NCT02919358

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

September 27, 2016

Last Update Submit

May 15, 2018

Conditions

FeedingNICUPreterm InfantsMozartWeight Gain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Assessment of Feeding Cues

    2 weeks

Study Arms (2)

Music

EXPERIMENTAL

Exposure to music, twice per day for the study period

Other: Music

Control

OTHER

No intervention; standard care.

Other: No music.

Interventions

MusicOTHER
Music
No music.OTHER

This is the control group.

Control

Eligibility Criteria

Age28 Weeks - 31 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Congenital anomalies affecting hearing or feeding skills
  • Patients requiring HFOV or HFJV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Care Health System

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Weight Gain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 29, 2016

Study Start

December 1, 2016

Primary Completion

April 1, 2018

Study Completion

May 1, 2018

Last Updated

May 16, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)