Trial Outcomes & Findings for Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk (NCT NCT02573779)
NCT ID: NCT02573779
Last Updated: 2025-02-25
Results Overview
Stool samples during the first 6 weeks of life will be analyzed to compare development of microbial diversity
Recruitment status
COMPLETED
Target enrollment
125 participants
Primary outcome timeframe
6 weeks
Results posted on
2025-02-25
Participant Flow
Eligible study participants included premature inborn infants at \<1500 g BW with no barriers to enteral milk feeding. Infants were approached and enrolled within the first 72 hr of life.
Of 223 inborn infants \<1500 g BW between September 2015 to August 2016, 33 infants were excluded, 59 could not be enrolled within 72 h, and 6 were not enrolled because their parents declined. Of the 125 enrolled infants, 8 were removed from the study owing to GI defects or complications unknown at time of enrollment that precluded enteral feeding.
Participant milestones
| Measure |
Infants Fed Mother's Own Milk
Infants fed \>50% mother's own milk with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
Donor Milk Fed Infants
Infants fed \<50% mother's own milk (and thus \>50% donor human milk) with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
43
|
|
Overall Study
COMPLETED
|
74
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Growth and Microbiome Development in Very Low Birth Weight Infants Fed Primarily Mother's Own Milk vs. Donor Human Milk
Baseline characteristics by cohort
| Measure |
Infants Fed Mother's Own Milk
n=74 Participants
Infants fed \>50% mother's own milk with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
Donor Milk Fed Infants
n=43 Participants
Infants fed \<50% mother's own milk (and thus \>50% donor human milk) with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Gestational age
|
28.7 weeks
STANDARD_DEVIATION 2.0 • n=99 Participants
|
28.4 weeks
STANDARD_DEVIATION 2.5 • n=107 Participants
|
28.6 weeks
STANDARD_DEVIATION 2.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Stool samples were selected for microbiota analysis from infants who had samples collected at every time point over the first 6 weeks of life (n=90).
Stool samples during the first 6 weeks of life will be analyzed to compare development of microbial diversity
Outcome measures
| Measure |
Infants Fed Mother's Own Milk
n=58 Participants
Infants fed \>50% mother's own milk with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
Donor Milk Fed Infants
n=32 Participants
Infants fed \<50% mother's own milk (and thus \>50% donor human milk) with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
|---|---|---|
|
Intestinal Microbiome Diversity
|
55.7 taxa represented
Standard Error 3.6
|
46.3 taxa represented
Standard Error 4.1
|
PRIMARY outcome
Timeframe: Birth to dischargeHospital length of stay will be calculated from birth to discharge of infant.
Outcome measures
| Measure |
Infants Fed Mother's Own Milk
n=74 Participants
Infants fed \>50% mother's own milk with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
Donor Milk Fed Infants
n=43 Participants
Infants fed \<50% mother's own milk (and thus \>50% donor human milk) with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
|---|---|---|
|
Hospital Length of Stay
|
72.5 days
Standard Deviation 33.2
|
88.2 days
Standard Deviation 62.2
|
PRIMARY outcome
Timeframe: 6-10 weeksWeight gain will be evaluated weekly throughout the study (defined as g/kg/day)
Outcome measures
| Measure |
Infants Fed Mother's Own Milk
n=74 Participants
Infants fed \>50% mother's own milk with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
Donor Milk Fed Infants
n=43 Participants
Infants fed \<50% mother's own milk (and thus \>50% donor human milk) with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
|---|---|---|
|
Weight Gain
|
13.6 g/kg/day
Standard Deviation 2.2
|
12.5 g/kg/day
Standard Deviation 1.5
|
PRIMARY outcome
Timeframe: 6-10 weeksLinear growth will be measured weekly (defined as cm/week)
Outcome measures
| Measure |
Infants Fed Mother's Own Milk
n=74 Participants
Infants fed \>50% mother's own milk with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
Donor Milk Fed Infants
n=43 Participants
Infants fed \<50% mother's own milk (and thus \>50% donor human milk) with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
|---|---|---|
|
Linear Growth
|
1 cm/week
Standard Deviation 0.23
|
1 cm/week
Standard Deviation 0.22
|
PRIMARY outcome
Timeframe: 6-10 weeksGrowth in head circumference will be measured weekly (defined as cm/wk)
Outcome measures
| Measure |
Infants Fed Mother's Own Milk
n=74 Participants
Infants fed \>50% mother's own milk with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
Donor Milk Fed Infants
n=43 Participants
Infants fed \<50% mother's own milk (and thus \>50% donor human milk) with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
|---|---|---|
|
Head Circumference Growth
|
0.8 cm/week
Standard Deviation 0.19
|
0.8 cm/week
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: 6-10 weeksPopulation: Infants in both groups
Number of days for infant to reach full enteral feeds.
