Clinical trial NCT05272956: Parental Involvement in Enteral Nutrition in Neonatal Units
Official title: Impact of Parental Involvement in Enteral Nutrition on Their Presence in Neonatal Units
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Birth
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 72
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: parental presence
timeFrame: from start to the end of enteral feeding, with a maximum of 10 weeks
Secondary outcomes:
measure: Corrected age at which oral feeding skills are acquired
timeFrame: from start to the end of enteral feeding, with a maximum of 10 weeks
measure: Weight gain in g / kg / day during the study time
timeFrame: from start to the end of enteral feeding, with a maximum of 10 weeks
measure: Mean daily skin-to-skin duration
timeFrame: from start to the end of enteral feeding, with a maximum of 10 weeks
measure: Percentage of breastfeeding at inclusion and at the end of the participation period
timeFrame: from start to the end of enteral feeding, with a maximum of 10 weeks
measure: Anxiety mean score for both parents (PARENTAL STRESSOR SCALE)
timeFrame: from start to the end of enteral feeding, with a maximum of 10 weeks
measure: Mother-newborn bond assessment scale (MIBS) score
timeFrame: from start to the end of enteral feeding, with a maximum of 10 weeks
measure: Adherence of pushed bolus syringue feeding under parent's visual control
timeFrame: from start to the end of enteral feeding, with a maximum of 10 weeks
Other outcomes:
Locations:
city: Avignon
country: France
facility: Centre Hospitalier Henri Duffaut
city: Limoges
country: France
facility: Limoges university hospital
Study officials:
References: