Trial Outcomes & Findings for Effect of Colostrum on Mucosal Immunity in Very Low Birth Weight (VLBWs) Premature Infants (NCT NCT01776268)
NCT ID: NCT01776268
Last Updated: 2017-07-07
Results Overview
Saliva will be sampled on day 1-2 of life prior to oral priming. Investigators are assessing saliva for a change in the concentration of antimicrobial proteins.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
99 participants
Primary outcome timeframe
days 1-2 of life
Results posted on
2017-07-07
Participant Flow
Participant milestones
| Measure |
Colostrum Priming
Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
|
no Oral Priming
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
51
|
|
Overall Study
COMPLETED
|
48
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Colostrum on Mucosal Immunity in Very Low Birth Weight (VLBWs) Premature Infants
Baseline characteristics by cohort
| Measure |
Oral Priming
n=48 Participants
Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
|
no Oral Priming
n=51 Participants
No oral priming: no intervention
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 weeks
n=113 Participants
|
29 weeks
n=163 Participants
|
29 weeks
n=160 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=113 Participants
|
30 Participants
n=163 Participants
|
54 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=113 Participants
|
21 Participants
n=163 Participants
|
45 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=113 Participants
|
7 Participants
n=163 Participants
|
15 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=113 Participants
|
44 Participants
n=163 Participants
|
84 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=113 Participants
|
13 Participants
n=163 Participants
|
32 Participants
n=160 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=113 Participants
|
35 Participants
n=163 Participants
|
63 Participants
n=160 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=113 Participants
|
2 Participants
n=163 Participants
|
3 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=113 Participants
|
51 participants
n=163 Participants
|
99 participants
n=160 Participants
|
|
Birth Weight
|
1272 grams
n=113 Participants
|
1170 grams
n=163 Participants
|
1219 grams
n=160 Participants
|
|
APGAR
|
7 units on a scale
n=113 Participants
|
7 units on a scale
n=163 Participants
|
7 units on a scale
n=160 Participants
|
PRIMARY outcome
Timeframe: days 1-2 of lifeSaliva will be sampled on day 1-2 of life prior to oral priming. Investigators are assessing saliva for a change in the concentration of antimicrobial proteins.
Outcome measures
| Measure |
Oral Priming
n=48 Participants
Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
|
No Oral Priming
n=51 Participants
|
|---|---|---|
|
Concentration of APPs Before Oral Priming
S100a7-S1
|
17 femtomole (fmol)
Interval 8.0 to 39.0
|
22 femtomole (fmol)
Interval 7.0 to 45.0
|
|
Concentration of APPs Before Oral Priming
S100a7-S2
|
35 femtomole (fmol)
Interval 5.0 to 60.0
|
42 femtomole (fmol)
Interval 5.0 to 169.0
|
|
Concentration of APPs Before Oral Priming
S100a8-S1
|
101 femtomole (fmol)
Interval 39.0 to 313.0
|
102 femtomole (fmol)
Interval 49.0 to 305.0
|
|
Concentration of APPs Before Oral Priming
S100a8-S2
|
495 femtomole (fmol)
Interval 190.0 to 854.0
|
683 femtomole (fmol)
Interval 109.0 to 1064.0
|
|
Concentration of APPs Before Oral Priming
S100a9-S1
|
1669 femtomole (fmol)
Interval 755.0 to 2540.0
|
2392 femtomole (fmol)
Interval 287.0 to 3465.0
|
|
Concentration of APPs Before Oral Priming
S100a9-S2
|
198 femtomole (fmol)
Interval 112.0 to 337.0
|
364 femtomole (fmol)
Interval 67.0 to 614.0
|
|
Concentration of APPs Before Oral Priming
Surfactant protein A
|
5 femtomole (fmol)
Interval 0.0 to 5.0
|
0 femtomole (fmol)
Interval 0.0 to 7.0
|
|
Concentration of APPs Before Oral Priming
α-Defensin 1-S1
|
1 femtomole (fmol)
Interval 0.0 to 1.0
|
1 femtomole (fmol)
Interval 0.0 to 3.0
|
|
Concentration of APPs Before Oral Priming
α-Defensin 5
|
1 femtomole (fmol)
Interval 1.0 to 1.0
|
1 femtomole (fmol)
Interval 1.0 to 7.0
|
|
Concentration of APPs Before Oral Priming
Lactoferrin-S1
|
11 femtomole (fmol)
Interval 1.0 to 23.0
|
15 femtomole (fmol)
Interval 1.0 to 40.0
|
|
Concentration of APPs Before Oral Priming
Lactoferrin-S2
|
10 femtomole (fmol)
Interval 7.0 to 17.0
|
14 femtomole (fmol)
Interval 8.0 to 20.0
|
|
Concentration of APPs Before Oral Priming
Immunoglobulin A
|
10 femtomole (fmol)
Interval 10.0 to 196.0
|
10 femtomole (fmol)
Interval 10.0 to 68.0
|
|
Concentration of APPs Before Oral Priming
Lysozyme C-S1
|
1257 femtomole (fmol)
Interval 698.0 to 2184.0
|
1122 femtomole (fmol)
Interval 559.0 to 2058.0
|
|
Concentration of APPs Before Oral Priming
Lysozyme C-S2
|
0 femtomole (fmol)
Interval 0.0 to 12.0
|
0 femtomole (fmol)
Interval 0.0 to 20.0
|
PRIMARY outcome
Timeframe: days 7-9 of lifeSaliva will be sampled 24-48 hours after the 5-days of oral priming is completed. Investigators are assessing saliva for a change in the concentration of antimicrobial proteins.
