Very Low Birth Weight Preterm Infant Bundled Care in the NICU



Status:Enrolling by invitation
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:9/8/2018
Start Date:December 11, 2017
End Date:June 2019

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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

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.

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.

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.
We found this trial at
1
site
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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from
Durham, NC
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