Please select the eligibility criteria that correspond to the clinical trial below.
Title: Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers: International Randomized Trial
Brief Summary: Background: Preterm birth has major medical, psychological and socio-economic consequences worldwide. A recent systematic review suggests positive effects of music therapy (MT) on physiological measures of preterm infants and maternal anxiety, but methodologically rigorous studies including long-term follow-up of infant and parental outcomes are missing. Drawing upon caregivers' inherent resources, this study emphasizes caregiver involvement in MT to promote attuned, developmentally-appropriate musical interactions that may be of mutual benefit to infant and parent. This study will determine whether MT, as delivered by a qualified music therapist during neonatal intensive care unit (NICU) hospitalization and/or in home/municipal settings following discharge, is superior to standard care in improving bonding between primary caregivers and preterm infants, parent well-being and infant development.

Methods: Design: International multi-center, assessor-blind, 2x2 factorial, pragmatic randomized controlled trial. A feasibility study has been completed; ethical approval for the main trial is pending. Participants: 250 preterm infants and their parents. Intervention: MT focusing on singing specifically tailored to infant responses, will be delivered during NICU and/or during a post-discharge 6-month period. Primary outcome: Changes in mother-infant bonding until 6 months corrected age (CA), as measured by the Postpartum Bonding Questionnaire. Secondary outcomes: Mother-infant bonding at discharge and over 12 months CA; child development over 24 months; and parental depression, anxiety, and stress, and infant re-hospitalization, all over 12 months.

Discussion: This study fills a gap by measuring the long-term impact of MT for preterm infants/caregivers, and of MT beyond the hospital context. Outcomes related to highly involving parents in MT will directly inform the development of clinical practice in Scandinavia and other contexts with similar social welfare practices. By incorporating family-centered care, continuity of care, user involvement, and cultural relevance, this study can potentially contribute to improved quality of care for premature infants and their parents worldwide.


Options:
A: 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
B: 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
C: Inclusion Criteria:

* Infants inborn at NICHD NRN centers that are:
* 401-1000 grams birth weight, and/or
* 20 0/7 to 28 6/7 weeks (\<29 weeks) gestational age
* Infants enrolled in one or more additional NICHD NRN interventional trials or time-limited observational studies. For infants that do not meet the inclusion criteria above, inclusion and exclusion criteria for the Generic Database are determined by the criteria for the additional trial(s). In these cases, infants that are larger than 1,000 grams and/or older than 29 weeks may be included in the GDB.

Exclusion Criteria:

* Infants \>1,000 grams birth weight and/or \>29 weeks gestational age

Note: These inclusion criteria were changed as of 1/1/2008. Prior to this date, all infants with birth weights between 401 and 1500 grams who are admitted to NRN NICUs within 14 days of birth were included in the database.
D: 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)

Answer: B