Outcome measures
| Measure |
Oral Priming
n=48 Participants
Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
|
No Oral Priming
n=51 Participants
|
|---|---|---|
|
Concentration of APPs After Oral Priming
S100a7-S1
|
15 femtomole (fmol)
Interval 8.0 to 27.0
|
20 femtomole (fmol)
Interval 9.0 to 28.0
|
|
Concentration of APPs After Oral Priming
S100a7-S2
|
18 femtomole (fmol)
Interval 5.0 to 68.0
|
38 femtomole (fmol)
Interval 5.0 to 88.0
|
|
Concentration of APPs After Oral Priming
S100a8-S1
|
144 femtomole (fmol)
Interval 44.0 to 308.0
|
206 femtomole (fmol)
Interval 57.0 to 457.0
|
|
Concentration of APPs After Oral Priming
S100a8-S2
|
511 femtomole (fmol)
Interval 197.0 to 789.0
|
562 femtomole (fmol)
Interval 252.0 to 1037.0
|
|
Concentration of APPs After Oral Priming
S100a9-S1
|
1777 femtomole (fmol)
Interval 934.0 to 2473.0
|
1886 femtomole (fmol)
Interval 731.0 to 4008.0
|
|
Concentration of APPs After Oral Priming
S100a9-S2
|
241 femtomole (fmol)
Interval 114.0 to 311.0
|
319 femtomole (fmol)
Interval 114.0 to 498.0
|
|
Concentration of APPs After Oral Priming
Surfactant protein A
|
0 femtomole (fmol)
Interval 0.0 to 5.0
|
5 femtomole (fmol)
Interval 0.0 to 6.0
|
|
Concentration of APPs After Oral Priming
α-Defensin 1-S1
|
1 femtomole (fmol)
Interval 0.0 to 5.0
|
1 femtomole (fmol)
Interval 0.0 to 10.0
|
|
Concentration of APPs After Oral Priming
α-Defensin 5
|
1 femtomole (fmol)
Interval 0.0 to 1.0
|
1 femtomole (fmol)
Interval 0.0 to 1.0
|
|
Concentration of APPs After Oral Priming
Lactoferrin-S1
|
57 femtomole (fmol)
Interval 1.0 to 92.0
|
29 femtomole (fmol)
Interval 1.0 to 91.0
|
|
Concentration of APPs After Oral Priming
Lactoferrin-S2
|
49 femtomole (fmol)
Interval 14.0 to 103.0
|
21 femtomole (fmol)
Interval 12.0 to 38.0
|
|
Concentration of APPs After Oral Priming
Immunoglobulin A
|
102 femtomole (fmol)
Interval 29.0 to 1373.0
|
42 femtomole (fmol)
Interval 10.0 to 328.0
|
|
Concentration of APPs After Oral Priming
Lysozyme C-S1
|
1680 femtomole (fmol)
Interval 836.0 to 3416.0
|
1972 femtomole (fmol)
Interval 1344.0 to 2617.0
|
|
Concentration of APPs After Oral Priming
Lysozyme C-S2
|
15 femtomole (fmol)
Interval 0.0 to 31.0
|
8 femtomole (fmol)
Interval 0.0 to 23.0
|
Adverse Events
Oral Priming
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
no Oral Priming
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Priming
n=48 participants at risk
Intervention:Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
|
no Oral Priming
n=51 participants at risk
No oral priming: no intervention
|
|---|---|---|
|
General disorders
Death
|
2.1%
1/48 • Number of events 1
|
0.00%
0/51
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place