Parental Involvement in Enteral Nutrition in Neonatal Units
PREMALIM
Impact of Parental Involvement in Enteral Nutrition on Their Presence in Neonatal Units
1 other identifier
interventional
72
1 country
2
Brief 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 and enteral feeding with a syringe pump.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2022
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2022
CompletedFirst Posted
Study publicly available on registry
March 10, 2022
CompletedStudy Start
First participant enrolled
August 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2024
CompletedNovember 21, 2025
November 1, 2025
2.3 years
February 9, 2022
November 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
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
from start to the end of enteral feeding, with a maximum of 10 weeks
Weight gain in g / kg / day during the study time
from start to the end of enteral feeding, with a maximum of 10 weeks
Mean daily skin-to-skin duration
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
from start to the end of enteral feeding, with a maximum of 10 weeks
Anxiety mean score for both parents (PARENTAL STRESSOR SCALE)
from start to the end of enteral feeding, with a maximum of 10 weeks
- +2 more secondary outcomes
Study Arms (2)
control group
NO INTERVENTIONEnteral feeding is carried out with a syringe pump
intervention group
EXPERIMENTALthe 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
Interventions
enteral feeding pushed by parents with a syringe
Eligibility Criteria
You may qualify if:
- Gestational age between 30 and 34 WA (weeks of amenorrhea)
- Patient affiliated to a social security scheme
- Hospitalized in neonatal intensive care unit (NICU)
- days of life or more
You may not qualify if:
- 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
- Multiple pregnancy
- Poor understanding of french
- Digestive rest greater than 5 days
- Death
- No enteral nutrition pushed by parents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre Hospitalier Henri Duffaut
Avignon, 84000, France
Limoges university hospital
Limoges, 87042, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2022
First Posted
March 10, 2022
Study Start
August 10, 2022
Primary Completion
November 12, 2024
Study Completion
November 12, 2024
Last Updated
November 21, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share