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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Infants
• Intervention / Treatment: Other: 3-hour bundled care; Other: 6-hour bundled care

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.	During hospitalization, approximately four weeks

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, Denmark). 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.	During hospitalization, approximately four weeks
Microbiota Diversity of the Skin at Both the Buttocks and Chest Sites and Stool by Group	The Shannon Diversity index measures the alpha diversity of a bacterial sample. Function of richness and evenness of 16S rRNA gene amplicon sequence variants (i.e., proxy for prokaryote species-like groupings) within each sample. A higher Shannon diversity means that a sample had a combination of a higher number of species of archaea and bacteria, and/or a more even relative abundance of those species within a sample.	During hospitalization, approximately four weeks

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Kimberly-Clark Corporation
• Investigators: Principal Investigator: Debra Brandon, PhD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2018
• Primary Completion (Actual): August 23, 2019
• Study Completion (Actual): August 23, 2019

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: Pro00086595

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No