PréPaLim: Assessment of Factors Influencing Parents' Attendance Time During Feeding Time of Premature Infants Born Before 35 Weeks of Amenorrhea in Besançon University Hospital

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Recruiting

CT.gov ID

NCT05177913

Collaborator

(none)

Enrollment

Location

11.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Birth

Detailed Description

Considering the importance of the bond of attachment, and in particular the emotional tuning between the adult and the premature baby and the particularly important interactions during feeding, it seemed essential to us to make an evaluation of the parental presence during the meals. , which sheds light on the factors influencing this presence.

The presence time seems to vary depending on: the child's background, the profile of the parents, the profile of the child and environmental factors.

Knowing the factors influencing this presence is essential in order to understand the obstacles to the arrival of parents, to think as a team and to offer personalized support in order to allow them to be more present with their baby.

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assessment of Factors Influencing Parents' Attendance Time During Feeding Time of Premature Infants Born Before 35 Weeks of Amenorrhea in Besançon University Hospital

Actual Study Start Date :

Sep 16, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Outcome Measures

Primary Outcome Measures

The time of parental presence [Up to 6 months]
Quantify the time of parental presence during the meals of premature children born before 35 weeks of amenorrhea (AS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 10 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Besancon	Besançon		France	25000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT05177913

Other Study ID Numbers:

P/2019/409

First Posted:

Jan 5, 2022

Last Update Posted:

Jan 5, 2022

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Premature Birth

Amenorrhea

Study Results

No Results Posted as of Jan 5, 2022