Premature BirthPREMALIMNCT05272956
Parental Involvement in Enteral Nutrition in Neonatal Units
A study testing enteral feeding with pushed syringe by the parents in people with Premature Birth, run by University Hospital, Limoges at 2 sites in France.
Trial summary
Hypothesis : Bolus feeding of the newborn with a syringe under parents' visual control increases parental presence when compared to enteral feeding with a syringe pump. Main criteria : Comparison of parental presence (mean time in hours) between the two arms : pushed bolus syringe feeding under parent's visual control… Read more about this study
- Who is it for?
- Ages 3 days and older
- Conditions the study is for
- Premature Birth
- What is being tested?
- enteral feeding with pushed syringe by the parents
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesFrance
- Study dates
- 10 Aug 2022to 12 Nov 2024
- 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 3 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age between 30 and 34 WA (weeks of amenorrhea)
- Patient affiliated to a social security scheme
- Hospitalized in neonatal intensive care unit (NICU)
- 3 days of life or more
Who cannot join
- Corrected age> 34WA and 4 days
- Mechanical ventilation or non-invasive ventilation with FIO2> 35%
- Serious congenital malformation
- Planned transfer to another hospital
- Enteral nutrition <40ml / kg / day
- Immediate post-operative care
Show all 12Show fewer
- Multiple pregnancy
- Poor understanding of french
- Secondary exclusion criteria
- Digestive rest greater than 5 days
- Death
- No enteral nutrition pushed by parents
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Henri Duffaut
Avignon, 84000
Limoges university hospital
Limoges, 87042
About this study
Official title: Impact of Parental Involvement in Enteral Nutrition on Their Presence in Neonatal Units
- Hypothesis : Bolus feeding of the newborn with a syringe under parents' visual control increases parental presence when compared to enteral feeding with a syringe pump.
- Main criteria : Comparison of parental presence (mean time in hours) between the two arms : pushed bolus syringe feeding under parent's visual control and enteral feeding with a syringe pump.
Read the detailed description
- Nutrition is the cornerstone of neonatology. Adequate nutrition is necessary for a healthy brain growth and a physiological development. When oral feeding skills are not acquired, enteral feeding is used via a nasogastric tube by an electric syringe pump. The birth a premature child jeopardizes parent-infant bonding and hinders parental feeding skills. Family-centered care has shown to be beneficial for the child and his parents by promoting early interactions, which lay the foundations for the child's psychological development. As such, pushed bolus enteral feeding by the parents with a syringe has been a common practice in Sweden since the 1980s to involve the parents in enteral feeding practices. In France, this practice has been used in neonatal intensive care units (NICU). Two French studies on this subject have been published. One focused on using parental pushed bolus enteral feeding in a hospitalization at home setting, whereas the other study investigated the impact of parental observation on pushed bolus enteral feeding. To our knowledge, there is no study proving the superiority of bolus feeding with a syringe under parents' visual control over enteral feeding with a syringe pump.
- This study is an open-label, randomized, comparative interventional study with an intention-to-treat analysis. We compared a control group (enteral nutrition with an electric syringe pump while the neonate is lying in a cocoon or carried by their parent) to an intervention group (pushed bolus enteral nutrition under parents' visual control)
- In the control group, enteral feeding used an electric syringe pump.
- In the intervention group, the first enteral feeding is pushed with a syringe by the nurse. Following enteral feeding attempts are pushed with a syringe by the parents only if they can or will grow. Bolus feeding speed is at the discretion of the person pushing the syringe (nurse or parent) and is adjusted to the child's signs of discomfort. When the parents are absent, enteral feeding is carried out with a syringe pump.
