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Comparative Effectiveness of Prophylactic Therapies for Necrotizing Enterocolitis in Preterm Infants: Protocol for a
Behnam Sadeghirad1,2, Ivan D Florez1,3, Yaping Chang1
1Department of Health Research Methods, Evidence, and Impact (HEI), McMaster University, Hamilton, ON, Canada.
Insights
This study compares therapies to prevent necrotizing enterocolitis (NEC) in premature infants. It aims to provide evidence for optimal NEC prevention strategies, improving infant outcomes.
Area of Science:
- Neonatal Medicine
- Pediatric Gastroenterology
- Evidence-Based Medicine
Background:
- Necrotizing enterocolitis (NEC) is a severe gastrointestinal disease affecting premature infants, characterized by high morbidity and mortality.
- Existing research on NEC prevention lacks comprehensive comparisons of available therapies, hindering evidence-based clinical decision-making.
- Identifying effective preventive strategies is crucial for improving outcomes in vulnerable preterm and low birth weight infants.
Purpose of the Study:
- To systematically identify and evaluate all eligible trials assessing preventive interventions for necrotizing enterocolitis (NEC) in preterm and/or low birth weight infants.
- To compare the efficacy and safety of various NEC preventive therapies through conventional and network meta-analyses.
- To provide a comprehensive overview of evidence for NEC prevention, informing clinical practice and future research.
Main Methods:
- A systematic literature search will be conducted across multiple databases (MEDLINE, EMBASE, etc.) and grey literature.
- Eligible studies will include randomized trials in preterm or low birth weight infants comparing preventive interventions to placebo or other interventions.
- Conventional and network meta-analyses will be performed to assess outcomes including severe NEC, mortality, sepsis, and hospitalization duration, with certainty assessed using GRADE.
Main Results:
- The study will synthesize data from eligible randomized controlled trials on NEC preventive therapies.
- Meta-analyses will quantify the relative effects of different interventions on key clinical outcomes.
- The certainty of evidence for direct, indirect, and network estimates will be rigorously assessed.
Conclusions:
- This systematic review and meta-analysis will provide a robust comparison of NEC preventive therapies.
- Findings will address current literature limitations, offering valuable insights for optimizing NEC prevention in clinical settings.
- The study aims to contribute to improved survival and reduced long-term complications for infants at risk of NEC.
Abstract:
Necrotizing enterocolitis (NEC) is a common and devastating disease with high morbidity and mortality in premature infants. Current literature on the prevention of NEC has limitations including lack of direct and indirect comparisons of available therapies. We will search MEDLINE, EMBASE, Science Citation Index Expanded, Social Sciences Citation Index, CINAHL, Scopus, ProQuest Dissertations and Theses database, and grey literature sources to identify eligible trials evaluating NEC preventive therapies. Eligible studies will (1) enroll preterm (gestational age <37 weeks) and/or low birth weight (birth weight <2500 g) infants, (2) randomize infants to any preventive intervention or a placebo, or alternative active or nonactive intervention. Our outcomes of interest are severe NEC (stage II or more, based on Bell's criteria), all-cause mortality, NEC-related mortality, late-onset sepsis, duration of hospitalization, weight gain, time to establish full enteral feeds, and treatment-related adverse events. Two reviewers will independently screen trials for eligibility, assess risk of bias, and extract data. All discrepancies will be resolved by discussion. We will specify a priori explanations for heterogeneity between studies. For available comparisons between treatment and no treatment, and direct comparisons of treatments, we will conduct conventional meta-analysis using a random effects model. We will conduct a network meta-analysis using a random effects model within the Bayesian framework using Markov chain Monte Carlo methods to assess relative effects of eligible interventions. We will assess the certainty in direct, indirect, and network estimates using the Grading of Recommendations Assessment, Development and Evaluation approach.
Ethics And Dissemination:
We will disseminate our findings through a peer-reviewed publication and conference presentations.
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