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Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns

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ClinicalTrials.gov Identifier: NCT00930761
Recruitment Status : Completed
First Posted : June 30, 2009
Results First Posted : August 19, 2009
Last Update Posted : October 15, 2009
Maternidade Escola da UFRJ
Instituto de Puericultura e Pediatria Martagão Gesteira
Information provided by:
Universidade Federal do Rio de Janeiro

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Breastfeeding
Intervention: Behavioral: Music therapy

  Participant Flow

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
Control No text entered.
Music Therapy No text entered.

Participant Flow:   Overall Study
    Control   Music Therapy
STARTED   50   51 
COMPLETED   46   48 
3 newborns died; 1 mother quit the study                4                0 
less than 3 music therapy sessions                0                3 

  Baseline Characteristics

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
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
[Units: Participants]
Female   50   51   101 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
Brazil   50   51   101 

  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

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

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


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
First Submitted: June 29, 2009
First Posted: June 30, 2009
Results First Submitted: July 8, 2009
Results First Posted: August 19, 2009
Last Update Posted: October 15, 2009