Preterm BirthNCT05253924
Biological Underpinnings of Socio-emotional Regulation in Preterm Infants and Healthy Controls
An observational study of Preterm Birth and Parent-Child Relations, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
Preterm infants (PT) often need to spend their first weeks of life in the Neonatal Intensive Care Unit (NICU) where they are exposed to several adverse conditions. Whereas a consistent number of studies suggest that NICU-related experiences may have effects on infant development including long-term impairments in… Read more about this study
- Who is it for?
- Ages 6 months to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Parent-Child Relations, Epigenetics
- What is being tested?
- DNA methylation of target genes and EEG acquisition
- How many people
- 76 participants
- Where
- 1 siteItaly
- Study dates
- 13 Jul 2021to 31 Dec 2024
- 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 6 months to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm infants. Preterm infants infants will be pre-screened for medical status variables by the NICU neonatologists of different hospital in Lombardy. Following a letter outlining the general research, parents will be meet per person in NICU or contacted by telephone and asked to voluntarily participate. Full-term infants. Mothers and their infants will be enrolled during the prenatal/postnatal parenting course in different hospital and nursery school in Lombardy. Following a letter outlining the general research, parents will be contacted by telephone and asked to voluntarily participate.
Who may be able to join
- gestational age< 37weeks;
- gestational age ≥ 37weeks;
- mothers of Italian nationality;
- mother over 18 years of age;
- mother with absence of manifest psychiatric and/or cognitive pathologies (must be previously diagnosed major psychiatric pathologies);
- non-addicted/no habitual use of psychotropic medications, drugs, alcohol no smoking;
- non-single-parent families.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Italy1 site
Associalzione La Nostra Famiglia - IRCCS Eugenio Medea
Bosisio Parini, Lecco, 23842
About this study
Official title: Biological Underpinnings of Socio-emotional Regulation in Preterm Infants and Healthy Controls: Insights From EEG and Epigenetic Data
Preterm infants (PT) often need to spend their first weeks of life in the Neonatal Intensive Care Unit (NICU) where they are exposed to several adverse conditions. Whereas a consistent number of studies suggest that NICU-related experiences may have effects on infant development including long-term impairments in emotional regulation, the underlying mechanisms remain partially unexplored. Spectral analysis of EEG signal has demonstrated that frontal alpha-band asymmetry represents a reliable biomarker of social-emotional functioning. In the literature, higher right frontal activation has been associated with worse emotional regulation but no study has measured this value during a condition of social-emotional stress such as the Still Face paradigm. Our hypothesis is that higher alpha activity will be recorded in right frontal areas in premature infants compared to healthy controls and that this activation will be associated with higher negative emotionality (i.e., worse socio-emotional regulation) expressed during the Still Face paradigm. Moreover, despite several changes in epigenetic patterns have already been reported in association with prematurity and early adverse experiences, the relationship between epigenetic changes and electroencephalographic patterns (i.e. frontal alpha asymmetry) remains unexplored. The investigators therefore expect to find associations between increased methylation levels of socio-emotional and stress related genes (i.e. SLC6A4, NR3C1, OXTR, Piezo1, Piezo2, TRPV1 and TRPM8) with spontaneous oscillations of neural activity at frontal sites measured by EEG (i.e. frontal alpha asymmetry). Finally, there is ample evidence that infant's socio-emotional regulation abilities are highly dependent on the behaviors of their caregivers. More recent studies have shown that behavior can be influenced by interoceptive awareness, i.e., the ability to perceive the physiological condition of one's body in this way and to represent one's internal states. Better interoceptive awareness is associated with better recognition of others' needs, more empathetic behaviors, and better emotional regulation. Therefore, with the present exploratory study, the investigators will compare the interceptive awareness of mothers of preterm infants with that of mothers of full-term infants by exploring possible associations of this dimension with the socio-emotional responses of preterm infants and healthy controls. The investigators expect that better socio-emotional regulation of infants is predicted by a higher level of interoceptive awareness in mothers, regardless of prematurity condition.
