Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Han-Suk Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01536093
First received: January 6, 2012
Last updated: August 11, 2014
Last verified: August 2014
Results First Received: July 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Extremely Low Gestational Age Newborn
Premature Infant
Interventions: Other: oropharyngeal administration of own mother's colostrum
Other: oropharyngeal administration of sterile water

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Colostrum

oropharyngeal administration of own mother's colostrum

oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.

Placebo

oropharyngeal administration of sterile water

oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.


Participant Flow:   Overall Study
    Colostrum     Placebo  
STARTED     24     24  
COMPLETED     21     21  
NOT COMPLETED     3     3  
Death                 1                 2  
absence of maternal colostrum                 2                 0  
Withdrawal by Subject                 0                 1  



  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
Colostrum

oropharyngeal administration of own mother's colostrum

oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.

Placebo

oropharyngeal administration of sterile water

oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.

Total Total of all reporting groups

Baseline Measures
    Colostrum     Placebo     Total  
Number of Participants  
[units: participants]
  21     21     42  
Age [1]
[units: weeks]
Mean ± Standard Deviation
  26.1  ± 1.4     26.0  ± 1.4     26.1  ± 1.4  
Gender  
[units: participants]
     
Female     10     11     21  
Male     11     10     21  
Birth weight  
[units: g]
Mean ± Standard Deviation
  862.2  ± 234.8     842.4  ± 250.4     849.3  ± 239.8  
[1] Gestational Age



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Urinary Secretary IgA Concentration at 2 Weeks of Age   [ Time Frame: 2 weeks of age ]

2.  Secondary:   Urinary Secretary IgA Concentration at 1 Week of Age   [ Time Frame: 1 week of age ]

3.  Secondary:   Salivary TGF-beta 1 Concentration at 2 Week of Age   [ Time Frame: 2 week of age ]

4.  Secondary:   Salivary IL-8 Concentration at 2 Weeks of Age   [ Time Frame: 2 weeks of age ]

5.  Secondary:   Concentration of Urinary Lactoferrin   [ Time Frame: 1 week of age ]

6.  Secondary:   Concentration of Urinary IL-1 Beta   [ Time Frame: 2 weeks of age ]

7.  Secondary:   Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines   [ Time Frame: 1 week of age ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines   [ Time Frame: 2 weeks of age ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Time to Reach Full Feeding   [ Time Frame: up to 2 months of age ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Total Hospital Admission Duration   [ Time Frame: up to 4 months of age ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

11.  Secondary:   Episodes of Culture Positive Sepsis   [ Time Frame: from date of randomization up to 4 months of age ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2   [ Time Frame: from date of randomization up to 4 months of age ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   Episodes of Pneumonia   [ Time Frame: from date of randomization up to 4 months of age ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

14.  Secondary:   Development of Bronchopulmonary Dysplasia ≥ Moderate   [ Time Frame: up to 4 months of age ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

15.  Secondary:   Development of Intraventricular Hemorrhage ≥ Grade 3   [ Time Frame: up to 4 months of age ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

16.  Secondary:   In-hospital Death   [ Time Frame: up to 4 months of age ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

17.  Secondary:   Development of Adverse Effects   [ Time Frame: from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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
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  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.


Results Point of Contact:  
Name/Title: Dr. Juyoung Lee
Organization: Seoul National University College of Medicine
phone: 82-31-787-7301
e-mail: lamb4122@snu.ac.kr


No publications provided


Responsible Party: Han-Suk Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01536093     History of Changes
Other Study ID Numbers: OAC-01-ELGAN
Study First Received: January 6, 2012
Results First Received: July 17, 2014
Last Updated: August 11, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)