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

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).

Study Overview

• Status: Completed
• Conditions: Preterm Birth
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

• Study Contact: Name: Hugues PATURAL, MD PhD; Phone Number: +33 (0)4.77.82.85.42; Email: hugues.patural@chu-st-etienne.fr
• Study Contact Backup: Name: Flavie VIAL, Resident; Phone Number: +33 (0)4.77.82.85.42; Email: flavie_1401@hotmail.fr

Study Locations

• France
  • Saint-Étienne, France
    • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis fundamental frequency (f0)	Measured by PRAAT software for 24h every week	at the end of hospitalization (on average 2 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis roughness of the cry (PC1)	Measured by PRAAT software for 24h every week	at the end of hospitalization (on average 2 months)
Analysis pitch of the cry (PC2)	Measured by PRAAT software for 24h every week	at the end of hospitalization (on average 2 months)
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)
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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Hugues PATURAL, MD PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: preterm infants; Newborn; ontogeny of crying
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: IRBN212020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No