Read the detailed description
The main objective of the present study is to:
- explore frontal and parietal alpha EEG signal asymmetry in association with social-emotional regulation in a group of preterm infants aged 6-12 months (age corrected, CA). Secondary aims are:
- the investigation of epigenetic correlates (methylation of target genes:(i.e. SLC6A4, NR3C1, OXTR, Piezo1, Piezo2, TRPV1 and TRPM8) associated with social-emotional regulation
- the contribution of mother's interoceptive awareness (Heartbeat Counting Task index) in social-emotional regulation in a sample of premature infants aged 6-12 months (CA).
The study involves the following procedures:
- EEG signal recording and analysis (frontal alpha rhythm asymmetry; FAA) in PT and FT infants
- Video recording of mother-child interaction in accordance with a modified version of the Still Face paradigm.
- Collection of biological material (DNA)
- Assessment of mothers' interoceptive awareness via Heartbeat Counting Task
Significance and innovation:
To the best of our knowledge, no study has evaluated the association between (1) EEG signal asymmetry, (2) methylation patterns of candidate genes, (3) mothers' interoceptive awareness (Heartbeat Counting Task index), and socio-emotional regulation in premature infants during the first months of life.
The present study will integrate several biomarkers and observational data to better elucidate the role of electroencephalographic activation patterns, epigenetic variations, and mothers' interoceptive awareness in the socio-emotional regulation abilities of infants born prematurely. In addition, a particularly novel aspect of this study is the application of EEG signal recording during the Still Face paradigm. The measurement of the EEG signal during this paradigm could increase our knowledge with respect to the brain mechanisms underlying socio-emotional regulation in premature infants and in healthy control.
Moreover, the focus on parental bodily states might provide a new perspective suggesting that enteroceptive awareness may contribute to support caregiver's ability to understand (and respond to) the infant's signals and emotional states.
Impact:
This study is warranted to provide relevant insights for the biochemical and neurological underpinnings of socio-emotional development in preterm infants and will provide new evidence-base information for improving the quality of supportive interventions for preterm infants and caregivers in and outside the NICU. In addition, the identification of potential electroencephalographic patterns associated with emotional regulation in premature and term infants may prove to be a novel biomarker for the early detection of children at risk for emotional and behavioral problems.
- Conditions
- Preterm Birth, Parent-Child Relations, Epigenetics
- Being tested
- DNA methylation of target genes, EEG acquisition
- Keywords
- At-risk Infants, Developmental Care, DNA methylation, Affectionate touch, Frontal alpha asymmetry
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA methylation of target genesDiagnostic test
The methylation status of target genes (BDNF, SLC6A4, OXTR, NR3C1, Piezo1, Piezo2, TRPV1 andTRPM8) will be investigated. Saliva sample will be collected for PT and FT. Genomic DNA will be extracted from aliquots of 0. 4 ml of each saliva sample with the Oragene OG575 (DNA Genotek) and stored at -20°C. Aliquots of 250 ng of each DNA will be edited for methylation analysis with the EZ DNA Methylation Lightning kit (Zymo Research). Amplification of samples and their preparation for NGS sequencing will be performed. Samples will be sequenced on NextSeq 500 (Illumina). Individual processed sequences (PE reads) will be independently aligned to reference sequences using a parallel Smith-Waterman algorithm. Only reads that consistently align to the same reference sequence will be retained. At each CpG site in each analyzed sequence, the frequencies of the four bases will be evaluated.
EEG acquisitionDiagnostic test
Both PT and FT infants will have their EEG signal recorded during mother-baby interaction according to a modified version of the Still Face paradigm; the EEG signal will be recorded by means of the medical system eego mylab (AntNeuro), using special headphones equipped with 32 electrodes and suitable to acquire the EEG signal since early childhood. After spectral analysis of the EEG signal, the difference in signal strength in the alpha band recorded by two homologous electrodes (or electrode clusters) (i.e. right alpha - left alpha) will be calculated to obtain the FAA index. Because the alpha frequency band is associated with cortical inhibitory activity, a lower asymmetry reflects less left hemisphere activation than right hemisphere activation. The analysis of EEG data will be performed in MatLab environment using the eeglab software and algorithms developed ad hoc.
| Study group | Role | What they receive |
|---|---|---|
| Preterm children (PT) | gestational age at birth <37 Receives: Diagnostic Test: DNA methylation of target genes; Diagnostic Test: EEG acquisition | |
| Full-term children (FT) | gestational age at birth ≥ 37 weeks Receives: Diagnostic Test: DNA methylation of target genes; Diagnostic Test: EEG acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative emotionality assessed during the Still-Face Paradigm (FFSF).
