Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions (PREMIAM)
Primary Purpose
Premature, Parent-Child Relations
Status
Enrolling by invitation
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
parent-pushed enteral feeding
syringe-push enteral feeding
Sponsored by
About this trial
This is an interventional other trial for Premature focused on measuring Premature, child at 32 of gestational age, enteral nutrition, skin to skin, push on syringe pump, Parent-Child Relations
Eligibility Criteria
Inclusion Criteria:
Children born before 30 SA Age of child at start of study: 32 SA
Exclusion Criteria:
- 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
- Parents under guardianship or protection of justice
- Refusal to sign consent
- Parents not affiliated with a social security system
Sites / Locations
- Centre Hospitalier Intercommunal Créteil
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
nutrition pushed by parents
syringe pump
Arm Description
enteral nutrition pushed by parents
Enteral nutrition with syringe pump
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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)
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).
Number of desaturation
Number of desaturation
Number of vomiting
Number of vomiting
Exit age on return home
age of the infant when leaving the hospital
Parental time in hours
time spend withe child
Number of meals and baths given by parents
Number of meals and baths given by parents
Duration of transition from passive to active feeding in number of days
Duration of transition from passive to active feeding in number of days
Average duration (minutes) of feeding/feeding
Average duration (minutes) of feeding/feeding
Number and duration of skin-to-skin sessions in minutes
Number and duration of skin-to-skin sessions in minutes
Duration of breastfeeding in number of days.
Duration of breastfeeding in number of days.
Number of children with infant formula change
Number of children with infant formula change
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.
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.).
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
Number bradycardia
Number bradycardia
Full Information
NCT ID
NCT05313464
First Posted
February 4, 2022
Last Updated
September 5, 2023
Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Le Laboratoire de Psychopathologie et Processus de Santé
1. Study Identification
Unique Protocol Identification Number
NCT05313464
Brief Title
Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions
Acronym
PREMIAM
Official Title
Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions: Prospective Randomized Monocentric Study (PREMIAM)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
April 15, 2024 (Anticipated)
Study Completion Date
December 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Le Laboratoire de Psychopathologie et Processus de Santé
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature, Parent-Child Relations
Keywords
Premature, child at 32 of gestational age, enteral nutrition, skin to skin, push on syringe pump, Parent-Child Relations
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nutrition pushed by parents
Arm Type
Experimental
Arm Description
enteral nutrition pushed by parents
Arm Title
syringe pump
Arm Type
Active Comparator
Arm Description
Enteral nutrition with syringe pump
Intervention Type
Other
Intervention Name(s)
parent-pushed enteral feeding
Intervention Description
skin-to-skin enteral nutrition pushed by the parent
Intervention Type
Other
Intervention Name(s)
syringe-push enteral feeding
Intervention Description
skin to skin nutrition with syringe pump
Primary Outcome Measure Information:
Title
behavioural interactions (visual, vocal, mimic)
Description
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
Time Frame
34 (W) weeks of gestational age
Secondary Outcome Measure Information:
Title
Mother and Father Self-Question Assessment of Parental Competence: The Cognitive and Parental Behaviour Scale (PACOTIS)
Description
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.
Time Frame
at Month 4
Title
Edinburgh Postpartum Depression Risk Rating Scale (EPDS)
Description
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)
Time Frame
at inclusion, at 32, 34 and 37 weeks of gestation
Title
Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU)
Description
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).
Time Frame
at 32, 34, and 37 weeks of gestation
Title
Number of desaturation
Description
Number of desaturation
Time Frame
every day betwenn 32 and 34 weeks of gestation
Title
Number of vomiting
Description
Number of vomiting
Time Frame
every day between 32 and 34 weeks of gestation
Title
Exit age on return home
Description
age of the infant when leaving the hospital
Time Frame
through study completion, an average of 41 week of gestation
Title
Parental time in hours
Description
time spend withe child
Time Frame
at 34 week of gestation and 37 week of gestation, calculated over 7 days
Title
Number of meals and baths given by parents
Description
Number of meals and baths given by parents
Time Frame
from 32 week of gestation to 37 week of gestation
Title
Duration of transition from passive to active feeding in number of days
Description
Duration of transition from passive to active feeding in number of days
Time Frame
from 32 week of gestation to 37 week of gestation
Title
Average duration (minutes) of feeding/feeding
Description
Average duration (minutes) of feeding/feeding
Time Frame
at 37 week of gestation
Title
Number and duration of skin-to-skin sessions in minutes
Description
Number and duration of skin-to-skin sessions in minutes
Time Frame
from inclusion to exit of service ( up to 45 week of gestation)
Title
Duration of breastfeeding in number of days.
Description
Duration of breastfeeding in number of days.
Time Frame
from 32 week of gestation to 37 week of gestation
Title
Number of children with infant formula change
Description
Number of children with infant formula change
Time Frame
between 32 week of gestation and 37 week of gestation
Title
Evolution of the Z-weight score
Description
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.
Time Frame
32 week of gestation at the exit of the child.
Title
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
Description
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.).
Time Frame
4 months of age corrected.
Title
The Montreal Children's Hospital Feeding Scale [MCH-Feeding Scale]
Description
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
Time Frame
4 months of age corrected
Title
Number bradycardia
Description
Number bradycardia
Time Frame
every day betwenn 32 and 34 weeks of gestation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children born before 30 SA Age of child at start of study: 32 SA
Exclusion Criteria:
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
Parents under guardianship or protection of justice
Refusal to sign consent
Parents not affiliated with a social security system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelly THOMAS
Organizational Affiliation
Centre Hospitalier Intercommunal Créteil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Intercommunal Créteil
City
Créteil
State/Province
Val-deMarne
ZIP/Postal Code
94000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions
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