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Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns

This study has been completed.
Sponsor:
Collaborators:
Maternidade Escola da UFRJ
Instituto de Puericultura e Pediatria Martagão Gesteira
Information provided by:
Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00930761
First received: June 29, 2009
Last updated: October 13, 2009
Last verified: October 2009
Results First Received: July 8, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Breastfeeding
Intervention: Behavioral: Music therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: 03/01/2004 to 07/31/2007. Mothers of LBW newborns (≤ 1750g) that have reached clinical stability and signed an informed consent.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible mothers: 190. Excluded: 89 (26 because their neonates fullfiled one of the exclusion criteria, 18 because their newborns died before being considered in clinical stability, 11 because they did not agree to participate and 34 because they could not be accessed during the newborn hospital stay, most for receiving early hospital discharge).

Reporting Groups
  Description
Control No text entered.
Music Therapy No text entered.

Participant Flow:   Overall Study
    Control   Music Therapy
STARTED   50   51 
COMPLETED   46   48 
NOT COMPLETED   4   3 
3 newborns died; 1 mother quit the study                4                0 
less than 3 music therapy sessions                0                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control No text entered.
Music Therapy No text entered.
Total Total of all reporting groups

Baseline Measures
   Control   Music Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   51   101 
Age, Customized [1] 
[Units: Participants]
     
12-20 years   13   13   26 
21-30 years   22   27   49 
31-40 years   12   9   21 
> 40 years   3   2   5 
[1] 12-20 years; 21-30 years; 31-40 years; > 40 years
Gender 
[Units: Participants]
     
Female   50   51   101 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Brazil   50   51   101 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maternal Breastfeeding at Infant Discharge   [ Time Frame: At the time of the infant hospital discharge ]

2.  Primary:   Maternal Breastfeeding 7-15 Days After Discharge   [ Time Frame: At the first follow-up visit (7-15 days after discharge) ]

3.  Secondary:   Maternal Breastfeeding at 30 Days After Discharge   [ Time Frame: At 30 days after the infant hospital discharge ]

4.  Secondary:   Maternal Breastfeeding at 60 Days After Discharge   [ Time Frame: At 60 days after the infant hospital discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Arnaldo Prata Barbosa
Organization: Instituto de Puericultura e Pediatria Martagão Gesteira - UFRJ
phone: +55 21 25904891
e-mail: arnaldoprata@globo.com


Publications:


Responsible Party: Arnaldo P Barbosa, Department of Pediatris, UFRJ School of Medicine
ClinicalTrials.gov Identifier: NCT00930761     History of Changes
Other Study ID Numbers: MAME-21-2001
Study First Received: June 29, 2009
Results First Received: July 8, 2009
Last Updated: October 13, 2009
Health Authority: Brazil: National Committee of Ethics in Research