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

NCT04522414 | Completed

• 1 other identifier: IRBN212020
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Preterm Birth

Keywords

Newborn; ontogeny of crying; preterm infants

Outcome Measures

Primary Outcomes (1)

• Analysis fundamental frequency (f0)

  Measured by PRAAT software for 24h every week

  at the end of hospitalization (on average 2 months)

Secondary Outcomes (4)

• Analysis roughness of the cry (PC1)

  at the end of hospitalization (on average 2 months)

• Analysis pitch of the cry (PC2)

  at the end of hospitalization (on average 2 months)

• Analysis NIP∑ (neonatal index of parasympathetic activity) index

  at the end of hospitalization (on average 2 months)

• Correlation between crying acoustic structures and parent's responses

  at the end of hospitalization (on average 2 months)

Study Arms (1)

Preterm infant

Other: cries longitudinally registered

Interventions

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.

Preterm infant

Eligibility Criteria

• Age: 1 Day - 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- Intubated infant

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Hugues PATURAL, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 21, 2020
• Study Start: November 20, 2020
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)