Clinical trial NCT02404272: Effectiveness of an Oral Feeding Educational Nurse Program on Feeding Performance in Preterm Neonates
Official title: Evaluation de la Formation Des infirmières à la Stimulation de l'oralité Des Nouveau-nés Dans Une unité de Réanimation néonatale et Néonatologie : Impact Sur Les Connaissances, Les Pratiques et Sur la qualité Des Soins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Neonates and Feeding
Keywords: Neonate
oral feeding disorder
full oral feeding
training
quality of health care
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 729
Sex: ALL
Minimum age (years): 24
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm neonates of less than 34 weeks' of gestation requiring no surgery with endotracheal intubation admitted to the Neonatology or Neonatal Intensive Care Unit of an university hospital, Lyon.

Brief summary: Poor oral motor development in preterm neonates is common. Feeding problems lead to longer hospital stay and higher hospital cost. Different interventions have shown their efficacy to accelerate transition and move faster to full oral feeding autonomy. Our study aimed to evaluate the impact of a 2-year education nurse program on feeding pattern and hospital stay of preterm neonates.

This is an interrupted time series study placed in Intensive Care and Neonatal unit of an university hospital located in Lyon, France. All preterm neonates are included in the study, from April 2013 to January 2016.


Eligibility criteria: Inclusion Criteria:

* Preterm neonates of less than 34 weeks' of gestation
* Preterm neonates not requiring surgery with endotracheal intubation
* Preterm neonates hospitalized in the Neonatology and Neonatal Intensive Care Unit of an university hospital, Lyon.
* Preterm neonates discharged from hospital during the study period from April 2013 to January 2016

  --- Exclusion Criteria:
* Preterm neonates presenting delivery age above 34 weeks' of gestation
* Preterm neonates whose parents have expressed their opposition to participate to the study

Primary outcomes:
measure: Mean age per month of full oral feeding achievement
timeFrame: Monthly for 34 months
Secondary outcomes:
measure: Percent of preterm neonates presenting with feeding difficulty symptoms
timeFrame: Monthly for 34 months
measure: Mean length of hospital stay per month
timeFrame: Monthly for 34 months
measure: Morbidity and mortality per month
timeFrame: Monthly for 34 months
measure: Nurses and childcare assistants' satisfaction concerning the educational session
timeFrame: 34 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme-Mère-Enfant des Hospices Civils de Lyon
state: Lyon
Study officials:
affiliation: Hôpital Femme-Mère-Enfant des Hospices Civils de Lyon
name: Fabienne PILLET
role: STUDY_DIRECTOR
References:
citation: Touzet S, Beissel A, Denis A, Pillet F, Gauthier-Moulinier H, Hommey S, Claris O; TOP Study Group. Effectiveness of a nurse educational oral feeding programme on feeding outcomes in neonates: protocol for an interrupted time series design. BMJ Open. 2016 Apr 15;6(4):e010699. doi: 10.1136/bmjopen-2015-010699.