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Direct swallowing training and oral sensorimotor stimulation in preterm infants: a randomised controlled trial
  1. Ju Sun Heo1,2,
  2. Ee-Kyung Kim1,
  3. Sae Yun Kim1,3,
  4. In Gyu Song1,4,
  5. Young Mi Yoon1,5,
  6. Hannah Cho1,2,
  7. Eun Sun Lee1,6,
  8. Seung Han Shin1,
  9. Byung-Mo Oh7,8,9,
  10. Hyung-Ik Shin7,9,
  11. Han-Suk Kim1
  1. 1 Department of Paediatrics, Seoul National University College of Medicine, Seoul, Korea (the Republic of)
  2. 2 Department of Paediatrics, Korea University Anam Hospital, Seoul, Korea (the Republic of)
  3. 3 Department of Paediatrics, Catholic University of Korea Yeouido Saint Mary's Hospital, Seoul, Korea (the Republic of)
  4. 4 Department of Paediatrics, Korea University Guro Hospital, Seoul, Korea (the Republic of)
  5. 5 Department of Paediatrics, Jeju National University Hospital, Jeju, Korea (the Republic of)
  6. 6 Department of Paediatrics, Chung-Ang University Hospital, Seoul, Korea (the Republic of)
  7. 7 Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul, Korea (the Republic of)
  8. 8 Department of Rehabilitation Medicine, National Traffic Injury Rehabilitation Hospital, Yangpyeong, Korea (the Republic of)
  9. 9 Department of Rehabilitation Medicine, Seoul National University Hospital, Seoul, Korea (the Republic of)
  1. Correspondence to Professor Ee-Kyung Kim, Department of Paediatrics, Seoul National University College of Medicine, Seoul, Korea (the Republic of) 03080; kimek{at}snu.ac.kr

Abstract

Objective To evaluate the effects of direct swallowing training (DST) alone and combined with oral sensorimotor stimulation (OSMS) on oral feeding ability in very preterm infants.

Design Blinded, parallel group, randomised controlled trial (1:1:1).

Setting Neonatal intensive care unit of a South Korean tertiary hospital.

Participants Preterm infants born at <32 weeks of gestation who achieved full tube feeding.

Interventions Two sessions per day were provided according to the randomly assigned groups (control: two times per day sham intervention; DST: DST and sham interventions, each once a day; DST+OSMS: DST and OSMS interventions, each once a day).

Primary outcome Time from start to independent oral feeding (IOF).

Results Analyses were conducted in 186 participants based on modified intention-to-treat (63 control; 63 DST; 60 DST+OSMS). The mean time from start to IOF differed significantly between the control, DST and DST+OSMS groups (21.1, 17.2 and 14.8 days, respectively, p=0.02). Compared with non-intervention, DST+OSMS significantly shortened the time from start to IOF (effect size: −0.49; 95% CI: −0.86 to –0.14; p=0.02), whereas DST did not. The proportion of feeding volume taken during the initial 5 min, an index of infants’ actual feeding ability when fatigue is minimal, increased earlier in the DST+OSMS than in the DST.

Conclusions In very preterm infants, DST+OSMS led to the accelerated attainment of IOF compared with non-intervention, whereas DST alone did not. The effect of DST+OSMS on oral feeding ability appeared earlier than that of DST alone.

Trial registration number ClinicalTrials.gov Registry (NCT02508571).

  • neonatology
  • rehabilitation

Data availability statement

Data are available upon reasonable request. Deidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan and the informed consent form. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to kimek@snu.ac.kr.

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Data availability statement

Data are available upon reasonable request. Deidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan and the informed consent form. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to kimek@snu.ac.kr.

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Footnotes

  • Contributors Study concept and design—JSH, E-KK and B-MO. Acquisition, analysis or interpretation of data—JSH, E-KK, SYK, IGS, YMY, HC, ESL, SHS, B-MO, H-IS and H-SK. Drafting of the manuscript—JSH. Critical revision of the manuscript for important intellectual content—E-KK and H-IS. Statistical analysis—JSH. Obtained funding—E-KK and SHS. Administrative, technical or material support—SYK, IGS, YMY, HC, ESL, B-MO and H-IS. Supervision—E-KK. JSH and E-KK had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

  • Funding This study was supported by a grant (0420170410) from the Seoul National University Hospital Research Fund and Basic Science Research Programme through the National Research Foundation of Korea (NRF) funded by the Ministry of Education (2017R1D1A1B04030931).

  • Disclaimer The funding sources had no role in the design and conduct of the study, collection, management, analysis, and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.

  • Competing interests None declared.

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

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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