Oropharyngeal colostrum administration in neonates with gastroschisis: a randomized clinical trial.

OBJECTIVE: To evaluate the effect of colostrum therapy on days to start a suckling diet in newborns diagnosed with simple gastroschisis. METHODS: Randomized clinical trial with newborns diagnosed with simple gastroschisis at a federal hospital in Rio de Janeiro who were randomized to receive oropharyngeal administration of 0.2mL of colostrum or a "sham procedure" during the first 3 days of life. The analysis included clinical outcomes such as days without food, days with parenteral feeding, days until the start of enteral feeding, days to reach complete enteral feeding, sepsis and length of hospital stay. RESULTS: The onset of oral feeding (suction) in patients with simple gastroschisis in both groups occurred at a median of 15 days. CONCLUSION: The present study showed that there were no significant differences in the use of colostrum therapy and the number of days to the start of enteral feeding and suction diet between groups of newborns with simple gastroschisis.

Preterm vs term delivery in antenatally diagnosed gastroschisis: a systematic review and meta-analysis.

OBJECTIVE: To review the evidence regarding gestational age at birth, length of stay, sepsis incidence, days on mechanical ventilation, and mortality between preterm and term deliveries in pregnancies complicated by gastroschisis. DATA SOURCES: We conducted database searches of PubMed, Cochrane Central Register of Controlled Trials, Embase, the World Health Organization International Clinical Trials Registry Platform, and ClinicalTrials.gov without language restrictions through August 16, 2021. References of all relevant articles were reviewed. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials, nonrandomized controlled trials, and observational studies were evaluated comparing length of stay, sepsis, days on mechanical ventilation, and mortality between either elective preterm delivery and expectant management (Group 1) or preterm gestational age and term gestational age (Group 2). METHODS: Two researchers independently selected studies and evaluated risk of bias with the Risk of Bias 2 tool for randomized controlled trials and the Newcastle-Ottawa Scale for cohort studies. Mean differences and odds ratios were calculated using a random-effects model for inclusion and methodological quality. The primary outcome was length of stay. Secondary outcomes were incidence of sepsis, mortality, days on mechanical ventilation, and gestational age. RESULTS: Thirty studies with a total of 7409 patients were included in the systematic review, of which 25 were included in the analysis. Group 1 studies found no difference in length of stay or mortality and a trend toward fewer days on mechanical ventilation (mean difference, -0.40; 95% confidence interval, -0.89 to -0.10; P=.12; I2=35%). Subgroup analysis excluding premature delivery demonstrated lower sepsis incidence in elective preterm delivery (odds ratio, 0.46; 95% confidence interval, 0.25-0.84; P=.01; I2=0%). Group 2 studies found increased length of stay (mean difference, 15.44; 95% confidence interval, 8.44-21.83; P<.00001; I2=94%), sepsis (odds ratio, 1.69; 95% confidence interval, 1.15-2.50; P=.008; I2=51%), days on mechanical ventilation (mean difference, 1.38; 95% confidence interval, 0.10-2.66; P=.03; I2=66%), and mortality (odds ratio, 2.97; 95% confidence interval, 1.59-5.55; P=.0007; I2=0%). Gestational age was significantly lower in Group 2 studies than in Group 1 studies. CONCLUSION: Data continue to be conflicting, but subgroup analysis suggested a possible reduction in sepsis incidence and mean days on mechanical ventilation with elective early term delivery.

Gastroschisis prognostic score successfully identifies Brazilian newborns with high-risk gastroschisis.

