Parental Involvement in Enteral Nutrition in Neonatal Units (PREMALIM)
Primary Purpose
Premature Birth
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
enteral feeding with pushed syringe by the parents
Sponsored by
About this trial
This is an interventional other trial for Premature Birth
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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
• Secondary exclusion criteria
- Digestive rest greater than 5 days
- Death
- No enteral nutrition pushed by parents
Sites / Locations
- Centre Hospitalier Henri DuffautRecruiting
- Limoges university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
intervention group
Arm Description
Enteral feeding is carried out with a syringe pump
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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.
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.
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.
Full Information
NCT ID
NCT05272956
First Posted
February 9, 2022
Last Updated
September 13, 2023
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT05272956
Brief Title
Parental Involvement in Enteral Nutrition in Neonatal Units
Acronym
PREMALIM
Official Title
Impact of Parental Involvement in Enteral Nutrition on Their Presence in Neonatal Units
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
August 10, 2024 (Anticipated)
Study Completion Date
August 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
Enteral feeding is carried out with a syringe pump
Arm Title
intervention group
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
enteral feeding with pushed syringe by the parents
Intervention Description
enteral feeding pushed by parents with a syringe
Primary Outcome Measure Information:
Title
parental presence
Description
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
Time Frame
from start to the end of enteral feeding, with a maximum of 10 weeks
Secondary Outcome Measure Information:
Title
Corrected age at which oral feeding skills are acquired
Description
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
Time Frame
from start to the end of enteral feeding, with a maximum of 10 weeks
Title
Weight gain in g / kg / day during the study time
Description
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
Time Frame
from start to the end of enteral feeding, with a maximum of 10 weeks
Title
Mean daily skin-to-skin duration
Description
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
Time Frame
from start to the end of enteral feeding, with a maximum of 10 weeks
Title
Percentage of breastfeeding at inclusion and at the end of the participation period
Description
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
Time Frame
from start to the end of enteral feeding, with a maximum of 10 weeks
Title
Anxiety mean score for both parents (PARENTAL STRESSOR SCALE)
Description
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.
Time Frame
from start to the end of enteral feeding, with a maximum of 10 weeks
Title
Mother-newborn bond assessment scale (MIBS) score
Description
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.
Time Frame
from start to the end of enteral feeding, with a maximum of 10 weeks
Title
Adherence of pushed bolus syringue feeding under parent's visual control
Description
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.
Time Frame
from start to the end of enteral feeding, with a maximum of 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
• Secondary exclusion criteria
Digestive rest greater than 5 days
Death
No enteral nutrition pushed by parents
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabienne Mons, MD
Phone
555058666
Ext
33
Email
fabienne.mons@chu-limoges.fr
Facility Information:
Facility Name
Centre Hospitalier Henri Duffaut
City
Avignon
ZIP/Postal Code
84000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Es-Sathi, MD
Email
aessathi@ch-avignon.fr
First Name & Middle Initial & Last Name & Degree
Ali Es-Sathi, MD
Facility Name
Limoges university hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabienne MONS, MD
Email
fabienne.mons@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
Léa DOUZIECH
Email
lea.douziech@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
MONS Fabienne, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Parental Involvement in Enteral Nutrition in Neonatal Units
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