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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02919358
Other study ID # DDD603441
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2016
Est. completion date May 2018

Study information

Verified date May 2018
Source Christiana Care Health Services
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of classical music exposure on improved time to regain birth weight and improved feeding readiness in healthy premature infants in the NICU.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 2018
Est. primary completion date April 2018
Accepts healthy volunteers No
Gender All
Age group 28 Weeks to 31 Weeks
Eligibility Inclusion Criteria:

- • Neonates between the gestational ages of 28 weeks and 32 weeks and 6 days

- Parents =18 years of age

- English speaking parents

- Breastmilk as intended primary form of nutrition

Exclusion Criteria:

- Congenital anomalies affecting hearing or feeding skills

- Patients requiring HFOV or HFJV

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Music

No music.
This is the control group.

Locations

Country Name City State
United States Christiana Care Health System Newark Delaware

Sponsors (1)

Lead Sponsor Collaborator
Christiana Care Health Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome is time to regain birth weight We will track weight gain and will monitor how long it takes for the babies to regain their birth weight. 2 weeks
Secondary Assessment of Feeding Cues At 33 weeks corrected gestational age; a speech therapist will assess feeding cues daily using an objective oral feeding assessment tool 2 weeks
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