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

NCT04759573 | Unknown DMC

• 1 other identifier: Early Vocal Contact
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early Intervention; Prematurity

Keywords

Early Vocal Contact; Neonatal Intensive Care Unite; Preterm Infants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in General Movement Assessment

  Pre intervention (baseline)

• Change in General Movement Assessment

  After the intervention, at Term Equivalent Age

• Change in General Movement Assessment

  At 3 months

• The Griffiths Mental Development Scales (GMDS)

  At 6 months corrected age

• The Griffiths Mental Development Scales (GMDS)

  At 12 months corrected age

Study Arms (2)

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.

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.

Behavioral: Behavioral Observation

Interventions

Early Vocal Contact BEHAVIORAL

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

Behavioral Observation BEHAVIORAL

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.

Behavioral observation

Eligibility Criteria

• Age: 25 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Presence of depressive symptoms
• Drug abuse
• Age ˂18 years

Sponsors & Collaborators

• Elisa Della Casa Muttini: lead

Study Sites (1)

Uiversity Hospital of Modena and Reggio Emilia

Modena, 41100, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 23848529 BACKGROUND

• Filippa 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.

  PMID: 31266053 RESULT

• Filippa 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.

  PMID: 38057574 DERIVED

• Filippa 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.

  PMID: 33917889 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Behavior Observation Techniques

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Psychological Techniques; Investigative Techniques; Behavioral Disciplines and Activities

Central Study Contacts

Manuela Filippa, PhD

CONTACT

00393478878668; manuela.filippa@gmail.com

Elisa Muttini, MD

CONTACT

+39 335 829 9501; dellacasa.elisa@aou.mo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The intervention is performed by mothers who have to administer the speech or singing or they have to observe. The research assistant will support mothers to deliver the intervention The outcome assessors will be blinded
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A four-site randomized controlled trial will be conducted to investigate the short- and long-term physiological and neurobehavioral effects of Early Vocal Contact.

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: February 18, 2021
• Study Start: February 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2024
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)