Early InterventionEVCNCT04759573
Effects of Early Vocal Contact (EVC) in the Neonatal Intensive Care Unit
A study testing Early Vocal Contact and Behavioral Observation in people with Early Intervention and Prematurity, run by Elisa Della Casa Muttini at 1 site in Italy.
Trial summary
Background: Preterm infants are at risk for developing altered trajectories of cognitive, social, and linguistic competences compared to a term population. This is mainly due to medical and environmental factors, as they are exposed to an atypical auditory environment and, simultaneously, to long periods of early… Read more about this study
- Who is it for?
- Ages 25 to 33 weeks
- Conditions the study is for
- Early Intervention, Prematurity
- What is being tested?
- Early Vocal Contact and Behavioral Observation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2019to 1 Jun 2024
- Phase
- Interventional
- 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 25 to 33 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • GA between 25+0 and 32 +6 weeks at birth
- Apgar score: ≥ 7 at 10 minutes
- Birth weight: >3th centile and <97th centile
- Birth cranial circumference: >10th centile
- Periventricular leukomalacia (PVL) grade 1
- Intraventricular haemorrhage (IVH) grade 1-2
Show all 9Show fewer
- Hypoglycaemia
- Hyponatremia acceptable, provided they are not persistent and severe
- Hypocalcaemia
Who cannot join
- • PVL, grade III and IV
- IVH, grade III and IV
- Sepsis (vertical and horizontal)
- Congenital malformations and/or genetic abnormalities
- Need of respiratory support with high flow/nCPAP
- Repeated apnoea associated with bradycardia and fall of saturation
Show all 14Show fewer
- Hyaline membrane disease
- Respiratory Distress Syndrome
- Hyperbilirubinemia, requiring exchange transfusions during hospitalization
- Lack of informed consent signed by the parents
- The exclusion criteria for the mothers will be:
- Presence of depressive symptoms
- Drug abuse
- Age ˂18 years
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Uiversity Hospital of Modena and Reggio Emilia
Modena, 41100
Elisa Muttini, MD, 0039 335 829 9501, dellacasa.elisa@aou.mo.it
About this study
Official title: Effects of Early Vocal Contact (EVC) in the Neonatal Intensive Care Unit: A Multi-centre, Randomized Clinical Trial
Background: Preterm infants are at risk for developing altered trajectories of cognitive, social, and linguistic competences compared to a term population. This is mainly due to medical and environmental factors, as they are exposed to an atypical auditory environment and, simultaneously, to long periods of early separation from their parents. The short-term effects of Early Vocal Contact (EVC) on an infant's early stability have been investigated, but currently, there is limited evidence of its impact on the infant's autonomic nervous system maturation, as indexed by the heart rate variability, as well as on its long-term impact on infant neurodevelopment. This multi-centric study aims to investigate the effects of EVC on a preterm infant's physiology, neurobehaviour, and development.
Methods: Eighty stable preterm infants, born at 25 to 32 weeks and 6 days gestational age, without specific abnormalities, will be selected and randomized to either an intervention or a control group. The intervention group will receive EVC: mothers talking and singing to their preterm infants for 10 minutes thrice a week for 2 weeks. Mothers in the control group will be encouraged to spend the same amount of time next to the incubator, observing the infant's behaviour through a standard cluster of indicators. Infants will be assessed at baseline, at the end of the intervention, at term equivalent age, and at 3, 6, 12- and 24-months corrected age, with a battery of physiological, neurobehavioral, and developmental measures.
Discussion: Early interventions in the neonatal intensive care unit have shown important effects on the neurodevelopment of preterm infants, lowering the negative long-term effects of an atypical auditory and interactional environment. This study will provide new insights into the mother-infant early contact as protective intervention against the sequelae of prematurity during the sensitive period of development. An early intervention, such as EVC, is intuitive and easy to implement in the daily care of preterm infants. However, its long-term effects on infant neurodevelopment and on maternal sensitivity and stress still need accurate investigations.
Read the detailed description
Aims This study aims to test the effects of EVC on infants born prematurely between 25 and 32 weeks and 6 days GA.
The effects on newborns will be assessed at physiological (primary outcome), neurobehavioral, and developmental levels during the intervention, at term equivalent age, and at 12- and 24-months CA. The effect of EVC will also be assessed on maternal stress at hospital discharge and on the mother's presence in the NICU.
Design A four-site randomized controlled trial will be conducted to investigate the short- and long-term physiological and neurobehavioral effects of EVC.
Participants Eighty preterm infants, born at 25 to 32 weeks and 6 days GA, will be recruited from the four centres (20 per centre).
