Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759573
Status:
UNKNOWN
Last Update Posted:
2021-02-18
First Post:
2021-02-06
Brief Title:
Effects of Early Vocal Contact EVC in the Neonatal Intensive Care Unit
Sponsor:
Elisa Della Casa Muttini
Organization:
Azienda Ospedaliero-Universitaria di Modena
Study Overview
Official Title:
Effects of Early Vocal Contact EVC in the Neonatal Intensive Care Unit A Multi-centre Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVC
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 infants early stability have been investigated but currently there is limited evidence of its impact on the infants 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 infants 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 infants 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
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 infants 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 mothers 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
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 mothers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None