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Original research
Individualising care in severe bronchopulmonary dysplasia: a series of N-of-1 trials comparing transpyloric and gastric feeding
  1. Erik A Jensen1,
  2. Huayan Zhang1,
  3. Rui Feng2,
  4. Kevin Dysart1,
  5. Kathleen Nilan1,
  6. David A Munson1,
  7. Haresh Kirpalani1
  1. 1 Division of Neonatology, Department of Pediatrics, the Children's Hospital of Philadelphia and the University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA
  2. 2 Department of Biostatistics and Epidemiology, the Children's Hospital of Philadelphia and the University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104, United States
  1. Correspondence to Dr Erik A Jensen, Division of Neonatology, Department of Pediatrics, the Children's Hospital of Philadelphia and the University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104, USA; jensene{at}email.chop.edu

Abstract

Objective Compare rates of hypoxaemia during transpyloric and gastric feedings in very preterm infants with severe bronchopulmonary dysplasia.

Design N-of-1 multiple crossover trials with individual patient and pooled data analyses.

Setting Level IV intensive care nursery.

Patients Infants receiving positive airway pressure between 36 and 55 weeks postmenstrual age were enrolled between December 2014–July 2016.

Intervention N-of-1 trial consisting of two blocks, each with a 4-day gastric and 4-day transpyloric feeding period assigned in random order.

Main outcome measures The primary outcome was the frequency of daily intermittent hypoxaemic events (SpO2 ≤80% lasting 10–180 s). Secondary outcomes included the daily proportion of time with an SpO2 ≤80% and mean daily fraction of inspired oxygen.

Results Of 15 infants, 13 completed the trial and 2 stopped early for transient worsening in respiratory status during gastric feedings. In the intention-to-treat analyses, transpyloric feedings resulted in increased rates of intermittent hypoxaemia in five infants, greater time per day in hypoxaemia in three infants and more supplemental oxygen use in three infants. One infant received more supplemental oxygen during gastric feedings. The remaining study outcomes were similar between the feeding routes in all other infants. Pooling all data, transpyloric feedings resulted in a higher frequency of intermittent hypoxaemic events (median 7.5/day (IQR 1–23.5) vs 3/day (1–11); adjusted incidence rate ratio 1.8, 95% CI 1.3 to 2.5) and a greater proportion of daily hypoxaemia time (median 0.8% (IQR 0.1–2.3) vs 0.4% (0.07–1.8); adjusted mean difference 1.6, 95% CI 1.1 to 2.5).

Conclusions Transpyloric compared with gastric feedings modestly increased rates of hypoxaemia among study participants.

Trial registration number NCT02142621

  • neonatology
  • respiratory

https://doi.org/10.1136/archdischild-2019-317148

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    Footnotes

    • Contributors EAJ conceptualised and designed the study, drafted the initial and final manuscripts and collaborated with RF to perform the statistical analyses. HZ, KD, DAM, HK and KN assisted with study design, data interpretation, critically reviewed and revised the manuscript for important intellectual content and approved the final manuscript as submitted. RF assisted with study design, data analysis and interpretation, critically reviewed and revised the manuscript for important intellectual content and approved the final manuscript as submitted.

    • Funding Children’s Hospital of Philadelphia Center for Pediatric Clinical Effectiveness. EAJ was supported by a grant from the National Health, Lung, and Blood Institute (K23HL136843).

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.