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Completed

NCT Number: NCT05177913

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

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.

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Key information

Age range

1 day–10 day

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Besancon

Besançon, 25000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. The time of parental presence

    Time frame: Up to 6 months

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: PréPaLim

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 5, 2022
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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