Extreme Prematurity (gestational Age Below 29 Weeks)NUTRIONCT06657729
Oral Feeding Skills of Very Premature Infants
An observational study of Extreme Prematurity (gestational Age Below 29 Weeks), run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Extremely premature infants, born at a gestational age (GA) of less than 29 weeks, are exposed to numerous complications in the neonatal period (digestive, cardiac, infectious, respiratory, neurological) and in the longer term (neurosensory and cognitive development, impaired growth, oral feeding disorders). Read more about this study
- Who is it for?
- Ages Up to 5 months
- Conditions the study is for
- Extreme Prematurity (gestational Age Below 29 Weeks)
- What is being tested?
- Succiometry
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 17 Dec 2024to 17 May 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 Up to 5 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants born before 29 GA (extreme prematurity), hospitalized in the Neonatal unit of Croix Rousse Hospital.
Who may be able to join
- Infant born before 29 GA
- Hospitalized in the Croix Rousse neonatology department
- Admitted within the first three days of life
Who cannot join
- Discharge (transfer) planned within 15 days of birth
- Silicone allergy
- Severe congenital malformation
- Pathology requiring surgery
- Parental refusal
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, 1 recruiting
- Recruiting
Hopital Croix Rousse
Lyon, 69004
Jean-Charles PICAUD, Pr, MD, PhD, 04 72 00 41 21 ext. +33, jean-charles.picaud@chu-lyon.fr
About this study
Official title: Evaluation of Oral Feeding Skills of Very Premature Infants
Extremely premature infants, born at a gestational age (GA) of less than 29 weeks, are exposed to numerous complications in the neonatal period (digestive, cardiac, infectious, respiratory, neurological) and in the longer term (neurosensory and cognitive development, impaired growth, oral feeding disorders). In premature babies, non-nutritive sucking is present from 27 weeks' gestation, but the "suck, swallow, breathe" sequence, which is essential for feeding autonomy, does not mature until 34 weeks, with wide individual variations. Therefore, preterm newborns initially needs a gastric tube to receive enteral nutrition. During this period, the oral sphere is often dys-stimulated by the insertion/attachment of the gastric tube, aspirations of oral secretions, etc. The earlier children are born, the more frequent and serious the pathologies associated with prematurity, the more frequent these dys-stimulations are and the longer enteral feeding via gastric tube is required. As a result, the more immature the child, the more the development of oral performance is disrupted. This disrupts the transition from enteral feeding to oral feeding and therefore the acquisition of autonomous feeding, which is essential if the child is to be able to go out at home. This has an impact on the length of hospitalisation. Individualised developmental care, the current standard of care in neonatology, aims on the one hand to reduce dys-stimulation and on the other hand to offer positive oral stimulation such as non-nutritive sucking and perioral stimulation. Non-nutritive sucking consists of providing the child with a dummy as often and for as long as possible, i.e. as soon as the child is awake. Some departments also use specific and adapted perioral stimulation protocols. For several years, the department of neonatology at the Croix Rousse University Hospital included in care protocols, a protocol for peri-oral stimulation. It begins as soon as the baby is no longer suffering from any major (haemodynamic or respiratory) problems. It is stopped when feeding is active and autonomy has been achieved. It consists of stimulating the perioral and oral area, ideally four times a day, when the child is awake and particularly before meals. Perioral stimulation is performed on the baby's face, then, depending on the baby's reactions, oral stimulation is performed using a cotton bud soaked in milk. When the baby places his tongue in the sucking position and closes his lips, oral feeding can begin.
In a retrospective, single-centre study carried out in neonatology at the Croix Rousse hospital in 163 babies born before 29 weeks' gestation, the investigator calculated that the average corrected GA for the acquisition of feeding autonomy was 38.3 weeks' gestation, with significant inter-individual variability.
The hypothesis is that extremely premature infants already have oral skills very early, then lose them due to the numerous dys-stimulations of the oral sphere during intensive care period. Stimulations of the oral and perioral sphere, implemented early, could make it possible to limit this loss of competence and to observe a physiological evolution of oral skills.
- Being tested
- Succiometry
- Keywords
- prematurity, orality, sucking, feeding autonomy
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucciometryOther
Assessement of sucking performance by measuring pressures (suction, crushing) with a succiometer every 10 days. This instrument consists of a standard silicone teat for premature newborns, which is connected via two silicone tubes to pressure micro-sensors. These pressure sensors measure the child's sucking activity on the teat. This activity is characterised by suction and crushing movements. It is a non-nutritive sucking activity (no fluid is delivered). Sucking performance is recorded during a period of calm awakening of the infant and over a period of 5 minutes, and is part of routine care since non-nutritive sucking is a common practice in neonatal unit. The first measurement will be taken in the first week of life and then every 7-10 days until discharge from the neonatal unit.
| Study group | Role | What they receive |
|---|---|---|
| Extremely preterm infants | Extremely preterm infants born before 29 weeks. Receives: Other: Succiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suckling performances
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 1 - the number of suction peaks.
Measured: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
Suckling performances
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 2 - the amplitude of suction peaks.
Measured: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
Suckling performances
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 3 - the timing of suction peaks.
Measured: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
Suckling performances
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 4 - the number of crushing peaks.
Measured: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
Suckling performances
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 5 - the amplitude of crushing peaks.
Measured: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
Suckling performances
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 6 - the timing of crushing peaks.
