Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04849234
Other study ID # IRBN262021/CHUSTE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2021
Est. completion date May 2, 2021

Study information

Verified date December 2022
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Interpreting the cry of new-borns is a real challenge not only for perinatal professionals but also for parents, who are confronted daily with those sounds. The description and the acoustic analysis of baby's cry can allow healthcare professionals to better adapt their care during the first months of life. Thanks to an objective analysis method as acoustic analysis, the particularities of the first cry should provide us information on the quality of adaptation to ambient air life.


Description:

Interpreting the cry of new-borns is a real challenge not only for perinatal professionals but also for parents, who are confronted daily with those sounds. The description and the acoustic analysis of baby's cry can allow healthcare professionals to better adapt their care during the first months of life. Aiming for this objective, many studies have already been carried out on infants crying in the first months of life, in order to better understand their significance (pain, discomfort, hunger) and the mechanisms of recognition and discrimination by parents or listeners. Various techniques are promising to characterize the acoustic space of cry (maximum frequency, intensity, harmonics, duration…). However, few studies have investigated the acoustic characteristics of the first cry of life in the delivery room. Its intensity and characteristics are closely related to the laryngeal anatomy and respiratory capacity. Thus, a vigorous cry with its own acoustic characteristics could be the witness of a good adaptation to extra uterine life, while a weak or plaintive cry should warn the caregiver on difficulties in this adaptation. Thanks to an objective analysis method as acoustic analysis, the particularities of the first cry should provide us information on the quality of adaptation to ambient air life. The investigators hypothesize that the acoustic characteristics of the first cries of newborns recorded at birth are correlated with the criteria of extra uterine life adaptation (Apgar score, pH and lactates collected from the umbilical cord), with the respiratory score (Silverman) and with the early neonatal outcome (transfer to the intensive care unit).


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date May 2, 2021
Est. primary completion date May 2, 2021
Accepts healthy volunteers
Gender All
Age group 1 Minute to 15 Minutes
Eligibility Inclusion Criteria: - Infant born between 37 and 42 SA - Live infant at birth - Parent who received informed written information about the study Exclusion Criteria: - Emergency after childbirth (haemorrhage)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
newborn cries
Their cries will be longitudinally registered from the age of birth until the first 15 minutes of birth using an automatic record device: Recorder ZOOM H4N. The wav-sized files obtained from each recording will then be analyzed indiscriminately via an acoustic processing script created for the PRAAT software® by the post-doctoral fellows of the ENES laboratory (Sensory NeuroEthology Team) on the site of the Faculty of Sciences of Saint-Etienne.

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 Fo : maximum fundamental frequency (Hz) of the cry Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software
The F0 and Apgar score will be correlated
During the first 15 minutes of life
Primary Apgar score (0-10) The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting score ranges from zero to 10.
The five criteria are : appearance, pulse, grimace, activity, respiration.
The F0 and Apgar score will be correlated
During the first 15 minutes of life
Secondary Pitch of the cry (Hz) Crying acoustic structures Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software During the first 15 minutes of life
Secondary roughness of the cry (Hz) Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software During the first 15 minutes of life
Secondary Duration of cry (s) Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software During the first 15 minutes of life
Secondary Number of cry Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software During the first 15 minutes of life
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05048550 - Babies in Glasses; a Feasibility Study. N/A
Active, not recruiting NCT03655639 - Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants
Enrolling by invitation NCT05542108 - Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants N/A
Completed NCT03680157 - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed NCT03337659 - A Cluster Randomized Controlled Trial of FICare at 18 Months N/A
Completed NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing Phase 1
Completed NCT03251729 - Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix Phase 4
Not yet recruiting NCT05039918 - Neonatal Experience of Social Touch N/A
Not yet recruiting NCT03418311 - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome N/A
Not yet recruiting NCT03418012 - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB N/A
Not yet recruiting NCT02880696 - Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates N/A
Completed NCT02913495 - Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth Phase 4
Completed NCT02952950 - Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study N/A
Completed NCT02879799 - Family Integrated Care (FICare) in Level II NICUs N/A
Completed NCT02661360 - Effects of Swaddling on Infants During Feeding N/A
Completed NCT02743572 - Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants N/A
Completed NCT01352234 - Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia Phase 4
Completed NCT01163188 - Social Adjustment and Quality of Life After Very Preterm Birth N/A
Terminated NCT00675753 - Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families N/A
Completed NCT00271115 - Kangaroo Holding and Maternal Stress N/A