BACKGROUND: The Gastroschisis Prognostic Score (GPS) stratifies patients as high or low risk based on the visual assessment of intestinal matting, atresia, perforation, or necrosis. Despite being a simple score, its applicability to low and middle-income countries (LMICs) remains unknown. We tested the hypothesis that GPS can predict outcomes in LMICs, by assessing the prognostic value of the GPS in a middle-income country. METHODS: This prospective study followed all newborns with gastroschisis in a Brazilian neonatal unit based in a public hospital from 2015-2019. Infants were stratified into low and high-risk cohorts based on the GPS. In addition to basic demographics, data collected included duration of parenteral nutrition (TPN), mechanical ventilation (MV), length of stay (LOS), suspicion of infection that led to the use of antibiotics, and mortality. Univariate and multivariate analyses were conducted to identify which outcomes the GPS independently predicted. RESULTS: Sixty-one newborns with gastroschisis were treated during the study period. The mean birth weight, gestational age, and 5' Apgar score were 2258 g, 36 weeks, and 9. Twenty-four infants (39.3%) were identified as low-risk (GPS < 2) and 37 (60.7%) as high-risk (GPS > 2). The high-risk group presented with prolonged TPN use (p<0.001), MV (p<0.001), and LOS (p:0.002). GPS did not predict antibiotic therapy or mortality. CONCLUSION: In the first study in a middle-income country, the GPS predicted several important clinical outcomes. The GPS is a reliable tool for parental counseling and resource allocation in diverse settings. LEVEL OF EVIDENCE: II.c (cohort prospective).

Gastroschisis with intestinal atresia leads to longer hospitalization and poor feeding outcomes.

OBJECTIVE: Compare in-hospital outcomes in gastroschisis with intestinal atresia versus simple gastroschisis (GS) using a national database. STUDY DESIGN: The Children's Hospitals Neonatal Database identified infants with gastroschisis from 2010 to 2016. RESULTS: 2078 patients with gastroschisis were included: 183 (8.8%) with co-existing intestinal atresia, 1713 (82.4%) with simple gastroschisis, the remainder with complex gastroschisis without atresia. Length of hospitalization was longer for those with atresia, and yielded higher rates of mortality, medical NEC, and intestinal perforation. They began enteral feedings later, were less likely to initiate feeds orally, and reached full feedings later. They were less likely to be receiving any maternal breast milk or breastfeeding at discharge and more likely than simple gastroschisis to be discharged with a feeding tube. CONCLUSION: A large multicenter cohort showed gastroschisis with atresia results in worse outcomes and complications, including necrotizing enterocolitis, feeding delays, and enteral feeding tube dependence.

The association between fluid restriction and hyponatremia in newborns with gastroschisis.

INTRODUCTION: Newborns with gastroschisis require appropriate fluid resuscitation but are also at risk for hyponatremia that may lead to adverse outcomes. The etiology of hyponatremia in gastroschisis has not been defined. METHODS: Over a 24-month period, all newborns with gastroschisis in a free-standing pediatric hospital had sodium levels measured from serum, urine, gastric output, and the bowel bag around the eviscerated contents for the first 48 h of life. Total fluid intake and output were measured. Maintenance fluids were standardized at 120 mL/kg/day. Hyponatremia was defined as a serum sodium <132 mEq/L. A logistic regression model was created to determine independent predictors of hyponatremia. RESULTS: 28 infants were studied, and 14 patients underwent primary closure. While serum sodium was normal in all patients at birth, 9 (32%) infants developed hyponatremia at a median of 17.4 h of life. On univariate analysis, hyponatremic babies had a greater net positive fluid balance (74.9 vs 114.7 mL/kg, p = 0.001) primarily due to a decrease in total fluid output (p = 0.05). On multivariable regression, a 10 mL/kg increase in overall fluid balance was associated with an increased risk of developing hyponatremia (OR 1.84 [1.23, 3.45], p = 0.016). No differences in the sodium content of urine, gastric, or bowel bag fluid were observed, and sodium balance was equivalent between cohorts. DISCUSSION: Hyponatremia in babies with gastroschisis in the early postnatal period was associated with positive fluid balance and decreased fluid output. Prospective studies to determine the appropriate fluid resuscitation strategy in this population are warranted.

Minimizing Variance in Gastroschisis Management Leads to Earlier Full Feeds in Delayed Closure.

