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

Premature Birth Clinical Trial

— PréPaLim  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177913
• Other study ID #: P/2019/409
• Status: Recruiting
• Start date: September 16, 2021
• Est. completion date: September 2022

Study information

• Verified date: December 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Boillot Sandrine
• Phone: 0381668166
• Email: sboillot[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Days

Eligibility

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).

Related Conditions & MeSH terms

• Amenorrhea
• Premature Birth

Locations

Country	Name	City	State
France	CHU de Besancon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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