Outcome measures
| Measure |
Infants Fed Mother's Own Milk
n=74 Participants
Infants fed \>50% mother's own milk with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
Donor Milk Fed Infants
n=43 Participants
Infants fed \<50% mother's own milk (and thus \>50% donor human milk) with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
|---|---|---|
|
Days to Final Enteral Feed Volume
|
12.4 days
Standard Deviation 4.5
|
13.9 days
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: 6-10 weeksthe number of patients with a diagnosis of NEC (Stage ≥ IIA) will be collected
Outcome measures
| Measure |
Infants Fed Mother's Own Milk
n=74 Participants
Infants fed \>50% mother's own milk with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
Donor Milk Fed Infants
n=43 Participants
Infants fed \<50% mother's own milk (and thus \>50% donor human milk) with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
|---|---|---|
|
Rates of Necrotizing Enterocolitis (NEC)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6-10 weeksthe number of patients who develop a spontaneous intestinal perforation will be collected
Outcome measures
| Measure |
Infants Fed Mother's Own Milk
n=74 Participants
Infants fed \>50% mother's own milk with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
Donor Milk Fed Infants
n=43 Participants
Infants fed \<50% mother's own milk (and thus \>50% donor human milk) with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
|---|---|---|
|
Rates of Spontaneous Intestinal Perforation (SIP)
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6-10 weeksthe number of patients with late-onset sepsis will be collected
Outcome measures
| Measure |
Infants Fed Mother's Own Milk
n=74 Participants
Infants fed \>50% mother's own milk with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
Donor Milk Fed Infants
n=43 Participants
Infants fed \<50% mother's own milk (and thus \>50% donor human milk) with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
|---|---|---|
|
Rates of Late-onset Sepsis
|
4 Participants
|
6 Participants
|
Adverse Events
Infants Fed Mother's Own Milk
Serious events: 14 serious events
Other events: 26 other events
Deaths: 2 deaths
Donor Milk Fed Infants
Serious events: 20 serious events
Other events: 17 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Infants Fed Mother's Own Milk
n=74 participants at risk
Infants fed \>50% mother's own milk with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
Donor Milk Fed Infants
n=43 participants at risk
Infants fed \<50% mother's own milk (and thus \>50% donor human milk) with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
|---|---|---|
|
Gastrointestinal disorders
Necrotizing Enterocolitis (NEC)- Stage ≥ IIA
|
1.4%
1/74 • Through study completion (1 year).
|
4.7%
2/43 • Through study completion (1 year).
|
|
Gastrointestinal disorders
Spontaneous Intestinal Perforation (SIP)
|
0.00%
0/74 • Through study completion (1 year).
|
4.7%
2/43 • Through study completion (1 year).
|
|
Infections and infestations
Late-onset sepsis
|
5.4%
4/74 • Through study completion (1 year).
|
14.0%
6/43 • Through study completion (1 year).
|
|
Respiratory, thoracic and mediastinal disorders
Severe bronchopulmonary dysplasia (BPD)
|
10.8%
8/74 • Through study completion (1 year).
|
25.6%
11/43 • Through study completion (1 year).
|
|
General disorders
death
|
2.7%
2/74 • Through study completion (1 year).
|
4.7%
2/43 • Through study completion (1 year).
|
Other adverse events
| Measure |
Infants Fed Mother's Own Milk
n=74 participants at risk
Infants fed \>50% mother's own milk with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
Donor Milk Fed Infants
n=43 participants at risk
Infants fed \<50% mother's own milk (and thus \>50% donor human milk) with enteral feeding.
Observational - no intervention: This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
BPD
|
35.1%
26/74 • Through study completion (1 year).
|
39.5%
17/43 • Through study completion (1 year).
|
Additional Information
Dr. Amy B. Hair
Baylor College of Medicine/Texas Children's Hospital
Phone: 832-826-1398
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place