PrematurePREMIAMNCT05313464
Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions
A study testing parent-pushed enteral feeding and syringe-push enteral feeding in people with Premature and Parent-Child Relations, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
Studies underline both the importance of the link and contact that occurs in the earliest days of life and the need to involve parents early with their premature child. However, the impact of parental nutrition on the later active nutrition and on the quality of parent-child interactions is currently unknown. Read more about this study
- Who is it for?
- Ages 30 to 32 weeks
- Conditions the study is for
- Premature, Parent-Child Relations
- What is being tested?
- parent-pushed enteral feeding and syringe-push enteral feeding
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2022to 30 Aug 2026
- 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 30 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children born before 30 SA Age of child at start of study: 32 SA
Who cannot join
- Child with ongoing infection, neurological pathology More than one desaturation and/or bradycardia per hour within 12 last hours Balloon ventilation in last 12 hours
- Medical contraindication to oral nutrition
- Intubated child
- Parents with a disabling mental illness
- Parents not available
- Minor parents
Show all 9Show fewer
- Parents under guardianship or protection of justice
- Refusal to sign consent
- Parents not affiliated with a social security system
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Intercommunal Créteil
Créteil, Val-deMarne, 94000
About this study
Official title: Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions: Prospective Randomized Monocentric Study (PREMIAM)
Studies underline both the importance of the link and contact that occurs in the earliest days of life and the need to involve parents early with their premature child.
However, the impact of parental nutrition on the later active nutrition and on the quality of parent-child interactions is currently unknown.
PREMIAM study investigates whether active parental participation in enteral nutrition improves the interactions between the infant and his parents, making them more sensitive to their baby's signals and promoting their relational adjustment.
Read the detailed description
The importance of parental participation in the feeding of preterm infants has been highlighted by Gianni. In his study of 81 preterm infants in the tertiary centre , the early parental bottle feeding and the skin-to-skin contact were factors promoting withdrawal from enteral nutrition. Moreover, actively participate in care even complex, is desired by parents.
Recently, a study compared 10 parent-child dyads and showed that enteral nutrition pushed by a parent (parental nutrition, NP) in comparison of the electric syringe pump , allowed a better perception of the tube by the parents and gave them a sense of utility. The same team randomized 17 preterm infants, born after 28 WA( week amenorrhoea), to receive or not à parent-pushed enteral nutrition The child's behavior changes during nutrition were analyzed in both arms, after scoring of the videos feeding according to the NICAP® ( individualized neonatal assessment and developmental care program) method. Signs of well-being and relaxation of members were more present in case of parental involvement in the delivery of nutrition. These preliminary studies suggest that parental nutrition is well tolerated and improves the comfort of the child and parent during nutrition.
However, the impact of parental nutrition on the subsequent active nutrition and on the quality of parent-child interactions is currently unknown.
- Conditions
- Premature, Parent-Child Relations
- Being tested
- parent-pushed enteral feeding, syringe-push enteral feeding
- Keywords
- Premature, child at 32 of gestational age, enteral nutrition, skin to skin, push on syringe pump, Parent-Child Relations
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parent-pushed enteral feedingOther
skin-to-skin enteral nutrition pushed by the parent
syringe-push enteral feedingOther
skin to skin nutrition with syringe pump
| Study group | Role | What they receive |
|---|---|---|
| nutrition pushed by parents | Experimental | enteral nutrition pushed by parents Receives: Other: parent-pushed enteral feeding |
| syringe pump | Active comparator | Enteral nutrition with syringe pump Receives: Other: syringe-push enteral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
behavioural interactions (visual, vocal, mimic)
interactions during the first 10 minutes of an interactive sequence of a premature in the arms of his parent, filmed and coded with The Observer XT software to 34 WA, starting from 3 behaviors of the premature: vocalization, face look mother" and smile
Measured: 34 (W) weeks of gestational age
Secondary outcomes (17)
Mother and Father Self-Question Assessment of Parental Competence: The Cognitive and Parental Behaviour Scale (PACOTIS)
Parents indicate on an eleven point scale (0 = not at all what I think, feel, or do; 10 = exactly what I think, feel, or do) to what extent each statement accurately describes their actions, thoughts or feelings in the context of interacting with their infants. The parental self-efficacy (6 items, α = .82), and perceived parental impact (5 items, α = .68) subscales include statements relating to beliefs about parenting competence and their impact on the child, while the parental hostile-reactive behaviours (7 items, α = .73), parental overprotection (5 items, α = .60), and parental warmth (5 items, α= .78) subscales assess parents' involvement in different types of behaviour with their child.
Scores from each subscale are averaged out of 10; higher scores indicating greater use of these behaviours. the Perceived parental impact subscale items are reverse coded.
Measured: at Month 4
Edinburgh Postpartum Depression Risk Rating Scale (EPDS)
Questionnaire EPSD QUESTIONS 1, 2, \& 4 (without an *) Are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3.
QUESTIONS 3, 5-10 (marked with an *) Are reverse scored, with the top box scored as a 3 and the bottom box scored as 0.