Negative emotionality (withdrawn, protesting, complaining, being fussy or crying behaviors) will be assessed using the validated coding system Infant and Caregiver Engagement Phases - ICEP. Coders have to detect the presence or the absence of negative emotionality-related behaviors for each episode of FFSF. Then, a proportion index of negative emotionality will be obtained for each of the five episodes of FFSF dividing the total score of negative emotionality displayed in every FFSF episode for the actual length of the episode, resulting in five negative emotionality indexes. Higher indexes of negative emotionality are indicative of worse social emotional regulation.
Measured: Once, From 6 to 12 months (CA for prematurity) of infant's life
Frontal Alpha Asymmetry (FAA)
Frontal Alpha Asymmetry (FAA) will be assessed by computing the difference in signal power in the alpha band recorded by two homologous electrodes (or electrode clusters) (i.e. right alpha - left alpha). The EEG signal will be recorded through the medical system eego mylab (AntNeuro), using special headphones equipped with 32 electrodes and suitable to acquire the EEG signal since early childhood.
Frontal Alpha Asymmetry (FAA) will also be correlated with Negative emotionality indexes.
Measured: Once, From 6 to 12 months (CA for prematurity) of infant's life
Secondary outcomes (2)
DNA methylation level of target genes
DNA methylation level of target genes will be assessed by the collection of a saliva sample using non-invasive modalities and the Oragene OG575 kit (Genotek DNA). Genomic DNA will be extracted, quantified with Qubit 2.0 (Invitrogen) and stored at -20°C at the Molecular Biology laboratory of the Scientific Institute E. Medea. Samples will be sequenced with NextSeq 500 (Illumina).
DNA methylation levels of target genes will also be correlated with Negative emotionality indexes.
Measured: Once, From 6 to 12 months (CA for prematurity) of infant's life
Heartbeat Counting Task index
Maternal perceptions of bodily self assessed by the Heartbeat Counting Task index.
During the Heartbeat Counting Task mothers will be asked to mentally count the number of their own heartbeats over a period of time. The response will be compared with a measurement made using a pulse oximeter that allows for noninvasive determination of heart rate by photoplethysmography. The procedure is repeated in 4 different time intervals administered in random order among participants, without giving feedback on whether or not the responses are correct.
Maternal perceptions of bodily self will also be correlated with Negative emotionality indexes.
Measured: Once, From 6 to 12 months (CA for prematurity) of infant's life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start13 Jul 2021
- Primary completion30 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253924
- Sponsor's protocol ID
- Id. 867
- Status last verified
- Nov 2026
- First submitted
- 1 Feb 2022
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Underpinnings of Socio-emotional Regulation in Preterm Infants and Healthy Controls: Insights From EEG and Epigenetic Data
- ClinicalTrials.gov ID
- NCT05253924
- Acronym / sponsor ID
- Id. 867
- Conditions
- Preterm Birth, Parent-Child Relations, Epigenetics
- Keywords
- At-risk Infants, Developmental Care, DNA methylation, Affectionate touch, Frontal alpha asymmetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 Feb 2022 (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.
