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Very Low Birth Weight Preterm Infant Bundled Care in the NICU

NCT03370757 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2024-04-19

Study results available
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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.

Conditions

  • Preterm Infants

Interventions

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.

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.

Sponsors & Collaborators

  • Kimberly-Clark Corporation

    collaborator INDUSTRY

  • Duke University

    lead OTHER

Principal Investigators

  • Debra Brandon, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-02
Primary Completion
2019-08-23
Completion
2019-08-23

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03370757 on ClinicalTrials.gov