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A clinical trial to study the effectiveness of instrumental Indian classical musicon serum cortisol concentrations of preterm infants on assisted ventilation admitted to a tertiary level neonatal intensive care unit (NICU)

Effectiveness of Instrumental Indian Classical music on serum cortisol concentrations of preterm infants on assisted ventilation admitted to a tertiary level neonatal intensive care unit (NICU)- a prospective, randomized controlled trialâ??

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/11/003117
Enrollment
130
Registered
2012-11-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- preterm neonates

Interventions

Intervention1: instrumental Indian Classical music: music refers to the playing of recorded Indian Classical instrumental music, which has soft pitch (shruthi shuddi -frequency of sound waves or acous

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: â??Very preterm infants on assisted ventilation(requiring mechanical ventilation at birth),admitted to tertiary level NICU, Kasturba Hospital, Manipal â??Gestational age of 28-30 weeks (7-7.5 months) of postmenstrual age â??Appropriate for gestational age (AGA) â??have passed the hearing screening test to confirm hearing ability by OAE test â??Parental consent

Exclusion criteria

Exclusion criteria: â??Preterm infants who are large for gestational age(LGA)or small for gestational age(SGA) â??weighing 1500 gms at birth â??death in the first 48 hours of life â??having major congenital malformations â??having major surgical complications â??preterm infants of mothers with endocrine disorders like thyroid and adrenal problems â??preterm infants with adrenal haemorrhage (confirmed by USG) â??preterm infants who have congenital sepsis (confirmed by blood culture on day 1) â??preterm infants exposed to chorioamnionitis (confirmed in the antenatal record)

Design outcomes

Primary

MeasureTime frame
1.The main outcome variable will be to determine the effectiveness of instrumental Indian classical music on serum cortisol concentrations of very preterm infants on assisted ventilation in the first and second week of life 2.To find the Effectiveness on the developmental responses as measured by weight gain, Head circumference and vital signs Timepoint: first and second week of life weight, HC will be done every day and weekly vital signs before, during and after the sessions

Secondary

MeasureTime frame
The secondary outcome measures will include Maximum respiratory support as measured by Respiratory Acuity score, short term growth, Severity of illness among very preterm infants on assisted ventilation as measured by proforma for severity of illness and duration of hospital stayTimepoint: first and second week of life and at discharge

Countries

India

Contacts

Public ContactDrLeslie Lewis

Manipal College of Nursing,Manipal University, Manipal

sonia.r@manipal.edu0820-2922462

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026