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PremCry Study : Study of Ontogeny of Crying in Preterm Infants.

Completed
Conditions
Preterm Birth
Interventions
Other: cries longitudinally registered
Registration Number
NCT04522414
Lead Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Brief Summary

Crying is a survival mechanism for babies and their almost exclusive means of expression until the age of 4 months. Babies 'cry is mostly related to pain, a feeling of hunger, discomfort or separation following the departure of a parent around. Crying is a complex but essential means of communication and information between a baby and his parents that raises the question of their meaning.

Very few longitudinal studies have been produced on preterm's crying. As the term approaches, the characteristics of preterm babies' crying are similar to those of term infants. But these studies date back more than 30 years and are obsolete in terms of the quality and performance of sound recording equipment and signal processing.

No study has looked at the genesis of the cry itself and the varieties of the cry of the preterm baby, depending on whether it was in a situation of hunger, pain, discomfort (bath).

Detailed Description

This longitudinal study recordings of crying babies from 26 amenorrhea week to 33 amenorrhea week, 24 hours per week, each week until the return home. In the same time, parents will be asked to know the situation of the baby (hunger, pain, bath).

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
Inclusion Criteria
  • Infant born between 26 and 33 amenorrhea week
  • Live infant at birth
  • Parent affiliated or entitled to a social security scheme
  • Parent who received informed written information about the study
Exclusion Criteria
  • Intubated infant

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Preterm infantcries longitudinally registered-
Primary Outcome Measures
NameTimeMethod
Analysis fundamental frequency (f0)at the end of hospitalization (on average 2 months)

Measured by PRAAT software for 24h every week

Secondary Outcome Measures
NameTimeMethod
Correlation between crying acoustic structures and parent's responsesat the end of hospitalization (on average 2 months)

Measured by completed questionnaire by parents (Linear Mixed Model) every week

Analysis roughness of the cry (PC1)at the end of hospitalization (on average 2 months)

Measured by PRAAT software for 24h every week

Analysis pitch of the cry (PC2)at the end of hospitalization (on average 2 months)

Measured by PRAAT software for 24h every week

Analysis NIP∑ (neonatal index of parasympathetic activity) indexat the end of hospitalization (on average 2 months)

Measured by monitor MDoloris® for 24h every week

Trial Locations

Locations (1)

CHU Saint-Etienne

🇫🇷

Saint-Étienne, France

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