Very Low Birth Weight Preterm Infant Bundled Care in the NICU

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

Sponsors

Lead Sponsor: Duke University

Collaborator: Kimberly-Clark Corporation

Source Duke University
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.

Overall Status Completed
Start Date February 2, 2018
Completion Date August 23, 2019
Primary Completion Date August 23, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in infants physiological stability as measured by infant vital signs 3 hours, 6 hours
Secondary Outcome
Measure Time Frame
Change in infant skin health as measured by transepidermal water loss (TEWL). 3 hours, 6 hours
Enrollment 49
Condition
Intervention

Intervention Type: Other

Intervention Name: 3-hour bundled care

Description: 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.

Arm Group Label: 3-hour bundled care

Intervention Type: Other

Intervention Name: 6-hour bundled care

Description: 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.

Arm Group Label: 6-hour 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.

Gender: All

Minimum Age: N/A

Maximum Age: 32 Weeks

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Debra Brandon, PhD Principal Investigator Duke University
Location
Facility: Duke University
Location Countries

United States

Verification Date

April 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 3-hour bundled care

Type: Active Comparator

Description: Infants in this group will have their diaper changed every 3 hours during 3-hour bundled care.

Label: 6-hour bundled care

Type: Active Comparator

Description: Infants in this group will have their diaper changed every 6 hours.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

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

Masking: None (Open Label)

Source: ClinicalTrials.gov