Preterm infants (PT) often need to spend their first weeks of life in the Neonatal Intensive Care Unit (NICU) where they are exposed to several adverse conditions. Whereas a consistent number of studies suggest that NICU-related experiences may have effects on infant development including long-term impairments in emotional regulation, the underlying mechanisms remain partially unexplored. Spectral analysis of EEG signal has demonstrated that frontal alpha-band asymmetry represents a reliable biomarker of social-emotional functioning. In the literature, higher right frontal activation has been associated with worse emotional regulation but no study has measured this value during a condition of social-emotional stress such as the Still Face paradigm. Our hypothesis is that higher alpha activity will be recorded in right frontal areas in premature infants compared to healthy controls and that this activation will be associated with higher negative emotionality (i.e., worse socio-emotional regulation) expressed during the Still Face paradigm. Moreover, despite several changes in epigenetic patterns have already been reported in association with prematurity and early adverse experiences, the relationship between epigenetic changes and electroencephalographic patterns (i.e. frontal alpha asymmetry) remains unexplored. The investigators therefore expect to find associations between increased methylation levels of socio-emotional and stress related genes (i.e. SLC6A4, NR3C1, OXTR, Piezo1, Piezo2, TRPV1 and TRPM8) with spontaneous oscillations of neural activity at frontal sites measured by EEG (i.e. frontal alpha asymmetry). Finally, there is ample evidence that infant's socio-emotional regulation abilities are highly dependent on the behaviors of their caregivers. More recent studies have shown that behavior can be influenced by interoceptive awareness, i.e., the ability to perceive the physiological condition of one's body in this way and to represent one's internal states. Better interoceptive awareness is associated with better recognition of others' needs, more empathetic behaviors, and better emotional regulation. Therefore, with the present exploratory study, the investigators will compare the interceptive awareness of mothers of preterm infants with that of mothers of full-term infants by exploring possible associations of this dimension with the socio-emotional responses of preterm infants and healthy controls. The investigators expect that better socio-emotional regulation of infants is predicted by a higher level of interoceptive awareness in mothers, regardless of prematurity condition.
Detailed description
The main objective of the present study is to:
- explore frontal and parietal alpha EEG signal asymmetry in association with social-emotional regulation in a group of preterm infants aged 6-12 months (age corrected, CA). Secondary aims are:
- the investigation of epigenetic correlates (methylation of target genes:(i.e. SLC6A4, NR3C1, OXTR, Piezo1, Piezo2, TRPV1 and TRPM8) associated with social-emotional regulation
- the contribution of mother's interoceptive awareness (Heartbeat Counting Task index) in social-emotional regulation in a sample of premature infants aged 6-12 months (CA).
The study involves the following procedures:
- EEG signal recording and analysis (frontal alpha rhythm asymmetry; FAA) in PT and FT infants
- Video recording of mother-child interaction in accordance with a modified version of the Still Face paradigm.
- Collection of biological material (DNA)
- Assessment of mothers' interoceptive awareness via Heartbeat Counting Task
Significance and innovation:
To the best of our knowledge, no study has evaluated the association between (1) EEG signal asymmetry, (2) methylation patterns of candidate genes, (3) mothers' interoceptive awareness (Heartbeat Counting Task index), and socio-emotional regulation in premature infants during the first months of life.
The present study will integrate several biomarkers and observational data to better elucidate the role of electroencephalographic activation patterns, epigenetic variations, and mothers' interoceptive awareness in the socio-emotional regulation abilities of infants born prematurely. In addition, a particularly novel aspect of this study is the application of EEG signal recording during the Still Face paradigm. The measurement of the EEG signal during this paradigm could increase our knowledge with respect to the brain mechanisms underlying socio-emotional regulation in premature infants and in healthy control.
Moreover, the focus on parental bodily states might provide a new perspective suggesting that enteroceptive awareness may contribute to support caregiver's ability to understand (and respond to) the infant's signals and emotional states.
Impact:
This study is warranted to provide relevant insights for the biochemical and neurological underpinnings of socio-emotional development in preterm infants and will provide new evidence-base information for improving the quality of supportive interventions for preterm infants and caregivers in and outside the NICU. In addition, the identification of potential electroencephalographic patterns associated with emotional regulation in premature and term infants may prove to be a novel biomarker for the early detection of children at risk for emotional and behavioral problems.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm children (PT) | – | Diagnostic Test: DNA methylation of target genes, Diagnostic Test: EEG acquisitiongestational age at birth <37 |
| Full-term children (FT) | – | Diagnostic Test: DNA methylation of target genes, Diagnostic Test: EEG acquisitiongestational age at birth ≥ 37 weeks |
Who may qualify
- Ages
- 6 months to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm infants. Preterm infants infants will be pre-screened for medical status variables by the NICU neonatologists of different hospital in Lombardy. Following a letter outlining the general research, parents will be meet per person in NICU or contacted by telephone and asked to voluntarily participate. Full-term infants. Mothers and their infants will be enrolled during the prenatal/postnatal parenting course in different hospital and nursery school in Lombardy. Following a letter outlining the general research, parents will be contacted by telephone and asked to voluntarily participate.
