Parental Involvement in Enteral Nutrition in Neonatal Units

NCT ID: NCT05272956

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-10
• Study Completion Date: 2024-11-12

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.

Conditions

Premature Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

control group

Enteral feeding is carried out with a syringe pump

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

enteral feeding with pushed syringe by the parents

Intervention Type: PROCEDURE

enteral feeding pushed by parents with a syringe

Interventions

enteral feeding with pushed syringe by the parents

enteral feeding pushed by parents with a syringe

Intervention Type: PROCEDURE

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

• Digestive rest greater than 5 days
• Death
• No enteral nutrition pushed by parents

• Minimum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Henri Duffaut

Avignon, , France

Limoges university hospital

Limoges, , France

Countries

France

Other Identifiers

87RI21_0030 (PREMALIM)

Identifier Type: -

Identifier Source: org_study_id