Recruitment will be undertaken in each centre by a trained research assistant (RA), who will review birth records daily. After obtaining permission from the attending physicians of both the mother and the infant, the RA will invite qualifying families to participate in the study and will obtain written informed consent from those enrolling. Infants will be then assigned to the EVC intervention or control group using a randomized design, stratifying infants by gender and GA (see Randomization). Mothers whose infants are assigned to the control group will be asked to spend the same amount of time as that of mothers in the intervention group, observing their infants' spontaneous behaviour, with the subsequent compilation of an observation grid developed ad hoc, according to few indicators drawn from The Neonatal Behavioural Assessment Scale (NBAS).
- Conditions
- Early Intervention, Prematurity
- Being tested
- Early Vocal Contact, Behavioral Observation
- Keywords
- Early Vocal Contact, Neonatal Intensive Care Unite, 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.
Early Vocal ContactBehavioural
Mothers will be asked to speak and sing to their infants continuously over a 10-min period for each type of intervention (20 min in total). Mothers will be asked to talk in their native language and to sing familiar songs, while observing their infant's reactions. The order of the two vocalizations, speaking and singing, will be reversed in the next intervention.
Behavioral ObservationBehavioural
Mothers in the active control group will be encouraged to spend the same amount of time next to the incubator, observing the infant's behaviours through a standard cluster of indicators.
| Study group | Role | What they receive |
|---|---|---|
| Early Vocal Contact | Experimental | The EVC will take place in the hospital room while infants are in their individual incubators or open cribs. In the intervention group, mothers will be asked to speak and sing to their infants continuously over a 10-min period for each type of intervention (20 min in total). Mothers will be asked to talk in their native language and to sing familiar songs, while observing their infant's reactions. The order of the two vocalizations, speaking and singing, will be reversed in the next intervention.
Early Vocal Contact will be performed by mothers three times a week for 2 weeks, more than one hour after afternoon feeding. It will begin when the newborns are in an active sleep state, in calm awake state or in active awake state, but not in deep sleep or crying. Preterm infants will be enrolled from 25+0 to 32+6 weeks of GA, following the established inclusion criteria. Receives: Behavioral: Early Vocal Contact |
| Behavioral observation | Active comparator | Mothers in the active control group will be encouraged to spend the same amount of time next to the incubator, observing the infant's behaviours through a standard cluster of indicators. Receives: Behavioral: Behavioral Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate Variability
Heart rate is the number of heartbeats per minute.
Measured: Pre intervention (baseline), during the intervention and immediately after the intervention
Secondary outcomes (12)
Change in General Movement Assessment
The General Movement quality from video recording will be scored according to the Ferrari optimality score. Two blinded coders will attribute a single final score for each infant at each time point. For each item a description of optimal performance is given and scored with "2" (e.g., cramped components are absent). Less optimal performance is scored with "1" (e.g., cramped components are occasionally present); non-optimal performance is scored with "0" (e.g., cramped components are predominately present).
Adding the scores of each item within a category ("neck and trunk", "upper extremity" and "lower extremity") plus the score for "sequence" gives the GM optimality score with a minimum value of 5 and a maximum value of 42, indicating optimal performance. The minimum score (worst performance) is 5.
Measured: Pre intervention (baseline)
Change in General Movement Assessment
The General Movement quality from video recording will be scored according to the Ferrari optimality score. Two blinded coders will attribute a single final score for each infant at each time point. For each item a description of optimal performance is given and scored with "2" (e.g., cramped components are absent). Less optimal performance is scored with "1" (e.g., cramped components are occasionally present); non-optimal performance is scored with "0" (e.g., cramped components are predominately present).
Adding the scores of each item within a category ("neck and trunk", "upper extremity" and "lower extremity") plus the score for "sequence" gives the GM optimality score with a minimum value of 5 and a maximum value of 42, indicating optimal performance. The minimum score (worst performance) is 5.
Measured: After the intervention, at Term Equivalent Age
Change in General Movement Assessment
The General Movement quality from video recording will be scored according to the Ferrari optimality score. Two blinded coders will attribute a single final score for each infant at each time point. For each item a description of optimal performance is given and scored with "2" (e.g., cramped components are absent). Less optimal performance is scored with "1" (e.g., cramped components are occasionally present); non-optimal performance is scored with "0" (e.g., cramped components are predominately present).
Adding the scores of each item within a category ("neck and trunk", "upper extremity" and "lower extremity") plus the score for "sequence" gives the GM optimality score with a minimum value of 5 and a maximum value of 42, indicating optimal performance. The minimum score (worst performance) is 5.
