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RATIONALE: Children with neurological impairment (NI) represent a vulnerable pediatric population who often experience multiple co-occurring chronic conditions and may develop worsening comorbidities over time due to primary dysfunctions of the nervous system. Among the most significant of these are gastro-esophageal reflux (GER) and dysphagia, which likely account for much of the associated morbidity and mortality. There is substantial variation in the management of GER, and few studies have been conducted to evaluate the effects of antireflux procedures in preventing and improving outcomes in this population. OBJECTIVES: To assess the benefits and harms of the two most common enteral feeding tubes and associated antireflux procedures. We aimed to compare: 1) gastrostomy tube (GT) plus fundoplication, 2) gastrostomy plus insertion of a gastro-jejunal (GJ) tube, and 3) GT alone for treating or preventing GER in children and adolescents with NI. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, six other databases, and two trials registers, together with reference checking and contact with two experts in the field, to identify studies for inclusion in the review. There were no restrictions on language. The latest search date was 17 September 2024. ELIGIBILITY CRITERIA: Randomized controlled trials (RCTs) and non-randomized studies of interventions (NRSIs) in children with NI, with or without GER, comparing the three interventions. We excluded studies of neurologically normal children. OUTCOMES: Our critical outcomes were symptoms of GER and mortality. Important outcomes included major surgical complications (perforation or peritonitis), length of stay (LOS), number of hospitalizations for respiratory morbidity (pneumonia), number of emergency department (ED) visits, and child's quality of life (QoL). RISK OF BIAS: We used the ROBINS-I tool to assess bias in NRSIs. We did not find any RCTs. SYNTHESIS METHODS: We meta-analyzed the results for each outcome where possible (inverse-variance, random-effects). Where this was precluded by the nature of the data, we synthesized results according to Synthesis Without Meta-analysis (SWiM) guidelines. We used GRADE to assess the certainty of evidence. INCLUDED STUDIES: We included 11 NRSIs with a total of 3122 children with NI. Among these, seven cohort studies compared GT plus fundoplication versus GT alone (2654 participants); one cohort study compared GJ tubes versus GT alone (50 participants); and three cohort studies compared GT plus fundoplication versus GJ tubes (418 participants). SYNTHESIS OF RESULTS: GT plus fundoplication compared to GT alone for GER in children with NI The evidence is very uncertain about the effect of GT plus fundoplication on symptoms of GER (odds ratio OR 2.02, 95% confidence interval CI 0.64 to 6.44; 3 NRSIs, 180 participants; very low-certainty evidence); mortality (OR 2.62, 95% CI 0.41 to 16.80; 3 NRSIs, 415 participants; very low-certainty evidence); major surgical complications (OR 2.61, 95% CI 0.46 to 14.87; 3 NRSIs, 412 participants; very low-certainty evidence); and LOS (1 NRSI with no comparison, 130 participants; very low-certainty evidence). GT plus fundoplication may result in little to no difference in the number of hospitalizations for pneumonia (mean difference MD 0.04 higher, 95% CI 0.01 lower to 0.09 higher; 1 NRSI, 2054 participants; low-certainty evidence). The evidence is very uncertain about the effect of GT plus fundoplication on the number of ED visits (OR 1.82, 95% CI 0.78 to 4.27; 1 NRSI, 130 participants; very low-certainty evidence). Child's QoL was not reported. GJ tubes compared to GT alone for GER in children with NI The evidence is very uncertain about the effect of GJ tubes on mortality (OR 5.38, 95% CI 0.40 to 73.09; 1 NRSI, 50 participants; very low-certainty evidence) and child's QoL (effect estimate not reported; no effect of the type of tube on quality of life; 1 prospective NRSI, 50 participants; very low-certainty evidence). Symptoms of GER, major surgical complications, LOS, number of hospitalizations for respiratory morbidity (pneumonia), and number of ED visits were not reported. GT plus fundoplication compared to GJ tubes for GER in children with NI The evidence is very uncertain about the effect of GT plus fundoplication on symptoms of GER (3 NRSIs with conflicting results, including 1 unmatched cohort, 1531 participants; very low-certainty evidence); mortality (OR 1.12, 95% CI 0.52 to 2.41; 3 NRSIs, 418 participants; very low-certainty evidence); major surgical complications (OR 2.84, 95% CI 0.45 to 17.82; 2 NRSIs, 190 participants; very low-certainty evidence); and LOS (1 NRSI with no comparison, 79 participants; very low-certainty evidence). GT plus fundoplication may result in little to no difference in the number of hospitalizations for pneumonia (MD 0.05 lower, 95% CI 0.21 lower to 0.11 higher; 1 NRSI, 228 participants; low-certainty evidence). Number of ED visits and child's QoL were not reported. We downgraded the certainty of evidence for risk of bias and imprecision. Most studies were at serious risk of bias due to confounding, except for hospitalizations for pneumonia for the comparisons of GT plus fundoplication versus GT alone and versus GJ tubes. AUTHORS' CONCLUSIONS: In children with NI, the evidence is very uncertain about the effect of GT plus fundoplication on symptoms of GER, mortality, major surgical complications, and LOS, when compared to GT alone or GJ tubes (very low-certainty evidence). GT plus fundoplication may result in little to no difference in the number of hospitalizations for pneumonia when compared to GT alone or GJ tubes (low-certainty evidence). The evidence is very uncertain about the effect of GT plus fundoplication on the number of ED visits when compared to GT alone (very low-certainty evidence). The evidence is very uncertain about the effect of GJ tubes on mortality and child's QoL when compared to GT alone (very low-certainty evidence). We found no RCTs, and our results should be interpreted with caution due to the limited number of studies and the limitations of NRSIs. Additional research is necessary. It is likely that RCTs will be difficult to conduct; however, better-designed NRSIs could improve the quality of evidence in this area. FUNDING: This review was funded by Foundation Fresno, Universidad Católica de Chile, for librarian support only. The foundation had no role in the design or conduct of this review. REGISTRATION: Protocol available via DOI: 10.1002/14651858.CD015007.
Flores et al. (Wed,) studied this question.