Very Low Birth Weight Preterm Infant Bundled Care in the NICU

Duke University

Status: Completed

Conditions: Preterm Infants

Treatments: Other: 3-hour bundled care; Other: 6-hour bundled care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03370757

Pro00086595

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: Under 32 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

3-hour bundled care

Active Comparator group

Description:

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

Treatment:

Other: 3-hour bundled care

6-hour bundled care

Active Comparator group

Description:

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

Treatment:

Other: 6-hour bundled care