Measured: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start17 Dec 2024
- Primary completion17 May 2026 (estimated)
- Study completion17 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extreme Prematurity (gestational Age Below 29 Weeks)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657729
- Sponsor's protocol ID
- 69HCL24_0741
- Other IDs
- 2024-A01791-46
- Acronym
- NUTRIO
- Status last verified
- Jan 2025
- First submitted
- 16 Oct 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Feeding Skills of Very Premature Infants
- ClinicalTrials.gov ID
- NCT06657729
- Acronym / sponsor ID
- NUTRIO / 69HCL24_0741
- Keywords
- prematurity, orality, sucking, feeding autonomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 17 May 2026 (estimated)
- Study completion
- 17 May 2026 (estimated)
- First posted
- 24 Oct 2024 (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.
Extremely premature infants, born at a gestational age (GA) of less than 29 weeks, are exposed to numerous complications in the neonatal period (digestive, cardiac, infectious, respiratory, neurological) and in the longer term (neurosensory and cognitive development, impaired growth, oral feeding disorders). In premature babies, non-nutritive sucking is present from 27 weeks' gestation, but the "suck, swallow, breathe" sequence, which is essential for feeding autonomy, does not mature until 34 weeks, with wide individual variations. Therefore, preterm newborns initially needs a gastric tube to receive enteral nutrition. During this period, the oral sphere is often dys-stimulated by the insertion/attachment of the gastric tube, aspirations of oral secretions, etc. The earlier children are born, the more frequent and serious the pathologies associated with prematurity, the more frequent these dys-stimulations are and the longer enteral feeding via gastric tube is required. As a result, the more immature the child, the more the development of oral performance is disrupted. This disrupts the transition from enteral feeding to oral feeding and therefore the acquisition of autonomous feeding, which is essential if the child is to be able to go out at home. This has an impact on the length of hospitalisation. Individualised developmental care, the current standard of care in neonatology, aims on the one hand to reduce dys-stimulation and on the other hand to offer positive oral stimulation such as non-nutritive sucking and perioral stimulation. Non-nutritive sucking consists of providing the child with a dummy as often and for as long as possible, i.e. as soon as the child is awake. Some departments also use specific and adapted perioral stimulation protocols. For several years, the department of neonatology at the Croix Rousse University Hospital included in care protocols, a protocol for peri-oral stimulation. It begins as soon as the baby is no longer suffering from any major (haemodynamic or respiratory) problems. It is stopped when feeding is active and autonomy has been achieved. It consists of stimulating the perioral and oral area, ideally four times a day, when the child is awake and particularly before meals. Perioral stimulation is performed on the baby's face, then, depending on the baby's reactions, oral stimulation is performed using a cotton bud soaked in milk. When the baby places his tongue in the sucking position and closes his lips, oral feeding can begin.
In a retrospective, single-centre study carried out in neonatology at the Croix Rousse hospital in 163 babies born before 29 weeks' gestation, the investigator calculated that the average corrected GA for the acquisition of feeding autonomy was 38.3 weeks' gestation, with significant inter-individual variability.
The hypothesis is that extremely premature infants already have oral skills very early, then lose them due to the numerous dys-stimulations of the oral sphere during intensive care period. Stimulations of the oral and perioral sphere, implemented early, could make it possible to limit this loss of competence and to observe a physiological evolution of oral skills.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extremely preterm infants | – | Other: SucciometryExtremely preterm infants born before 29 weeks. |
Who may qualify
- Ages
- Up to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants born before 29 GA (extreme prematurity), hospitalized in the Neonatal unit of Croix Rousse Hospital.
Key inclusion criteria (3 listed)
- Infant born before 29 GA
- Hospitalized in the Croix Rousse neonatology department
- Admitted within the first three days of life
Key exclusion criteria (5 listed)
- Discharge (transfer) planned within 15 days of birth
- Silicone allergy
- Severe congenital malformation
- Pathology requiring surgery
- Parental refusal
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 |
|---|---|---|
| SucciometryAssessement of sucking performance by measuring pressures (suction, crushing) with a succiometer every 10 days. This instrument consists of a standard silicone teat for premature newborns, which is connected via two silicone tubes to pressure micro-sensors. These pressure sensors measure the child's sucking activity on the teat. This activity is characterised by suction and crushing movements. It is a non-nutritive sucking activity (no fluid is delivered). Sucking performance is recorded during a period of calm awakening of the infant and over a period of 5 minutes, and is part of routine care since non-nutritive sucking is a common practice in neonatal unit. The first measurement will be taken in the first week of life and then every 7-10 days until discharge from the neonatal unit. | Other | Extremely preterm infants |
Primary outcome
Suckling performances
Time frame: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 1 - the number of suction peaks.
Suckling performances
Time frame: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 2 - the amplitude of suction peaks.
Suckling performances
Time frame: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 3 - the timing of suction peaks.
Suckling performances
Time frame: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 4 - the number of crushing peaks.
Suckling performances
Time frame: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 5 - the amplitude of crushing peaks.
Suckling performances
Time frame: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months
The pressure variations recorded when the infant has the teat in its mouth are analysed. Various parameters are quantified to assess suckling performances: 6 - the timing of crushing peaks.
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 30 Jan 2025.
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.
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 Extreme Prematurity (gestational Age Below 29 Weeks), 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 3 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: looking for participants now, as of the sponsor's last update on 30 Jan 2025. 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 Jean-Charles PICAUD, Pr, MD, PhD (04 72 00 41 21 ext. +33, jean-charles.picaud@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suckling performances (time frame: From date of inclusion until the date of discharge from the neonatal unit, assessed up to 5 months). The study lists 6 primary outcomes in all. 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 30 Jan 2025.