BACKGROUND: Limited guidance exists regarding appropriate timing for feed initiation and advancement in gastroschisis. We hypothesized that implementation of a gastroschisis management protocol would allow for standardization of antibiotic and nutritional treatment for these patients. METHODS: We conducted a retrospective comparison of patients with simple gastroschisis at two pediatric hospitals before and after initiation of our gastroschisis care protocol. Complicated gastroschisis and early mortality were excluded. The control group extended from January 2012 to January 2014 and the protocol group from July 2014 to July 2016. Variables of interest included time to feed initiation, time to goal feeds, length of stay, and National Surgical Quality Improvement Program-defined complications. We performed a subgroup analysis for primary versus delayed gastroschisis closure. Statistical analyses, including F-tests for variance, were conducted in Prism. RESULTS: Forty-seven patients with simple gastroschisis were included (control = 22, protocol = 25). Protocol compliance was 76% with no increase in complication rates. There was no difference in length of stay or time from initiation to full feeds overall between the control and protocol groups. However, neonates who underwent delayed closure reached full feeds significantly earlier, averaging 9 d versus 15 d previously (P = 0.04). CONCLUSIONS: For infants undergoing delayed closure, the time to full feeds in this group now appears to match that of patients undergoing primary closure, indicating that delayed closure should not be a reason for slower advancement. Additional studies are needed to assess the impact of earlier full enteral nutrition on rare complications and rates of necrotizing enterocolitis.

Estimating Length of Stay for Simple Gastroschisis.

BACKGROUND: Length of stay (LOS) is an important measure of quality; however, estimating LOS for rare populations such as gastroschisis is problematic. Our objective was to identify explanatory variables for LOS and build a model to estimate LOS in neonates with simple gastroschisis. METHODS: In 73 neonates with simple gastroschisis (47% female, 67% White), statistical correlations for 31 potential explanatory variables for LOS were evaluated using multivariate linear regression. Poisson regression was used to estimate LOS in predetermined subpopulations, and a life table model was developed to estimate LOS for simple gastroschisis. RESULTS: Female sex (-2.4 d), "time to silo placement" (0.9 d), total parenteral nutrition days (0.6 d), need for any nasogastric feedings (11.4 d) and at discharge (-7 d), "feeding tolerance" (0.4 d), days to first postoperative stool (-0.3 d), and human milk exposure (-3.4 d) associated with LOS in simple gastroschisis. Estimated LOS for preterm neonates was longer than term infants (5.4 versus 4.6 wk) but similar for estimates based on sex and race. Based on these associations, we estimate that >50% of neonates with simple gastroschisis will be discharged by hospital day 35. CONCLUSIONS: We identified several associations that explained variations in LOS and developed a novel model to estimate LOS in simple gastroschisis, which may be applied to other rare populations.

Failure of primary closure predicts prolonged length of stay in gastroschisis patients.

PURPOSE: Current literature regarding outcomes of gastroschisis closure methods do not highlight differences in patients who successfully undergo primary closure with those who fail and require silo placement. We hypothesize that failure of primary closure has significant effects on clinical outcomes such as length of stay and time to enteral feeding. METHODS: We conducted a retrospective review between 2009 and 2018 of gastroschisis patients at a tertiary pediatric referral hospital. We compared patients successfully undergoing primary closure to patients who failed an initial primary closure attempt. Bivariate and multivariate linear regression models were used to assess the association of closure method on clinical outcomes. RESULTS: Sixty-eight neonates were included for analysis, with 44 patients who underwent primary closure and 24 who failed primary closure. On multivariate regression analysis, primary closure patients had shorter estimated time to starting and to full enteral feeds and decreased LOS as compared to those who failed primary closure. Two patients (4.44%) had complications related to primary closure. CONCLUSION: Patients able to undergo primary closure for gastroschisis were more likely to have a shorter length of stay, shorter time to enteral feeds, and use much fewer medical resources. Initial primary closure is a safe method for most patients.

Major abdominal wall defects in the low- and middle-income setting: current status and priorities.

Major congenital abdominal wall defects (gastroschisis and omphalocele) may account for up to 21% of emergency neonatal interventions in low- and middle-income countries. In many low- and middle-income countries, the reported mortality of these malformations is 30-100%, while in high-income countries, mortality in infants with major abdominal wall reaches less than 5%. This review highlights the challenges faced in the management of newborns with major congenital abdominal wall defects in the resource-limited setting. Current high-income country best practice is assessed and opportunities for appropriate priority setting and collaborations to improve outcomes are discussed.

