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Effects of Prefeeding Oral Stimulation on Feeding Performance in Preterm Infants

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ClinicalTrials.gov Identifier: NCT01649362
Recruitment Status : Completed
First Posted : July 25, 2012
Results First Posted : December 18, 2013
Last Update Posted : March 12, 2014
Sponsor:
Collaborator:
Luxembourg Institute of Health
Information provided by (Responsible Party):
Dr Manon BACHE, Centre Hospitalier du Luxembourg

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Preterm Infant
Oral Feeding Performance
Intervention Other: prefeeding oral stimulation program
Enrollment 101
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group Oral Stimulation
Hide Arm/Group Description no prefeeding oral stimulation preterm infants receiving an prefeeding oral stimulation program
Period Title: Overall Study
Started 47 54
Completed 46 40
Not Completed 1 14
Arm/Group Title Control Group Oral Stimulation Total
Hide Arm/Group Description no prefeeding oral stimulation preterm infants receiving an prefeeding oral stimulation program Total of all reporting groups
Overall Number of Baseline Participants 46 40 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 40 participants 86 participants
<=18 years
46
 100.0%
40
 100.0%
86
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Weeks' gestational age
Number Analyzed 46 participants 40 participants 86 participants
31.3  (1.7) 31.4  (1.5) 31.3  (1.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 40 participants 86 participants
Female
21
  45.7%
15
  37.5%
36
  41.9%
Male
25
  54.3%
25
  62.5%
50
  58.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Luxembourg Number Analyzed 46 participants 40 participants 86 participants
46 40 86
1.Primary Outcome
Title Length of Transition Period
Hide Description transition period was defined as the period from the introduction of enteral feeding to full enteral feeding
Time Frame participants were followed from date of randomization until full enteral feeding was acquired,an expected average of 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Oral Stimulation
Hide Arm/Group Description:
no prefeeding oral stimulation
preterm infants receiving an prefeeding oral stimulation program
Overall Number of Participants Analyzed 46 40
Mean (Standard Deviation)
Unit of Measure: days
16.0  (6.9) 16.9  (9.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Oral Stimulation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Length of Hospital Stay
Hide Description [Not Specified]
Time Frame participants were followed for the duration of hospital stay, an expected average of 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Oral Stimulation
Hide Arm/Group Description:
no prefeeding oral stimulation
preterm infants receiving an prefeeding oral stimulation program
Overall Number of Participants Analyzed 46 40
Mean (Standard Deviation)
Unit of Measure: days
42.5  (15.1) 45.7  (16.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Oral Stimulation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Breastfeeding Rate at Discharge
Hide Description [Not Specified]
Time Frame hospital discharge, an expected average of 5 weeks from the beginning of oral feeding introduction
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Oral Stimulation
Hide Arm/Group Description:
no prefeeding oral stimulation
preterm infants receiving an prefeeding oral stimulation program
Overall Number of Participants Analyzed 46 40
Measure Type: Number
Unit of Measure: participants
21 28
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Oral Stimulation
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Oral Stimulation
Hide Arm/Group Description no prefeeding oral stimulation preterm infants receiving an prefeeding oral stimulation program
All-Cause Mortality
Control Group Oral Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group Oral Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control Group Oral Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/40 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Manon Bache
Organization: Centre Hospitalier de Luxembourg
Phone: +352 4411 3157
EMail: manon.bache@hotmail.com
Publications:
Layout table for additonal information
Responsible Party: Dr Manon BACHE, Centre Hospitalier du Luxembourg
ClinicalTrials.gov Identifier: NCT01649362     History of Changes
Other Study ID Numbers: 201105/04
First Submitted: July 18, 2012
First Posted: July 25, 2012
Results First Submitted: October 29, 2013
Results First Posted: December 18, 2013
Last Update Posted: March 12, 2014