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Trial Outcomes & Findings for Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns (NCT NCT00930761)

NCT ID: NCT00930761

Last Updated: 2009-10-15

Results Overview

Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

101 participants

Primary outcome timeframe

At the time of the infant hospital discharge

Results posted on

2009-10-15

Participant Flow

Recruitment period: 03/01/2004 to 07/31/2007. Mothers of LBW newborns (≤ 1750g) that have reached clinical stability and signed an informed consent.

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).

Participant milestones

Participant milestones
Measure
Control
Music Therapy
Overall Study
STARTED
50
51
Overall Study
COMPLETED
46
48
Overall Study
NOT COMPLETED
4
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Control
Music Therapy
Overall Study
3 newborns died; 1 mother quit the study
4
0
Overall Study
less than 3 music therapy sessions
0
3

Baseline Characteristics

Effects of Music Therapy on Breastfeeding Among Mothers of Premature Newborns

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control
n=50 Participants
Music Therapy
n=51 Participants
Total
n=101 Participants
Total of all reporting groups
Age, Customized
12-20 years
13 participants
n=93 Participants
13 participants
n=4 Participants
26 participants
n=27 Participants
Age, Customized
21-30 years
22 participants
n=93 Participants
27 participants
n=4 Participants
49 participants
n=27 Participants
Age, Customized
31-40 years
12 participants
n=93 Participants
9 participants
n=4 Participants
21 participants
n=27 Participants
Age, Customized
> 40 years
3 participants
n=93 Participants
2 participants
n=4 Participants
5 participants
n=27 Participants
Sex: Female, Male
Female
50 Participants
n=93 Participants
51 Participants
n=4 Participants
101 Participants
n=27 Participants
Sex: Female, Male
Male
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Region of Enrollment
Brazil
50 participants
n=93 Participants
51 participants
n=4 Participants
101 participants
n=27 Participants

PRIMARY outcome

Timeframe: At the time of the infant hospital discharge

Population: Analysis by intention to treat (ITT)

Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).

Outcome measures

Outcome measures
Measure
Control
n=46 Participants
Music Therapy
n=48 Participants
Maternal Breastfeeding at Infant Discharge
33 participants
42 participants

PRIMARY outcome

Timeframe: At the first follow-up visit (7-15 days after discharge)

Population: Analysis was by intention to treat (ITT)

Maternal breastfeeding means: exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).

Outcome measures

Outcome measures
Measure
Control
n=46 Participants
Music Therapy
n=48 Participants
Maternal Breastfeeding 7-15 Days After Discharge
32 participants
42 participants

SECONDARY outcome

Timeframe: At 30 days after the infant hospital discharge

Population: Analysis by intention to treat (ITT)

Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).

Outcome measures

Outcome measures
Measure
Control
n=46 Participants
Music Therapy
n=48 Participants
Maternal Breastfeeding at 30 Days After Discharge
30 participants
38 participants

SECONDARY outcome

Timeframe: At 60 days after the infant hospital discharge

Maternal breastfeeding means exclusive maternal breastfeeding, predominant maternal breastfeeding (maternal milk associated to other liquid, except formula) and continuous maternal breastfeeding (maternal milk associate to other food, including formula).

Outcome measures

Outcome measures
Measure
Control
n=46 Participants
Music Therapy
n=48 Participants
Maternal Breastfeeding at 60 Days After Discharge
27 participants
36 participants

Adverse Events

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Music Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Arnaldo Prata Barbosa

Instituto de Puericultura e Pediatria Martagão Gesteira - UFRJ

Phone: +55 21 25904891

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place