Consensus definition and diagnostic criteria for neonatal encephalopathy-study protocol for a real-time modified delphi study.

BACKGROUND: 'Neonatal encephalopathy' (NE) describes a group of conditions in term infants presenting in the earliest days after birth with disturbed neurological function of cerebral origin. NE is aetiologically heterogenous; one cause is peripartum hypoxic ischaemia. Lack of uniformity in the terminology used to describe NE and its diagnostic criteria creates difficulty in the design and interpretation of research and complicates communication with families. The DEFINE study aims to use a modified Delphi approach to form a consensus definition for NE, and diagnostic criteria. METHODS: Directed by an international steering group, we will conduct a systematic review of the literature to assess the terminology used in trials of NE, and with their guidance perform an online Real-time Delphi survey to develop a consensus diagnosis and criteria for NE. A consensus meeting will be held to agree on the final terminology and criteria, and the outcome disseminated widely. DISCUSSION: A clear and consistent consensus-based definition of NE and criteria for its diagnosis, achieved by use of a modified Delphi technique, will enable more comparability of research results and improved communication among professionals and with families. IMPACT: The terms Neonatal Encephalopathy and Hypoxic Ischaemic Encephalopathy tend to be used interchangeably in the literature to describe a term newborn with signs of encephalopathy at birth. This creates difficulty in communication with families and carers, and between medical professionals and researchers, as well as creating difficulty with performance of research. The DEFINE project will use a Real-time Delphi approach to create a consensus definition for the term 'Neonatal Encephalopathy'. A definition formed by this consensus approach will be accepted and utilised by the neonatal community to improve research, outcomes, and parental experience.

The impact of a multifaceted quality improvement program on the incidence of necrotizing enterocolitis in very low birth weight infants.

BACKGROUND: Necrotizing enterocolitis (NEC) is a multifactorial gastrointestinal disease which mostly occurs in very low birth weight (VLBW) infants. In addition to decreasing gestational age (GA) or birth weight (BW), artificial formula, delayed initiation or rapidly advanced feeding, severe anemia and systemic infections were associated with NEC. Several studies demonstrated that breast milk, standardized feeding advancement regimens and treatment of anemia are associated with less incidence of NEC. It is not known if including all these interventions in one multifaceted program will lead to significant reduction in NEC. METHODS: The NICU team at The George Washington University Hospital created a multifaceted interdisciplinary quality improvement project to tackle several aspects of NEC prevention that addressed researched risk factors for NEC. The program was made of four quality improvement protocols: 1) Standardized Structured Feeding Program, 2) Feeding Intolerance Management Algorithm, 3) Enteral Osmolality Control Tool, and 4) Packed Red Blood Cell (RBC) Standardized Transfusion Protocol. This time-series, quasi experimental study design examined the differences in the incidence of NEC between infants with BW < 1500 g who were admitted to the GW Hospital NICU before and after the program implementation. RESULTS: Data from 408 VLBW infants were included in the study. Although not statistically significant, there was a decreasing trend of NEC incidence in the post-implementation group (n = 199) compared to the pre-implementation group (n = 209), (3.5% vs. 5.3%, p = 0.88). The trend in the incidence of NEC declined further after the introduction of RBC transfusion protocol which was introduced ten month after starting the other elements of the program. CONCLUSION: Integration of the multifaceted quality improvement program may be associated with a decline in the occurrence of NEC. Further analysis with a larger sample size is required to determine if the changes seen are statistically significant.

Fetal and neonatal programming: evidence and clinical implications.

Fetal and neonatal programming is the phenomenon describing deviations from normal developmental patterns. These deviations can increase risks for diseases later in life and are an example of phenotypic plasticity seen throughout nature. For instance, infants born with low birth weight, as a marker of an unfavorable intrauterine environment, are programmed differently and may have an increased risk for multiple diseases in adulthood. These risks include coronary heart disease, increased insulin resistance, hypertension, and imbalances in the immune system. This article discusses mechanisms responsible for fetal and neonatal programming. We also introduce possible changes to current clinical management and practices that reflect the current findings of fetal and neonatal programming.

Is it a safe practice to administer oxygen during uncomplicated delivery: a randomized controlled trial?

BACKGROUND: Newborns exposed to oxygen suffer from an oxidative stress with significant alterations in the concentrations of superoxide dismutase (SOD) and glutathione (GSSG). OBJECTIVE: To investigate the biological and clinical effects of oxygen administration to delivering mothers. METHODS: We conducted a randomized, double-blinded, controlled trial on a cohort of delivering women (n=56) with an uncomplicated term pregnancy. Women were randomly assigned to one of two groups: Oxygen group or Room Air group. The Oxygen group received 100% oxygen (2l/min) via nasal cannula for at least 30 min before delivery. Subjects in the Room Air group were connected to a nasal cannula while on room air. Concentrations of SOD (µg/g of Hb) and GSSG (µM/ml) were measured in maternal and umbilical cord blood. Bivariate and multivariate analyses were used to compare the two groups using the SAS system. RESULTS: Maternal SOD and GSSG did not differ between the two groups at baseline or after delivery. Concentrations of SOD and GSSG in umbilical cord blood did not differ between groups. More infants in Oxygen Group required delivery room resuscitation (20% vs. 0%, P=0.03). This difference could not be explained by mode of delivery, infant sex, or other confounders. CONCLUSIONS: Maternal exposure to oxygen during delivery is not associated with changes in umbilical cord SOD or GSSG. Further studies are needed to explore mechanisms responsible for the need of resuscitation in the oxygen group.

Exposure to oxygen and head growth in infants with bronchopulmonary dysplasia.

Infants with bronchopulmonary dysplasia (BPD) are known to have developmental delays, but a direct link between oxygen (O (2)) exposure and brain growth has not been explored. Our objective was to test the hypothesis that the use of O (2) is associated with delays in head growth (DHG) in premature infants with BPD. We conducted a retrospective study on a cohort of infants with BPD (birthweight [BW] < 1500 g, gestational age < 34 weeks). The study population was divided into two groups based on their head circumference (HC) measured at birth. Group 1 represented infants with birth HC > or = 50% for their age on growth chart, and Group 2 represented infants with birth HC < 50% for their age. We recorded HC at hospital discharge and at 6 months of age; and the amount of DHG was calculated (DHG = current age in weeks - the age that matches the 50th percentile for current HC). Regression analysis was conducted to determine the relationship between the duration of O (2) use and DHG in both groups, controlling for BW, discharge weight, gender, and duration of mechanical ventilation (MV). Data were expressed in mean +/- standard error of mean. A total of 137 sequential infants with BPD were studied; of them 65 infants were included in group 1 and 72 infants were included in group 2. The 2 groups did not differ in GA, gender total O (2) days, and total days on MV. At hospital discharge there was no difference between groups in terms of DHG (78% versus 83%, respectively). At 6 months of age, there were more infants in group 2 who had DHG (44% versus 67%, respectively; P < 0.01). In group 1, the amount of DHG correlated only with BW ( P = 0.05). It did not correlate with discharge weight, gender, duration of O (2) use, or duration of MV. In group 2, the amount of DHG correlated only with the duration of O (2) use ( P = 0.04) It did not correlate with BW, discharge weight, gender, or duration of MV. Each 10 days of O (2) use in group 2 was associated with 1.5 +/- 0.1 days of DHG. We concluded that duration of O (2) use is associated with a delay in head growth in infants born with HC < 50th percentile. This study does not clarify whether the use of O (2) is a marker of severity of illness or a contributing factor to DHG in infants with BPD. The mechanisms for this relation require further exploration.