Preterm BirthPremCryNCT04522414
PremCry Study : Study of Ontogeny of Crying in Preterm Infants.
An observational study of Preterm Birth, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 day to 10 days
- Conditions the study is for
- Preterm Birth
- What is being tested?
- cries longitudinally registered
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2020to 1 May 2023
- 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 day to 10 days
- All sexes
- No healthy volunteers
- Child
Study population: Infant born between 26 and 33 amenorrhea week will be included.
Who may be able to join
- 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
Who cannot join
- Intubated infant
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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).
- Conditions
- Preterm Birth
- Being tested
- cries longitudinally registered
- Keywords
- Newborn, ontogeny of crying, preterm infants
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cries longitudinally registeredOther
Their cries will be longitudinally registered from the age of birth to the return home using an automatic record device: Song Meter SM4.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infant | Not described Receives: Other: cries longitudinally registered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis fundamental frequency (f0)
Measured by PRAAT software for 24h every week
Measured: at the end of hospitalization (on average 2 months)
Secondary outcomes (4)
Analysis roughness of the cry (PC1)
Measured by PRAAT software for 24h every week
Measured: at the end of hospitalization (on average 2 months)
Analysis pitch of the cry (PC2)
Measured by PRAAT software for 24h every week
Measured: 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
Measured: 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
Measured: at the end of hospitalization (on average 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start20 Nov 2020
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm 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
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugues PATURAL, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522414
- Sponsor's protocol ID
- IRBN212020
- Acronym
- PremCry
- Status last verified
- Jun 2023
- First submitted
- 3 Aug 2020
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bonafos G, Vial F, Cornec C, Papet L, Lego L, Audouard J, De Vito A, Reby D, Rouch J, Emonet R, Patural H, Mathevon N. Premature baby cries remain different from those of full-term babies. J Acoust Soc Am. 2025 Jun 1;157(6):4175-4183. doi: 10.1121/10.0036842.
PubMed 40464705
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PremCry Study : Study of Ontogeny of Crying in Preterm Infants.
- ClinicalTrials.gov ID
- NCT04522414
- Acronym / sponsor ID
- PremCry / IRBN212020
- Conditions
- Preterm Birth
- Keywords
- Newborn, ontogeny of crying, preterm infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 21 Aug 2020 (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.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infant | – | Other: cries longitudinally registered |
Who may qualify
- Ages
- 1 day to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infant born between 26 and 33 amenorrhea week will be included.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Intubated infant
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 |
|---|---|---|
| cries longitudinally registeredTheir cries will be longitudinally registered from the age of birth to the return home using an automatic record device: Song Meter SM4. | Other | Preterm infant |
Primary outcome
Analysis fundamental frequency (f0)
Time frame: at the end of hospitalization (on average 2 months)
Measured by PRAAT software for 24h every week
4 secondary outcomes
Analysis roughness of the cry (PC1)
Time frame: at the end of hospitalization (on average 2 months)
Analysis pitch of the cry (PC2)
Time frame: at the end of hospitalization (on average 2 months)
Analysis NIP∑ (neonatal index of parasympathetic activity) index
Time frame: at the end of hospitalization (on average 2 months)
Correlation between crying acoustic structures and parent's responses
Time frame: at the end of hospitalization (on average 2 months)
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 23 Jun 2023.
- Derived from this study: PubMed 40464705Bonafos G, Vial F, Cornec C, Papet L, Lego L, Audouard J, De Vito A, Reby D, Rouch J, Emonet R, Patural H, Mathevon N. Premature baby cries remain different from those of full-term babies. J Acoust Soc Am. 2025 Jun 1;157(6):4175-4183. doi: 10.1121/10.0036842.
- Individual participant dataSharing planned: No
Related trials for Preterm Birth
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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
Centre Hospitalier Universitaire de Saint Etienne
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 Preterm 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 4 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 23 Jun 2023. 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?
Analysis fundamental frequency (f0) (time frame: at the end of hospitalization (on average 2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04522414, which also lists 1 linked publication.
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 23 Jun 2023.