continuous data. We used the GRADE approach to assess the certainty of the evidence.Main resultsWe included four trials enrolling 300 infants in our updated review. We included one new study and excluded another previously included study (because the inclusion criteria of the review have been narrowed). We compared the use of CGM to intermittent modalities in preterm infants at risk of hypoglycaemia or hyperglycaemia; however, one of these trials was analyzed separately because CGM was used as a standalone device, without being coupled to a control algorithm as in the other trials. We identified no studies in preterm infants with proven hypoglycaemia or hyperglycaemia. None of the four included trials reported the neurodevelopmental outcome (i.e. the primary outcome of this review), or seizures. The effect of the use of CGM on mortality during hospitalization is uncertain (RR 0.59, 95% CI 0.16 to 2.13; RD -0.02, 95% CI -0.07 to 0.03; 230 participants; 2 studies; very low-certainty evidence). The certainty of the evidence was very low for all outcomes because of limitations in study design, and imprecision of estimates. One study is ongoing (estimated sample size 60 infants) and planned to be completed in 2022.Authors' conclusionsThere is insufficient evidence to determine if CGM affects preterm infant mortality or morbidities. We are very uncertain of the safety of CGM and the available management algorithms, and many morbidities remain unreported. Preterm infants at risk of hypoglycaemia or hyperglycaemia were enrolled in all four included studies. No studies have been conducted in preterm infants with proven hypoglycaemia or hyperglycaemia. Long-term outcomes were not reported. Events of necrotizing enterocolitis, reported in the study published in 2021, were lower in the CGM group. However, the effect of CGM on this outcome remains very uncertain. Clinical trials are required to determine the most effective CGM and glycaemic management regimens in preterm infants before larger studies can be performed to assess the efficacy of CGM for reducing mortality, morbidity, and long-term neurodevelopmental impairments.
Project description:BackgroundIdentifying preterm infants at risk for mortality or major morbidity traditionally relies on gestational age, birth weight, and other clinical characteristics that offer underwhelming utility. We sought to determine whether a newborn metabolic vulnerability profile at birth can be used to evaluate risk for neonatal mortality and major morbidity in preterm infants.MethodsThis was a population-based retrospective cohort study of preterm infants born between 2005 and 2011 in California. We created a newborn metabolic vulnerability profile wherein maternal/infant characteristics along with routine newborn screening metabolites were evaluated for their association with neonatal mortality or major morbidity.ResultsNine thousand six hundred and thirty-nine (9.2%) preterm infants experienced mortality or at least one complication. Six characteristics and 19 metabolites were included in the final metabolic vulnerability model. The model demonstrated exceptional performance for the composite outcome of mortality or any major morbidity (AUC 0.923 (95% CI: 0.917-0.929). Performance was maintained across mortality and morbidity subgroups (AUCs 0.893-0.979).ConclusionsMetabolites measured as part of routine newborn screening can be used to create a metabolic vulnerability profile. These findings lay the foundation for targeted clinical monitoring and further investigation of biological pathways that may increase the risk of neonatal death or major complications in infants born preterm.ImpactWe built a newborn metabolic vulnerability profile that could identify preterm infants at risk for major morbidity and mortality. Identifying high-risk infants by this method is novel to the field and outperforms models currently in use that rely primarily on infant characteristics. Utilizing the newborn metabolic vulnerability profile for precision clinical monitoring and targeted investigation of etiologic pathways could lead to reductions in the incidence and severity of major morbidities associated with preterm birth.
Project description:Provision of human milk has important implications for the health and outcomes of extremely preterm (EP) infants. This study evaluated the effects of an exclusive human milk diet on the health of EP infants during their stay in the neonatal intensive care unit.EP infants <1,250?g birth weight received a diet consisting of either human milk fortified with a human milk protein-based fortifier (HM) (n=167) or a diet containing variable amounts of milk containing cow milk-based protein (CM) (n=93). Principal outcomes were mortality, necrotizing enterocolitis (NEC), growth, and duration of parenteral nutrition (PN).Mortality (2% versus 8%, p=0.004) and NEC (5% versus 17%, p=0.002) differed significantly between the HM and CM groups, respectively. For every 10% increase in the volume of milk containing CM, the risk of sepsis increased by 17.9% (p<0.001). Growth rates were similar between groups. The duration of PN was 8 days less in the subgroup of infants receiving a diet containing <10% CM versus ?10% CM (p<0.02).An exclusive human milk diet, devoid of CM-containing products, was associated with lower mortality and morbidity in EP infants without compromising growth and should be considered as an approach to nutritional care of these infants.