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CompletedNCT04522414PremCryUpdated Jun 23, 2023

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

An observational study in Preterm Birth, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 1 Day to 10 Days. Per ClinicalTrials.gov, last updated 2023-06-23.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
1 Day to 10 Days
Sex
All
01

Study 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).

Read the 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).

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Conditions studied

  • Preterm Birth

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Keywords

  • Newborn
  • ontogeny of crying
  • preterm infants
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In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 20 is below the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Day to 10 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Infant born between 26 and 33 amenorrhea week will be included.

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

Exclusion Criteria:

  • Intubated infant
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Preterm infant

    Other: cries longitudinally registered

Interventions

  • Othercries 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.

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What researchers measure

Primary outcomes

  1. Analysis fundamental frequency (f0)

    Measured by PRAAT software for 24h every week

    Time frame: at the end of hospitalization (on average 2 months)

Secondary outcomes

  1. Analysis roughness of the cry (PC1)

    Measured by PRAAT software for 24h every week

    Time frame: at the end of hospitalization (on average 2 months)

  2. Analysis pitch of the cry (PC2)

    Measured by PRAAT software for 24h every week

    Time frame: at the end of hospitalization (on average 2 months)

  3. Analysis NIP∑ (neonatal index of parasympathetic activity) index

    Measured by monitor MDoloris® for 24h every week

    Time frame: at the end of hospitalization (on average 2 months)

  4. Correlation between crying acoustic structures and parent's responses

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

    Time frame: at the end of hospitalization (on average 2 months)

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Study locations

1 site
  • CHU Saint-Etienne
    Saint-Étienne, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04522414
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Aug 21, 2020
Start date
Nov 20, 2020
Primary completion
May 1, 2023
Completion
May 1, 2023
Last update
Jun 23, 2023

Study contacts

Hugues PATURAL, MD PhD
principal investigator · CHU SAINT-ETIENNE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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