Maximum score: 30 Possible Depression: 10 or greater Always look at item 10 (suicidal thoughts)
Measured: at inclusion, at 32, 34 and 37 weeks of gestation
Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU)
The scale consists of four subscales that measure stress related to (a) the sights and sounds of the unit (5 items), (b) the appearance and behaviours of the infant (19 items), (c) the impact on the parents' role and their relationship with their baby (10 items), and (d) the staff behaviours and communications (11 items). There is also a general stress-level question that summarizes the parents' overall feeling of stress related to having an infant in the NICU.
The responses to the PSS: NICU were scored on a 5- point Likert scale from 0 to 5 where 0 means no experience at all with the situation or phenomenon, 1 (not at all stressful) to 5 (extremely stressful).
Mean scores and standard deviation were obtained for each subscale and total scale separately for mothers and fathers and the overall stress scores was then calculated. Parental stress levels were classified according to the points on Likert scale as low (1-1.9), moderate (2-3.9) and high (4-5).
Measured: at 32, 34, and 37 weeks of gestation
Number of desaturation
Number of desaturation
Measured: every day betwenn 32 and 34 weeks of gestation
Number of vomiting
Number of vomiting
Measured: every day between 32 and 34 weeks of gestation
Exit age on return home
age of the infant when leaving the hospital
Measured: through study completion, an average of 41 week of gestation
Parental time in hours
time spend withe child
Measured: at 34 week of gestation and 37 week of gestation, calculated over 7 days
Number of meals and baths given by parents
Number of meals and baths given by parents
Measured: from 32 week of gestation to 37 week of gestation
Duration of transition from passive to active feeding in number of days
Duration of transition from passive to active feeding in number of days
Measured: from 32 week of gestation to 37 week of gestation
Average duration (minutes) of feeding/feeding
Average duration (minutes) of feeding/feeding
Measured: at 37 week of gestation
Number and duration of skin-to-skin sessions in minutes
Number and duration of skin-to-skin sessions in minutes
Measured: from inclusion to exit of service ( up to 45 week of gestation)
Duration of breastfeeding in number of days.
Duration of breastfeeding in number of days.
Measured: from 32 week of gestation to 37 week of gestation
Number of children with infant formula change
Number of children with infant formula change
Measured: between 32 week of gestation and 37 week of gestation
Evolution of the Z-weight score
The score shows the standard deviation above or below the mean on the growth chart. If you have looked at a growth chart of a patient or your own child, you will recall it contains curve shaped lines with various percentiles on it.
The middle line is the 50th%Ile and they extend out to the 97%ile percentile and 3rd%Ile. So, a z score of 0 is the equivalent of the 50th%ile or average of what you are measuring (weight, height, weight for height or BMI) for that age.
A z score of +1 means your plots fall at the 15th%ile or 85th%Ile and a z score of +2 falls roughly at the 3rd or 97%Ile. z scores run positively (+1. +2.+3) or negatively (-1, -2. -3) and so on.
Measured: 32 week of gestation at the exit of the child.
Brunet-Lézine and Neurological Evaluation of Amiel Tison simplified by a psychomotor specialized in the development of premature babies to assess the psychomotor development of infants at
It may apply from the first month up to 5 years. It includes observations on posture, coordination, language, social-personal conduct.
The Brunet-Lézine scale was developed by Odette Brunet and Irene Lézine. It provides a development quotient (Q.D.).
Measured: 4 months of age corrected.
The Montreal Children's Hospital Feeding Scale [MCH-Feeding Scale]
scale for identification of feeding problems. The final scale consisted of 14 items covering the following feeding domains with some overlap: oral motor (items 8 and 11), oral sensory (items 7 and 8) and appetite (items 3 and 4). Other items covered maternal concerns about feeding (items 1, 2 and 12), mealtime behaviours (items 6 and 8), maternal strategies used (items 5, 9 and 10) and family reactions to their child's feeding (items 13 and 14).
Each item is rated on a seven-point Likert scale with anchor points at either end. Seven items are scored from the negative to positive direction, and the other seven from the positive to negative direction. The primary feeder marks each item according to frequency or difficulty level of a particular behaviour or the level of parental concern. The total feeding problem score is obtained by adding the scores for each item after reversing the scores of seven items from negative to positive
Measured: 4 months of age corrected
Number bradycardia
Number bradycardia
Measured: every day betwenn 32 and 34 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start15 Apr 2022
- Primary completion17 Apr 2026
- Study completion30 Aug 2026
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Le Laboratoire de Psychopathologie et Processus de Santé
- Responsible party
- Sponsor
- Investigators
- Nelly THOMAS, Principal investigator, Centre Hospitalier Intercommunal Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313464
- Sponsor's protocol ID
- PREMIAM
- Acronym
- PREMIAM
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2022
- Last updated
- 10 Sep 2026
- Results posted
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions: Prospective Randomized Monocentric Study (PREMIAM)
- ClinicalTrials.gov ID
- NCT05313464
- Acronym / sponsor ID
- PREMIAM / PREMIAM
- Conditions
- Premature, Parent-Child Relations
- Keywords
- Premature, child at 32 of gestational age, enteral nutrition, skin to skin, push on syringe pump, Parent-Child Relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Le Laboratoire de Psychopathologie et Processus de Santé
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 6 Apr 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.
