PrematureRESOF-36NCT07495709
Reactions to Oro-facial Solicitations : a Predictor of Eating Difficulties for Premature Babies of 36 Weeks Gestation Adjusted Age
An observational study of Premature, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The goal of this observational study is to assess the link between reactions to orofacial stimuli observed at 29 weeks of amenorrhoea, and feeding difficulties at 36 weeks of amenorrhoea, in babies born prematurely between 26 and 27 + 6 weeks of gestation, admitted to the CHSF between 1 May 2025 and 31 March 2026. Read more about this study
- Who is it for?
- Ages 26 to 28 weeks
- Conditions the study is for
- Premature
- What is being tested?
- Oro-facial stimulation
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 26 to 28 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Premature babies hospitalised at the CHSF in neonatal resuscitation or intensive care units
Who may be able to join
- Premature babies born between 26 and 27 + 6 weeks of gestation
- Admitted to the CHSF between 1 May 2025 and 31 March 2026
- Criteria grid completed upon admission
- Parents or guardians informed of the study and not opposed to it.
Who cannot join
- ENT malformation
- Neurological pathology
- Dysplasia or oxygen therapy greater than or equal to 0.3L/min (these children are seen systematically)
- Extreme prematurity (gestational age less than 26 weeks)
- Genetic syndrome
- Anoxic-ischaemic encephalopathy
- Digestive malformation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91100
Hasinirina RAZAFIMAHEFA, MD, 1 61 69 78 23 ext. +33, hasinirina.razafimahefa@chsf.fr
Caroline TOURTE, 1 61 69 31 50 ext. +33, caroline.tourte@chsf.fr
About this study
The goal of this observational study is to assess the link between reactions to orofacial stimuli observed at 29 weeks of amenorrhoea, and feeding difficulties at 36 weeks of amenorrhoea, in babies born prematurely between 26 and 27 + 6 weeks of gestation, admitted to the CHSF between 1 May 2025 and 31 March 2026. The main questions it aims to answer are : Can reactions to orofacial stimulation in babies born very prematurely be used as a tool for early detection of feeding difficulties before discharge from hospital? Is it possible to establish a predictive score for potential feeding difficulties as early as 29 weeks of gestation corrected, based on reactions to orofacial stimuli ? Participants will have their reactions to orofacial stimulations recorded in the 'Suivi oralité' grid completed by the nurses in the neonatal medicine and intensive care unit, which will then collect.
- Conditions
- Premature
- Being tested
- Oro-facial stimulation
- Keywords
- premature, Early intervention, orofacial stimulation, feeding difficulties, orality
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oro-facial stimulationOther
massages and sensory stimulation aimed at stimulating the oral-facial reflexes of newborns (hand-to-mouth connection, cardinal points, milk smell, digging, crushing (finger or teat), sucking (crushing + suction))
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants | Preterm infants born between 26 and 27+6 weeks of gestation Receives: Other: Oro-facial stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enteral nutrition
Necessity for newborns to be fed exclusively by enteral nutrition at 36 weeks' gestation for at least 24 hours, percentage of milk volume taken orally at 36 weeks' gestation compared to prescription, average duration of bottle feeding at 36 weeks' gestation
Measured: at 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies 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
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hasinirina RAZAFIMAHEFA, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495709
- Sponsor's protocol ID
- 2025/0053
- Acronym
- RESOF-36
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 27 Mar 2026
- 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 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactions to Oro-facial Solicitations : a Predictor of Eating Difficulties for Premature Babies of 36 Weeks Gestation Adjusted Age
- ClinicalTrials.gov ID
- NCT07495709
- Acronym / sponsor ID
- RESOF-36 / 2025/0053
- Conditions
- Premature
- Keywords
- premature, Early intervention, orofacial stimulation, feeding difficulties, orality
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Mar 2026 (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 goal of this observational study is to assess the link between reactions to orofacial stimuli observed at 29 weeks of amenorrhoea, and feeding difficulties at 36 weeks of amenorrhoea, in babies born prematurely between 26 and 27 + 6 weeks of gestation, admitted to the CHSF between 1 May 2025 and 31 March 2026. The main questions it aims to answer are : Can reactions to orofacial stimulation in babies born very prematurely be used as a tool for early detection of feeding difficulties before discharge from hospital? Is it possible to establish a predictive score for potential feeding difficulties as early as 29 weeks of gestation corrected, based on reactions to orofacial stimuli ? Participants will have their reactions to orofacial stimulations recorded in the 'Suivi oralité' grid completed by the nurses in the neonatal medicine and intensive care unit, which will then collect.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infants | – | Other: Oro-facial stimulationPreterm infants born between 26 and 27+6 weeks of gestation |
Who may qualify
- Ages
- 26 to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature babies hospitalised at the CHSF in neonatal resuscitation or intensive care units
Key inclusion criteria (4 listed)
- Premature babies born between 26 and 27 + 6 weeks of gestation
- Admitted to the CHSF between 1 May 2025 and 31 March 2026
- Criteria grid completed upon admission
- Parents or guardians informed of the study and not opposed to it.
Key exclusion criteria (7 listed)
- ENT malformation
- Neurological pathology
- Dysplasia or oxygen therapy greater than or equal to 0.3L/min (these children are seen systematically)
- Extreme prematurity (gestational age less than 26 weeks)
- Genetic syndrome
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 |
|---|---|---|
| Oro-facial stimulationmassages and sensory stimulation aimed at stimulating the oral-facial reflexes of newborns (hand-to-mouth connection, cardinal points, milk smell, digging, crushing (finger or teat), sucking (crushing + suction)) | Other | Preterm infants |
Primary outcome
Enteral nutrition
Time frame: at 36 weeks
Necessity for newborns to be fed exclusively by enteral nutrition at 36 weeks' gestation for at least 24 hours, percentage of milk volume taken orally at 36 weeks' gestation compared to prescription, average duration of bottle feeding at 36 weeks' gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- 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.
Hasinirina RAZAFIMAHEFA, MD principal investigator
Centre Hospitalier Sud Francilien
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 Premature, run by Centre Hospitalier Sud Francilien 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 27 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hasinirina Hasinirina RAZAFIMAHEFA, MD (+33 ext. 1 61 69 78 23, hasinirina.razafimahefa@chsf.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enteral nutrition (time frame: at 36 weeks). 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 27 Mar 2026.