Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NIH AT001901
Study information
Scientific title
Acronym
Study hypothesis
The null hypothesis is that harp music has no effect compared with usual care or a quiet room on any parameter of heart rate variability, salivary cortisol or activity of premature infants.
Ethics approval
Approved by Wake Forest University School of Medicine (WFUSM) Institutional Review Board on 03/31/2005 (Protocol no. BG05-162)
Study design
Randomized controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Prematurity
Intervention
Harp music vs quiet room. The infants allocated to the intervention group had harp music for 45 minutes each day for 3 days.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Salivary cortisol was measured just prior to harp music/quiet/usual care observation period and just after each day
2. HRV was measured during the intervention each day
3. Activity was measured during and after the intervention each day
4. Weight, meausred at baseline (Monday) and 5 days (Friday)
Secondary outcome measures
Growth, measured as weight gain at 5 days (this trial is 5 days long).
Overall trial start date
01/04/2005
Overall trial end date
30/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Infants hospitalized at Brenner Children's Hospital Neonatal Intensive Care or Intermediate Care UnitsInfants were eligible if they satisfied the following criteria:
1. Born between 25 and 36 weeks gestational age
2. At least 34 weeks gestational age by the time of enrollment
3. Had been medically stable in the intermediate care nursery for at least three days
4. Had passed the neonatal hearing screen
5. Slept in a crib rather than an isolette
6. Took full oral feedings
7. Free of apnea and bradycardia spells
8. Expected to remain in the intermediate nursery for at least seven more days to achieve stable body temperature
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
90
Participant exclusion criteria
1. Any medical condition known to adversely affect either:
1.1. Central nervous system (e.g. intraventricular hemorrhage of Grade II or higher)
1.2. Cardiac or adrenal function (e.g. major cardiac anomaly)
1.3. Movement (e.g. spasticity, hypotonia, or fractured clavicle)
2. Any ongoing need for stressful or invasive medical procedures or steroid medications
Recruitment start date
01/04/2005
Recruitment end date
30/12/2006
Locations
Countries of recruitment
United States of America
Trial participating centre
Wake Forest University School of Medicine
Winston-Salem
27157
United States of America
Funders
Funder type
Government
Funder name
National Institutes of Health (ref: NCCAM AT001901)
Alternative name(s)
NIH
Funding Body Type
government organisation
Funding Body Subtype
federal/national government
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list