Effectiveness of a nurse educational oral feeding programme on feeding outcomes in neonates: protocol for an interrupted time series design

Sandrine Touzet, Anne Beissel, Angélique Denis, Fabienne Pillet, Hélène Gauthier-Moulinier, Sophie Hommey, Olivier Claris, TOP Study Group, Celine Bellet, Isabelle Conti, Fabienne Deruy, Fabienne Doiret, Laetitia Fernandez, Anne-Sophie Goyet, Caroline Keita, Sophie Laborie, Marie-Annick Le Pogam, Cateina Maggi-Perpoint, Anne-Sophie Magrou, Pauline Occelli, Franck Plaisant, Helene Tarifa-Buisson, Sandrine Touzet, Anne Beissel, Angélique Denis, Fabienne Pillet, Hélène Gauthier-Moulinier, Sophie Hommey, Olivier Claris, TOP Study Group, Celine Bellet, Isabelle Conti, Fabienne Deruy, Fabienne Doiret, Laetitia Fernandez, Anne-Sophie Goyet, Caroline Keita, Sophie Laborie, Marie-Annick Le Pogam, Cateina Maggi-Perpoint, Anne-Sophie Magrou, Pauline Occelli, Franck Plaisant, Helene Tarifa-Buisson

Abstract

Introduction: Oral feeding is a complex physiological process. Several scales have been developed to assess the ability of the neonate to begin suck feedings and assist caregivers in determining feeding advancement. However, feeding premature neonates remains an ongoing challenge and depends above all on caregivers' feeding expertise. We will evaluate the effect of a nurse training programme on the achievement of full oral feeding with premature neonates.

Methods and analysis: The study design will be an interrupted time series design with 3 phases: (1) A 6-month baseline period; (2) a 22-month intervention period and (3) a 6-month postintervention period. The intervention will consist of an educational programme, for nurses and assistant nurses, on feeding patterns in neonates. The training modules will be composed of a 2-day conference, 2 interactive multidisciplinary workshops, and routine practice nurse coaching. A total of 120 nurses and 12 assistant nurses, who work at the neonatal unit during the study period, will participate in the study. All premature neonates of <34 weeks postmenstrual age (PMA) will be included. The primary outcome will be the age of tube withdrawal PMA and chronological age are taken into account. The secondary outcomes will be the transition time, length of hospital stay, competent suckle feeding without cardiorespiratory compromise, rate of neonates presenting with feeding issues or feeding rejection signs, and current neonatal pathologies or deaths during hospital stay. A segmented regression analysis will be performed to assess the impact of the programme.

Ethics and dissemination: Approval for the study was obtained from the Hospital Ethics Committee, and the Institutional Review Board, as well as the French Data Protection Agency. The findings from the study will be disseminated through peer-reviewed journals, national and international conference presentations and public events.

Trial registration number: NCT02404272 (https://clinicaltrials.gov).

Keywords: Feeding skills; Interrupted time series design; Oral feeding nurse program.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Figures

Figure 1
Figure 1
The standardised individualised feeding protocol. This figure describes the oral and perioral stimulation gestures. PMA, postmenstrual age.
Figure 2
Figure 2
Oral-motor rehabilitation. Infants presenting with an oral stimulation refusal or marked vomiting reflex will benefit from the oral-motor rehabilitation protocol described in diagram 1. Infants presenting with feeding difficulties (excluding the stimulation refusal or marked vomiting reflex) will benefit from the oral-motor rehabilitation protocol described in diagrams 1 and 2.

