Preterm InfantsNCT01116765
Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants
A study testing no stimulation of the oral structure and stimulation of the oral structure in people with Preterm Infants, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
To assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations (episodes of oxygen désaturations, and/or apnea- bradycardia), and the oral feeding performance, in preterm infants born between 26 to 29 weeks of gestation age. Read more about this study
- Who is it for?
- Ages 29 to 33 weeks
- Conditions the study is for
- Preterm Infants
- What is being tested?
- no stimulation of the oral structure and stimulation of the oral structure
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2010to 13 Apr 2023
- Phase
- Interventional
- 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 29 to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children whose born term is included between 26 and 29SA past and whose postnatal age is lower or more equal in 33SA past, at the time of the inclusion.
- Term of certain child (calculated according to the date of the last rules and\or a premature obstetric echography).
- Children devoid of neurological pathology making him(it) clinically unstable (echography transfontanellar and\or intellectual MRI, electroencephalogram normal, either, intraventricular bleeding of rank 1 and 2 of Papile [40], or, intellectual abnormalities in the MRI of type(chap) 1 - 4 according to the classification of modified Paneth [41]. (Annex X)
- Children devoid of infectious pathology making him(it) clinically unstable (Protein C-reactive lower than 7).
- In case of ebb gastroenteritis - esophageal symptomatic ( RGO): the child will be treated(handled), by oral route, by location + thickening +/-prokinetic +/-inhibitor pumps in proton.
- According to a protocol of service, all the premature babies of less than 32.
Who cannot join
- Born Child > 29 limited companies.
- Child not included at the postnatal age of 33 past(over) LIMITED COMPANIES.
- Child presenting a genic syndrome, an evolutionary neurological disease, a pathology malformative.
- Child presenting a bleeding intraventricular of rank 3-4 [ 40 ], intellectual abnormalities in the MRI of type(chap) 5 and 6 according to the classification of modified Paneth [ 41 ], an ulcer-necrotizing entérocolitis.
- Child among whom both relatives(parents) or legal representatives refused that their child participates in the study.
Trial locations and contacts
1 site in 1 country.
About this study
To assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations (episodes of oxygen désaturations, and/or apnea- bradycardia), and the oral feeding performance, in preterm infants born between 26 to 29 weeks of gestation age.
Read the detailed description
Preterm infant were randomized into an experimental or an control group. Infants in the experimental group receive an oral stimulation program consisting of stimulation of the oral structures during 10 consecutive days. Infant in the control group receive no stimulation only non nutritive sucking during feeding. Both were administered twice per day, during 20 minutes, 48 hours after discontinuation of nasal continuous positive air pressure. A long term evaluation of oral feeding difficulties and neuromotor development are organized.
- Conditions
- Preterm Infants
- Being tested
- no stimulation of the oral structure, stimulation of the oral structure
- Keywords
- preterm infants born between 26 to 29 weeks of gestation age.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no stimulation of the oral structureOther
stimulation of the oral structureOther
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Infants in the experimental group receive an oral stimulation program consisting of stimulation of the oral structures during 10 consecutive days Receives: Other: stimulation of the oral structure |
| control group | Other | Infant in the control group receive no stimulation only non nutritive sucking during feeding Receives: Other: no stimulation of the oral structure |
What is being measured
The primary outcome is the main question the study is designed to answer.
the cardiorespiratory manifestations
to assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations
Measured: 2 years
Secondary outcomes (1)
the oral feeding performance
the oral feeding performance
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study start1 May 2010
- Primary completion24 Feb 2014
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MURIEL BUSUTIL, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116765
- Sponsor's protocol ID
- 2009-A01191-56
- Other IDs
- 2009-27
- Status last verified
- Apr 2023
- First submitted
- 3 May 2010
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Oral Stimulation on Reducing Cardiorespiratory Events and Transition to Oral Feeding in Preterm Infants
- ClinicalTrials.gov ID
- NCT01116765
- Acronym / sponsor ID
- 2009-A01191-56
- Conditions
- Preterm Infants
- Keywords
- preterm infants born between 26 to 29 weeks of gestation age.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 May 2010 (actual)
- Primary completion
- 24 Feb 2014 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 5 May 2010 (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.
To assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations (episodes of oxygen désaturations, and/or apnea- bradycardia), and the oral feeding performance, in preterm infants born between 26 to 29 weeks of gestation age.
Detailed description
Preterm infant were randomized into an experimental or an control group. Infants in the experimental group receive an oral stimulation program consisting of stimulation of the oral structures during 10 consecutive days. Infant in the control group receive no stimulation only non nutritive sucking during feeding. Both were administered twice per day, during 20 minutes, 48 hours after discontinuation of nasal continuous positive air pressure. A long term evaluation of oral feeding difficulties and neuromotor development are organized.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: stimulation of the oral structureInfants in the experimental group receive an oral stimulation program consisting of stimulation of the oral structures during 10 consecutive days |
| control group | Other | Other: no stimulation of the oral structureInfant in the control group receive no stimulation only non nutritive sucking during feeding |
Who may qualify
- Ages
- 29 to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children whose born term is included between 26 and 29SA past and whose postnatal age is lower or more equal in 33SA past, at the time of the inclusion.
- Term of certain child (calculated according to the date of the last rules and\or a premature obstetric echography).
- Children devoid of neurological pathology making him(it) clinically unstable (echography transfontanellar and\or intellectual MRI, electroencephalogram normal, either, intraventricular bleeding of rank 1 and 2 of Papile [40], or, intellectual abnormalities in the MRI of type(chap) 1 - 4 according to the classification of modified Paneth [41]. (Annex X)
- Children devoid of infectious pathology making him(it) clinically unstable (Protein C-reactive lower than 7).
- In case of ebb gastroenteritis - esophageal symptomatic ( RGO): the child will be treated(handled), by oral route, by location + thickening +/-prokinetic +/-inhibitor pumps in proton.
Key exclusion criteria (5 listed)
- Born Child > 29 limited companies.
- Child not included at the postnatal age of 33 past(over) LIMITED COMPANIES.
- Child presenting a genic syndrome, an evolutionary neurological disease, a pathology malformative.
- Child presenting a bleeding intraventricular of rank 3-4 [ 40 ], intellectual abnormalities in the MRI of type(chap) 5 and 6 according to the classification of modified Paneth [ 41 ], an ulcer-necrotizing entérocolitis.
- Child among whom both relatives(parents) or legal representatives refused that their child participates in the study.
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 |
|---|---|---|
| no stimulation of the oral structure | Other | control group |
| stimulation of the oral structure | Other | experimental group |
Primary outcome
the cardiorespiratory manifestations
Time frame: 2 years
to assess whether an oral stimulation program, before the introduction of oral feeding, enhances the cardiorespiratory manifestations
1 secondary outcome
the oral feeding performance
Time frame: 2 years
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 18 Apr 2023.
Related trials for Preterm Infants
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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.
MURIEL BUSUTIL principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing no stimulation of the oral structure and stimulation of the oral structure in people with Preterm Infants, run by Assistance Publique Hopitaux De Marseille 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 6 inclusion and 5 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 18 Apr 2023. 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?
the cardiorespiratory manifestations (time frame: 2 years). 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 18 Apr 2023.