Premature BirthPREMALIMNCT06634329
Preterm Newborn's Behavioral Responses During Feeding With Gastric Tube
An observational study of Premature Birth, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Preterm infants need aims of a tube named oral or naso gastric to grow until they acquire autonomy in suction-swallowing. In fact, several modes feed by a gastric tube exist : using an electric syringe pump (continuous administration), or manual and individualization administration. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Birth
- What is being tested?
- Oro or Nasogastric tube feeding
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2024to Nov 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Newborn infants needing nasogastric tube feeding hospitalized at Rénaimation et médecine du nouveau né / University Hospital of Strasbourg
Who may be able to join
- Hospitalized at the University Hospitals of Strasbourg during October 2024 and October 2025
- Needing nasogastric tube feeding during at least 4 days
- With parents (legal representants) having expressed their agreement with the use of video recording in the framework of the current study
Who cannot join
- ORL malformations
- Neurological dysfunction
- Sedated infant
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Pédiatrie - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67 200
Claire ZORES, claire.zores@chru-strasbourg.fr
Clara SANCHIS, clara.sanchis@chru-strasbourg.fr
About this study
Official title: Assessment of the Comfort of Preterm Newborns During Feeding, Comparison of Different Methods of Milk Administration With Gastric Tube
Preterm infants need aims of a tube named oral or naso gastric to grow until they acquire autonomy in suction-swallowing.
In fact, several modes feed by a gastric tube exist : using an electric syringe pump (continuous administration), or manual and individualization administration. In this second case, milk can be delivered by gravity, depending on the height the syringe is placed above the infant, or by manually pushing on the syringe. Milk can be administrated by nurses or by the parents after a learning period.
In this observational study, we would like to compare the preterm infants' behavioral during these different naso or oro gastric feeding modes by observing well-being signs and withdrawal signs (Dsilna grid) on video settings.
- Conditions
- Premature Birth
- Being tested
- Oro or Nasogastric tube feeding
- Keywords
- Preterm infants, Oro/nasogastric tube feeding, Developmental care, Parents integration
- 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 or Nasogastric tube feedingOther
Parental involvement in their premature baby's feeding
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the tolerance of these different types of food (gravity versus pushing the seringue), based on the child's behavioral and physiological signs of well-being.
Observation of preterm infants during and after naso/oro gastric tube feeding on videos to record well-being and withdrawal signs like classified in the Dsilna grid every 4 minutes.
Measured: 6 months
Secondary outcomes (2)
- Well-being and withdrawal signs by the Dsilna grid : comparison of manual methods versus electric syringe administration
Comparaison of the score of withdrawal or well being tube in this different situation. Survey to assess the feelings and experiences about feeding, filled by caregivers and parents.
Measured: 6 monts
- Well-being and withdrawal signs by the Dsilna grid : comparison during administration by parents or nurses
Comparaison of the score of withdrawal or well being tube in this different situation. Survey to assess the feelings and experiences about feeding, filled by caregivers and parents.
Measured: 6 monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire ZORES, Principal investigator, Service de Pédiatrie, CHU de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634329
- Sponsor's protocol ID
- CE-2024-56
- Acronym
- PREMALIM
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Comfort of Preterm Newborns During Feeding, Comparison of Different Methods of Milk Administration With Gastric Tube
- ClinicalTrials.gov ID
- NCT06634329
- Acronym / sponsor ID
- PREMALIM / CE-2024-56
- Conditions
- Premature Birth
- Keywords
- Preterm infants, Oro/nasogastric tube feeding, Developmental care, Parents integration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 9 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.
Preterm infants need aims of a tube named oral or naso gastric to grow until they acquire autonomy in suction-swallowing.
In fact, several modes feed by a gastric tube exist : using an electric syringe pump (continuous administration), or manual and individualization administration. In this second case, milk can be delivered by gravity, depending on the height the syringe is placed above the infant, or by manually pushing on the syringe. Milk can be administrated by nurses or by the parents after a learning period.
In this observational study, we would like to compare the preterm infants' behavioral during these different naso or oro gastric feeding modes by observing well-being signs and withdrawal signs (Dsilna grid) on video settings.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newborn infants needing nasogastric tube feeding hospitalized at Rénaimation et médecine du nouveau né / University Hospital of Strasbourg
Key inclusion criteria (3 listed)
- Hospitalized at the University Hospitals of Strasbourg during October 2024 and October 2025
- Needing nasogastric tube feeding during at least 4 days
- With parents (legal representants) having expressed their agreement with the use of video recording in the framework of the current study
Key exclusion criteria (3 listed)
- ORL malformations
- Neurological dysfunction
- Sedated infant
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 or Nasogastric tube feedingParental involvement in their premature baby's feeding | Other | – |
Primary outcome
Comparing the tolerance of these different types of food (gravity versus pushing the seringue), based on the child's behavioral and physiological signs of well-being.
Time frame: 6 months
Observation of preterm infants during and after naso/oro gastric tube feeding on videos to record well-being and withdrawal signs like classified in the Dsilna grid every 4 minutes.
2 secondary outcomes
- Well-being and withdrawal signs by the Dsilna grid : comparison of manual methods versus electric syringe administration
Time frame: 6 monts
- Well-being and withdrawal signs by the Dsilna grid : comparison during administration by parents or nurses
Time frame: 6 monts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Claire ZORES principal investigator
Service de Pédiatrie, CHU de Strasbourg
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 Birth, run by University Hospital, Strasbourg, France 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 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: status not confirmed, as of the sponsor's last update on 9 Oct 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire ZORES (+33 3 88 12 83 32, claire.zores@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the tolerance of these different types of food (gravity versus pushing the seringue), based on the child's behavioral and physiological signs of well-being. (time frame: 6 months). 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 9 Oct 2024.