Premature BirthFIRSTCRYNCT04849234
Acoustic Analysis of the First Babies Crying in Delivery Room and Adaptation to Extra Uterine Life
An observational study of Premature Birth, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 minute to 15 minutes
- Conditions the study is for
- Premature Birth
- What is being tested?
- newborn cries
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 2 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 15 minutes
- All sexes
- Child
Study population: Infant newborn
Who may be able to join
- Infant born between 37 and 42 SA
- Live infant at birth
- Parent who received informed written information about the study
Who cannot join
- Emergency after childbirth (haemorrhage)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FirstCRY Study : Acoustic Analysis of the First Babies Crying in Delivery Room and Adaptation to Extra Uterine Life
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.
Read the detailed 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).
- Conditions
- Premature Birth
- Being tested
- newborn cries
- Keywords
- Crying, Apgar score, Infant Behavior, First cry, delivery room, extra uterine life
- Medical subject headings
- Premature Birth, Crying, Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
newborn criesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| New born | New born population aged 37 Weeks of Amenorrhea (SA) to 42 Weeks of Amenorrhea (SA) will be included. Their cries will be longitudinally registered. Receives: Behavioral: newborn cries |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the first 15 minutes of life
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
Measured: During the first 15 minutes of life
Secondary outcomes (4)
Pitch of the cry (Hz) Crying acoustic structures
Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software
Measured: During the first 15 minutes of life
roughness of the cry (Hz)
Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software
Measured: During the first 15 minutes of life
Duration of cry (s)
Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software
Measured: During the first 15 minutes of life
Number of cry
Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software
Measured: During the first 15 minutes of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Apr 2021
- Primary completion2 May 2021
- Study completion2 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HUGUES PATURAL, MD PHD, Principal investigator, CHU ST ETIENNE FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849234
- Sponsor's protocol ID
- IRBN262021/CHUSTE
- Acronym
- FIRSTCRY
- Status last verified
- Dec 2022
- First submitted
- 13 Apr 2021
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FirstCRY Study : Acoustic Analysis of the First Babies Crying in Delivery Room and Adaptation to Extra Uterine Life
- ClinicalTrials.gov ID
- NCT04849234
- Acronym / sponsor ID
- FIRSTCRY / IRBN262021/CHUSTE
- Conditions
- Premature Birth
- Keywords
- Crying, Apgar score, Infant Behavior, First cry, delivery room, extra uterine life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 2 May 2021 (actual)
- Study completion
- 2 May 2021 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New born | – | Behavioral: newborn criesNew born population aged 37 Weeks of Amenorrhea (SA) to 42 Weeks of Amenorrhea (SA) will be included. Their cries will be longitudinally registered. |
Who may qualify
- Ages
- 1 minute to 15 minutes
- Sex
- All
- Age groups
- Child
- Study population
- Infant newborn
Key inclusion criteria (3 listed)
- Infant born between 37 and 42 SA
- Live infant at birth
- Parent who received informed written information about the study
Key exclusion criteria (1 listed)
- Emergency after childbirth (haemorrhage)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| newborn criesTheir 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. | Behavioural | New born |
Primary outcome
Fo : maximum fundamental frequency (Hz) of the cry
Time frame: During the first 15 minutes of life
Measured by device: Recorder ZOOM H4N and analyzed with PRAAT® software The F0 and Apgar score will be correlated
Apgar score (0-10)
Time frame: During the first 15 minutes of life
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
4 secondary outcomes
Pitch of the cry (Hz) Crying acoustic structures
Time frame: During the first 15 minutes of life
roughness of the cry (Hz)
Time frame: During the first 15 minutes of life
Duration of cry (s)
Time frame: During the first 15 minutes of life
Number of cry
Time frame: During the first 15 minutes of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HUGUES PATURAL, MD PHD principal investigator
CHU ST ETIENNE FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fo : maximum fundamental frequency (Hz) of the cry (time frame: During the first 15 minutes of life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.