Measured: At 3 months
The Griffiths Mental Development Scales (GMDS)
The GMDS will be assessed with mean values in 4 subscales (Locomotor, Per-Social, Hear/Speech, Hand/Eye). A composite final Performance score will also be assessed for each participant at each time point. The mean values will be compared between the intervention and control groups. Scores range from 0 to 109, with better results with higher values.
Measured: At 6 months corrected age
The Griffiths Mental Development Scales (GMDS)
The GMDS will be assessed with mean values in 4 subscales (Locomotor, Per-Social, Hear/Speech, Hand/Eye). A composite final Performance score will also be assessed for each participant at each time point. The mean values will be compared between the intervention and control groups. Scores range from 0 to 109, with better results with higher values.
Measured: At 12 months corrected age
MacArthur-Bates Communicative Development Inventories
Each child, at each time point, will receive a final score for each questionnaire, measured as a discrete numeric value; the mean values will be compared in the intervention and control groups. The minimum score il 0 and the maximum is 429, with higher scores for better performance.
Measured: At 12 months (Gestures and Words Form) and 24 months (Words and Sentences Form) corrected age.
MacArthur-Bates Communicative Development Inventories
Each child, at each time point, will receive a final score for each questionnaire, measured as a discrete numeric value; the mean values will be compared in the intervention and control groups. The minimum score il 0 and the maximum is 429, with higher scores for better performance.
Measured: At 12 months corrected age
MacArthur-Bates Communicative Development Inventories
Each child, at each time point, will receive a final score for each questionnaire, measured as a discrete numeric value; the mean values will be compared in the intervention and control groups. The minimum score il 0 and the maximum is 429, with higher scores for better performance.
Measured: At 24 months corrected age
Parole in Gioco (PinG) test
Linguistic test for assessing lexical comprehension and production for early childhood. The minimum score il 0 and the maximum is 60, with higher scores for better performance.
Measured: At 24 months corrected age
Change in Parental Stressor Scale (PSS-NICU)
The PSS-NICU aims at assessing the parental perception of stressors derived from the physical and psycho-social environment of the NICU across three domains: (i) their parental role, (ii) their infant's behaviour and appearance, and (iii) the sights and sounds in the NICU. For each domain, a mean score will be assessed, and a final composite stress score will be calculated from the mean values of the single scores. Each mother, at each time point, will receive a final score for the single questionnaire (range 0-10). The minimum score il 0 and the maximum is 156, with lower scores for better mental health levels.
Measured: Pre intervention
Change in Parental Stressor Scale (PSS-NICU)
The PSS-NICU aims at assessing the parental perception of stressors derived from the physical and psycho-social environment of the NICU across three domains: (i) their parental role, (ii) their infant's behaviour and appearance, and (iii) the sights and sounds in the NICU. For each domain, a mean score will be assessed, and a final composite stress score will be calculated from the mean values of the single scores. Each mother, at each time point, will receive a final score for the single questionnaire (range 0-10). The minimum score il 0 and the maximum is 156, with lower scores for better mental health levels.
Measured: At hospital discharge
Maternal presence in the NICU
Time that the mothers spend in the NICU (hours) using maternal self-report forms will be filled out after each visit to the NICU
Measured: At hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Feb 2019
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Early InterventionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A four-site randomized controlled trial will be conducted to investigate the short- and long-term physiological and neurobehavioral effects of Early Vocal Contact.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elisa Della Casa Muttini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elisa Della Casa Muttini, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759573
- Sponsor's protocol ID
- Early Vocal Contact
- Acronym
- EVC
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Filippa M, Devouche E, Arioni C, Imberty M, Gratier M. Live maternal speech and singing have beneficial effects on hospitalized preterm infants. Acta Paediatr. 2013 Oct;102(10):1017-20. doi: 10.1111/apa.12356. Epub 2013 Aug 8.
PubMed 23848529Filippa M, Lordier L, De Almeida JS, Monaci MG, Adam-Darque A, Grandjean D, Kuhn P, Huppi PS. Early vocal contact and music in the NICU: new insights into preventive interventions. Pediatr Res. 2020 Jan;87(2):249-264. doi: 10.1038/s41390-019-0490-9. Epub 2019 Jul 2.
PubMed 31266053Filippa M, Nardelli M, Sansavini A, Meloni S, Picciolini O, Lunardi C, Cecchi A, Corvaglia L, Grandjean D, Scilingo EP, Della Casa E, Berardi A; EVC Group; Ferrari F. Maternal singing sustains preterm hospitalized newborns' autonomic nervous system maturation: an RCT. Pediatr Res. 2024 Mar;95(4):1110-1116. doi: 10.1038/s41390-023-02932-4. Epub 2023 Dec 6.
