Clinical trial NCT03370757: Very Low Birth Weight Preterm Infant Bundled Care in the NICU
Official title: Very Low Birthweight (VLBW) Preterm Infant Skin Health With Bundled Care in the Neonatal Intensive Care Unit (NICU): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infants
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Kimberly-Clark Corporation
First posted: 2017-12-12
Enrollment: 49
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Heart Rate by Group
timeFrame: During hospitalization, approximately four weeks
Secondary outcomes:
measure: Estimates of Infant Buttock Transepidermal Water Loss (TEWL) by Group
timeFrame: During hospitalization, approximately four weeks
measure: Microbiota Diversity of the Skin at Both the Buttocks and Chest Sites and Stool by Group
timeFrame: During hospitalization, approximately four weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Debra Brandon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brandon DH, Hatch D, Barnes A, Vance AJ, Harney J, Voigtman B, Younge N. Impact of diaper change frequency on preterm infants' vital sign stability and skin health: A RCT. Early Hum Dev. 2022 Jan;164:105510. doi: 10.1016/j.earlhumdev.2021.105510. Epub 2021 Nov 20.