Parental Involvement in Enteral Nutrition in Neonatal Units (PREMALIM)

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

• 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.

Study Overview

• Status: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Procedure: enteral feeding with pushed syringe by the parents

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Avignon, France, 84000
    • Centre Hospitalier Henri Duffaut
  • Limoges, France, 87042
    • Limoges University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 days and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; Enteral feeding is carried out with a syringe pump
Experimental: 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. 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	Procedure: enteral feeding with pushed syringe by the parents; enteral feeding pushed by parents with a syringe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): November 12, 2024
• Study Completion (Actual): November 12, 2024

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth; Therapeutics; Nutrition Therapy; Feeding Methods; Nutritional Support; Enteral Nutrition
• Other Study ID Numbers: 87RI21_0030 (PREMALIM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No