Key inclusion criteria (7 listed)
- gestational age< 37weeks;
- gestational age ≥ 37weeks;
- mothers of Italian nationality;
- mother over 18 years of age;
- mother with absence of manifest psychiatric and/or cognitive pathologies (must be previously diagnosed major psychiatric pathologies);
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| DNA methylation of target genesThe methylation status of target genes (BDNF, SLC6A4, OXTR, NR3C1, Piezo1, Piezo2, TRPV1 andTRPM8) will be investigated. Saliva sample will be collected for PT and FT. Genomic DNA will be extracted from aliquots of 0. 4 ml of each saliva sample with the Oragene OG575 (DNA Genotek) and stored at -20°C. Aliquots of 250 ng of each DNA will be edited for methylation analysis with the EZ DNA Methylation Lightning kit (Zymo Research). Amplification of samples and their preparation for NGS sequencing will be performed. Samples will be sequenced on NextSeq 500 (Illumina). Individual processed sequences (PE reads) will be independently aligned to reference sequences using a parallel Smith-Waterman algorithm. Only reads that consistently align to the same reference sequence will be retained. At each CpG site in each analyzed sequence, the frequencies of the four bases will be evaluated. | Diagnostic test | Full-term children (FT), Preterm children (PT) |
| EEG acquisitionBoth PT and FT infants will have their EEG signal recorded during mother-baby interaction according to a modified version of the Still Face paradigm; the EEG signal will be recorded by means of the medical system eego mylab (AntNeuro), using special headphones equipped with 32 electrodes and suitable to acquire the EEG signal since early childhood. After spectral analysis of the EEG signal, the difference in signal strength in the alpha band recorded by two homologous electrodes (or electrode clusters) (i.e. right alpha - left alpha) will be calculated to obtain the FAA index. Because the alpha frequency band is associated with cortical inhibitory activity, a lower asymmetry reflects less left hemisphere activation than right hemisphere activation. The analysis of EEG data will be performed in MatLab environment using the eeglab software and algorithms developed ad hoc. | Diagnostic test | Full-term children (FT), Preterm children (PT) |
Primary outcome
Negative emotionality assessed during the Still-Face Paradigm (FFSF).
Time frame: Once, From 6 to 12 months (CA for prematurity) of infant's life
Negative emotionality (withdrawn, protesting, complaining, being fussy or crying behaviors) will be assessed using the validated coding system Infant and Caregiver Engagement Phases - ICEP. Coders have to detect the presence or the absence of negative emotionality-related behaviors for each episode of FFSF. Then, a proportion index of negative emotionality will be obtained for each of the five episodes of FFSF dividing the total score of negative emotionality displayed in every FFSF episode for the actual length of the episode, resulting in five negative emotionality indexes. Higher indexes of negative emotionality are indicative of worse social emotional regulation.
Frontal Alpha Asymmetry (FAA)
Time frame: Once, From 6 to 12 months (CA for prematurity) of infant's life
Frontal Alpha Asymmetry (FAA) will be assessed by computing the difference in signal power in the alpha band recorded by two homologous electrodes (or electrode clusters) (i.e. right alpha - left alpha). The EEG signal will be recorded through the medical system eego mylab (AntNeuro), using special headphones equipped with 32 electrodes and suitable to acquire the EEG signal since early childhood. Frontal Alpha Asymmetry (FAA) will also be correlated with Negative emotionality indexes.
2 secondary outcomes
DNA methylation level of target genes
Time frame: Once, From 6 to 12 months (CA for prematurity) of infant's life
Heartbeat Counting Task index
Time frame: Once, From 6 to 12 months (CA for prematurity) of infant's 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 5 Nov 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Parent-Child Relations, run by IRCCS Eugenio Medea at 1 site in Italy.
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 7 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 5 Nov 2026. 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 Italy. 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?
Negative emotionality assessed during the Still-Face Paradigm (FFSF). (time frame: Once, From 6 to 12 months (CA for prematurity) of infant's 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 5 Nov 2026.