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Very Low Birth Weight Preterm Infant Bundled Care in the NICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03370757
Recruitment Status : Completed
First Posted : December 12, 2017
Last Update Posted : October 1, 2020
Sponsor:
Collaborator:
Kimberly-Clark Corporation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Preterm Infants Other: 3-hour bundled care Other: 6-hour bundled care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Very Low Birthweight (VLBW) Preterm Infant Skin Health With Bundled Care in the Neonatal Intensive Care Unit (NICU): A Randomized Controlled Trial
Actual Study Start Date : February 2, 2018
Actual Primary Completion Date : August 23, 2019
Actual Study Completion Date : August 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

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.




Primary Outcome Measures :
  1. Change in infants physiological stability as measured by infant vital signs [ Time Frame: 3 hours, 6 hours ]
    Vital signs will be analyzed to determine physiological stability.


Secondary Outcome Measures :
  1. Change in infant skin health as measured by transepidermal water loss (TEWL). [ Time Frame: 3 hours, 6 hours ]
    TEWL will be calculated by taking the difference between two vapor pressure gradient measures (humidity and temperature) using a DermaLab TEWL skin probe.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370757


Locations
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United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Kimberly-Clark Corporation
Investigators
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Principal Investigator: Debra Brandon, PhD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03370757    
Other Study ID Numbers: Pro00086595
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications