Status:
UNKNOWN
Effects of Early Vocal Contact (EVC) in the Neonatal Intensive Care Unit
Lead Sponsor:
Elisa Della Casa Muttini
Conditions:
Early Intervention
Prematurity
Eligibility:
All Genders
25-33 years
Phase:
NA
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 environmen...
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), neurobe...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04759573
Start Date
February 1 2019
End Date
June 1 2024
Last Update
February 18 2021
Active Locations (1)
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1
Uiversity Hospital of Modena and Reggio Emilia
Modena, Italy, 41100