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

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ClinicalTrials.gov Identifier: NCT04522414
Recruitment Status : Recruiting
First Posted : August 21, 2020
Last Update Posted : December 2, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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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).


Condition or disease Intervention/treatment
Preterm Birth Other: cries longitudinally registered

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).
Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PremCry Study : Study of Ontogeny of Crying in Preterm Infants.
Actual Study Start Date : November 20, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
Preterm infant Other: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Analysis fundamental frequency (f0) [ Time Frame: at the end of hospitalization (on average 2 months) ]
    Measured by PRAAT software for 24h every week


Secondary Outcome Measures :
  1. Analysis roughness of the cry (PC1) [ Time Frame: at the end of hospitalization (on average 2 months) ]
    Measured by PRAAT software for 24h every week

  2. Analysis pitch of the cry (PC2) [ Time Frame: at the end of hospitalization (on average 2 months) ]
    Measured by PRAAT software for 24h every week

  3. Analysis NIP∑ (neonatal index of parasympathetic activity) index [ Time Frame: at the end of hospitalization (on average 2 months) ]
    Measured by monitor MDoloris® for 24h every week

  4. Correlation between crying acoustic structures and parent's responses [ Time Frame: at the end of hospitalization (on average 2 months) ]
    Measured by completed questionnaire by parents (Linear Mixed Model) every week


Eligibility Criteria
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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infant born between 26 and 33 amenorrhea week will be included.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04522414


Contacts
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Contact: Hugues PATURAL, MD PhD (0)4.77.82.85.42 ext +33 hugues.patural@chu-st-etienne.fr
Contact: Flavie VIAL, Resident (0)4.77.82.85.42 ext +33 flavie_1401@hotmail.fr

Locations
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France
CHU Saint-Etienne Recruiting
Saint-Étienne, France
Principal Investigator: Hugues PATURAL, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Hugues PATURAL, MD PhD CHU SAINT-ETIENNE
More Information
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT04522414    
Other Study ID Numbers: IRBN212020
First Posted: August 21, 2020    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Newborn
ontogeny of crying
preterm infants
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications