Effects of Early Vocal Contact (EVC) in the Neonatal Intensive Care Unit

Prematurity Clinical Trial

— EVC  

Official title:

Effects of Early Vocal Contact (EVC) in the Neonatal Intensive Care Unit: A Multi-centre, Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04759573
• Other study ID #: Early Vocal Contact
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2021
• Source: Azienda Ospedaliero-Universitaria di Modena
• Contact: Manuela Filippa, PhD
• Phone: 00393478878668
• Email: manuela.filippa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Weeks to 33 Weeks

Eligibility

Inclusion Criteria:

• • 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
• Hypoglycaemia
• Hyponatremia acceptable, provided they are not persistent and severe
• Hypocalcaemia

Exclusion Criteria:

• • 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
• 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

Related Conditions & MeSH terms

• Early Intervention
• Premature Birth
• Prematurity

Intervention

Behavioral:
• Early Vocal Contact
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 Observation
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.

Locations

Country	Name	City	State
Italy	Uiversity Hospital of Modena and Reggio Emilia	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Elisa Della Casa Muttini

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

Filippa M, Lordier L, De Almeida JS, Monaci MG, Adam-Darque A, Grandjean D, Kuhn P, Hüppi 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Heart Rate Variability	Heart rate is the number of heartbeats per minute.	Pre intervention (baseline), during the intervention and immediately after the intervention
Secondary	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.	Pre intervention (baseline)
Secondary	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.	After the intervention, at Term Equivalent Age
Secondary	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.	At 3 months
Secondary	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.	At 6 months corrected age
Secondary	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.	At 12 months corrected age
Secondary	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.	At 12 months (Gestures and Words Form) and 24 months (Words and Sentences Form) corrected age.
Secondary	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.	At 12 months corrected age
Secondary	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.	At 24 months corrected age
Secondary	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.	At 24 months corrected age
Secondary	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.	Pre intervention
Secondary	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.	At hospital discharge
Secondary	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	At hospital discharge