PubMed 38057574Filippa M, Della Casa E, D'amico R, Picciolini O, Lunardi C, Sansavini A, Ferrari F. Effects of Early Vocal Contact in the Neonatal Intensive Care Unit: Study Protocol for a Multi-Centre, Randomised Clinical Trial. Int J Environ Res Public Health. 2021 Apr 8;18(8):3915. doi: 10.3390/ijerph18083915.
PubMed 33917889
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Vocal Contact (EVC) in the Neonatal Intensive Care Unit: A Multi-centre, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04759573
- Acronym / sponsor ID
- EVC / Early Vocal Contact
- Conditions
- Early Intervention, Prematurity
- Keywords
- Early Vocal Contact, Neonatal Intensive Care Unite, Preterm Infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Elisa Della Casa MuttiniUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 18 Feb 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.
Background: Preterm infants are at risk for developing altered trajectories of cognitive, social, and linguistic competences compared to a term population. This is mainly due to medical and environmental factors, as they are exposed to an atypical auditory environment and, simultaneously, to long periods of early separation from their parents. The short-term effects of Early Vocal Contact (EVC) on an infant's early stability have been investigated, but currently, there is limited evidence of its impact on the infant's autonomic nervous system maturation, as indexed by the heart rate variability, as well as on its long-term impact on infant neurodevelopment. This multi-centric study aims to investigate the effects of EVC on a preterm infant's physiology, neurobehaviour, and development.
Methods: Eighty stable preterm infants, born at 25 to 32 weeks and 6 days gestational age, without specific abnormalities, will be selected and randomized to either an intervention or a control group. The intervention group will receive EVC: mothers talking and singing to their preterm infants for 10 minutes thrice a week for 2 weeks. Mothers in the control group will be encouraged to spend the same amount of time next to the incubator, observing the infant's behaviour through a standard cluster of indicators. Infants will be assessed at baseline, at the end of the intervention, at term equivalent age, and at 3, 6, 12- and 24-months corrected age, with a battery of physiological, neurobehavioral, and developmental measures.
Discussion: Early interventions in the neonatal intensive care unit have shown important effects on the neurodevelopment of preterm infants, lowering the negative long-term effects of an atypical auditory and interactional environment. This study will provide new insights into the mother-infant early contact as protective intervention against the sequelae of prematurity during the sensitive period of development. An early intervention, such as EVC, is intuitive and easy to implement in the daily care of preterm infants. However, its long-term effects on infant neurodevelopment and on maternal sensitivity and stress still need accurate investigations.
Detailed description
Aims This study aims to test the effects of EVC on infants born prematurely between 25 and 32 weeks and 6 days GA.
The effects on newborns will be assessed at physiological (primary outcome), neurobehavioral, and developmental levels during the intervention, at term equivalent age, and at 12- and 24-months CA. The effect of EVC will also be assessed on maternal stress at hospital discharge and on the mother's presence in the NICU.
Design A four-site randomized controlled trial will be conducted to investigate the short- and long-term physiological and neurobehavioral effects of EVC.
Participants Eighty preterm infants, born at 25 to 32 weeks and 6 days GA, will be recruited from the four centres (20 per centre).
Recruitment will be undertaken in each centre by a trained research assistant (RA), who will review birth records daily. After obtaining permission from the attending physicians of both the mother and the infant, the RA will invite qualifying families to participate in the study and will obtain written informed consent from those enrolling. Infants will be then assigned to the EVC intervention or control group using a randomized design, stratifying infants by gender and GA (see Randomization). Mothers whose infants are assigned to the control group will be asked to spend the same amount of time as that of mothers in the intervention group, observing their infants' spontaneous behaviour, with the subsequent compilation of an observation grid developed ad hoc, according to few indicators drawn from The Neonatal Behavioural Assessment Scale (NBAS).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A four-site randomized controlled trial will be conducted to investigate the short- and long-term physiological and neurobehavioral effects of Early Vocal Contact.
| Arm | Type | Receives |
|---|---|---|
| Early Vocal Contact | Experimental | Behavioral: Early Vocal ContactThe EVC will take place in the hospital room while infants are in their individual incubators or open cribs. In the intervention group, mothers will be asked to speak and sing to their infants continuously over a 10-min period for each type of intervention (20 min in total). Mothers will be asked to talk in their native language and to sing familiar songs, while observing their infant's reactions. The order of the two vocalizations, speaking and singing, will be reversed in the next intervention. Early Vocal Contact will be performed by mothers three times a week for 2 weeks, more than one hour after afternoon feeding. It will begin when the newborns are in an active sleep state, in calm awake state or in active awake state, but not in deep sleep or crying. Preterm infants will be enrolled from 25+0 to 32+6 weeks of GA, following the established inclusion criteria. |
| Behavioral observation | Active comparator | Behavioral: Behavioral ObservationMothers in the active control group will be encouraged to spend the same amount of time next to the incubator, observing the infant's behaviours through a standard cluster of indicators. |
Who may qualify
- Ages
- 25 to 33 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- • GA between 25+0 and 32 +6 weeks at birth
Key exclusion criteria (14 listed)
- • PVL, grade III and IV
- Presence of depressive symptoms
- Drug abuse
- Age ˂18 years
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 |
|---|---|---|
| Early Vocal ContactMothers will be asked to speak and sing to their infants continuously over a 10-min period for each type of intervention (20 min in total). Mothers will be asked to talk in their native language and to sing familiar songs, while observing their infant's reactions. The order of the two vocalizations, speaking and singing, will be reversed in the next intervention. | Behavioural | Early Vocal Contact |
| Behavioral ObservationMothers in the active control group will be encouraged to spend the same amount of time next to the incubator, observing the infant's behaviours through a standard cluster of indicators. | Behavioural | Behavioral observation |
Primary outcome
Change in Heart Rate Variability
Time frame: Pre intervention (baseline), during the intervention and immediately after the intervention
Heart rate is the number of heartbeats per minute.
12 secondary outcomes
Change in General Movement Assessment
Time frame: Pre intervention (baseline)
Change in General Movement Assessment
Time frame: After the intervention, at Term Equivalent Age
Change in General Movement Assessment
Time frame: At 3 months
The Griffiths Mental Development Scales (GMDS)
Time frame: At 6 months corrected age
The Griffiths Mental Development Scales (GMDS)
Time frame: At 12 months corrected age
MacArthur-Bates Communicative Development Inventories
Time frame: At 12 months (Gestures and Words Form) and 24 months (Words and Sentences Form) corrected age.
MacArthur-Bates Communicative Development Inventories
Time frame: At 12 months corrected age
MacArthur-Bates Communicative Development Inventories
Time frame: At 24 months corrected age
Parole in Gioco (PinG) test
Time frame: At 24 months corrected age
Change in Parental Stressor Scale (PSS-NICU)
Time frame: Pre intervention
Change in Parental Stressor Scale (PSS-NICU)
Time frame: At hospital discharge
Maternal presence in the NICU
Time frame: At hospital discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Background: PubMed 23848529Filippa M, Devouche E, Arioni C, Imberty M, Gratier M. Live maternal speech and singing have beneficial effects on hospitalized preterm infants. Acta Paediatr. 2013 Oct;102(10):1017-20. doi: 10.1111/apa.12356. Epub 2013 Aug 8.
- Results publication: PubMed 31266053Filippa M, Lordier L, De Almeida JS, Monaci MG, Adam-Darque A, Grandjean D, Kuhn P, Huppi PS. Early vocal contact and music in the NICU: new insights into preventive interventions. Pediatr Res. 2020 Jan;87(2):249-264. doi: 10.1038/s41390-019-0490-9. Epub 2019 Jul 2.
- Derived from this study: PubMed 38057574Filippa M, Nardelli M, Sansavini A, Meloni S, Picciolini O, Lunardi C, Cecchi A, Corvaglia L, Grandjean D, Scilingo EP, Della Casa E, Berardi A; EVC Group; Ferrari F. Maternal singing sustains preterm hospitalized newborns' autonomic nervous system maturation: an RCT. Pediatr Res. 2024 Mar;95(4):1110-1116. doi: 10.1038/s41390-023-02932-4. Epub 2023 Dec 6.
- Derived from this study: PubMed 33917889Filippa M, Della Casa E, D'amico R, Picciolini O, Lunardi C, Sansavini A, Ferrari F. Effects of Early Vocal Contact in the Neonatal Intensive Care Unit: Study Protocol for a Multi-Centre, Randomised Clinical Trial. Int J Environ Res Public Health. 2021 Apr 8;18(8):3915. doi: 10.3390/ijerph18083915.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Vocal Contact and Behavioral Observation in people with Early Intervention and Prematurity, run by Elisa Della Casa Muttini 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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 18 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuela Filippa, PhD (00393478878668, manuela.filippa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate Variability (time frame: Pre intervention (baseline), during the intervention and immediately after the intervention). 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 NCT04759573, which also lists 4 linked publications.
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 18 Feb 2021.