Studies underline both the importance of the link and contact that occurs in the earliest days of life and the need to involve parents early with their premature child.
However, the impact of parental nutrition on the later active nutrition and on the quality of parent-child interactions is currently unknown.
PREMIAM study investigates whether active parental participation in enteral nutrition improves the interactions between the infant and his parents, making them more sensitive to their baby's signals and promoting their relational adjustment.
Detailed description
The importance of parental participation in the feeding of preterm infants has been highlighted by Gianni. In his study of 81 preterm infants in the tertiary centre , the early parental bottle feeding and the skin-to-skin contact were factors promoting withdrawal from enteral nutrition. Moreover, actively participate in care even complex, is desired by parents.
Recently, a study compared 10 parent-child dyads and showed that enteral nutrition pushed by a parent (parental nutrition, NP) in comparison of the electric syringe pump , allowed a better perception of the tube by the parents and gave them a sense of utility. The same team randomized 17 preterm infants, born after 28 WA( week amenorrhoea), to receive or not à parent-pushed enteral nutrition The child's behavior changes during nutrition were analyzed in both arms, after scoring of the videos feeding according to the NICAP® ( individualized neonatal assessment and developmental care program) method. Signs of well-being and relaxation of members were more present in case of parental involvement in the delivery of nutrition. These preliminary studies suggest that parental nutrition is well tolerated and improves the comfort of the child and parent during nutrition.
However, the impact of parental nutrition on the subsequent active nutrition and on the quality of parent-child interactions is currently unknown.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nutrition pushed by parents | Experimental | Other: parent-pushed enteral feedingenteral nutrition pushed by parents |
| syringe pump | Active comparator | Other: syringe-push enteral feedingEnteral nutrition with syringe pump |
Who may qualify
- Ages
- 30 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children born before 30 SA Age of child at start of study: 32 SA
Key exclusion criteria (9 listed)
- Child with ongoing infection, neurological pathology More than one desaturation and/or bradycardia per hour within 12 last hours Balloon ventilation in last 12 hours
- Medical contraindication to oral nutrition
- Intubated child
- Parents with a disabling mental illness
- Parents not available
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 |
|---|---|---|
| parent-pushed enteral feedingskin-to-skin enteral nutrition pushed by the parent | Other | nutrition pushed by parents |
| syringe-push enteral feedingskin to skin nutrition with syringe pump | Other | syringe pump |
Primary outcome
behavioural interactions (visual, vocal, mimic)
Time frame: 34 (W) weeks of gestational age
interactions during the first 10 minutes of an interactive sequence of a premature in the arms of his parent, filmed and coded with The Observer XT software to 34 WA, starting from 3 behaviors of the premature: vocalization, face look mother" and smile
17 secondary outcomes
Mother and Father Self-Question Assessment of Parental Competence: The Cognitive and Parental Behaviour Scale (PACOTIS)
Time frame: at Month 4
Edinburgh Postpartum Depression Risk Rating Scale (EPDS)
Time frame: at inclusion, at 32, 34 and 37 weeks of gestation
Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU)
Time frame: at 32, 34, and 37 weeks of gestation
Number of desaturation
Time frame: every day betwenn 32 and 34 weeks of gestation
Number of vomiting
Time frame: every day between 32 and 34 weeks of gestation
Exit age on return home
Time frame: through study completion, an average of 41 week of gestation
Parental time in hours
Time frame: at 34 week of gestation and 37 week of gestation, calculated over 7 days
Number of meals and baths given by parents
Time frame: from 32 week of gestation to 37 week of gestation
Duration of transition from passive to active feeding in number of days
Time frame: from 32 week of gestation to 37 week of gestation
Average duration (minutes) of feeding/feeding
Time frame: at 37 week of gestation
Number and duration of skin-to-skin sessions in minutes
Time frame: from inclusion to exit of service ( up to 45 week of gestation)
Duration of breastfeeding in number of days.
Time frame: from 32 week of gestation to 37 week of gestation
Number of children with infant formula change
Time frame: between 32 week of gestation and 37 week of gestation
Evolution of the Z-weight score
Time frame: 32 week of gestation at the exit of the child.
Brunet-Lézine and Neurological Evaluation of Amiel Tison simplified by a psychomotor specialized in the development of premature babies to assess the psychomotor development of infants at
Time frame: 4 months of age corrected.
The Montreal Children's Hospital Feeding Scale [MCH-Feeding Scale]
Time frame: 4 months of age corrected
Number bradycardia
Time frame: every day betwenn 32 and 34 weeks of gestation
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 10 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Premature
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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.
Nelly THOMAS principal investigator
Centre Hospitalier Intercommunal Créteil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parent-pushed enteral feeding and syringe-push enteral feeding in people with Premature and Parent-Child Relations, run by Centre Hospitalier Intercommunal Creteil 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 1 inclusion and 9 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 10 Sep 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?
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?
behavioural interactions (visual, vocal, mimic) (time frame: 34 (W) weeks of gestational age). 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 10 Sep 2026.