NCT05313464

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Apr 2022Dec 2027

First Submitted

Initial submission to the registry

February 4, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

April 15, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2027

Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

5 years

First QC Date

February 4, 2022

Last Update Submit

August 26, 2025

Conditions

PrematureParent-Child Relations

Keywords

Prematurechild at 32 of gestational ageenteral nutritionskin to skinpush on syringe pumpParent-Child Relations

Outcome Measures

Primary Outcomes (1)

  • behavioural interactions (visual, vocal, mimic)

    interactions during the first 10 minutes of an interactive sequence of a premature in the arms of his parent, filmed and coded with The Observer XT software to 34 WA, starting from 3 behaviors of the premature: vocalization, face look mother" and smile

    34 (W) weeks of gestational age

Secondary Outcomes (17)

  • Mother and Father Self-Question Assessment of Parental Competence: The Cognitive and Parental Behaviour Scale (PACOTIS)

    at Month 4

  • Edinburgh Postpartum Depression Risk Rating Scale (EPDS)

    at inclusion, at 32, 34 and 37 weeks of gestation

  • Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU)

    at 32, 34, and 37 weeks of gestation

  • Number of desaturation

    every day betwenn 32 and 34 weeks of gestation

  • Number of vomiting

    every day between 32 and 34 weeks of gestation

  • +12 more secondary outcomes

Study Arms (2)

nutrition pushed by parents

EXPERIMENTAL

enteral nutrition pushed by parents

Other: parent-pushed enteral feeding

syringe pump

ACTIVE COMPARATOR

Enteral nutrition with syringe pump

Other: syringe-push enteral feeding

Interventions

parent-pushed enteral feedingOTHER

skin-to-skin enteral nutrition pushed by the parent

nutrition pushed by parents
syringe-push enteral feedingOTHER

skin to skin nutrition with syringe pump

syringe pump

Eligibility Criteria

Age30 Weeks - 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children born before 30 SA Age of child at start of study: 32 SA

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Intercommunal Créteil

Créteil, Val-deMarne, 94000, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Nelly THOMAS

    Centre Hospitalier Intercommunal Créteil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2022

First Posted

April 6, 2022

Study Start

April 15, 2022

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

December 28, 2027

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)