Clinical trial NCT05313464: Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions
Official title: Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions: Prospective Randomized Monocentric Study (PREMIAM)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Premature
Parent-Child Relations
Keywords: Premature
child at 32 of gestational age
enteral nutrition
skin to skin
push on syringe pump
Parent-Child Relations
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Le Laboratoire de Psychopathologie et Processus de Santé
First posted: 2022-04-06
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: behavioural interactions (visual, vocal, mimic)
timeFrame: 34 (W) weeks of gestational age
Secondary outcomes:
measure: Mother and Father Self-Question Assessment of Parental Competence: The Cognitive and Parental Behaviour Scale (PACOTIS)
timeFrame: at Month 4
measure: Edinburgh Postpartum Depression Risk Rating Scale (EPDS)
timeFrame: at inclusion, at 32, 34 and 37 weeks of gestation
measure: Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU)
timeFrame: at 32, 34, and 37 weeks of gestation
measure: Number of desaturation
timeFrame: every day betwenn 32 and 34 weeks of gestation
measure: Number of vomiting
timeFrame: every day between 32 and 34 weeks of gestation
measure: Exit age on return home
timeFrame: through study completion, an average of 41 week of gestation
measure: Parental time in hours
timeFrame: at 34 week of gestation and 37 week of gestation, calculated over 7 days
measure: Number of meals and baths given by parents
timeFrame: from 32 week of gestation to 37 week of gestation
measure: Duration of transition from passive to active feeding in number of days
timeFrame: from 32 week of gestation to 37 week of gestation
measure: Average duration (minutes) of feeding/feeding
timeFrame: at 37 week of gestation
measure: Number and duration of skin-to-skin sessions in minutes
timeFrame: from inclusion to exit of service ( up to 45 week of gestation)
measure: Duration of breastfeeding in number of days.
timeFrame: from 32 week of gestation to 37 week of gestation
measure: Number of children with infant formula change
timeFrame: between 32 week of gestation and 37 week of gestation
measure: Evolution of the Z-weight score
timeFrame: 32 week of gestation at the exit of the child.
measure: Brunet-Lézine and Neurological Evaluation of Amiel Tison simplified by a psychomotor specialized in the development of premature babies to assess the psychomotor development of infants at
timeFrame: 4 months of age corrected.
measure: The Montreal Children's Hospital Feeding Scale [MCH-Feeding Scale]
timeFrame: 4 months of age corrected
measure: Number bradycardia
timeFrame: every day betwenn 32 and 34 weeks of gestation
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal Créteil
state: Val-deMarne
Study officials:
affiliation: Centre Hospitalier Intercommunal Créteil
name: Nelly THOMAS
role: PRINCIPAL_INVESTIGATOR
References: