bims-hylehe Biomed News
on Hypoplastic left heart syndrome
Issue of 2020–07–05
two papers selected by
Richard James, University of Pennsylvania
  1. Stress ulcer prophylaxis versus placebo-a blinded randomized control trial to evaluate the safety of two strategies in critically ill infants with congenital heart disease (SUPPRESS-CHD).
  2. Congenital heart disease diagnosed with echocardiogram in newborns with asymptomatic cardiac murmurs: a systematic review.
  1. Trials. 2020 Jun 29. 21(1): 590
    Stress ulcer prophylaxis versus placebo-a blinded randomized control trial to evaluate the safety of two strategies in critically ill infants with congenital heart disease (SUPPRESS-CHD).
    Kimberly I Mills, Ben D Albert, Lori J Bechard, Christopher P Duggan, Aditya Kaza, Seth Rakoff-Nahoum, Hera Vlamakis, Lynn A Sleeper, Jane W Newburger, Gregory P Priebe, Nilesh M Mehta.
       BACKGROUND: Critically ill infants with congenital heart disease (CHD) are often prescribed stress ulcer prophylaxis (SUP) to prevent upper gastrointestinal bleeding, despite the low incidence of stress ulcers and limited data on the safety and efficacy of SUP in infants. Recently, SUP has been associated with an increased incidence of hospital-acquired infections, community-acquired pneumonia, and necrotizing enterocolitis. The objective of this pilot study is to investigate the feasibility of performing a randomized controlled trial to assess the safety and efficacy of withholding SUP in infants with congenital heart disease admitted to the cardiac intensive care unit.
    METHODS: A single center, prospective, double-blinded, randomized placebo-controlled pilot feasibility trial will be performed in infants with CHD admitted to the cardiac intensive care unit and anticipated to require respiratory support for > 24 h. Patients will be randomized to receive a histamine-2 receptor antagonist (H2RA) or placebo until they are discontinued from respiratory support. Randomization will be performed within 2 strata defined by admission type (medical or surgical) and age (neonate, age < 30 days, or infant, 1 month to 1 year). Allocation will be a 1:1 ratio using permuted blocks to ensure balanced allocations across the two treatment groups within each stratum. The primary outcomes include feasibility of screening, consent, timely allocation of study drug, and protocol adherence. The primary safety outcome is the rate of clinically significant upper gastrointestinal bleeding. The secondary outcomes are the difference in the relative and absolute abundance of the gut microbiota and functional microbial profiles between the two study groups. We plan to enroll 100 patients in this pilot study.
    DISCUSSION: Routine use of SUP to prevent upper gastrointestinal bleeding in infants is controversial due to a low incidence of bleeding events and concern for adverse effects. The role of SUP in infants with CHD has not been examined, and there is equipoise on the risks and benefits of withholding this therapy. In addition, this therapy has been discontinued in other neonatal populations due to the concern for hospital-acquired infections and necrotizing enterocolitis. Furthermore, exploring changes to the microbiome after exposure to SUP may highlight the mechanisms by which SUP impacts potential microbial dysbiosis of the gut and its association with hospital-acquired infections. Assessment of the feasibility of a trial of withholding SUP in critically ill infants with CHD will facilitate planning of a larger multicenter trial of safety and efficacy of SUP in this vulnerable population.
    TRIAL REGISTRATION: ClinicalTrials.gov , NCT03667703. Registered 12 September 2018, https://clinicaltrials.gov/ct2/show/NCT03667703?term=SUPPRESS+CHD&draw=2&rank=1 . All WHO Trial Registration Data Set Criteria are met in this manuscript.
    Keywords:  Congenital heart disease; Gastrointestinal hemorrhage; H2 blocker; Infection; Microbiome; Pediatric cardiac critical care; Pediatric critical care; Pediatric intensive care
    DOI:  https://doi.org/10.1186/s13063-020-04513-w
  2. BMC Pediatr. 2020 Jun 30. 20(1): 322
    Congenital heart disease diagnosed with echocardiogram in newborns with asymptomatic cardiac murmurs: a systematic review.
    Shin Ae Yoon, Woi Hyun Hong, Hwa Jin Cho.
       BACKGROUND: More than 50% of newborns with congenital heart disease (CHD) are unrecognized at birth; however, the use of echocardiogram (Echo) for diagnosing CHD in newborns with asymptomatic, non-syndromic cardiac murmurs (ANCM), has not been systematically reviewed yet. We aimed to identify the incidence of CHD diagnosed with Echo and systematically review whether Echo should be recommended in this patient group.
    METHODS: The methodology utilized in this systematic review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework. Using the MEDLINE, EMBASE, Web of Science, and Cochrane Library databases, we performed a systematic review of publications reporting CHD diagnosed with Echo in newborns with cardiac murmurs. The quality of the included studies was evaluated using the Study Quality Assessment Tools developed by the National Institutes of Health.
    RESULTS: Of the 630 studies screened, six cohort studies, four cross-sectional studies, and two case reports were included in this review. The incidence of cardiac murmurs ranged from 0.6-8.6%. Among the 1928 newborns with ANCM, 719 (37.3%) were diagnosed with Echo as having CHD, and ventricular septal defect was the most common congenital malformation. More than 50% of the newborns showed moderate CHD necessitating outpatient cardiology follow-up, and 2.5% had severe CHD requiring immediate interventions, such as cardiac catheterization and heart surgery.
    CONCLUSIONS: In this systematic review, a high incidence of CHD in newborns with ANCM was detected using Echo. This indicates that the use of Echo for diagnosing CHD in healthy newborns with cardiac murmurs could be helpful in earlier detection of CHD, thereby improving clinical outcomes for newborns with severe CHD.
    Keywords:  Asymptomatic non-syndromic cardiac murmurs; Cardiac assessment; Congenital heart disease; Echocardiogram; Newborns
    DOI:  https://doi.org/10.1186/s12887-020-02212-8
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