FeedingNCT02919358
Music and Feeding in NICU
A study testing Music and No music. in people with Feeding and NICU, run by Christiana Care Health Services at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 28 to 31 weeks
- Conditions the study is for
- Feeding, NICU, Preterm Infants
- What is being tested?
- Music and No music.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 31 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • 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
Who cannot join
- Congenital anomalies affecting hearing or feeding skills
- Patients requiring HFOV or HFJV
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health System
Newark, Delaware, 19713
About this study
Official title: The Mozart Effect and the Assessment of Weight Gain and Development of Feeding Skills in the NICU.
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.
- Conditions
- Feeding, NICU, Preterm Infants, Mozart, Weight Gain
- Being tested
- Music, No music.
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
No music.Other
This is the control group.
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | Exposure to music, twice per day for the study period Receives: Other: Music |
| Control | Other | No intervention; standard care. Receives: Other: No music. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (1)
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startDec 2016
- Primary completionApr 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919358
- Sponsor's protocol ID
- DDD603441
- Status last verified
- May 2018
- First submitted
- 27 Sep 2016
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mozart Effect and the Assessment of Weight Gain and Development of Feeding Skills in the NICU.
- ClinicalTrials.gov ID
- NCT02919358
- Acronym / sponsor ID
- DDD603441
- Conditions
- Feeding, NICU, Preterm Infants, Mozart, Weight Gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Other: MusicExposure to music, twice per day for the study period |
| Control | Other | Other: No music.No intervention; standard care. |
Who may qualify
- Ages
- 28 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Neonates between the gestational ages of 28 weeks and 32 weeks and 6 days
Key exclusion criteria (2 listed)
- Congenital anomalies affecting hearing or feeding skills
- Patients requiring HFOV or HFJV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music | Other | Music |
| No music.This is the control group. | Other | Control |
Primary outcome
The primary outcome is time to regain birth weight
Time frame: 2 weeks
We will track weight gain and will monitor how long it takes for the babies to regain their birth weight.
1 secondary outcome
Assessment of Feeding Cues
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and No music. in people with Feeding and NICU, run by Christiana Care Health Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is time to regain birth weight (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.