title: Effectiveness of a nurse educational oral feeding programme on feeding outcomes in neonates: protocol for an interrupted time series design.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  NCT02404272 (https://clinicaltrials.gov).
authors.affiliation: Hospices Civils de Lyon, Pôle Information Médicale Évaluation Recherche, Lyon F-69003, France Universite de Lyon, EA Laboratoire Health Services and Performance Research (HESPER) 7425, Lyon F-69008, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Touzet
authors.affiliation: Hospices Civils de Lyon, Hopital Femme Mère Enfant, Department of Neonatal Intensive Care Unit, Bron F-69500, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Beissel
authors.affiliation: Hospices Civils de Lyon, Pôle Information Médicale Évaluation Recherche, Lyon F-69003, France.
authors.forename: Angélique
authors.initials: A
authors.lastname: Denis
authors.affiliation: Hospices Civils de Lyon, Hopital Femme Mère Enfant, Department of Neonatal Intensive Care Unit, Bron F-69500, France.
authors.forename: Fabienne
authors.initials: F
authors.lastname: Pillet
authors.affiliation: Hospices Civils de Lyon, Hopital Femme Mère Enfant, Department of Neonatal Intensive Care Unit, Bron F-69500, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Gauthier-Moulinier
authors.affiliation: Hospices Civils de Lyon, Pôle Information Médicale Évaluation Recherche, Lyon F-69003, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Hommey
authors.affiliation: Hospices Civils de Lyon, Hopital Femme Mère Enfant, Department of Neonatal Intensive Care Unit, Bron F-69500, France Universite de Lyon, EA Santé Individu Société (SIS) 4128, Lyon F-69002, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Claris
mesh_terms: D001903:Bottle Feeding; D004750:Enteral Nutrition / Q000379:methods*; D005247:Feeding Behavior; D005260:Female; D005602:France; D006801:Humans; D007224:Infant Care / Q000379:methods; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D007234:Infant, Premature; D065186:Interrupted Time Series Analysis; D008297:Male; D015402:Nursing Education Research / Q000379:methods; D015403:Nursing Evaluation Research; D013391:Sucking Behavior
keywords: Feeding skills; Interrupted time series design; Oral feeding nurse program