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

NCT ID: NCT04522414

Last Updated: 2023-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-20

Study Completion Date

2023-05-01

Brief Summary

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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

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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).

Conditions

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Preterm Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preterm infant

cries longitudinally registered

Intervention Type OTHER

Their cries will be longitudinally registered from the age of birth to the return home using an automatic record device: Song Meter SM4.

Interventions

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cries longitudinally registered

Their cries will be longitudinally registered from the age of birth to the return home using an automatic record device: Song Meter SM4.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

10 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hugues PATURAL, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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IRBN212020

Identifier Type: -

Identifier Source: org_study_id

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