Parental Involvement in Enteral Nutrition in Neonatal Units

Premature Birth Clinical Trial

— PREMALIM  

Official title:

Impact of Parental Involvement in Enteral Nutrition on Their Presence in Neonatal Units

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05272956
• Other study ID #: 87RI21_0030 (PREMALIM)
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2022
• Est. completion date: February 10, 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Limoges
• Contact: Fabienne Mons, MD
• Phone: 555058666
• Email: fabienne.mons[@]chu-limoges.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: February 10, 2025
• Est. primary completion date: February 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Days and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Procedure:
• enteral feeding with pushed syringe by the parents
enteral feeding pushed by parents with a syringe

Locations

Country	Name	City	State
France	Centre Hospitalier Henri Duffaut	Avignon
France	Limoges university hospital	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	from start to the end of enteral feeding, with a maximum of 10 weeks
Secondary	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	from start to the end of enteral feeding, with a maximum of 10 weeks
Secondary	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	from start to the end of enteral feeding, with a maximum of 10 weeks
Secondary	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	from start to the end of enteral feeding, with a maximum of 10 weeks
Secondary	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.	from start to the end of enteral feeding, with a maximum of 10 weeks
Secondary	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.	from start to the end of enteral feeding, with a maximum of 10 weeks
Secondary	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.	from start to the end of enteral feeding, with a maximum of 10 weeks