Supplementation of Mother's Own Milk with Donor Milk in Infants with Gastroschisis or Intestinal Atresia: A Retrospective Study.

BACKGROUND: Mother's own milk (MOM) improves in-hospital outcomes for preterm infants. If unavailable, donor milk (DM) is often substituted. It is unclear if DM vs. formula to supplement MOM is associated with improved in-hospital outcomes in term/late preterm surgical infants with gastroschisis or intestinal atresia. METHODS: This retrospective study included infants born ≥33 weeks gestational age (GA) with a birth weight of >1500 g who were admitted to a quaternary neonatal intensive care unit (NICU). Using Chi square and Mann-Whitney u testing, we compared hospital outcomes (length of stay, parenteral nutrition and central line days) before and after a clinical practice change to offer DM instead of formula in this surgical population. RESULTS: Baseline characteristics were similar between eras for the 140 infants (median GA 37 weeks). Fewer infants in DM era were receiving formula at discharge (50.0% vs. 31.4%, p = 0.03). In sub-analyses including only small bowel atresia and gastroschisis infants, the median length of stay (35 vs. 25, p < 0.01) and the central line days (28 vs. 20, p < 0.01) were lower in the DM era. CONCLUSION: In this retrospective study, offering DM instead of formula was associated with less formula feeding at discharge, and in infants with gastroschisis or small bowel atresia, shorter length of stay and central line days.

Reducing Gastroschisis Mortality: A Quality Improvement Initiative at a Ugandan Pediatric Surgery Unit.

INTRODUCTION: With modern treatment, survival of gastroschisis exceeds 90% in high-income countries. Survival in these countries has been largely attributed to prenatal diagnosis, delivery at tertiary facilities with timely resuscitation, timely intervention, parenteral nutrition and intensive care facilities. In sub-Saharan Africa, due to lack of these facilities, mortality rates are still alarmingly high ranging from 75 to 100%. In Uganda the mortality is 98%. AIM: The aim of this study was to reduce gastroschisis mortality in a feasible, sustainable way using a locally derived gastroschisis care protocol at a referring hospital in Western Uganda. METHODS: Data collection was performed from January to October 2018. Nursing staff were interviewed regarding the survival and management of gastroschisis babies. A locally derived protocol was created with staff input and commitment from all the team members. RESULTS: Four mothers absconded and 17 babies were cared for using the newly designed protocol. Seven survived and were well at one month post discharge follow-up, reducing the mortality for this condition from 98 to 59%. CONCLUSION: A dedicated team with minimal resources can significantly reduce the mortality in gastroschisis by almost 40% using a locally derived protocol.

Factors that Influence Longitudinal Growth from Birth to 18 Months of Age in Infants with Gastroschisis.

OBJECTIVE: This study aimed to investigate factors that influence growth in infants with gastroschisis. STUDY DESIGN: Growth parameters at birth, discharge, 6, 12, and 18 months of age were collected from 42 infants with gastroschisis. RESULTS: The mean z-scores for weight, length, and head circumference were below normal at birth and decreased between birth and discharge. Lower gestational age correlated with a worsening change in weight z-score from birth to discharge (rho 0.38, p = 0.01), but not with the change in weight z-score from discharge to 18 months (rho 0.04, p = 0.81). There was no correlation between the day of life when the enteral feeds were started and the change in weight z-score from birth to discharge (rho 0.12, p = 0.44) or discharge to 18 months (rho -0.15, p = 0.41). CONCLUSION: Our study demonstrates that infants with gastroschisis experience a significant decline in weight z-score between birth and discharge, and start to catch up on all growth parameters after discharge. Prematurity in gastroschisis infants is associated with a greater risk for weight loss during this time. This information emphasizes the importance of minimizing weight loss prior to discharge in premature infants with gastroschisis and highlights the need for optimal management strategies for these infants.

Adherence to and outcomes of a University-Consortium gastroschisis pathway.

BACKGROUND: Our multi-institutional university consortium implemented a gastroschisis pathway in 2015 to standardize and improve care by promoting avoidance of routine intubation and paralysis during silo placement, expeditious abdominal wall closure, discontinuation of antibiotics/narcotics within 48 h of closure, and early initiation/advancement of feeds. METHODS: Adherence to the gastroschisis pathway was prospectively monitored. Outcomes for the contemporary cohort (2015-2018) were compared with a historical cohort (2007-2012). RESULTS: Good adherence to the pathway was observed for 70 cases of inborn uncomplicated gastroschisis. The contemporary cohort had significantly lower median mechanical ventilator days (2 versus 5; p < 0.01) and antibiotic days (5.5 versus 9; p < 0.01) as well as earlier days to initiation of feeds (12 versus 15; p < 0.01). However, no differences were observed in length of stay (28 versus 29 days; p = 0.70). A skin closure technique was performed in 66% of the patients, of which 46% were performed at bedside without intubation, the assistance of an operating-room team, or general anesthesia. CONCLUSION: In this study, adherence to a clinical pathway for gastroschisis across different facilities was feasible and led to reduction in exposure to mechanical ventilation and antibiotics. The adoption of a bedside skin closure technique appears to facilitate compliance with the pathway. LEVEL OF EVIDENCE: Level II/III TYPE OF STUDY: Prospective comparative study with historical cohort.

Central line associated blood stream infections in gastroschisis patients: A nationwide database analysis of risks, outcomes, and disparities.

PURPOSE: The aim of this study was to determine the risk of central line associated blood-stream infections (CLABSI) in neonatal gastroschisis patients, risk factors, outcomes, and financial implications. METHODS: The 2016 Healthcare Cost and Utilization Project (HCUP)'s kid's inpatient database (KID), a national database of pediatric inpatient admissions across the United States, was used to obtain a large sample of gastroschisis admissions. Incidence of CLABSI in the gastroschisis patient population was compared to the incidence of CLABSI in the database. To further study the factors influencing CLABSI in gastroschisis, demographic and clinical features of patients were analyzed. Categorical variables were analyzed using Fisher's exact test or Pearson's chi-squared test. Odds ratios (OR) with 95% confidence intervals (CI) for variables found to have significance (p < 0.05) were calculated. FINDINGS: Incidence of CLABSI in this database for pediatric inpatients was 4449 out of 298,862 central line insertions [1.48%] and was 81 out of 2032 [3.9%] (OR 2.83, 95% CI 2.26-3.54, p < 0.001) in the gastroschisis cohort. African American neonates had a significantly higher risk of CLABSI with gastroschisis. Prematurity and low birth-weight in gastroschisis were protective from CLABSI, along with patients from suburban areas or admitted in the Southern USA. Average costs were greater in gastroschisis patients with CLABSI, increasing from $281,779 to $421,970 (p = 0.008). The average length of stay increased from 31 days to 38 days with a CLABSI (p < 0.001). CONCLUSIONS: In gastroschisis patients, CLABSI incidence is high and adds great morbidity and expense. For uncertain reasons, premature and low birth weight babies appear to be protected. LEVEL OF EVIDENCE: Level III.

Predicting Morbidity and Mortality in Neonates Born With Gastroschisis.

