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

C

Centre Hospitalier Intercommunal Creteil

Status

Invitation-only

Conditions

Premature
Parent-Child Relations

Treatments

Other: parent-pushed enteral feeding
Other: syringe-push enteral feeding

Study type

Interventional

Funder types

Other

Identifiers

NCT05313464
PREMIAM

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 estimated patients

Sex

All

Ages

30 to 32 weeks old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

42 participants in 2 patient groups

nutrition pushed by parents
Experimental group
Description:
enteral nutrition pushed by parents
Treatment:
Other: parent-pushed enteral feeding
syringe pump
Active Comparator group
Description:
Enteral nutrition with syringe pump
Treatment:
Other: syringe-push enteral feeding

Trial contacts and locations

1

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Central trial contact

Camille Jung; Nelly THOMAS

Data sourced from clinicaltrials.gov

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