- Conditions
- Premature Birth
- Being tested
- enteral feeding with pushed syringe by the parents
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral feeding with pushed syringe by the parentsProcedure or surgery
enteral feeding pushed by parents with a syringe
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Enteral feeding is carried out with a syringe pump |
| intervention group | Experimental | the first enteral feeding is pushed with a syringe by the nurse. Following enteral feeding attempts are pushed with a syringe by the parents. Bolus feeding speed is at the discretion of the person pushing the syringe (nurse or parent) and is adjusted to the child's signs of discomfort. When the parents are absent, enteral feeding is carried out with a syringe pump Receives: Procedure: enteral feeding with pushed syringe by the parents |
What is being measured
The primary outcome is the main question the study is designed to answer.
parental presence
Comparison of parental presence (mean time in hours) between the two arms: pushed bolus syringe feeding under parent's visual control and enteral feeding with a syringe pump
Measured: from start to the end of enteral feeding, with a maximum of 10 weeks
Secondary outcomes (7)
Corrected age at which oral feeding skills are acquired
Comparison of corrected age at which oral feeding skill are acquired between the two arms : pushed bolus syringe feeding under parent's visual control and enteral feeding with a syringe pump
Measured: from start to the end of enteral feeding, with a maximum of 10 weeks
Weight gain in g / kg / day during the study time
Comparison of weight gain during the study time between the two arms : pushed bolus syringe feeding under parent's visual control and enteral feeding with a syringe pump
Measured: from start to the end of enteral feeding, with a maximum of 10 weeks
Mean daily skin-to-skin duration
Comparison of mean daily skin-to-skin during the study time between the two arms : pushed bolus syringe feeding under parent's visual control and enteral feeding with a syringe pump
Measured: from start to the end of enteral feeding, with a maximum of 10 weeks
Percentage of breastfeeding at inclusion and at the end of the participation period
Comparison of rate of breastfeeding at inclusion and at the end of the participation period between the two arms : pushed bolus syringe feeding under parent's visual control and enteral feeding with a syringe pump
Measured: from start to the end of enteral feeding, with a maximum of 10 weeks
Anxiety mean score for both parents (PARENTAL STRESSOR SCALE)
Comparison of anxiety level for both parents during the study time between the two arms : pushed bolus syringe feeding under parent's visual control and enteral feeding with a syringe pump. The Parental Stressor Scale (PSS) was published by Margaret S. Miles to evaluate the parental anxiety in neonatal intensive care unit. Higher score is associated with a high level of parental anxiety.
Measured: from start to the end of enteral feeding, with a maximum of 10 weeks
Mother-newborn bond assessment scale (MIBS) score
Comparison of mother-newborn bond assessment between the two arms : pushed bolus syringe feeding under parent's visual control and enteral feeding with a syringe pump.
The mother-to-infant Bonding Scale (MIBS) published by Taylor in 2005, is a simple 8 item self-rating mother-to-infant bonding questionnaire to assess the feelings of a mother towards her new baby.
Measured: from start to the end of enteral feeding, with a maximum of 10 weeks
Adherence of pushed bolus syringue feeding under parent's visual control
Likert Scale used to evaluate the satisfaction of both parent in pushed bolus syringue feeding under parent's visual control.
Likert scale provides five possible answers to a statement or question that allows respondents to indicate their positive-to-negative strength of agreement or strength of feeling regarding the question or statement.
Measured: from start to the end of enteral feeding, with a maximum of 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start10 Aug 2022
- Primary completion12 Nov 2024
- Study completion12 Nov 2024
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, LimogesThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272956
- Sponsor's protocol ID
- 87RI21_0030 (PREMALIM)
- Acronym
- PREMALIM
- Status last verified
- Nov 2025
- First submitted
- 9 Feb 2022
- Last updated
- 21 Nov 2025
- 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 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Parental Involvement in Enteral Nutrition on Their Presence in Neonatal Units
- ClinicalTrials.gov ID
- NCT05272956
- Acronym / sponsor ID
- PREMALIM / 87RI21_0030 (PREMALIM)
- Conditions
- Premature Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 10 Mar 2022 (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.
- Hypothesis : Bolus feeding of the newborn with a syringe under parents' visual control increases parental presence when compared to enteral feeding with a syringe pump.
- Main criteria : Comparison of parental presence (mean time in hours) between the two arms : pushed bolus syringe feeding under parent's visual control and enteral feeding with a syringe pump.
