Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions

NCT ID: NCT05313464

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2027-12-28

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.

Conditions

Premature; Parent-Child Relations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

nutrition pushed by parents

enteral nutrition pushed by parents

Group Type: EXPERIMENTAL

parent-pushed enteral feeding

Intervention Type: OTHER

skin-to-skin enteral nutrition pushed by the parent

syringe pump

Enteral nutrition with syringe pump

Group Type: ACTIVE_COMPARATOR

syringe-push enteral feeding

Intervention Type: OTHER

skin to skin nutrition with syringe pump

Interventions

parent-pushed enteral feeding

skin-to-skin enteral nutrition pushed by the parent

Intervention Type: OTHER

syringe-push enteral feeding

skin to skin nutrition with syringe pump

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Le Laboratoire de Psychopathologie et Processus de Santé

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nelly THOMAS

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Intercommunal Créteil

Locations

Centre Hospitalier Intercommunal Créteil

Créteil, Val-deMarne, France

Countries

France

Other Identifiers

PREMIAM

Identifier Type: -

Identifier Source: org_study_id