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Original Investigation | Journal Club, Comparative Effectiveness Research

Effectiveness of Fundoplication at the Time of Gastrostomy in Infants With Neurological Impairment

Douglas C. Barnhart, MD, MSPH1; Matthew Hall, PhD2; Sanjay Mahant, MD, FRCPC, MSc3; Adam B. Goldin, MD, MPH4; Jay G. Berry, MD, MPH5; Roger G. Faix, MD6; J. Michael Dean, MD6; Rajendu Srivastava, MD, FRCPC, MPH6
[+] Author Affiliations
1Department of Surgery, Primary Children’s Medical Center, University of Utah, Salt Lake City
2Children’s Hospital Association, Overland Park, Missouri
3Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada
4Department of Surgery, Seattle Children’s Hospital, University of Washington, Seattle
5Department of Pediatrics, Harvard Medical School, Boston, Massachusetts
6Department of Pediatrics, Primary Children’s Medical Center, University of Utah, Salt Lake City
JAMA Pediatr. 2013;167(10):911-918. doi:10.1001/jamapediatrics.2013.334.
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Importance  Gastrostomy tube (GT) placement is the most common gastrointestinal operation performed on neonates. Concomitant fundoplication is used variably to prevent complications of gastroesophageal reflux, but its effectiveness is unproven.

Objective  To compare the effect of fundoplication at the time of GT placement vs GT placement alone on subsequent reflux-related hospitalizations in infants with neurological impairment.

Design, Setting, and Participants  Retrospective, observational cohort study, defined by birth between January 1, 2005, and December 31, 2010, at 42 children’s hospitals in the United States, with a 1-year follow-up period among 4163 infants with neurological impairment who underwent GT placement with or without fundoplication during their neonatal intensive care unit stay.

Intervention  Fundoplication and GT placement vs GT placement alone.

Main Outcomes and Measures  One-year postprocedural reflux-related hospitalization rates, defined as hospitalization for asthma, mechanical ventilation, gastroesophageal reflux disease, and aspiration or other types of pneumonia. Propensity to undergo concomitant fundoplication was modeled using demographics, prior procedures (tracheostomy and mechanical ventilation), and prior diagnoses (eg, pneumonia, gastroesophageal reflux disease, and other comorbidities).

Results  Overall, 4163 of 42 796 infants (9.7%) with neurological impairment admitted to the neonatal intensive care unit underwent GT placement alone or with fundoplication. Infants who concomitantly underwent fundoplication had more reflux-related hospitalizations during the first year than those who underwent GT placement alone (mean, 1.02; 95% CI, 0.93-1.10 vs mean, 0.92; 95% CI, 0.91-1.00). Of 1404 infants who underwent fundoplication, 1027 (73.1%) were matched based on propensity scores. The mean difference of the matched cohort for any reflux-related hospitalizations was −0.05 (95% CI, −0.20 to 0.15) per year.

Conclusions and Relevance  Infants with neurological impairment who underwent fundoplication at the time of GT placement did not have a reduced rate of reflux-related hospitalizations during the first year compared with those who underwent GT placement alone, despite propensity score matching. This may be due to a lack of effectiveness of fundoplication in preventing these complications or due to differences in the patient groups that were inadequately accounted for in the matching.

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Figure 1.
Cohort of Infants With Neurological Impairment Who Underwent Gastrostomy Tube (GT) Placement

NICU indicates neonatal intensive care unit; PHIS, Pediatric Health Information System.

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Figure 2.
Percentage of Infants Who Underwent Concomitant Fundoplication by Center and Overall Volume of Gastrostomy Tube (GT) Placement by Center

Shown are each hospital’s volume of gastrostomies in infants with neurological impairment and the percentage who underwent concomitant fundoplication.

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