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

Preterm Birth Clinical Trial

— PremCry  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04522414
• Other study ID #: IRBN212020
• Status: Completed
• Start date: November 20, 2020
• Est. completion date: May 1, 2023

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 10 Days

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

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.

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis fundamental frequency (f0)	Measured by PRAAT software for 24h every week	at the end of hospitalization (on average 2 months)
Secondary	Analysis roughness of the cry (PC1)	Measured by PRAAT software for 24h every week	at the end of hospitalization (on average 2 months)
Secondary	Analysis pitch of the cry (PC2)	Measured by PRAAT software for 24h every week	at the end of hospitalization (on average 2 months)
Secondary	Analysis NIP? (neonatal index of parasympathetic activity) index	Measured by monitor MDoloris® for 24h every week	at the end of hospitalization (on average 2 months)
Secondary	Correlation between crying acoustic structures and parent's responses	Measured by completed questionnaire by parents (Linear Mixed Model) every week	at the end of hospitalization (on average 2 months)