Detailed description
- Nutrition is the cornerstone of neonatology. Adequate nutrition is necessary for a healthy brain growth and a physiological development. When oral feeding skills are not acquired, enteral feeding is used via a nasogastric tube by an electric syringe pump. The birth a premature child jeopardizes parent-infant bonding and hinders parental feeding skills. Family-centered care has shown to be beneficial for the child and his parents by promoting early interactions, which lay the foundations for the child's psychological development. As such, pushed bolus enteral feeding by the parents with a syringe has been a common practice in Sweden since the 1980s to involve the parents in enteral feeding practices. In France, this practice has been used in neonatal intensive care units (NICU). Two French studies on this subject have been published. One focused on using parental pushed bolus enteral feeding in a hospitalization at home setting, whereas the other study investigated the impact of parental observation on pushed bolus enteral feeding. To our knowledge, there is no study proving the superiority of bolus feeding with a syringe under parents' visual control over enteral feeding with a syringe pump.
- This study is an open-label, randomized, comparative interventional study with an intention-to-treat analysis. We compared a control group (enteral nutrition with an electric syringe pump while the neonate is lying in a cocoon or carried by their parent) to an intervention group (pushed bolus enteral nutrition under parents' visual control)
- In the control group, enteral feeding used an electric syringe pump.
- In the intervention group, the first enteral feeding is pushed with a syringe by the nurse. Following enteral feeding attempts are pushed with a syringe by the parents only if they can or will grow. Bolus feeding speed is at the discretion of the person pushing the syringe (nurse or parent) and is adjusted to the child's signs of discomfort. When the parents are absent, enteral feeding is carried out with a syringe pump.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Enteral feeding is carried out with a syringe pump |
| intervention group | Experimental | Procedure: enteral feeding with pushed syringe by the parentsthe first enteral feeding is pushed with a syringe by the nurse. Following enteral feeding attempts are pushed with a syringe by the parents. Bolus feeding speed is at the discretion of the person pushing the syringe (nurse or parent) and is adjusted to the child's signs of discomfort. When the parents are absent, enteral feeding is carried out with a syringe pump |
Who may qualify
- Ages
- 3 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Gestational age between 30 and 34 WA (weeks of amenorrhea)
- Patient affiliated to a social security scheme
- Hospitalized in neonatal intensive care unit (NICU)
- 3 days of life or more
Key exclusion criteria (12 listed)
- Corrected age> 34WA and 4 days
- Mechanical ventilation or non-invasive ventilation with FIO2> 35%
- Serious congenital malformation
- Planned transfer to another hospital
- Enteral nutrition <40ml / kg / day
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 |
|---|---|---|
| enteral feeding with pushed syringe by the parentsenteral feeding pushed by parents with a syringe | Procedure or surgery | intervention group |
Primary outcome
parental presence
Time frame: from start to the end of enteral feeding, with a maximum of 10 weeks
Comparison of parental presence (mean time in hours) between the two arms: pushed bolus syringe feeding under parent's visual control and enteral feeding with a syringe pump
7 secondary outcomes
Corrected age at which oral feeding skills are acquired
Time frame: from start to the end of enteral feeding, with a maximum of 10 weeks
Weight gain in g / kg / day during the study time
Time frame: from start to the end of enteral feeding, with a maximum of 10 weeks
Mean daily skin-to-skin duration
Time frame: from start to the end of enteral feeding, with a maximum of 10 weeks
Percentage of breastfeeding at inclusion and at the end of the participation period
Time frame: from start to the end of enteral feeding, with a maximum of 10 weeks
Anxiety mean score for both parents (PARENTAL STRESSOR SCALE)
Time frame: from start to the end of enteral feeding, with a maximum of 10 weeks
Mother-newborn bond assessment scale (MIBS) score
Time frame: from start to the end of enteral feeding, with a maximum of 10 weeks
Adherence of pushed bolus syringue feeding under parent's visual control
Time frame: from start to the end of enteral feeding, with a maximum of 10 weeks
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 21 Nov 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enteral feeding with pushed syringe by the parents in people with Premature Birth, run by University Hospital, Limoges at 2 sites 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 12 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
parental presence (time frame: from start to the end of enteral feeding, with a maximum of 10 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 21 Nov 2025.