References

    1. Jadcherla SR, Wang M, Vijayapal AS et al. . Impact of prematurity and co-morbidities on feeding milestones in neonates: a retrospective study. J Perinatol 2010;30:201–8. 10.1038/jp.2009.149
    1. Mercado-Deane MG, Burton EM, Harlow SA et al. . Swallowing dysfunction in infants less than 1 year of age. Pediatr Radiol 2001;31:423–8. 10.1007/s002470100456
    1. Lau C, Smith EO, Schanler RJ. Coordination of suck-swallow and swallow respiration in preterm infants. Acta Paediatr 2003;92:721–7. 10.1111/j.1651-2227.2003.tb00607.x
    1. Thoyre SM, Shaker CS, Pridham KF. The early feeding skills assessment for preterm infants. Neonatal Netw 2005;24:7–16. 10.1891/0730-0832.24.3.7
    1. Schmitt SK, Sneed L, Phibbs CS. Costs of newborn care in California: a population-based study. Pediatrics 2006;117:154–60. 10.1542/peds.2005-0484
    1. Rommel N, De Meyer A, Feenstra L et al. . The complexity of feeding problems in 700 infants and young children presenting to a tertiary care institution. J Pediatr Gastroenterol Nutr 2003;37:75–84. 10.1097/00005176-200307000-00014
    1. Pinelli J, Symington A. Non-nutritive sucking for promoting physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev 2005;(4):CD001071 10.1002/14651858.CD001071.pub2
    1. Pridham KF, Sondel S, Chang A et al. . Nipple feeding for preterm infants with bronchopulmonary dysplasia. J Obstet Gynecol Neonatal Nurs 1993;22:147–55. 10.1111/j.1552-6909.1993.tb01794.x
    1. Simpson C, Schanler RJ, Lau C. Early introduction of oral feeding in preterm infants. Pediatrics 2002;110:517–22. 10.1542/peds.110.3.517
    1. Arvedson J, Clark H, Lazarus C et al. . Evidence-based systematic review: effects of oral motor interventions on feeding and swallowing in preterm infants. Am J Speech Lang Pathol 2010;19:321–40. 10.1044/1058-0360(2010/09-0067)
    1. Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr 2002;141:230–6. 10.1067/mpd.2002.125731
    1. Lessen BS. Effect of the premature infant oral motor intervention on feeding progression and length of stay in preterm infants. Adv Neonatal Care 2011;11:129–39. 10.1097/ANC.0b013e3182115a2a
    1. Kish MZ. Oral feeding readiness in preterm infants: a concept analysis. Adv Neonatal Care 2013;13:230–7. 10.1097/ANC.0b013e318281e04e
    1. Bingham PM, Ashikaga T, Abbasi S. Relationship of neonatal oral motor assessment scale to feeding performance of premature infants. J Neonatal Nurs 2012;18:30–6. 10.1016/j.jnn.2010.09.004
    1. Fujinaga CI, de Moraes SA, Zamberlan-Amorim NE et al. . Clinical validation of the Preterm Oral Feeding Readiness Assessment Scale. Rev Lat Am Enfermagem 2013;21 Spec No:140–5. 10.1590/S0104-11692013000700018
    1. Crowe L, Chang A, Wallace K. Instruments for assessing readiness to commence suck feeds in preterm infants: effects on time to establish full oral feeding and duration of hospitalisation. Cochrane Database Syst Rev 2012;4:CD005586 10.1002/14651858.CD005586.pub2
    1. Hawdon JM, Beauregard N, Slattery J et al. . Identification of neonates at risk of developing feeding problems in infancy. Dev Med Child Neurol 2000;42:235–9. 10.1017/S0012162200000402
    1. Als H, Lawhon G, Brown E et al. . Individualized behavioral and environmental care for the very low birth weight preterm infant at high risk for bronchopulmonary dysplasia: neonatal intensive care unit and developmental outcome. Pediatrics 1986;78:1123–32.
    1. Ross ES, Philbin MK. Supporting oral feeding in fragile infants: an evidence-based method for quality bottle-feedings of preterm, ill, and fragile infants. J Perinat Neonatal Nurs 2011;25:349–57. 10.1097/JPN.0b013e318234ac7a
    1. Stark AR, American Academy of Pediatrics Committee on Fetus and Newborn. Levels of neonatal care. Pediatrics 2004;114:1341–7. 10.1542/peds.2004-1697
    1. Engle WA, American Academy of Pediatrics Committee on Fetus and Newborn. Age terminology during the perinatal period. Pediatrics 2004;114:1362–4. 10.1542/peds.2004-1915
    1. Rocha AD, Moreira MEL, Pimenta HP et al. . A randomized study of the efficacy of sensory-motor-oral stimulation and non-nutritive sucking in very low birthweight infant. Early Hum Dev 2007;83:385–8. 10.1016/j.earlhumdev.2006.08.003
    1. Wagner AK, Soumerai SB, Zhang F et al. . Segmented regression analysis of interrupted time series studies in medication use research. Clin Pharm Ther 2002;27:299–309. 10.1046/j.1365-2710.2002.00430.x
    1. French Health Authority. Statistical process control 2004:92
    1. Gennattasio A, Perri EA, Baranek D et al. . Oral feeding readiness assessment in premature infants. MCN Am J Matern Child Nurs 2015;40:96–104; E9–10 10.1097/NMC.0000000000000115
