|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
7 November 2016 |
|
Main ID: |
NCT02948491 |
|
Date of registration:
|
18/10/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Effectiveness of Music Therapy on the Development of Preterm Neonates
EMT-DRNP |
|
Scientific title:
|
Effectiveness of Music Therapy on the Intra-hospital Evolution and Neurodevelopment of Preterm Neonates Treated in Neonatal Intensive Care Units in the Bucaramanga Metropolitan Area |
|
Date of first enrolment:
|
June 2017 |
|
Target sample size:
|
90 |
|
Recruitment status: |
Not yet recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02948491 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Colombia
| | | | | | | |
|
Contacts
|
|
Name:
|
Alvaro J Idrovo, MD, PhD |
|
Address:
|
|
|
Telephone:
|
573125566493 |
|
Email:
|
alvaro.idrovo@docentes.umb.edu.co |
|
Affiliation:
|
|
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Belong to the group of neonates treated in neonatal intensive care units during the
dates on which the sample will be taken.
- Clinical evaluation by the neonatologist indicating the infant's possible
participation in the study.
- The neonate is between the gestational age of 28 and 37 weeks.
Exclusion Criteria:
- Mother is not able to give consent due to mental incapacity.
Age minimum:
28 Weeks
Age maximum:
37 Weeks
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Premature Birth
|
|
Intervention(s)
|
|
Other: Music therapy
|
|
Primary Outcome(s)
|
|
The Bayley-III Adaptive Behavior Scale
[Time Frame: six months]
|
|
The Bayley-III Language Scale
[Time Frame: six months]
|
|
The Bayley-III Cognitive Scale
[Time Frame: six month]
|
|
The Bayley-III Social-Emotional Scale
[Time Frame: six months]
|
|
The Bayley-III Motor Scale
[Time Frame: six months]
|
|
Secondary Outcome(s)
|
|
Weight
[Time Frame: Everyday during all the follow-up period in neonatal intensive care unit (an average of 1 month).]
|
|
Heart rate
[Time Frame: Everyday during all the follow-up period in neonatal intensive care unit (an average of 1 month). Also, it will be measured while neonate is receiving the intervention]
|
|
Blood pressure
[Time Frame: Everyday during all the follow-up period in neonatal intensive care unit (an average of 1 month).. Also, it will be measured while neonate is receiving the intervention]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|