Preterm Neonates and FeedingTOPNCT02404272
Effectiveness of an Oral Feeding Educational Nurse Program on Feeding Performance in Preterm Neonates
An observational study of Preterm Neonates and Feeding, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 34 weeks
- Conditions the study is for
- Preterm Neonates and Feeding
- What is being tested?
- Educational oral feeding nurse program
- Type of treatment
- Pill or oral medicine
- How many people
- 729 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 34 weeks
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Femme-Mère-Enfant des Hospices Civils de Lyon
Bron, Lyon, 69500
About this study
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
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.
- Conditions
- Preterm Neonates and Feeding
- Being tested
- Educational oral feeding nurse program
- Keywords
- Neonate, oral feeding disorder, full oral feeding, training, quality of health care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational oral feeding nurse programOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Educational oral feeding nurse program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Monthly for 34 months
Secondary outcomes (4)
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.
Measured: Monthly for 34 months
Mean length of hospital stay per month
Measured: 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.
Measured: 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.
Measured: 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startApr 2013
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm Neonates and FeedingStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 729 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne PILLET, Study director, Hôpital Femme-Mère-Enfant des Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404272
- Sponsor's protocol ID
- D50855
- Acronym
- TOP
- Status last verified
- Mar 2017
- First submitted
- 13 Mar 2015
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27084282
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02404272
- Acronym / sponsor ID
- TOP / D50855
- Conditions
- Preterm Neonates and Feeding
- Keywords
- Neonate, oral feeding disorder, full oral feeding, training, quality of health care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 729 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm neonates | – | Other: Educational oral feeding nurse programAll 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 |
Who may qualify
- Ages
- 24 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (7 listed)
- 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
- Preterm neonates presenting delivery age above 34 weeks' of gestation
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational oral feeding nurse programA 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 | Other | Preterm neonates |
Primary outcome
Mean age per month of full oral feeding achievement
Time frame: Monthly for 34 months
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.
4 secondary outcomes
Percent of preterm neonates presenting with feeding difficulty symptoms
Time frame: Monthly for 34 months
Mean length of hospital stay per month
Time frame: Monthly for 34 months
Morbidity and mortality per month
Time frame: Monthly for 34 months
Nurses and childcare assistants' satisfaction concerning the educational session
Time frame: 34 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Derived from this study: PubMed 27084282Touzet 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.
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Preterm, Preterm Infant Development
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Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding Outcomes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabienne PILLET study director
Hôpital Femme-Mère-Enfant des Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Neonates and Feeding, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean age per month of full oral feeding achievement (time frame: Monthly for 34 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02404272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.