Effectiveness of an Oral Feeding Educational Nurse Program on Feeding Performance in Preterm Neonates (TOP)

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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Neonates and Feeding
• Intervention / Treatment: Other: Educational oral feeding nurse program

• Study Type: Observational
• Enrollment (Actual): 729

Contacts and Locations

Study Locations

• France
  • Lyon
    • Bron, Lyon, France, 69500
      • Hôpital Femme-Mère-Enfant des Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Preterm neonates; All preterm neonates of less than 34 weeks' of gestation admitted to the Neonatology and Neonatal Intensive Care unit of an university hospital located in Lyon, France

Other: Educational oral feeding nurse program; A multidisciplinary group composed of childcare assistants, nurse guardians, speech therapist, physiotherapist, psychologist, and pediatricians will develop and implement the educational oral feeding program. They will provide the 2-day theoretical session as well as the three 2-hour practical sessions including reviews of video recording preterm neonates during bottle or breast feedings. The program will focus on non-nutritive sucking for all neonates from 24 up to 34 weeks' of gestation, early oral feeding from 29 weeks' of gestation and oral stimulation for all preterm neonates admitted to the unit. Additionally, all preterm neonates presenting feeding difficulties symptoms will be evaluated weekly by a physiotherapist or speech therapist. Each program session is composed of 20 nurses or childcare assistants. Six sessions will be organized in total and all nurses and childcare assistants will be trained

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean age per month of full oral feeding achievement	The age (real and corrected) of weaning of naso-gastric tube of preterm neonates taken out of hospitalization during the month will be computed by subtracting the date of weaning from the date of birth.	Monthly for 34 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of preterm neonates presenting with feeding difficulty symptoms	Preterm neonates will be considered as presenting with feeding difficulty symptoms if they present : no demonstration of hunger cues and/or,; Coughing,choking or vomiting during bottle or breast feeding and/or,; Feed intake exceeding 30 minutes and/or,; Excitement, discomfort or arching of the back during feedings and/or,; Gagging or falling asleep during feedings and/or,; Refusal to feed. The monthly rate of neonates presenting feeding difficulty symptoms will correspond to the total number of neonates presenting feeding difficulty symptoms divided by the number of neonates hospitalized during the month.	Monthly for 34 months
Mean length of hospital stay per month		Monthly for 34 months
Morbidity and mortality per month	The rate of following neonatal pathologies will be studied : Bronchopulmonary dysplasia,; Necrotizing enterocolitis,; Periventricular leukomalacia,; Intra-ventricular haemorrhage,; Premature retinopathy,; Hypoxic ischaemic encephalopathy.	Monthly for 34 months
Nurses and childcare assistants' satisfaction concerning the educational session	The opinion of nurses and childcare assistants will be collected about the program contents, the organization and the results waited on their practices of care. The qualities of teaching will be assessed by a 5-point Likert scale.	34 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Study Director: Fabienne PILLET, Hôpital Femme-Mère-Enfant des Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: March 13, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: training; Neonate; quality of health care; oral feeding disorder; full oral feeding
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: D50855