Immature NewbornALIJEUNCT03651258
Facilitate the Transition From Passive Feeding to Active Feeding in Preterm Infants Through Early Play
An observational study of Immature Newborn and Feeding Behavior, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
The approach described here is based both on theoretical concepts and on the work of several teams of researchers. By positioning the baby and the appropriate adult, a speech bath, a sustained look and an expressive face, it is hypothesized that this early communication exercise will significantly improve the… Read more about this study
- Who is it for?
- Ages Up to 4 weeksHealthy volunteers can take part
- Conditions the study is for
- Immature Newborn, Feeding Behavior
- What is being tested?
- Implementation of ALIJEU
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2017to 30 Jul 2018
- 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 Up to 4 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Premate newborn with an age inferior to 32 weeks of amenorrhea at birth
Who may be able to join
- Age of child at birth: <32 WA justified by the greater prevalence of oral disorders in these children.
- Age of the child at the start of the study: 35 WA, ie at the beginning of the establishment of active feeding within the unit.
Who cannot join
- Children with oral malformations
- Contra-indication to the realization to the ALIJEU (infection in progress, hemodynamic instability, etc.)
- Medical contraindications to oral diet
Trial locations and contacts
1 site in 1 country.
About this study
The approach described here is based both on theoretical concepts and on the work of several teams of researchers. By positioning the baby and the appropriate adult, a speech bath, a sustained look and an expressive face, it is hypothesized that this early communication exercise will significantly improve the transition from passive feeding, active feeding of the premature child, from a qualitative and quantitative point of view.
- Conditions
- Immature Newborn, Feeding Behavior
- Being tested
- Implementation of ALIJEU
- Keywords
- Feeding Behavior
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of ALIJEUBehavioural
The intervention concerns the passage from the passive feed (gastric tube) to the active feed (breast, feeding bottle).
We propose to set up a pleasant moment just before his meal. This is a practical exercise of a few minutes.
The aim of this special moment is to facilitate child-adult exchanges, improve active food intake and reduce the length of hospital stay.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | patient who can benefit from the ALIJEU for certain meals Receives: Behavioral: Implementation of ALIJEU | |
| Group of witnesses | patient who did not benefit from the ALIJEU |
What is being measured
The primary outcome is the main question the study is designed to answer.
age at the stoppage of enteral nutrition
Measured: 37 weeks of gestation
Secondary outcomes (4)
Duration of feeding
Duration of the feeding in case of early game play
Measured: 37 weeks of gestation
Quantities drunk
Evaluate the quantities drunk in case of early game play
Measured: 37 weeks of gestation
Awakening
Duration of the the newborn's waking state at the time of suckling
Measured: 37 weeks of gestation
Visual analogic scale for Satisfaction from 0 to 10
Assessing the satisfaction of the ALIJEU practice for the mother and the care team
Measured: 37 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start19 Sep 2017
- Primary completion1 May 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immature NewbornStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651258
- Sponsor's protocol ID
- ALIJEU
- Acronym
- ALIJEU
- Status last verified
- Jan 2019
- First submitted
- 4 Apr 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitate the Transition From Passive Feeding to Active Feeding in Preterm Infants Through Early Play
- ClinicalTrials.gov ID
- NCT03651258
- Acronym / sponsor ID
- ALIJEU / ALIJEU
- Conditions
- Immature Newborn, Feeding Behavior
- Keywords
- Feeding Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 29 Aug 2018 (actual)
- 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.
The approach described here is based both on theoretical concepts and on the work of several teams of researchers. By positioning the baby and the appropriate adult, a speech bath, a sustained look and an expressive face, it is hypothesized that this early communication exercise will significantly improve the transition from passive feeding, active feeding of the premature child, from a qualitative and quantitative point of view.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Behavioral: Implementation of ALIJEUpatient who can benefit from the ALIJEU for certain meals |
| Group of witnesses | – | –patient who did not benefit from the ALIJEU |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Premate newborn with an age inferior to 32 weeks of amenorrhea at birth
Key inclusion criteria (2 listed)
- Age of child at birth: <32 WA justified by the greater prevalence of oral disorders in these children.
- Age of the child at the start of the study: 35 WA, ie at the beginning of the establishment of active feeding within the unit.
Key exclusion criteria (3 listed)
- Children with oral malformations
- Contra-indication to the realization to the ALIJEU (infection in progress, hemodynamic instability, etc.)
- Medical contraindications to oral diet
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 |
|---|---|---|
| Implementation of ALIJEUThe intervention concerns the passage from the passive feed (gastric tube) to the active feed (breast, feeding bottle). We propose to set up a pleasant moment just before his meal. This is a practical exercise of a few minutes. The aim of this special moment is to facilitate child-adult exchanges, improve active food intake and reduce the length of hospital stay. | Behavioural | Experimental group |
Primary outcome
age at the stoppage of enteral nutrition
Time frame: 37 weeks of gestation
4 secondary outcomes
Duration of feeding
Time frame: 37 weeks of gestation
Quantities drunk
Time frame: 37 weeks of gestation
Awakening
Time frame: 37 weeks of gestation
Visual analogic scale for Satisfaction from 0 to 10
Time frame: 37 weeks of gestation
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 15 Jan 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Immature Newborn and Feeding Behavior, run by Centre Hospitalier Intercommunal Creteil 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 2 inclusion and 3 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 15 Jan 2019. 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?
age at the stoppage of enteral nutrition (time frame: 37 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2019.