Trial Outcomes & Findings for Very Low Birth Weight Preterm Infant Bundled Care in the NICU (NCT NCT03370757)
NCT ID: NCT03370757
Last Updated: 2024-04-19
Results Overview
Heart rate instability was defined as having a mean heart rate value during a bundled care event that was ≥1 standard deviation above or below the mean heart rate value during the 90 minutes before the event started. In addition, clinically meaningful parameters were added to indicate exceptions to this definition. For HR, mean values ≥ one standard deviation below the mean was categorized as physiologically unstable only if the mean value was \< 100. Based on these criteria, each observation was categorized as physiologically unstable or not.
COMPLETED
NA
49 participants
During hospitalization, approximately four weeks
2024-04-19
Participant Flow
Recruitment Period: 2/2018 - 7/2019 Location: Level IV NICU
1 infant was consented but discharged home before being randomized because the infant never reached q3 hour feedings (discharged home on G-tube).
Participant milestones
| Measure |
3-hour Bundled Care
Infants in this group will have their diaper changed every 3 hours during 3-hour bundled care.
3-hour bundled care: Infants in the 3-hour bundled care group will receive diaper changes every 3 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 3 times per week.
|
6-hour Bundled Care
Infants in this group will have their diaper changed every 6 hours.
6-hour bundled care: Infants in the 6-hour bundled care group will receive diaper changes every 6 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 4 times per week.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
28
|
|
Overall Study
COMPLETED
|
20
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Very Low Birth Weight Preterm Infant Bundled Care in the NICU
Baseline characteristics by cohort
| Measure |
3-hour Bundled Care
n=20 Participants
Infants in this group will have their diaper changed every 3 hours during 3-hour bundled care.
3-hour bundled care: Infants in the 3-hour bundled care group will receive diaper changes every 3 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 3 times per week.
|
6-hour Bundled Care
n=26 Participants
Infants in this group will have their diaper changed every 6 hours.
6-hour bundled care: Infants in the 6-hour bundled care group will receive diaper changes every 6 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 4 times per week.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Gestational Age at Birth
|
27.6 weeks
STANDARD_DEVIATION 2.8 • n=93 Participants
|
28.4 weeks
STANDARD_DEVIATION 2.8 • n=4 Participants
|
28.0 weeks
STANDARD_DEVIATION 2.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: During hospitalization, approximately four weeksHeart rate instability was defined as having a mean heart rate value during a bundled care event that was ≥1 standard deviation above or below the mean heart rate value during the 90 minutes before the event started. In addition, clinically meaningful parameters were added to indicate exceptions to this definition. For HR, mean values ≥ one standard deviation below the mean was categorized as physiologically unstable only if the mean value was \< 100. Based on these criteria, each observation was categorized as physiologically unstable or not.
Outcome measures
| Measure |
3-hour Bundled Care
n=20 Participants
Infants in this group had their diaper changed every 3 hours during 3-hour bundled care.
3-hour bundled care: Infants in the 3-hour bundled care group received diaper changes every 3 hours.
|
6-hour Bundled Care
n=26 Participants
Infants in this group had their diaper changed every 6 hours.
6-hour bundled care: Infants in the 6-hour bundled care group received diaper changes every 6 hours.
|
|---|---|---|
|
Mean Heart Rate by Group
|
200 beats per minute
Standard Deviation 75.19
|
185 beats per minute
Standard Deviation 73.41
|
SECONDARY outcome
Timeframe: During hospitalization, approximately four weeksTEWL was measured at the beginning of each bundled care event using the DermaLab® TEWL probe (Cortex Technology, Hadsund, Denmark). Transepidermal water loss is the process of water moving through the layers of the skin and evaporating. Linear mixed models (LMM) were used to examine group differences in TEWL. Outcomes in these models consisted of within-subject change over time in skin TEWL of the buttock. In the model, TEWL was regressed on diaper change group and the number of days since study initiation. TEWL estimates and confidence intervals are reported by group across all bundled care observations.
Outcome measures
| Measure |
3-hour Bundled Care
n=20 Participants
Infants in this group had their diaper changed every 3 hours during 3-hour bundled care.
3-hour bundled care: Infants in the 3-hour bundled care group received diaper changes every 3 hours.
|
6-hour Bundled Care
n=26 Participants
Infants in this group had their diaper changed every 6 hours.
6-hour bundled care: Infants in the 6-hour bundled care group received diaper changes every 6 hours.
|
|---|---|---|
|
Estimates of Infant Buttock Transepidermal Water Loss (TEWL) by Group
|
38.48 g/m^2/h
Interval 31.93 to 45.03
|
35.73 g/m^2/h
Interval 29.67 to 41.79
|
SECONDARY outcome
Timeframe: During hospitalization, approximately four weeksPopulation: A total of 273 skin swabs from the buttocks were analyzed from infants in the 3-hr bundled care group and 255 swabs from infants in the 6-hr bundled care group. A total of 266 skin swabs from the chest were analyzed from infants in the 3-hr bundled care group and 254 swabs from infants in the 6-hr bundled care group. A total of 65 stool samples were analyzed from infants in the 3-hr bundled care group and 66 samples from infants in the 6-hr bundled care group.
The Shannon Diversity index measures the alpha diversity of a bacterial sample. Function of richness and evenness of 16S rRNA gene amplicon sequence variants (i.e., proxy for prokaryote species-like groupings) within each sample. A higher Shannon diversity means that a sample had a combination of a higher number of species of archaea and bacteria, and/or a more even relative abundance of those species within a sample.
Outcome measures
| Measure |
3-hour Bundled Care
n=604 Samples
Infants in this group had their diaper changed every 3 hours during 3-hour bundled care.
3-hour bundled care: Infants in the 3-hour bundled care group received diaper changes every 3 hours.
|
6-hour Bundled Care
n=575 Samples
Infants in this group had their diaper changed every 6 hours.
6-hour bundled care: Infants in the 6-hour bundled care group received diaper changes every 6 hours.
|
|---|---|---|
|
Microbiota Diversity of the Skin at Both the Buttocks and Chest Sites and Stool by Group
Skin-Buttocks
|
4.14 score on a scale
Standard Deviation 0.67
|
3.99 score on a scale
Standard Deviation 0.78
|
|
Microbiota Diversity of the Skin at Both the Buttocks and Chest Sites and Stool by Group
Skin-Chest
|
4.14 score on a scale
Standard Deviation 0.74
|
4.18 score on a scale
Standard Deviation 0.75
|
|
Microbiota Diversity of the Skin at Both the Buttocks and Chest Sites and Stool by Group
Stool
|
4.16 score on a scale
Standard Deviation 0.70
|
3.56 score on a scale
Standard Deviation 0.77
|
Adverse Events
3 Hour Bundled Care
6 Hour Bundled Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place