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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04522414
Acronym
PremCry
Enrollment
20
Registered
2020-08-21
Start date
2020-11-20
Completion date
2023-05-01
Last updated
2023-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Keywords

Newborn, ontogeny of crying, preterm infants

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).

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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 10 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Analysis fundamental frequency (f0)at the end of hospitalization (on average 2 months)Measured by PRAAT software for 24h every week

Secondary

MeasureTime frameDescription
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
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026