BACKGROUND: Gastroschisis is an increasingly common congenital abdominal wall defect. Due to advances in neonatal critical care and early surgical management, mortality from gastroschisis and associated complications has decreased to less than 10% in most series. However, it has been recognized that the outcome of gastroschisis has a spectrum and that the disorder affects a heterogeneous cohort of neonates. The goal of this study is to predict morbidity and mortality in neonates with gastroschisis using clinically relevant variables. METHODS: A multicenter, retrospective observational study of neonates born with gastroschisis was conducted. Neonatal characteristics and outcomes were collected and compared. Prediction of morbidity and mortality was performed using multivariate clinical models. RESULTS: Five hundred and sixty-six neonates with gastroschisis were identified. Overall survival was 95%. Median hospital length of stay was 37 d. Sepsis was diagnosed in 107 neonates. Days on parenteral nutrition and mechanical ventilation were considerable with a median of 27 and 5 d, respectively. Complex gastroschisis (atresia, perforation, volvulus), preterm delivery (<37 wk), and very low birth weight (<1500 g) were associated with worse clinical outcomes including increased sepsis, short bowel syndrome, parenteral nutrition days, and length of stay. The composite metric of birth weight, Apgar score at 5 min, and complex gastroschisis was able to successfully predict mortality (area under the curve, 0.81). CONCLUSIONS: Clinical variables can be used in gastroschisis to distinguish those who will survive from nonsurvivors. Although these findings need to be validated in other large multicenter data sets, this prognostic score may aid practitioners in the identification and management of at-risk neonates.

Assessment of gastroschisis risk factors in Egypt.

AIM: Mortality in infants born with gastroschisis (GS) in low-to-middle-income countries (LMICs) is high. This study aimed to assess factors which might affect outcome in Egypt in order to improve survival. METHODS: A prospective study over a 15-month duration was completed. Variables assessed covered patient, maternal, antenatal, treatment, and complications. The Gastroschisis Prognostic Score (GPS) was used to predict outcome. A validated questionnaire was used to assess socioeconomic status. The main outcome was mortality. RESULTS: Twenty-four cases were studied. Median gestational age was 37 (26-40) weeks, and 9 (38%) were preterm. Mortality occurred in 15 (62%) infants. Median transfer time was 8 (1.5-35) hours, and 64% survived if transferred before 8 h. Median maternal age was 20 (16-27) years. All families were of a low or very-low socioeconomic level. Only 25% had antenatal scans. Most cases were simple GS, and only 3 (12.5%) were complex GS. Median length of stay was 14 (1-52) days, TPN duration was 12 (0-49) days, and days to full feeds was 5 (3-11) days. The GPS score ranged from 0 to 6 in the studied cases and negatively correlated with outcome (rS = -0.98; p = 0.03). CONCLUSION: The mortality of GS in Egypt is very high, mainly due to sepsis and prematurity. Young maternal age and poor socioeconomic status are linked to GS. The GPS is a good indicator of morbidity and mortality in a LMIC setting. Survival improved with better resuscitation and strict management protocols. More effort is needed to improve antenatal detection, and transfer time should be ideally below 8 h. LEVEL OF EVIDENCE: Level IV.

Differences in attitudes to feeding post repair of Gastroschisis and development of a standardized feeding protocol.

BACKGROUND: The purpose of this study was to examine differences in attitudes to feeding in neonates with Gastroschisis between clinical groups and to develop a standardized feeding protocol. Confusion, inconsistencies in practice and lack of evidence could be contributing to avoidable delays in the establishment of enteral feeds resulting in lengthy requirements for central venous access, dependence on total parenteral nutrition (TPN), increased risk of sepsis, TPN related cholestasis and prolongation in length of hospital stay. METHODS: A national survey of clinicians (neonatologists, neonatal intensive care nurses and paediatric surgeons), looking after neonates with gastroschisis was undertaken to determine differences in feeding practice post repair. In addition, an audit of practice in one hospital was undertaken to examine variations in practices between clinicians. A feeding protocol was then developed using inputs from surgeons and neonatologists. RESULTS: Gastric aspirates and residuals were typically used as indicators of feed readiness and feed tolerance; however, there was very little consistency within and between clinical groups in definitions of tolerance or intolerance of feeds and in how to initiate and progress feeds. A feeding protocol with clear definition of feed readiness and a clear pathway to progression of feeds was developed to help overcome these variations in practice with the possibility that this might reduce the length of stay (LOS) and have other secondary benefits. The protocol included early introduction of enteral feeds particularly direct breast or sucking feeds. CONCLUSIONS: Wide differences in attitudes to feeding neonates post Gastroschsis repair exist and the need for a consistent protocolized approach was felt. The feeding protocol we developed requires a change of practice and further clinical trials are needed to evaluate its effectiveness.