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)

Not Applicable

Conditions: Health Condition 1: null- preterm neonates

Registration Number: CTRI/2012/11/003117

Lead Sponsor: Indian Council of Medical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 130

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br/ ><br>2.To find the Effectiveness on the developmental responses as measured by weight gain, Head circumference and vital signs <br/ ><br>Timepoint: first and second week of life <br/ ><br>weight, HC will be done every day and weekly <br/ ><br>vital signs before, during and after the sessions

Secondary Outcome Measures

Name	Time	Method
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