    1. Pimenta HP, Moreira ME, Rocha AD et al. . Effects of non-nutritive sucking and oral stimulation on breastfeeding rates for preterm, low birth weight infants: a randomized clinical trial. J Pediatr (Rio J) 2008;84:423–7. 10.2223/JPED.1839
    1. Palmer MM, Crawley K, Blanco IA. Neonatal Oral-Motor Assessment scale: a reliability study. J Perinatol 1993;13:28–35.
    1. Kirk AT, Alder SC, King JD. Cue-based oral feeding clinical pathway results in earlier attainment of full oral feeding in premature infants. J Perinatol 2007;27:572–8. 10.1038/sj.jp.7211791
    1. .
    1. Marcellus L, Harrison A, Mackinnon K. Quality improvement for neonatal nurses, part II: using a PDSA quality improvement cycle approach to implement an oral feeding progression guideline for premature infants. Neonatal Netw 2012;31:215–22.
    1. Harding C. An evaluation of the benefits of non-nutritive sucking for premature infants as described in the literature. Arch Dis Child 2009;94:636–40. 10.1136/adc.2008.144204
    1. Lee TY, Lee TT, Kuo SC. The experiences of mothers in breastfeeding their very low birth weight infants. J Adv Nurs 2009;65:2523–31. 10.1111/j.1365-2648.2009.05116.x
    1. Flodgren G, Parmelli E, Doumit G et al. . Local opinion leaders: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2011;(8):CD000125 10.1002/14651858.CD000125.pub4
    1. Davis D, O'Brien MAT, Freemantle N et al. . Impact of formal continuing medical education. Do conferences, workshops, rounds, and other traditional continuing education activities change physician behavior or health care outcomes? JAMA 1999;282:867–74.
    1. Thomson O'Brien MA, Freemantle N, Oxman AD et al. . Continuing education meetings and workshops: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 2001;(2):CD003030 10.1002/14651858.CD003030
    1. Gallagher L. Continuing education in nursing: a concept analysis. Nurse Educ Today 2007;27:466–73. 10.1016/j.nedt.2006.08.007
    1. Cook TD, Campbell DT. Quasi-experiments: interrupted time-series designs in quasi-experimentation: design and analysis issues for field settings. Houghton Mifflin Company, 1979.
    1. Ramsey CR, Matowe L, Grilli R et al. . Interrupted time series designs in health technology assessment: lessons from two systematic reviews of behaviour change strategies. Int J Technol Assess Health Care 2003;19:613–23.
    1. Shadish WR, Cook TD, Campbell DT. Quasi-experiments: interrupted time-series designs. Experimental and Quasi-Experimental Designs for Generalised Causal Inference. Boston: Houghton Mifflin, 2002:171–206.
    1. Taljaard M, McKenzie JE, Ramsay CR et al. . The use of segmented regression in analysing interrupted time series studies: an example in pre-hospital ambulance care. Implement Sci 2014;9:77 10.1186/1748-5908-9-77
    1. Hanbury A, Farley K, Thompson C et al. . Immediate versus sustained effects: interrupted time series analysis of a tailored intervention. Implement Sci 2013;8:130 10.1186/1748-5908-8-130
    1. Hopewell S, Ravaud P, Baron G et al. . Effect of editors’ implementation of CONSORT guidelines on the reporting of abstracts in high impact medical journals: interrupted time series analysis. BMJ 2012;344:e4178.
    1. Bero L, Grilli R, Grimshaw JM et al. . The Cochrane Effective Practice and Organisation of Care Group (EPOC) Module. Oxford: The Cochrane Library, 2002. Issue 1. Update Software.
    1. Fretheim A, Soumerai SB, Zhang F et al. . Interrupted time-series analysis yielded an effect estimate concordant with the cluster-randomized controlled trial result. J Clin Epidemiol 2013;66:883–7. 10.1016/j.jclinepi.2013.03.016
    1. Lépée C, Klaber RE, Benn J et al. . The use of a consultant-led ward round checklist to improve paediatric prescribing: an interrupted time series study. Eur J Pediatr 2012;171:1239–45. 10.1007/s00431-012-1751-3
    1. Bastuji-Garin S, Sbidian E, Gaudy-Marqueste C et al. , European Dermatology Network (EDEN). Impact of STROBE statement publication on quality of observational study reporting: interrupted time series versus before-after analysis. PLoS ONE 2013;8:e64733 10.1371/journal.pone.0064733
    1. Bussières AE, Sales AE, Ramsay T et al. . Impact of imaging guidelines on X-ray use among American provider network chiropractors: interrupted time series analysis. Spine J 2014;14:1501–9. 10.1016/j.spinee.2013.08.051
    1. Colombet I, Sabatier B, Gillaizeau F et al. . Long-term effects of a multifaceted intervention to encourage the choice of the oral route for proton pump inhibitors: an interrupted time-series analysis. Qual Saf Health Care 2009;18:232–5. 10.1136/qshc.2007.023887

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera