NCT05177913

Brief Summary

The precise description of parental presence and the associated factors will make it possible to construct an intervention in order to correct potentially low parental participation. The demonstration of the effectiveness of such an intervention will be the subject of a larger study (PHRIP type). Ultimately, the investigators want to personalize the daily support for parents to offer optimal support for parenting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

September 16, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2023

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

1.7 years

First QC Date

September 14, 2021

Last Update Submit

June 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The time of parental presence

    Quantify the time of parental presence during the meals of premature children born before 35 weeks of amenorrhea (AS)

    Up to 6 months

Eligibility Criteria

Age1 Day - 10 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The premature newborn born before 35 weeks of amenorrhea at the Besançon University Hospital and his parents (birth couple).

You may qualify if:

  • Premature newborn under 35 weeks of amenorrhea (AS), hospitalized at Besançon University Hospital,
  • Newborn baby whose parents:
  • expressed their non-opposition to participate in the study, are affiliated to a social security scheme, are of age, express themselves easily in French.

You may not qualify if:

  • Newborn baby whose parents object to participating in the study,
  • Newborns presenting severe malformative anomalies, or malformations of the oral sphere,
  • Newborn baby whose transfer is scheduled before the end of hospitalization (excluding birthing pool at the CHU de Besançon).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besancon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2021

First Posted

January 5, 2022

Study Start

September 16, 2021

Primary Completion

May 26, 2023

Study Completion

May 26, 2023

Last Updated

June 24, 2024

Record last verified: 2024-06

Locations