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Completed

NCT Number: NCT04522414

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

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).

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–10 day

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne

Saint-Etienne, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

cries longitudinally registered

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: PremCry

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2020
Registry last updated
Jun 23, 2023

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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