Condition category
Neonatal Diseases
Date applied
06/08/2007
Date assigned
29/08/2007
Last edited
29/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kathi Kemper

ORCID ID

Contact details

Wake Forest University School of Medicine
Medical Center Blvd.
Winston-Salem
27157
United States of America

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 measures

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

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

Sponsor information

Organisation

National Institutes of Health, National Center for Complementary and Alternative Medicine (USA)

Sponsor details

6707 Democracy Blvd.
Suite 401
Bethesda
20892
United States of America

Sponsor type

Government

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes