Effects of Prefeeding Oral Stimulation on Feeding Performance in Preterm Infants

This study has been completed.
Sponsor:
Collaborator:
CRP-Santé Luxembourg
Information provided by (Responsible Party):
Dr Manon BACHE, Centre Hospitalier du Luxembourg
ClinicalTrials.gov Identifier:
NCT01649362
First received: July 18, 2012
Last updated: February 9, 2014
Last verified: February 2014
Results First Received: October 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Preterm Infant
Oral Feeding Performance
Intervention: Other: prefeeding oral stimulation program

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Control Group no prefeeding oral stimulation
Oral Stimulation preterm infants receiving an prefeeding oral stimulation program

Participant Flow:   Overall Study
    Control Group     Oral Stimulation  
STARTED     47     54  
COMPLETED     46     40  
NOT COMPLETED     1     14  



  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.
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Reporting Groups
  Description
Control Group no prefeeding oral stimulation
Oral Stimulation preterm infants receiving an prefeeding oral stimulation program
Total Total of all reporting groups

Baseline Measures
    Control Group     Oral Stimulation     Total  
Number of Participants  
[units: participants]
  46     40     86  
Age  
[units: participants]
     
<=18 years     46     40     86  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age, Customized  
[units: weeks'¬†gestational¬†age]
Mean ± Standard Deviation
  31.3  ± 1.7     31.4  ± 1.5     31.3  ± 1.6  
Gender  
[units: participants]
     
Female     21     15     36  
Male     25     25     50  
Region of Enrollment  
[units: participants]
     
Luxembourg     46     40     86  



  Outcome Measures
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1.  Primary:   Length of Transition Period   [ Time Frame: participants were followed from date of randomization until full enteral feeding was acquired,an expected average of 5 weeks ]

2.  Secondary:   Length of Hospital Stay   [ Time Frame: participants were followed for the duration of hospital stay, an expected average of 5 weeks ]

3.  Secondary:   Breastfeeding Rate at Discharge   [ Time Frame: hospital discharge, an expected average of 5 weeks from the beginning of oral feeding introduction ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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
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Results Point of Contact:  
Name/Title: Dr Manon Bache
Organization: Centre Hospitalier de Luxembourg
phone: +352 4411 3157
e-mail: manon.bache@hotmail.com


Publications:


Responsible Party: Dr Manon BACHE, Centre Hospitalier du Luxembourg
ClinicalTrials.gov Identifier: NCT01649362     History of Changes
Other Study ID Numbers: 201105/04
Study First Received: July 18, 2012
Results First Received: October 29, 2013
Last Updated: February 9, 2014
Health Authority: Luxembourg: Comite National d'Ethique de Recherche