Please select the eligibility criteria that correspond to the clinical trial below.
Title: Creative Music Therapy for Premature Infants: Testing a Possible Influence on Brain Structure, Function and Neurobehavioral Outcome
Brief Summary: This study investigates whether creative music therapy applied to premature infants will facilitate brain growth and development at term equivalent assessed by magnetic resonance imaging. Secondary objective are improvement of neurobehavioral outcomes of premature infants at 24 months, as well as at 5 years of age.


Options:
A: Inclusion Criteria (infants):

* born below 35 weeks gestational age
* determined by medical staff to have achieved sufficient medical stability to start MT
* likely to be hospitalized longer than 2 weeks from time of recruitment

Inclusion Criteria (parents):

* willing to engage in at least 2 of 3 MT sessions per week during NICU and/or in 5 of 7 MT post-discharge sessions, if randomized to receive MT
* live with reasonable commuting distance from the treating NICU
* sufficient understanding of the respective national language(s) to answer questionnaires and participate in MT

Exclusion Criteria (parents):

* documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments
B: Inclusion Criteria:

* Hospitalization at a study location
* Postmenstrual age of 32 weeks 0 days gestation to 36 weeks 0 days gestation

Exclusion Criteria:

* Ventilation using an endotracheal tube
* Major congenital malformations
* Family history of genetic hearing loss
* Use of sedatives or seizure medications

Secondary Study Inclusion Criteria:

* Enrolled in the control group of the main study
C: Inclusion Criteria:

* Born before 32 weeks of gestational age
* Clinically stable
* Chronological age ≥ 7 days of life
* Informed written parental consent

Exclusion Criteria:

* Born after 32 weeks of gestational age (due to a possible too short timeframe for music therapy treatment)
* Lack of parental consent
* Admitted a priori for palliative care
* Genetically defined syndrome
* Severe congenital malformation adversely affecting life expectancy or neurodevelopment
* (For the control group only: Regular singing or other kinds of music stimulation by the parents during hospitalization time)
D: 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

Answer: C