Preterm Infants
Conditions
Brief summary
The purpose of this study is to explore the impact of bundling nursing care activities on the overall health of Very Low Birthweight (VLBW) preterm infants who receive bundled care in a Level IV Neonatal Intensive Care Unit (NICU). The study will evaluate differences in infant health when diaper changes occur at 3- versus 6-hours during 3-hour bundled care. Differences in infant skin health between 3- and 6-hour bundled care diapering at two sites (buttocks and chest) will also be evaluated.
Detailed description
Preterm infants' growth and developmental outcomes vary with illness severity and degree of neurological insult and unpredictable variations in outcomes exist even among healthy preterm infants. The variations in preterm infants' outcomes have led to the supposition that the neonatal intensive care unit (NICU) environment may negatively impact the health and development of these infants and significant research has been devoted to examination of light, noise, and caregiving interventions. Consequently, many NICUs have implemented neuroprotective strategies to reduce over simulation, promote sleep and facilitate brain development in high-risk infants including the grouping of care activities around a single caregiving event described as clustering or bundling care. Yet, the number and type of caregiving activities that are included in bundled care and the timeframe between bundled care events has not been systematically studied. The inclusion and exclusion of certain care activities in any individual care event is often dictated by the infant's treatment plan or needs, but some activities like diapering may be optional. Understanding the impact of when to include optional, yet stress provoking interventions, will allow us to minimize overall environmental stress in hospitalized very low birthweight (VLBW) infants. Therefore, given the lack of data around bundled care, the investigators aim to explore through a randomized controlled design the impact of bundling diaper care activities on overall health of VLBW preterm infants. The investigators will include a focus on skin health because it is important to understand the benefits of decreased infant stress and any potential skin health trade-offs associated with longer versus shorter time between diapering care. Findings from this study will allow us to better understand the relationship between neonatal skin health while providing developmentally appropriate bundled care.
Interventions
OTHER3-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.
OTHER6-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.
Sponsors
Kimberly-Clark Corporation
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Infants will be randomly assigned and stratified by birth weight (≤ 800 grams, \>800 grams to 1150 grams, \> 1150 grams) to either 3- or 6- hour bundled diaper care.
Eligibility
Sex/Gender
ALL
Age
No minimum to 32 Weeks
Healthy volunteers
No
Inclusion criteria
1. Must be participating in the Intensive Care Nursery standard 3-hour bundled care 2. Must wear a breathable diaper 3. Must be ≤ 32 weeks gestation at birth and weigh ≤ 1500g at birth. 4. Infants are expected to remain hospitalized for at least 4 weeks
Exclusion criteria
1. Neonatal Abstinence Syndrome 2. Humidified incubator 3. Diaper rash 4. Pre-existing or genetic skin conditions 5. Use of barrier creams 6. Severe illness requiring 1:1 nursing care: e.g. minimal stimulation protocol, high frequency ventilation, vasopressor drug support, or body cooling.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Heart Rate by Group | During hospitalization, approximately four weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimates of Infant Buttock Transepidermal Water Loss (TEWL) by Group | During hospitalization, approximately four weeks | TEWL 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. |
| Microbiota Diversity of the Skin at Both the Buttocks and Chest Sites and Stool by Group | During hospitalization, approximately four weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: 2/2018 - 7/2019 Location: Level IV NICU
Pre-assignment details
1 infant was consented but discharged home before being randomized because the infant never reached q3 hour feedings (discharged home on G-tube).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 26 |
| Total | 46 |
Baseline characteristics
| Characteristic | 3-hour Bundled Care | Total | 6-hour Bundled Care |
|---|---|---|---|
| Age, Customized Gestational Age at Birth | 27.6 weeks STANDARD_DEVIATION 2.8 | 28.0 weeks STANDARD_DEVIATION 2.8 | 28.4 weeks STANDARD_DEVIATION 2.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 41 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 14 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 21 Participants | 13 Participants |
| Region of Enrollment United States | 20 Participants | 46 Participants | 26 Participants |
| Sex: Female, Male Female | 7 Participants | 25 Participants | 18 Participants |
| Sex: Female, Male Male | 13 Participants | 21 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 26 |
| other Total, other adverse events | 0 / 20 | 0 / 26 |
| serious Total, serious adverse events | 0 / 20 | 0 / 26 |
Outcome results
Primary
Mean Heart Rate by Group
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.
Time frame: During hospitalization, approximately four weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3-hour Bundled Care | Mean Heart Rate by Group | 200 beats per minute | Standard Deviation 75.19 |
| 6-hour Bundled Care | Mean Heart Rate by Group | 185 beats per minute | Standard Deviation 73.41 |
Secondary
Estimates of Infant Buttock Transepidermal Water Loss (TEWL) by Group
TEWL 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.
Time frame: During hospitalization, approximately four weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 3-hour Bundled Care | Estimates of Infant Buttock Transepidermal Water Loss (TEWL) by Group | 38.48 g/m^2/h |
| 6-hour Bundled Care | Estimates of Infant Buttock Transepidermal Water Loss (TEWL) by Group | 35.73 g/m^2/h |
Secondary
Microbiota Diversity of the Skin at Both the Buttocks and Chest Sites and Stool by 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.
Time frame: During hospitalization, approximately four weeks
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 3-hour Bundled Care | 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-hour Bundled Care | 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 |
| 3-hour Bundled Care | 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 0.7 |
| 6-hour Bundled Care | Microbiota Diversity of the Skin at Both the Buttocks and Chest Sites and Stool by Group | Skin-Buttocks | 3.99 score on a scale | Standard Deviation 0.78 |
| 6-hour Bundled Care | Microbiota Diversity of the Skin at Both the Buttocks and Chest Sites and Stool by Group | Skin-Chest | 4.18 score on a scale | Standard Deviation 0.75 |
| 6-hour Bundled Care | Microbiota Diversity of the Skin at Both the Buttocks and Chest Sites and Stool by Group | Stool | 3.56 score on a scale | Standard Deviation 0.77 |