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Effect of parental enteral nutrition on quality of Parent-Child interactions: prospective randomized monocentric study (PREMIAM)

NCT ID NCT05313464

NEW Sponsor: Centre Hospitalier Intercommunal Creteil Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

42 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 32 weeks

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parent-child relations Premature

Contacts and locations

Locations

  • Centre Hospitalier Intercommunal Créteil

    Créteil, Val-deMarne, 94000, France

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