Very Low Birth Weight Preterm Infant Bundled Care in the NICU

Study Overview
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Brief Summary
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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
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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.

Official Title
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Very Low Birthweight (VLBW) Preterm Infant Skin Health With Bundled Care in the Neonatal Intensive Care Unit (NICU): A Randomized Controlled Trial

Conditions
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Preterm Infants

Intervention / Treatment
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* Other: 3-hour bundled care
* Other: 6-hour bundled care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be participating in the Intensive Care Nursery standard 3-hour bundled care Must wear a breathable diaper Must be ≤ 32 weeks gestation at birth and weigh ≤ 1500g at birth. Infants are expected to remain hospitalized for at least 4 weeks Exclusion Criteria: Neonatal Abstinence Syndrome Humidified incubator Diaper rash Pre-existing or genetic skin conditions Use of barrier creams Severe illness requiring 1:1 nursing care: e.g. minimal stimulation protocol, high frequency ventilation, vasopressor drug support, or body cooling.

Ages Eligible for Study
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Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3-hour bundled care<br>Infants in this group will have their diaper changed every 3 hours during 3-hour bundled care. | Other: 3-hour bundled care<br>* 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.<br>|
| Active Comparator: 6-hour bundled care<br>Infants in this group will have their diaper changed every 6 hours. | Other: 6-hour bundled care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Heart rates were averaged per group for all infants across all bundled care events. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, Dermark). 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. | TEWL estimates were calculated from all bundled care events by group. |